Trial Outcomes & Findings for A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus (NCT NCT03445065)

Results Overview

The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

239 participants

Primary outcome timeframe

Day 180

Results posted on

2021-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1, Enabled - Eversense XL CGM System Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Overall Study STARTED	97	52	62	28
Overall Study COMPLETED	90	43	57	25
Overall Study NOT COMPLETED	7	9	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1, Enabled - Eversense XL CGM System Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Overall Study Withdrawal by Subject	3	6	2	2
Overall Study Other	4	3	3	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Total n=239 Participants Total of all reporting groups
Age, Continuous	43.7 Years STANDARD_DEVIATION 13.8 • n=97 Participants	41.1 Years STANDARD_DEVIATION 13.0 • n=52 Participants	45.1 Years STANDARD_DEVIATION 14.1 • n=62 Participants	47.7 Years STANDARD_DEVIATION 12.7 • n=28 Participants	44.0 Years STANDARD_DEVIATION 13.7 • n=239 Participants
Sex: Female, Male Female	55 Participants n=97 Participants	27 Participants n=52 Participants	17 Participants n=62 Participants	8 Participants n=28 Participants	107 Participants n=239 Participants
Sex: Female, Male Male	42 Participants n=97 Participants	25 Participants n=52 Participants	45 Participants n=62 Participants	20 Participants n=28 Participants	132 Participants n=239 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Type of Diabetes Type 1 Diabetes	84 Participants n=97 Participants	46 Participants n=52 Participants	62 Participants n=62 Participants	28 Participants n=28 Participants	220 Participants n=239 Participants
Type of Diabetes Type 2 Diabetes	13 Participants n=97 Participants	6 Participants n=52 Participants	0 Participants n=62 Participants	0 Participants n=28 Participants	19 Participants n=239 Participants
Hemoglobin A1c (HbA1c, %) Levels at Baseline	9.0 HbA1c (%) STANDARD_DEVIATION 0.9 • n=97 Participants	9.1 HbA1c (%) STANDARD_DEVIATION 0.9 • n=52 Participants	7.3 HbA1c (%) STANDARD_DEVIATION 0.8 • n=62 Participants	6.9 HbA1c (%) STANDARD_DEVIATION 1.0 • n=28 Participants	8.3 HbA1c (%) STANDARD_DEVIATION 1.3 • n=239 Participants
Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 0 to Day 30	1.2 Percentage of time STANDARD_DEVIATION 1.8 • n=97 Participants	1.4 Percentage of time STANDARD_DEVIATION 2.4 • n=52 Participants	4.7 Percentage of time STANDARD_DEVIATION 4.0 • n=62 Participants	5.4 Percentage of time STANDARD_DEVIATION 4.5 • n=28 Participants	2.6 Percentage of time STANDARD_DEVIATION 3.0 • n=239 Participants

PRIMARY outcome

Timeframe: Day 180

Population: This analysis of the primary outcome measure for Cohort 1 used the Full Analysis Set Population, which included all randomized participants in Cohort 1 only with sensor inserted and at least one CGM data point available. The results for Cohort 2 are presented below as a secondary outcome measure.

The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 1: HbA1c (%) Levels at Day 180	8.8 HbA1c (%) Interval 8.5 to 9.0	—	8.6 HbA1c (%) Interval 8.4 to 8.9	—	—

PRIMARY outcome

Timeframe: From Day 90 to Day 120

Population: This analysis of the primary outcome measure for Cohort 2 used the Full Analysis Set Population, which included all randomized participants in Cohort 2 only with sensor inserted and at least one CGM data point available. The results for Cohort 1 are presented below as a secondary outcome measure.

