Trial Outcomes & Findings for Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation (NCT NCT04877730)

NCT ID: NCT04877730

Last Updated: 2024-05-23

Results Overview

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: The 5 hour period following breakfast during the study admission
• Results posted on: 2024-05-23

Participant Flow

50 participants signed informed consent between May 2021 and March 2022. Four did not pass screening and ten participants withdrew prior to randomization. Thirty-six were randomized and the trial was completed by 35 (97%) participants; one participant was excluded after randomization.

A minimum of 14 days of CGM and pump information were required for analysis of baseline glycemic control, meal patterns, and insulin use. For participants already using a Dexcom G6, retrospective data prior to enrollment could be used. Participants not using a Dexcom G6 CGM were trained and sent equipment for a minimum 30 days of data prior to study admission. Participants were asked to keep daily meal records to determine the "expected" timing of breakfast and dinner for the admission.

Participant milestones

Measure	Fully Closed Loop (FCL) , Fully Closed Loop With Meal Anticipation (FCL+), Hybrid Closed Loop (HCL) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: FCL, FCL+, HCL. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus.	FCL (Fully Closed Loop), HCL (Hybrid Closed Loop), FCL+ (Fully Closed Loop With Meal Anticipation) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: FCL, HCL, FCL+. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus.	FCL+ (Fully Closed Loop With Meal Anticipation), FCL (Fully Closed Loop), HCL (Hybrid Closed Loop) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: FCL+, FCL, HCL. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus.	FCL+ (Fully Closed Loop With Meal Anticipation), HCL(Hybrid Closed Loop), FCL(Fully Closed Loop) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: FCL+, HCL, FCL. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus.	HCL (Hybrid Closed Loop), FCL (Fully Closed Loop), FCL+ (Fully Closed Loop With Meal Anticipation) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: HCL, FCL, FCL+. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus.	HCL (Hybrid Closed Loop), FCL+ (Fully Closed Loop With Meal Anticipation), FCL(Fully Closed Loop) Participants completed three 24 hour sequential assessments of the closed loop control modalities in randomized order in a supervised hotel environment. At the end of each 24-hour period participants were transferred to the next controller modalities following the randomization order. The three 24-hour study periods were designed to be as similar as possible with respect to the timing and content of food and activity. On each day, participants ate dinner 1.5 hours after the "expected" time from the Baseline analysis and ate breakfast at the "expected" time. Lunch was at 13:00. On the HCL day, participants informed the control system of the carbohydrates they intended to eat prior to the meal. On FCL and FCL+ days, no manual bolus was given at mealtimes. A mid-afternoon snack of carbohydrate-free food (deli meat and/or cheese) was provided at 4 pm if desired (and repeated every day if taken). At 10:30 a.m. for each study period, participants together went on a light walk for 25 minutes. Participants in this group completed the three 24 hour admissions in the following order: HCL, FCL+, FCL. Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus. Fully Closed Loop with meal anticipation module (FCL+): Closed-loop control with meal anticipation module without meal bolus. Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus.
Overall Study STARTED	5	7	7	8	4	5
Overall Study COMPLETED	5	6	7	8	4	5
Overall Study NOT COMPLETED	0	1	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

Baseline characteristics by cohort

Measure	All Participants n=35 Participants Baseline characteristics of all study participants regardless of randomization.
Age, Continuous	44.5 years STANDARD_DEVIATION 15.4 • n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	32 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
HbA1c	6.7 percentage of glycated hemoglobin STANDARD_DEVIATION 0.9 • n=93 Participants
Diabetes duration (years)	26 years STANDARD_DEVIATION 14 • n=93 Participants
Body mass index (BMI)	28.6 kg/m^2 STANDARD_DEVIATION 5.3 • n=93 Participants
Previous CGM users	34 Participants n=93 Participants

PRIMARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following breakfast. Higher TIR is a positive outcome.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Range (TIR) 70-180 mg/dL From Breakfast Time + 5 Hours	58 percentage of time Standard Deviation 21	63 percentage of time Standard Deviation 19	75 percentage of time Standard Deviation 23

