Trial Outcomes & Findings for Post Approval Study of the Eversense® Continuous Glucose Monitoring (NCT NCT03908125)

NCT ID: NCT03908125

Last Updated: 2025-06-12

Results Overview

The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 273 participants
• Primary outcome timeframe: up to 27 months
• Results posted on: 2025-06-12

Participant Flow

Participant milestones

Measure	Continuous Glucose Monitoring Device Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Overall Study STARTED	273
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	100

Reasons for withdrawal

Measure	Continuous Glucose Monitoring Device Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Overall Study Withdrawal by Subject	92
Overall Study Lost to Follow-up	8

Baseline Characteristics

Post Approval Study of the Eversense® Continuous Glucose Monitoring

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Age, Continuous	44.7 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	259 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants
Race (NIH/OMB) White	235 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	273 participants n=5 Participants
Diabetes Type Type 1	218 Participants n=5 Participants
Diabetes Type Type 2	55 Participants n=5 Participants
Years Since Diabetes Diagnosis	19 years STANDARD_DEVIATION 13 • n=5 Participants
CGM Naive	71 Participants n=5 Participants
Diabetes Therapy Regimen Non-insulin medications,basal insulin, lifestyle	10 Participants n=5 Participants
Diabetes Therapy Regimen Intensive insulin therapy	263 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 27 months

The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of < 4%.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1528 Sensor cycle Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. Infection	5 Sensor cycle
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. Secondary procedure to remove sensor	24 Sensor cycle
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. Procedure-related adverse event of at least moderate severity	15 Sensor cycle

PRIMARY outcome

Timeframe: Baseline and Month 12

The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. Baseline	62.9 % time in range Standard Deviation 18.3
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. Month 12	62.4 % time in range Standard Deviation 20.1

SECONDARY outcome

Timeframe: up to 27 months

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1448 sensors Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
The Additional Effectiveness Endpoint of Average Hours of Use Per Day	19 Daily use [hours] Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline, Month 6, Month 12, Month 18, and Month 24

Population: Change in HbA1c from Baseline at 6-Month Intervals. Window for 6, 12, and 18-month intervals was ± 30 days. Window for 24-month interval was -30 days to anything greater than 24 months.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline 24-month	0.06 percentage of HbA1c Standard Deviation 1.31
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline Baseline	0 percentage of HbA1c Standard Deviation 0
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline 6-month	-0.16 percentage of HbA1c Standard Deviation 1.04
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline 12-month	-0.14 percentage of HbA1c Standard Deviation 0.96
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline 18-month	-0.10 percentage of HbA1c Standard Deviation 0.96

SECONDARY outcome

Timeframe: up to 27 months

CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Patient Satisfaction With CGM System Use (CGM-SAT Scale) Day 180	4.0 score on a scale Standard Deviation 0.5
Patient Satisfaction With CGM System Use (CGM-SAT Scale) Day 360	4.1 score on a scale Standard Deviation 0.5
Patient Satisfaction With CGM System Use (CGM-SAT Scale) Day 720	4.1 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Screening, Day 180, Day 360, and Day 720

The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Patient Reported Diabetes Distress Scale (DDS) Screening	1.9 score on a scale Standard Deviation 0.8
Patient Reported Diabetes Distress Scale (DDS) Day 180	1.7 score on a scale Standard Deviation 0.7
Patient Reported Diabetes Distress Scale (DDS) Day 360	1.7 score on a scale Standard Deviation 0.7
Patient Reported Diabetes Distress Scale (DDS) Day 720	1.7 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: up to 27 months

Population: The number analyzed in the first 2 rows are the subsets of the overall insertions based on HCP experience.

Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1528 sensor insertions Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Success Rate of Insertion Procedures: Overall and by HCP Experience First 3 procedures	100 percentage of successful insertion
Success Rate of Insertion Procedures: Overall and by HCP Experience >3 procedures done	99.8 percentage of successful insertion
Success Rate of Insertion Procedures: Overall and by HCP Experience Overall	99.8 percentage of successful insertion

SECONDARY outcome

Timeframe: up to 27 months

Population: The number analyzed in the first 2 rows are the subsets of the overall removals based on HCP experience.

Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1517 sensor removals Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Success Rate of Removal Procedures: Overall and by HCP Experience First 3 procedures	96.1 percentage of successful removals
Success Rate of Removal Procedures: Overall and by HCP Experience >3 procedures done	98.7 percentage of successful removals
Success Rate of Removal Procedures: Overall and by HCP Experience Overall	98.4 percentage of successful removals

SECONDARY outcome

Timeframe: up to 27 months

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1528 insertions Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Rate of Insertion Procedures With Serious Adverse Events	1 insertions

SECONDARY outcome

Timeframe: up to 27 months

Outcome measures

Measure	Continuous Glucose Monitoring Device n=1517 removals Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Rate of Removal Procedures With Serious Adverse Events	0 removals

SECONDARY outcome

Timeframe: up to 27 Months

The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
HCP Feedback Questionnaire Regarding Insertion The insertion procedure was easy	1.1 score on a scale Standard Deviation 0.4
HCP Feedback Questionnaire Regarding Insertion The labeling for use of the blunt dissector and the insertion tool are easy to understand	1.1 score on a scale Standard Deviation 0.4
HCP Feedback Questionnaire Regarding Insertion The blunt dissector and insertion tool are easy to use	1.1 score on a scale Standard Deviation 0.3
HCP Feedback Questionnaire Regarding Insertion The training was reflective of what I encountered during the insertion procedure	1.2 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: up to 27 Months

The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
HCP Feedback Questionnaire Regarding Removal The removal procedure was easy	1.5 score on a scale Standard Deviation 0.8
HCP Feedback Questionnaire Regarding Removal The instructions and labeling for the removal were easy to understand	1.2 score on a scale Standard Deviation 0.5
HCP Feedback Questionnaire Regarding Removal The clamp was easy to use to remove the sensor	1.5 score on a scale Standard Deviation 0.7
HCP Feedback Questionnaire Regarding Removal The training was reflective of what I encountered during the removal procedure	1.4 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: up to 27 months

The residual dexamethasone (DXA) content in Sensors was analyzed after removal.

Outcome measures

Measure	Continuous Glucose Monitoring Device n=273 Participants Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Residual Dexamethasone Level in Explanted Sensors	82.5 percentage of residual DXA Standard Deviation 5.2

Adverse Events

Continuous Glucose Monitoring Device

Serious events: 21 serious events

Other events: 115 other events

Deaths: 0 deaths

Serious adverse events

Measure	Continuous Glucose Monitoring Device n=273 participants at risk Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Psychiatric disorders Depression requiring hospitalization	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Appendicitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Fracture of tibia and fibula	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hypoglycemic episode	1.8% 5/273 • Number of events 8 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hypoglycemia w/acute metabolic encephalopathy	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Acute stroke with ataxia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Diabetic Ketoacidosis	1.5% 4/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Cellulitis, bilateral lower extremity	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Foot infection, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Congestive heart failure exacerbation	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Subdural hemorrhage	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Subarachnoid hemorrhage	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders COVID-19 infection	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Renal and urinary disorders Acute renal failure	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Acute on chronic systolic heart failure	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hyperglycemic hyperosmolar nonketotic	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Infections and infestations Sepsis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Infections and infestations Infection, Sensor insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Myxedema crisis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.