The analysis of the primary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm spent in hypoglycemia with a blood glucose level \<54 milligrams per decilitre (mg/dL) between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120	5.7 Percentage of time Interval 4.2 to 7.1	—	4.0 Percentage of time Interval 3.0 to 5.1	—	—

SECONDARY outcome

Timeframe: At sensor insertion (Day 0)

Population: The Safety Population included participants with sensors inserted.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Itching and/or Pruritus	0 Participants	2 Participants	2 Participants	1 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Discoloration of Skin	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Hematoma Formation	2 Participants	3 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Pain and/or Burning Sensation	1 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Infection, Local or Systemic	1 Participants	1 Participants	1 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Bleeding	0 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Edema or Swelling	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Scar Formation and/or Keloid	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Skin Irritation and/or Redness	1 Participants	1 Participants	4 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Nerve Damage Causing Tingling, Numbness, Pain, or Weakness	0 Participants	0 Participants	1 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion At Least One Device Migration	0 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: At sensor removal (up to Day 180)

Population: The Safety Population included participants with sensors inserted.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Device Migration	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Infection, Local or Systemic	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Bleeding	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Edema or Swelling	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Scar Formation and/or Keloid	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Skin Irritation and/or Redness	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Nerve Damage Causing Tingling, Numbness, Pain, or Weakness	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Itching and/or Pruritus	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Discoloration of Skin	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Hematoma Formation	1 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal At Least One Pain and/or Burning Sensation	1 Participants	1 Participants	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Day 0 (Insertion) up to Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180

Population: The Safety Population included participants with sensors inserted.

An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the investigational medical device. AEs were coded using the MedDRA dictionary version 20.1. All AEs were assessed by the investigator for relation to the device, seriousness (according to serious AE criteria), and severity (i.e., intensity of the event: mild, moderate, or severe). AEs of hypoglycemia were identified using a Standardized MedDRA Query (SMQ) for a list of Preferred Terms; all terms for hypoglycemia reported in the AE forms were considered symptomatic hypoglycemia. 'Severe hypoglycemia' included all serious and severe/life-threatening events of the SMQ for hypoglycemia. Serious diabetic ketoacidosis was identified in the AE forms using a set list of MedDRA terms. Adverse device effects (ADEs) included all AEs that were pre-specified in the electronic Case Report Form (eCRF).

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Overall Number of Participants With at Least One Adverse Event At Least One AE of Symptomatic Hypoglycemia	2 Participants	4 Participants	2 Participants	2 Participants	1 Participants
Overall Number of Participants With at Least One Adverse Event At Least One AE of Severe Hypoglycemia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One AE of Serious Diabetic Ketoacidosis	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Adverse Device Effect (ADE), Collected in the eCRF	30 Participants	40 Participants	59 Participants	13 Participants	5 Participants
Overall Number of Participants With at Least One Adverse Event At Least One ADE, Reported to the Hotline	17 Participants	28 Participants	39 Participants	7 Participants	5 Participants
Overall Number of Participants With at Least One Adverse Event At Least One AE	19 Participants	25 Participants	46 Participants	9 Participants	2 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Serious AE	5 Participants	2 Participants	7 Participants	0 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Fatal AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Mild AE (Maximum Severity)	14 Participants	14 Participants	27 Participants	8 Participants	1 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Moderate AE (Maximum Severity)	8 Participants	14 Participants	28 Participants	3 Participants	1 Participants
Overall Number of Participants With at Least One Adverse Event At Least One Severe AE (Maximum Severity)	5 Participants	2 Participants	6 Participants	0 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One AE Leading to Discontinuation of Device	4 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Overall Number of Participants With at Least One Adverse Event At Least One AE Related (Possible or Probable) to Device	7 Participants	11 Participants	15 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and centre (and diabetes type for Cohort 1) as fixed classification effects and the time in euglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120	42.1 Percentage of time Interval 35.8 to 48.4	59.8 Percentage of time Interval 57.2 to 62.3	47.4 Percentage of time Interval 42.0 to 52.9	55.0 Percentage of time Interval 51.5 to 58.6	—

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120	24.0 Percentage of time Interval 19.0 to 29.1	8.5 Percentage of time Interval 6.4 to 10.6	18.5 Percentage of time Interval 14.1 to 22.9	9.5 Percentage of time Interval 6.7 to 12.4	—

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120	55.2 Percentage of time Interval 48.6 to 61.8	30.7 Percentage of time Interval 28.0 to 33.5	50.0 Percentage of time Interval 44.3 to 55.8	34.0 Percentage of time Interval 30.2 to 37.9	—