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) during the 24hr study admission. Higher TIR is a positive outcome.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Range (TIR) 70-180 mg/dL Overall	77 percentage of time Standard Deviation 11	77 percentage of time Standard Deviation 12	86 percentage of time Standard Deviation 10

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following dinner. Higher TIR is a positive outcome.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Range (TIR) 70-180 mg/dL From Dinner Time + 5 Hours	72 percentage of time Standard Deviation 29	71 percentage of time Standard Deviation 34	88 percentage of time Standard Deviation 20

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Frequency of CGM values falling between 70 mg/dL and 180mg/dL (included) in the 5 hours following lunch. Higher TIR is a positive outcome.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Range (TIR) 70-180 mg/dL From Lunch Time + 5 Hours	65 percentage of time Standard Deviation 28	61 percentage of time Standard Deviation 29	84 percentage of time Standard Deviation 22

SECONDARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following breakfast.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Below Range (TBR) From Breakfast Time + 5 Hours	0 percentage of time Interval 0.0 to 4.4	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Frequency of CGM values falling below 70 mg/dL (excluded) during the 24hr study admission.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Below Range (TBR) Overall	1.4 percentage of time Interval 0.0 to 4.5	0.3 percentage of time Interval 0.0 to 1.9	1.0 percentage of time Interval 0.0 to 3.5

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following dinner.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Below Range (TBR) From Dinner Time + 5 Hours	0 percentage of time Interval 0.0 to 0.8	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 1.7

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Frequency of CGM values falling below 70 mg/dL (excluded) in the 5 hours following lunch.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Below Range (TBR) From Lunch Time + 5 Hours	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following breakfast.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Above Range (TAR) From Breakfast Time + 5 Hours	39 percentage of time Standard Deviation 21	34 percentage of time Standard Deviation 20	22 percentage of time Standard Deviation 24

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Frequency of CGM values falling above 180 mg/dL (excluded) during the 24hr study admission.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Above Range (TAR) Overall	20 percentage of time Standard Deviation 11	21 percentage of time Standard Deviation 12	12 percentage of time Standard Deviation 10

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following dinner.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Above Range (TAR) From Dinner Time + 5 Hours	26 percentage of time Standard Deviation 29	29 percentage of time Standard Deviation 34	9.6 percentage of time Standard Deviation 20

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Frequency of CGM values falling above 180 mg/dL (excluded) in the 5 hours following lunch.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time Above Range (TAR) From Lunch Time + 5 Hours	33 percentage of time Standard Deviation 28	38 percentage of time Standard Deviation 29	15 percentage of time Standard Deviation 21

SECONDARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following breakfast.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hyperglycemia From Breakfast Time + 5 Hours	0 percentage of time Interval 0.0 to 9.5	0 percentage of time Interval 0.0 to 1.9	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Frequency of CGM values falling above 250 mg/dL (excluded) during the 24hr study admission.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hyperglycemia Overall	1 percentage of time Interval 0.0 to 4.2	0 percentage of time Interval 0.0 to 5.6	0 percentage of time Interval 0.0 to 3.5

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following dinner.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hyperglycemia From Dinner Time + 5 Hours	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Frequency of CGM values falling above 250 mg/dL (excluded) in the 5 hours following lunch.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hyperglycemia From Lunch Time + 5 Hours	0 percentage of time Interval 0.0 to 1.82	0 percentage of time Interval 0.0 to 14.64	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following breakfast.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hypoglycemia From Breakfast Time +5 Hours	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Frequency of CGM values falling below 54 mg/dL (excluded) during the 24hr study admission.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hypoglycemia Overall	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following dinner.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hypoglycemia Dinner Time + 5 Hours	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Frequency of CGM values falling below 54 mg/dL (excluded) in the 5 hours following lunch

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Time in Significant Hypoglycemia Lunch Time + 5 Hours	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0	0 percentage of time Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following breakfast during the study admission