Other adverse events

Measure	Continuous Glucose Monitoring Device n=273 participants at risk Eversense® CGM system: Continuous Glucose monitoring device that lasts up to 90 days
Musculoskeletal and connective tissue disorders Tennis elbow, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Thrombophlebitis, superficial, right arm	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Thumb fracture, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Abdominal pain, gastritis, constipation	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Abdominal pain, post-operative	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Abscess, right buttock	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Adhesive capsulitis	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Anemia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Ankle sprain, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Ataxia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Atrial fibrillation	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Axillary swelling, post insertion	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bicep tear, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Bilateral Corneal Abrasions	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bilateral Thumb Pain	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Bleeding, insertion site	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Blepharitis, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Blister, foot	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Blistering, sensor insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Bruise, sensor insertion site	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bump on left wrist	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bursitis, bilateral shoulders	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bursitis, left knee	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bursitis, left olecranon	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bursitis, shoulder, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Bursitis, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Cataracts, left eye	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Cellulitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Cellulitis, insertion site post removal	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Cellulitis, insulin pump site, left hip	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Cellulitis, left elbow	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Cholelithiasis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Renal and urinary disorders Chronic Kidney Disease	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Cold sweat	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Concussion	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Congestion	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Congestive heart failure	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Contusion, left knee	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Contusion, left shoulder	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Coronary Artery Disease	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders COVID-19	6.2% 17/273 • Number of events 19 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Cracked tooth requiring extraction	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Deep venous thrombosis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Psychiatric disorders Depression	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Dermatitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Dermatitis, adhesive patch location	0.73% 2/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Dermatitis, due to dermabond	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Diabetic neuropathy, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Diabetic retinopathy	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Diaphoresis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Diarrhea	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Diverticulitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Dizziness	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Dry eye syndrome	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Dry eyes	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Dyspepsia	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Reproductive system and breast disorders Dysuria	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Ear and labyrinth disorders Ear Infection	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Edema, bilateral lower extremities	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Elbow fracture, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Elbow fracture, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Erythema, adhesive patch location	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Erythema, sensor insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Fall with nasal fracture	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Fatty liver	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Fecal impaction	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Frozen shoulder, right	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Gastroenteritis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders GERD	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Head inury	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Headache/Migraine	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Headaches	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Heel pain	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Hepatitis A exposure	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Herpes Zoster infection	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Herpes zoster, eyelid	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Metabolism and nutrition disorders Hyperlipidemia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hyperlipidemia, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Hypersomnia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Hypertension	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Hypertension, worsening	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hypoglycemia	1.1% 3/273 • Number of events 7 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Hypothyroidism, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Impetigo	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Infection, left eye	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Infection, sensor insertion site	1.5% 4/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Influenza	1.5% 4/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Insomnia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Ischemia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Laceration, chin	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Laceration, upper lip	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Laryngeal papilloma, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Laryngitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Lateral Epicondylitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Left jaw nodule	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Left Knee Pain	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Lightheadedness	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Lipoma, paraspinal	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Lower extremity edema, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract infection, viral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Lumbago exacerbation	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Macular edema, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Marginal ulcer	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Meniscal tear	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Reproductive system and breast disorders Menorragia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Psychiatric disorders Mild Depression	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Muscle strain, lower back	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Metabolism and nutrition disorders Muscle strain, ribcage	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Nasal fracture	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Nausea	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Nausea and diarrhea, due to Covid-19	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnea	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Onchomycosis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Onychocryptosis, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Surgical and medical procedures Oral surgery	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Orthostatic hypotension	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Osteoarthritis, right knee	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Osteoarthritis, spine	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Osteopenia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Ear and labyrinth disorders Otitis Media	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Pain, sensor location	1.8% 5/273 • Number of events 5 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Pain, sensor insertion site	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Pain, sensor removal site	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Psychiatric disorders Panic attack	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Paroxysmal Supraventricular Tachycardia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Patellar fracture, closed, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Pedal edema, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Reproductive system and breast disorders Penile discharge	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Pharyngitis	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Phlebitis, superficial, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Plantar fascitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Possible rabies exposure	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Proliferative Retinopathy requiring Rx	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Prolonged wound healing	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Prolonged wound healing, removal site	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Pruritis	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Pruritis, adhesive patch location	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Pruritis, insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Psoriatric arthritis, worsening	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary nodule	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Radiculopathy, cervical	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Rash, axilla and trunk	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Rash, insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Rash, lower extremities	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Rash, pruritic	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Respiratory infection due to Covid-19	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Restless arm syndrome	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Retinal tear, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Retinopathy, proliferative, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders RLS, worsened	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Scar, removal site	1.1% 3/273 • Number of events 3 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Scarring, insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Sciatica	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Product Issues Sensor broke during removal	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Sensor Location Site - Redness	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Sensory deficit, left heel	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Seroma, post surgical	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Sinus infection	2.2% 6/273 • Number of events 6 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin atrophy, sensor site	1.5% 4/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin depigmentation and atrophy	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin discoloration, sensor site	1.8% 5/273 • Number of events 6 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin irritation	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin irritation, adhesive patch location	1.5% 4/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin irritation, sensor insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Skin irritation, sensor removal site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Sleep disturbance	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Sprain, left ankle	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Sprain, neck and back	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Squamous Cell Carcinoma	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Strep throat	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Swelling, incision site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Skin and subcutaneous tissue disorders Swelling, insertion site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Swelling, right foot	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Symptomatic Hyperglycemia	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Tendonitis, finger	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Ear and labyrinth disorders Tinnitus	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Toe fractures, right	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Tooth fracture	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
General disorders Tooth infection	1.1% 3/273 • Number of events 4 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Torn meniscus, left	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Torn meniscus, right knee	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Gastrointestinal disorders Transaminitis	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Tremor, right hand	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Surgical and medical procedures Unable to remove sensor on first attempt	7.3% 20/273 • Number of events 22 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Cardiac disorders Unstable angina	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	2.9% 8/273 • Number of events 11 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Renal and urinary disorders Urinary tract infection	1.5% 4/273 • Number of events 5 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Varicose veins, bilateral	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Vasovagal episode	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Vascular disorders Venous insufficiency	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Immune system disorders Vibrating sensation at removal site	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Endocrine disorders Vitamin D deficiency	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Vitreous detachment, right eye	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Eye disorders Vitreous syneresis, left eye	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Nervous system disorders Weakness, right arm	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Musculoskeletal and connective tissue disorders Wrist fracture, left	0.73% 2/273 • Number of events 2 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.
Reproductive system and breast disorders Yeast infection, vaginal	0.37% 1/273 • Number of events 1 • Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members. The reported adverse events are reported by number of sensor insertion cycles.

Additional Information

Sr. Director of Clinical Operations

Senseonics, Inc.

Phone: 301-407-2946

Email: Kathleen.Davis@senseonics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60