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120	2.8 Percentage of time Interval 1.7 to 3.9	9.5 Percentage of time Interval 7.9 to 11.1	2.6 Percentage of time Interval 1.6 to 3.5	11.3 Percentage of time Interval 9.1 to 13.5	—

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: The analysis of this secondary outcome measure for Cohort 1 used the Full Analysis Set Population, which included all randomized participants in Cohort 1 only with sensor inserted and at least one CGM data point available. The results for Cohort 2 are presented as a primary outcome measure.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm, center, and diabetes type as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120	1.2 Percentage of time Interval 0.5 to 1.8	—	1.1 Percentage of time Interval 0.5 to 1.6	—	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180	48.0 Percentage of time Interval 41.4 to 54.6	60.7 Percentage of time Interval 57.8 to 63.6	47.0 Percentage of time Interval 41.3 to 52.8	61.1 Percentage of time Interval 57.1 to 65.1	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>250 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180	19.4 Percentage of time Interval 14.9 to 23.9	8.7 Percentage of time Interval 6.9 to 10.4	18.5 Percentage of time Interval 14.6 to 22.5	6.3 Percentage of time Interval 3.9 to 8.8	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level \>180 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia \>180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180	49.5 Percentage of time Interval 42.5 to 56.5	30.9 Percentage of time Interval 27.6 to 34.2	50.8 Percentage of time Interval 44.7 to 56.8	27.8 Percentage of time Interval 23.3 to 32.3	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<70 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180	2.4 Percentage of time Interval 1.1 to 3.8	8.4 Percentage of time Interval 6.3 to 10.5	2.1 Percentage of time Interval 0.9 to 3.2	11.7 Percentage of time Interval 8.8 to 14.5	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL between the Day 150 and Day 180 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180	1.0 Percentage of time Interval 0.3 to 1.8	3.4 Percentage of time Interval 2.1 to 4.8	1.1 Percentage of time Interval 0.4 to 1.7	6.0 Percentage of time Interval 4.1 to 7.9	—

SECONDARY outcome

Timeframe: Day 90 to Day 120; Day 150 to Day 180

Population: The analysis included all randomized participants in the Cohort 2, Enabled arm only, with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Enabled arm of Cohort 2 spent in hypoglycemia with a blood glucose level \<54 mg/dL over two different time periods (between the Days 90-120 and Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group	3.430 Percentage of time Interval 2.469 to 4.391	—	4.232 Percentage of time Interval 3.242 to 5.222	—	—

SECONDARY outcome

Timeframe: For Cohort 2, Control arm: Day 90 to Day 120; For Cohort 2, Switch from Control to Enabled arm: Day 150 to Day 180

Population: Of the Cohort 2, Control arm participants with sensor inserted and at least one CGM data point available, only the 24 participants who switched from their usual glucose monitoring system (Days 90 to 120) to use the enabled Eversense XL CGM system (Days 150 to 180) were included in the analysis.

The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Cohort 2, Control arm spent in hypoglycemia with a blood glucose level \<54 mg/dL with a different intervention over each of the two time periods (the control period, using their usual glucose monitoring system: Days 90-120, and the enabled period, using the Eversense XL CGM system: Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=24 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=24 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System	6.263 Percentage of time Interval 2.737 to 9.788	—	5.792 Percentage of time Interval 3.672 to 7.913	—	—

SECONDARY outcome

Timeframe: From Day 90 to Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 90 to 120). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation	28.0 Coefficient of variation (%) Interval 26.0 to 30.0	35.8 Coefficient of variation (%) Interval 34.3 to 37.3	29.3 Coefficient of variation (%) Interval 27.5 to 31.1	36.3 Coefficient of variation (%) Interval 34.3 to 38.3	—

SECONDARY outcome

Timeframe: From Day 150 to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 150 to 180). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation	25.0 Coefficient of variation (%) Interval 22.6 to 27.5	34.4 Coefficient of variation (%) Interval 32.8 to 36.0	26.0 Coefficient of variation (%) Interval 23.9 to 28.1	35.1 Coefficient of variation (%) Interval 32.8 to 37.3	—