Number of hypoglycemia events in the 5 hours following breakfast. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Metrics are number of hypoglycemia events per participant.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Number of Hypoglycemia Events From Breakfast Time + 5 Hours	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Number of hypoglycemia events during the 24hr study admission. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Number of Hypoglycemia Events Overall	0 events per participant Interval 0.0 to 1.5	0 events per participant Interval 0.0 to 1.0	0 events per participant Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: The 5 hour period following dinner during the study admission

Number of hypoglycemia events in the 5 hours following dinner. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one). Values reported as the number of hypoglycemia events per participant.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Number of Hypoglycemia Events Dinner Time + 5 Hours	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 5 hour period following lunch during the study admission

Number of hypoglycemia events in the 5 hours following lunch. A hypoglycemia event is defined as at least two consecutive CGM values <70mg/dL or a hypoglycemia treatment (two events separated by less than 30 minutes are counted as one).

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Number of Hypoglycemia Events Lunch Time + 5 Hours	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0	0 events per participant Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: The 7 hour period including the two hours before and the 5 hours after breakfast

Sum of all system provided insulin for breakfast (as planned) post-prandial excursion, including anticipation

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Breakfast	0.14 units of insulin / kg Standard Deviation 0.05	0.14 units of insulin / kg Standard Deviation 0.06	0.18 units of insulin / kg Standard Deviation 0.10

SECONDARY outcome

Timeframe: The 24 hour study admission from 4pm to 4pm

Calculation of all system-provided insulin (units/kg) injected during the 24hr study admission.

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Units of Insulin Injected (Units/kg) Overall	0.5 units of insulin / kg Standard Deviation 0.2	0.5 units of insulin / kg Standard Deviation 0.2	0.6 units of insulin / kg Standard Deviation 0.25

SECONDARY outcome

Timeframe: The 7 hour period including the 2 hours before and 5 hours after dinner

Sum of all system provided insulin for dinner (late) post-prandial excursion, including anticipation

Outcome measures

Measure	FCL (Fully Closed Loop) n=35 Participants Closed-loop control without meal anticipation module without meal bolus	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 Participants Closed-loop control with meal anticipation module without meal bolus	HCL (Hybrid Closed Loop) n=35 Participants Closed-loop control without meal anticipation module with meal bolus
Units of Insulin Injected Between 2 Hours Before and 5 Hours After Dinner	0.02 units of insulin / kg Standard Deviation 0.03	0.03 units of insulin / kg Standard Deviation 0.02	0.02 units of insulin / kg Standard Deviation 0.02

Adverse Events

Fully Closed Loop (FCL)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

FCL+ (Fully Closed Loop With Meal Anticipation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HCL (Hybrid Closed Loop)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fully Closed Loop (FCL) n=36 participants at risk Fully Closed Loop (FCL): Closed-loop control without meal anticipation module without meal bolus. Fully Closed Loop with meal anticipation module.	FCL+ (Fully Closed Loop With Meal Anticipation) n=35 participants at risk (FCL+): Closed-loop control with meal anticipation module without meal bolus.	HCL (Hybrid Closed Loop) n=35 participants at risk Hybrid Closed Loop (HCL): Closed-loop control without meal anticipation module with meal bolus.
Endocrine disorders Persistent hyperglycemia and ketonemia	2.8% 1/36 • Number of events 1 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.	0.00% 0/35 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.	0.00% 0/35 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.
Gastrointestinal disorders Emesis followed by ketonemia	0.00% 0/36 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.	0.00% 0/35 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.	2.9% 1/35 • Number of events 1 • The AE data were reported in randomized participants for the remaining duration of their participation in the trial (up to approximately 2 weeks from randomization). 1 participant was randomized and started the trial in FCL phase but was withdrawn due to an AE and did not start the FCL+ or HCL phase.

Additional Information

Sue Brown

University of Virginia

Phone: 434-982-0602

Email: sab2f@virginia.edu

Results disclosure agreements

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