SECONDARY outcome

Timeframe: Day 120

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

The results show an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 120 visit between the Enabled and Control arms for Cohorts 1 and 2. The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
HbA1c (%) Levels at Day 120	8.7 HbA1c (%) Interval 8.4 to 9.0	7.2 HbA1c (%) Interval 7.0 to 7.3	8.6 HbA1c (%) Interval 8.4 to 8.9	7.3 HbA1c (%) Interval 7.0 to 7.5	—

SECONDARY outcome

Timeframe: Day 180

Population: This analysis of this secondary outcome measure for Cohort 2 used the Full Analysis Set Population, which included all randomized participants in Cohort 2 only with sensor inserted and at least one CGM data point available. The results for Cohort 1 are presented as a primary outcome measure.

The analysis of this secondary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm and center as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Cohort 2: HbA1c (%) Levels at Day 180	7.2 HbA1c (%) Interval 6.9 to 7.4	—	7.2 HbA1c (%) Interval 7.0 to 7.4	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 150 and Day 180

Population: Only participants with non-missing sensor data were included in this analysis.

This measure assesses sensor life by counting the number of participants with their first inserted CGM sensor still operating at 150 days and at 180 days post-insertion. The assessment was based on the lifespan of the first sensor: for example, if lifespan of the first sensor was ≥150 days and ≥180 days, then the participant was counted as having their first sensor operating at 150 days and 180 days, respectively. The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants With the First Sensor Operating at Day 150 and Day 180 Day 150	27 Participants	40 Participants	73 Participants	19 Participants	—
Number of Participants With the First Sensor Operating at Day 150 and Day 180 Day 180	10 Participants	27 Participants	38 Participants	12 Participants	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 180

Population: Only participants with non-missing sensor data were included in this analysis.

The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=61 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=96 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Mean Lifespan of the First Sensor	139.8 Days Standard Deviation 46.3	147.3 Days Standard Deviation 47.8	159.2 Days Standard Deviation 33.0	156.9 Days Standard Deviation 33.2	—

SECONDARY outcome

Timeframe: From Day 0 to Day 180

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Median Number of Sensors Used by Each Participant During the Study	1.0 Sensors per participant Interval 1.0 to 2.0	1.0 Sensors per participant Interval 1.0 to 2.0	1.0 Sensors per participant Interval 1.0 to 2.0	1.0 Sensors per participant Interval 1.0 to 2.0	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 150 and Day 180

Population: Only participants with non-missing transmitter data were included in this analysis.

This measure assesses transmitter wear time by counting the number of participants with their first CGM transmitter still operating at 150 days and at 180 days after first use. The assessment was based on the lifespan of the first transmitter: for example, if lifespan of the first transmitter was ≥150 days and ≥180 days, then the participant was counted as having their first transmitter operating at 150 days and 180 days, respectively. The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants With the First Transmitter Operating at Day 150 and Day 180 Day 150	23 Participants	0 Participants	1 Participants	3 Participants	—
Number of Participants With the First Transmitter Operating at Day 150 and Day 180 Day 180	13 Participants	0 Participants	1 Participants	3 Participants	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 180

Population: Only participants with non-missing transmitter data were included in this analysis.

The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=50 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=61 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=94 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Mean Lifespan of the First Transmitter	140.6 Days Standard Deviation 46.5	33.8 Days Standard Deviation 12.4	34.6 Days Standard Deviation 19.2	114.6 Days Standard Deviation 39.2	—

SECONDARY outcome

Timeframe: From Day 0 to Day 180

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Median Number of Transmitters Used by Each Participant During the Study	1.0 Transmitters per participant Interval 1.0 to 2.0	2.0 Transmitters per participant Interval 1.0 to 3.0	2.0 Transmitters per participant Interval 1.0 to 4.0	2.0 Transmitters per participant Interval 1.0 to 4.0	—

SECONDARY outcome

Timeframe: At Days 60, 120, and 180

Population: Only participants from the Enabled groups with non-missing assessments at Days 60, 120, and 180 were included in this analysis.

This was a descriptive analysis of the number of participants in the Eversense XL CGM System Enabled groups who accessed the various CGM application (app) pages/functions at study Days 60, 120, and 180. The data were collected in the electronic Case Report Form.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 60 - Participant uses the 'Report' function	43 Participants	—	67 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 60 - Participant uses the 'Historic of Alerts' function	44 Participants	—	75 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 60 - Participant uses the 'Log Event' function	38 Participants	—	61 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 60 - Participant uses phone to look at their glucose levels	61 Participants	—	95 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 120 - Participant uses the 'Report' function	50 Participants	—	66 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 120 - Participant uses the 'Historic of Alerts' function	40 Participants	—	74 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 120 - Participant uses the 'Log Event' function	28 Participants	—	63 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 120 - Participant uses phone to look at their glucose levels	58 Participants	—	89 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 180 - Participant uses the 'Report' function	49 Participants	—	58 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 180 - Participant uses the 'Historic of Alerts' function	46 Participants	—	61 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 180 - Participant uses the 'Log Event' function	35 Participants	—	54 Participants	—	—
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180 Day 180 - Participant uses phone to look at their glucose levels	55 Participants	—	81 Participants	—	—

SECONDARY outcome

Timeframe: From Day 0 up to Day 180

Population: Full Analysis Set Population, which included all randomized participants with sensor inserted and at least one CGM data point available.

This outcome measure is a descriptive analysis of the number of participants who were issued various types of alarms and alerts by the Eversense XL CGM System through the mobile medical application. The alarms listed in the results table are a higher level classification for the different types of alerts that immediately follow it, until the next type of alarm is listed (for example, the 'Calibration' alarm included both 'Calibrate Now' and 'Calibration Past Due' alerts). Only participants in the Enabled groups of both cohorts actually received these alarms/alerts because the CGM remained in blinded mode for participants in the Control groups.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 Alarm of Any Type	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Calibration' Alarm	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Calibrate Now' Alert	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Calibration Past Due' Alert	50 Participants	61 Participants	95 Participants	26 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Sensor Glucose' Alarm	2 Participants	61 Participants	95 Participants	22 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'High Glucose' Alert	2 Participants	61 Participants	95 Participants	22 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Low Glucose' Alert	2 Participants	61 Participants	94 Participants	22 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Out of Range High Glucose' Alert	1 Participants	47 Participants	86 Participants	8 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Out of Range Low Glucose' Alert	2 Participants	61 Participants	84 Participants	22 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Predicted High Glucose' Alert	1 Participants	39 Participants	44 Participants	8 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Predicted Low Glucose' Alert	1 Participants	38 Participants	44 Participants	8 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Rate Falling' Alert	1 Participants	27 Participants	31 Participants	6 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Rate Rising' Alert	1 Participants	27 Participants	31 Participants	6 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Sensor Glucose and Calibration' Alarm	19 Participants	18 Participants	31 Participants	10 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Sensor Check' Alert	19 Participants	18 Participants	31 Participants	10 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Sensor Related' Alarm	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'High Ambient Light Alert' Alert	40 Participants	47 Participants	84 Participants	19 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'High Sensor Temperature' Alert	1 Participants	3 Participants	1 Participants	0 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Low Sensor Temperature' Alert	4 Participants	4 Participants	7 Participants	4 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'New Sensor Detected' Alert	51 Participants	62 Participants	95 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Sensor Replacement' Alert	46 Participants	58 Participants	93 Participants	27 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'System Related' Alarm, 'Displayed on the Status Bar of the App' Alert	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Transmitter Related' Alarm	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Battery Empty' Alert	44 Participants	57 Participants	82 Participants	21 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Charge Transmitter' Alert	49 Participants	59 Participants	94 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'High Transmitter Temperature' Alert	11 Participants	16 Participants	21 Participants	4 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Transmitter Disconnect' Alert	52 Participants	62 Participants	97 Participants	28 Participants	—
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study At Least 1 'Transmitter Error' Alert	2 Participants	6 Participants	9 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction, dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment. These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180 Baseline	24.4 Score on a scale Standard Deviation 6.3	26.4 Score on a scale Standard Deviation 5.4	27.0 Score on a scale Standard Deviation 6.0	26.8 Score on a scale Standard Deviation 5.7	—
Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180 Day 60	24.3 Score on a scale Standard Deviation 5.9	27.9 Score on a scale Standard Deviation 4.9	28.3 Score on a scale Standard Deviation 5.8	24.4 Score on a scale Standard Deviation 6.1	—
Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180 Day 180	24.5 Score on a scale Standard Deviation 7.1	27.6 Score on a scale Standard Deviation 4.2	26.8 Score on a scale Standard Deviation 6.4	26.2 Score on a scale Standard Deviation 6.1	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. For the change from baseline analysis, a positive value indicates an improvement in treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180 Change from Baseline at Day 180	-0.1 Score on a scale Standard Deviation 6.6	1.3 Score on a scale Standard Deviation 4.4	-0.1 Score on a scale Standard Deviation 6.4	-0.1 Score on a scale Standard Deviation 4.8	—
Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180 Change from Baseline at Day 60	0.2 Score on a scale Standard Deviation 6.3	1.7 Score on a scale Standard Deviation 5.5	1.3 Score on a scale Standard Deviation 5.1	-1.8 Score on a scale Standard Deviation 4.1	—

SECONDARY outcome

Timeframe: Day 180

The DTSQc questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from -3 to +3). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of -18 and a maximum value of +18; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180	7.1 Score on a scale Standard Deviation 7.0	8.6 Score on a scale Standard Deviation 6.6	8.6 Score on a scale Standard Deviation 7.8	5.3 Score on a scale Standard Deviation 8.7	—

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 180

Population: Only participants with non-missing data at each timepoint were included in the analysis.

The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180 Baseline	-3.0 Score on a scale Standard Deviation 1.6	-2.7 Score on a scale Standard Deviation 1.9	-2.9 Score on a scale Standard Deviation 1.9	-1.9 Score on a scale Standard Deviation 1.4	—
Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180 Day 180	-3.2 Score on a scale Standard Deviation 2.1	-2.5 Score on a scale Standard Deviation 1.7	-2.7 Score on a scale Standard Deviation 1.9	-1.4 Score on a scale Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Baseline (Day 0) and Day 180

Population: Only participants with non-missing data at Baseline and Day 180 were included in this analysis.

The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life. For the change from baseline analysis, a positive value indicates an improvement in quality of life.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=33 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=45 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=64 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=21 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180	0.0 Score on a scale Standard Deviation 1.0	0.1 Score on a scale Standard Deviation 1.1	0.1 Score on a scale Standard Deviation 1.4	0.4 Score on a scale Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: Day 60 and Day 180

Population: The CGM-SAT questionnaire was completed only by participants in the Enabled groups in Cohorts 1 and 2. Only participants who completed at least one item at Day 60 or Day 180 were included in the analysis.

The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180 Day 60	3.0 Score on a scale Standard Deviation 0.3	—	2.9 Score on a scale Standard Deviation 0.3	—	—
The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180 Day 180	2.8 Score on a scale Standard Deviation 0.3	—	2.8 Score on a scale Standard Deviation 0.3	—	—

SECONDARY outcome

Timeframe: Day 60 and Day 180

Population: The CGM-SAT questionnaire was completed only by participants in the Enabled groups in Cohorts 1 and 2. Only participants who completed at least one item at both Days 60 and 180 were included in the analysis.

The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score (or positive change from baseline score) reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=42 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=62 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180	-0.1 Score on a scale Standard Deviation 0.2	—	-0.1 Score on a scale Standard Deviation 0.3	—	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

Population: Only participants with non-missing data at each timepoint were included in the analysis.

The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180 Day 60	3.0 Score on a scale Standard Deviation 1.2	2.6 Score on a scale Standard Deviation 1.5	2.1 Score on a scale Standard Deviation 1.0	3.0 Score on a scale Standard Deviation 2.0	—
Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180 Day 180	2.6 Score on a scale Standard Deviation 1.1	2.4 Score on a scale Standard Deviation 1.3	2.1 Score on a scale Standard Deviation 1.2	2.0 Score on a scale Standard Deviation 1.1	—
Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180 Baseline	3.1 Score on a scale Standard Deviation 1.6	2.8 Score on a scale Standard Deviation 1.2	2.4 Score on a scale Standard Deviation 1.1	2.3 Score on a scale Standard Deviation 1.0	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

Population: Only participants with non-missing data at Baseline and Day 60 or Day 180 were included in the analysis.

The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=13 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=14 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=21 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=5 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180 Change from Baseline at Day 60	0.0 Score on a scale Standard Deviation 1.2	-0.3 Score on a scale Standard Deviation 2.1	-0.2 Score on a scale Standard Deviation 0.8	0.6 Score on a scale Standard Deviation 1.4	—
Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180 Change from Baseline at Day 180	-0.6 Score on a scale Standard Deviation 1.5	-0.5 Score on a scale Standard Deviation 1.9	-0.2 Score on a scale Standard Deviation 0.9	0.0 Score on a scale Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

Population: Only participants with non-missing data at each timepoint were included in the analysis.

HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=97 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=28 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180 Baseline	21.6 Score on a scale Standard Deviation 9.4	26.6 Score on a scale Standard Deviation 14.4	21.4 Score on a scale Standard Deviation 12.0	19.0 Score on a scale Standard Deviation 7.9	—
Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180 Day 60	21.3 Score on a scale Standard Deviation 9.7	27.1 Score on a scale Standard Deviation 16.2	17.4 Score on a scale Standard Deviation 10.7	18.8 Score on a scale Standard Deviation 13.8	—
Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180 Day 180	24.4 Score on a scale Standard Deviation 6.2	28.9 Score on a scale Standard Deviation 17.0	15.4 Score on a scale Standard Deviation 11.3	14.8 Score on a scale Standard Deviation 11.4	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

Population: Only participants with non-missing data at Baseline and Day 60 or Day 180 were included in the analysis.

HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=13 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=14 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=21 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=5 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180 Change from Baseline at Day 60	-0.3 Score on a scale Standard Deviation 6.8	-1.4 Score on a scale Standard Deviation 7.2	-4.0 Score on a scale Standard Deviation 8.7	-1.4 Score on a scale Standard Deviation 6.2	—
Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180 Change from Baseline at Day 180	1.4 Score on a scale Standard Deviation 12.5	0.9 Score on a scale Standard Deviation 10.1	-5.2 Score on a scale Standard Deviation 9.8	-3.0 Score on a scale Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 60, and Day 180

Population: This analysis includes partners with non-missing data (i.e., who filled out the Partner-DDS) for each dimension. The total number of participants analyzed includes the overall number of partners of the participants who had filled out the DDS2 questionnaire.

The Partner-DDS is a 21-item self-report scale that highlights four critical dimensions of partner-related distress: "my partner's diabetes management", "how best to help", "diabetes and me", and "hypoglycemia". The scale ranges from 0 (not at all) to 4 (a great deal). The Partner-DDS yields a total diabetes distress score plus 4 subscale scores: Total Partner-DDS Score = Mean of the 21 items; My partner's diabetes management = Mean of item 3, 4, 10, 12, 14, 15 and 20; How best to help = Mean of item 2, 6, 7, 11 and 13; Diabetes and me = Mean of items 5, 8, 9, 16 and 21; Hypoglycemia = Mean of items 1, 17, 18 and 19. A lower Partner-DDS score (or a negative change from baseline score) indicates a lower level of distress.

Outcome measures

Outcome measures
Measure	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=14 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=18 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Enabled - Eversense XL CGM System n=22 Participants Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM) n=8 Participants Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 My Partner's Diabetes Management - Change from BL at Day 180	0.6 Score on a scale Standard Deviation NA Standard deviation could not be calculated using data from a single participant.	-0.3 Score on a scale Standard Deviation 0.0	-1.1 Score on a scale Standard Deviation 1.5	-0.7 Score on a scale Standard Deviation 0.2	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 How Best to Help - Change from BL at Day 60	0.9 Score on a scale Standard Deviation 0.1	0.1 Score on a scale Standard Deviation 0.4	-1.7 Score on a scale Standard Deviation 1.0	-0.2 Score on a scale Standard Deviation 0.0	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 My Partner's Diabetes Management - Change from Baseline (BL) at Day 60	0.1 Score on a scale Standard Deviation 0.7	0.1 Score on a scale Standard Deviation 0.3	0.0 Score on a scale Standard Deviation 0.4	-0.4 Score on a scale Standard Deviation 0.4	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 How Best to Help - Change from BL at Day 180	1.4 Score on a scale Standard Deviation NA Standard deviation could not be calculated using data from a single participant.	-0.8 Score on a scale Standard Deviation 0.3	-0.5 Score on a scale Standard Deviation 0.4	-0.3 Score on a scale Standard Deviation 0.1	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 Diabetes and Me - Change from BL at Day 60	0.2 Score on a scale Standard Deviation 0.3	0.1 Score on a scale Standard Deviation 0.4	-0.3 Score on a scale Standard Deviation 0.7	-0.3 Score on a scale Standard Deviation 0.4	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 Diabetes and Me - Change from BL at Day 180	0.4 Score on a scale Standard Deviation NA Standard deviation could not be calculated using data from a single participant.	-0.9 Score on a scale Standard Deviation 0.1	0.3 Score on a scale Standard Deviation 0.4	-0.5 Score on a scale Standard Deviation 0.4	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 Hypoglycemia - Change from BL at Day 60	-0.1 Score on a scale Standard Deviation 0.5	0.1 Score on a scale Standard Deviation 0.2	-0.3 Score on a scale Standard Deviation 0.0	0.5 Score on a scale Standard Deviation 1.1	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 Hypoglycemia - Change from BL at Day 180	0.0 Score on a scale Standard Deviation NA Standard deviation could not be calculated using data from a single participant.	0.4 Score on a scale Standard Deviation 0.9	0.6 Score on a scale Standard Deviation 1.2	-0.3 Score on a scale Standard Deviation 0.4	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 PDDS Score - Change from BL at Day 60	0.3 Score on a scale Standard Deviation 0.1	0.1 Score on a scale Standard Deviation 0.3	-0.5 Score on a scale Standard Deviation 0.3	-0.2 Score on a scale Standard Deviation 0.2	—
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180 PDDS Score - Change from BL at Day 180	0.6 Score on a scale Standard Deviation NA Standard deviation could not be calculated using data from a single participant.	-0.4 Score on a scale Standard Deviation 0.2	-0.3 Score on a scale Standard Deviation 0.9	-0.5 Score on a scale Standard Deviation 0.1	—

Adverse Events

Cohort 1, Enabled - Eversense XL CGM System

Serious events: 7 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2, Enabled - Eversense XL CGM System

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1, Enabled - Eversense XL CGM System n=97 participants at risk Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 participants at risk Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) n=28 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. From Day 0 to 120, those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System n=28 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.1% 2/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Nervous system disorders Hypoglycaemic coma	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Nervous system disorders Neuritis	1.0% 1/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Nervous system disorders Optic neuritis	1.0% 1/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Eye disorders Retinopathy proliferative	1.0% 1/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Musculoskeletal and connective tissue disorders Polyarthritis	1.0% 1/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.0% 1/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Psychiatric disorders Burnout syndrome	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Renal and urinary disorders Acute kidney injury	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Renal and urinary disorders Renal failure	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Psychiatric disorders Anxiety	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.6% 1/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.6% 1/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	0.00% 0/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180

Other adverse events

Other adverse events
Measure	Cohort 1, Enabled - Eversense XL CGM System n=97 participants at risk Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM) n=52 participants at risk Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Enabled - Eversense XL CGM System n=62 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.	Cohort 2, Control (Day 0 to 120) - Usual Glucose Monitoring System (SMBG or FGM) n=28 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. From Day 0 to 120, those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.	Cohort 2, Control (Day 120 to 180) - Eversense XL CGM System or Usual Glucose Monitoring System n=28 participants at risk Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. At Day 120, participants in this Cohort 2 Control group had the opportunity to switch to have the CGM system enabled until the end of the study (Day 180).
Metabolism and nutrition disorders Hypoglycaemia	2.1% 2/97 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	1.9% 1/52 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	6.5% 4/62 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	3.6% 1/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180	3.6% 1/28 • From Day 0 (sensor insertion) until Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER