Trial Outcomes & Findings for The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas (NCT NCT02105324)

NCT ID: NCT02105324

Last Updated: 2017-10-20

Results Overview

Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Days 2 to 5 of each period
• Results posted on: 2017-10-20

Participant Flow

Participant milestones

Measure	Bionic Pancreas Then Usual Care Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days in Period 1, followed by Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 2. There was a 3-day washout period between periods.	Usual Care Then Bionic Pancreas Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days in Period 1, followed by Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a CGM device, for 5 days in Period 2. There was a 3-day washout period between periods.
Period 1 STARTED	9	10
Period 1 COMPLETED	9	10
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	9	10
Period 2 COMPLETED	9	10
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

Baseline characteristics by cohort

Measure	All Randomized Participants n=19 Participants All randomized participants who completed both periods of the study.
Age, Categorical <=18 years	19 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9.8 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5	136.8 milligrams/deciliter (mg/dL) Standard Deviation 10.8	167.4 milligrams/deciliter (mg/dL) Standard Deviation 30.6

PRIMARY outcome

Timeframe: Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5	1.2 percentage of time Standard Deviation 1.1	2.8 percentage of time Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 1 and Days 1-5 in each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Mean CGMG Values Day 1	153.6 mg/dL Standard Deviation 19.7	179.2 mg/dL Standard Deviation 37.8
Mean CGMG Values Days 1 to 5	140.6 mg/dL Standard Deviation 12.0	169.9 mg/dL Standard Deviation 27.6

SECONDARY outcome

Timeframe: Day 1 of each period

Population: All randomized participants who completed both periods of the study.

Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8 mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With CGMG Concentration by Ranges During Day 1 < 50 mg/dL (2.8 mmol/L)	0.2 percentage of time Standard Deviation 0.6	1.0 percentage of time Standard Deviation 2.6
Percentage of Time With CGMG Concentration by Ranges During Day 1 < 70 mg/dL (3.9 mmol/L)	1.8 percentage of time Standard Deviation 2.0	3.7 percentage of time Standard Deviation 4.5
Percentage of Time With CGMG Concentration by Ranges During Day 1 70-180 mg/dL (3.9 to 10.0 mmol/L)	71.6 percentage of time Standard Deviation 11.7	52.1 percentage of time Standard Deviation 21.3
Percentage of Time With CGMG Concentration by Ranges During Day 1 > 180 mg/dL (10.0 mmol/L)	26.6 percentage of time Standard Deviation 11.3	44.2 percentage of time Standard Deviation 23.4

SECONDARY outcome

Timeframe: Days 1 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 < 50 mg/dl (2.8 mmol/L)	0.4 percentage of time Standard Deviation 0.4	1.1 percentage of time Standard Deviation 0.8
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 < 70 mg/dl (3.9 mmol/L)	2.7 percentage of time Standard Deviation 1.8	5.6 percentage of time Standard Deviation 2.5
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 70-180 mg/dl (3.9 to 10.0 mmol/L)	78.8 percentage of time Standard Deviation 7.4	56.5 percentage of time Standard Deviation 13.9
Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5 > 180 mg/dL (10.0 mmol/L)	18.5 percentage of time Standard Deviation 6.6	37.9 percentage of time Standard Deviation 15.4

SECONDARY outcome

Timeframe: Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 < 50 mg/dl (2.8 mmol/L)	0.4 percentage of time Standard Deviation 0.5	1.1 percentage of time Standard Deviation 0.8
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 < 70 mg/dl (3.9 mmol/L)	2.9 percentage of time Standard Deviation 2.1	6.1 percentage of time Standard Deviation 2.8
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 70-180 mg/dl (3.9 to 10.0 mmol/L)	80.6 percentage of time Standard Deviation 7.4	57.6 percentage of time Standard Deviation 14.0
Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5 > 180 mg/dL (10.0 mmol/L)	16.5 percentage of time Standard Deviation 6.4	36.3 percentage of time Standard Deviation 15.7

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean CGMG Glucose <154 mg/dL Day 1	57.9 percentage of participants	15.8 percentage of participants
Percentage of Participants With Mean CGMG Glucose <154 mg/dL Days 1 to 5	84.2 percentage of participants	36.8 percentage of participants
Percentage of Participants With Mean CGMG Glucose <154 mg/dL Days 2 to 5	94.7 percentage of participants	42.1 percentage of participants

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean CGMG Glucose <169 mg/dL Day 1	89.5 percentage of participants	36.8 percentage of participants
Percentage of Participants With Mean CGMG Glucose <169 mg/dL Days 1 to 5	94.7 percentage of participants	57.9 percentage of participants
Percentage of Participants With Mean CGMG Glucose <169 mg/dL Days 2 to 5	100 percentage of participants	68.4 percentage of participants

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All randomized participants who completed both periods of the study.

Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean CGMG Glucose <183 mg/dL Day 1	89.5 percentage of participants	57.9 percentage of participants
Percentage of Participants With Mean CGMG Glucose <183 mg/dL Days 1 to 5	100 percentage of participants	68.4 percentage of participants
Percentage of Participants With Mean CGMG Glucose <183 mg/dL Days 2 to 5	100 percentage of participants	73.7 percentage of participants

SECONDARY outcome

Timeframe: Days 1-5

A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <70 mg/dl	9.4 times below threshold Standard Deviation 5.8	9.4 times below threshold Standard Deviation 5.1
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <60 mg/dl	4.4 times below threshold Standard Deviation 3.3	6.3 times below threshold Standard Deviation 3.0
Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <50 mg/dl	1.9 times below threshold Standard Deviation 1.9	3.1 times below threshold Standard Deviation 2.1

SECONDARY outcome

Timeframe: Day 1, Days 1 to 5, and Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Mean Plasma Glucose Values Day 1	137.2 mg/dL Standard Deviation 20.1	169.7 mg/dL Standard Deviation 32.2
Mean Plasma Glucose Values Days 1 to 5	136.8 mg/dL Standard Deviation 7.2	176.4 mg/dL Standard Deviation 25.2
Mean Plasma Glucose Values Days 2 to 5	135.8 mg/dL Standard Deviation 5.4	178.8 mg/dL Standard Deviation 27.4

SECONDARY outcome

Timeframe: Day 1 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With Plasma Glucose Values by Ranges on Day 1 < 60 mg/dL (3.3 mmol/L)	0.9 percentage of values Standard Deviation 0.4	2.8 percentage of values Standard Deviation 0.06
Percentage of Time With Plasma Glucose Values by Ranges on Day 1 < 70 mg/dL (3.9 mmol/L)	4.4 percentage of values Standard Deviation 0.1	3.7 percentage of values Standard Deviation 0.07
Percentage of Time With Plasma Glucose Values by Ranges on Day 1 < 50 mg/dL (2.8 mmol/L)	0 percentage of values Standard Deviation 0	0.9 percentage of values Standard Deviation 0.04

SECONDARY outcome

Timeframe: Days 1 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 < 70 mg/dL (3.9 mmol/L)	2.7 percentage of values Standard Deviation 0.03	4.3 percentage of values Standard Deviation 0.04
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 < 60 mg/dL (3.3 mmol/L)	1.1 percentage of values Standard Deviation 0.02	2.1 percentage of values Standard Deviation 0.02
Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5 < 50 mg/dL (2.8 mmol/L)	0.4 percentage of values Standard Deviation 0.01	0.5 percentage of values Standard Deviation 0.01

SECONDARY outcome

Timeframe: Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 < 70 mg/dl (3.9 mmol/L)	2.2 percentage of values Standard Deviation 0.03	4.4 percentage of values Standard Deviation 0.04
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 < 60 mg/dL (3.3 mmol/L)	1.1 percentage of values Standard Deviation 0.02	1.9 percentage of values Standard Deviation 0.02
Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5 < 50 mg/dl (2.8 mmol/L)	0.4 percentage of values Standard Deviation 0.013	0.2 percentage of values Standard Deviation 0.01

SECONDARY outcome

Timeframe: Day 1, Days 1 to 5, and Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean Plasma Glucose <154 mg/dL Day 1	84 percentage of participants	37 percentage of participants
Percentage of Participants With Mean Plasma Glucose <154 mg/dL Days 1 to 5	100 percentage of participants	16 percentage of participants
Percentage of Participants With Mean Plasma Glucose <154 mg/dL Days 2 to 5	100 percentage of participants	11 percentage of participants

SECONDARY outcome

Timeframe: Day 1, Days 1 to 5, and Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean Plasma Glucose <169 mg/dL Day 1	95 percentage of participants	58 percentage of participants
Percentage of Participants With Mean Plasma Glucose <169 mg/dL Days 1 to 5	100 percentage of participants	37 percentage of participants
Percentage of Participants With Mean Plasma Glucose <169 mg/dL Days 2 to 5	100 percentage of participants	53 percentage of participants

SECONDARY outcome

Timeframe: Day 1, Days 1 to 5, and Days 2 to 5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants With Mean Plasma Glucose <183 mg/dL Day 1	95 percentage of participants	68 percentage of participants
Percentage of Participants With Mean Plasma Glucose <183 mg/dL Days 1 to 5	100 percentage of participants	68 percentage of participants
Percentage of Participants With Mean Plasma Glucose <183 mg/dL Days 2 to 5	100 percentage of participants	63 percentage of participants

SECONDARY outcome

Timeframe: Days 1-5

A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <50 mg/dl	0.47 times below threshold Standard Deviation 0.61	0.53 times below threshold Standard Deviation 0.61
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <60 mg/dl	1.26 times below threshold Standard Deviation 1.19	2.11 times below threshold Standard Deviation 1.97
Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL) <70 mg/dl	2.84 times below threshold Standard Deviation 2.39	4.79 times below threshold Standard Deviation 3.52

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of the Usual Care Period

Population: All randomized participants who completed both periods of the study.

The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care Day 1	0 percentage of days	—
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care Days 1 to 5	0 percentage of days	—
Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care Days 2 to 5	0 percentage of days	—

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL Day 1	1 carbohydrate interventions Interval 0.0 to 3.0	1 carbohydrate interventions Interval 0.0 to 5.0
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL Days 1 to 5	3 carbohydrate interventions Interval 0.0 to 8.0	5 carbohydrate interventions Interval 0.0 to 14.0
Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL Days 2 to 5	2 carbohydrate interventions Interval 0.0 to 7.0	3 carbohydrate interventions Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All randomized participants who completed both periods of the study.

Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL Day 1	1.6 grams of carbohydrate Interval 0.0 to 8.0	2.2 grams of carbohydrate Interval 0.0 to 10.0
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL Days 1 to 5	7.3 grams of carbohydrate Interval 0.0 to 19.0	12.7 grams of carbohydrate Interval 0.0 to 40.0
Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL Days 2 to 5	5.7 grams of carbohydrate Interval 0.0 to 16.0	9.6 grams of carbohydrate Interval 0.0 to 31.0

SECONDARY outcome

Timeframe: 11 days

Population: All randomized participants who completed both periods of the study.

Insulin total daily dose is reported in units per kilogram per day (U/kg/day).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Insulin Total Daily Dose Day 1	0.7 U/kg/day Standard Deviation 0.2	0.66 U/kg/day Standard Deviation 0.15
Insulin Total Daily Dose Days 1 to 5	0.68 U/kg/day Standard Deviation 0.14	0.68 U/kg/day Standard Deviation 0.13
Insulin Total Daily Dose Days 2 to 5	0.68 U/kg/day Standard Deviation 0.15	0.68 U/kg/day Standard Deviation 0.13

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 of each period

Population: All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.

Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm Day 1	11.9 µg/kg/day Standard Deviation 5.2	—
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm Days 1 to 5	11.1 µg/kg/day Standard Deviation 3.8	—
Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm Days 2 to 5	10.9 µg/kg/day Standard Deviation 4.0	—

SECONDARY outcome

Timeframe: Day 1 through Day 5

Population: All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.

The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Daily Basal Insulin Dose in the Bionic Pancreas Period Day 1	0.2 U/kg/day Standard Deviation 0.0	—
Daily Basal Insulin Dose in the Bionic Pancreas Period Day 2	0.3 U/kg/day Standard Deviation 0.1	—
Daily Basal Insulin Dose in the Bionic Pancreas Period Day 3	0.3 U/kg/day Standard Deviation 0.1	—
Daily Basal Insulin Dose in the Bionic Pancreas Period Day 4	0.3 U/kg/day Standard Deviation 0.0	—
Daily Basal Insulin Dose in the Bionic Pancreas Period Day 5	0.3 U/kg/day Standard Deviation 0.1	—

SECONDARY outcome

Timeframe: Day 1 through Day 5

Population: All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.

The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Daily Bolus Insulin Dose in the Bionic Pancreas Period Day 1	0.4 U/kg/day Standard Deviation 0.1	—
Daily Bolus Insulin Dose in the Bionic Pancreas Period Day 2	0.4 U/kg/day Standard Deviation 0.2	—
Daily Bolus Insulin Dose in the Bionic Pancreas Period Day 3	0.4 U/kg/day Standard Deviation 0.1	—
Daily Bolus Insulin Dose in the Bionic Pancreas Period Day 4	0.4 U/kg/day Standard Deviation 0.1	—
Daily Bolus Insulin Dose in the Bionic Pancreas Period Day 5	0.4 U/kg/day Standard Deviation 0.1	—

SECONDARY outcome

Timeframe: Day 1, Days 1-5 and Days 2-5

Population: All randomized participants who completed both periods of the study.

Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Carbohydrate Intake Day 1	5.51 g/kg/day Standard Deviation 1.46	6.09 g/kg/day Standard Deviation 2.08
Carbohydrate Intake Days 1 to 5	6.09 g/kg/day Standard Deviation 1.53	6.66 g/kg/day Standard Deviation 1.72
Carbohydrate Intake Days 2 to 5	6.24 g/kg/day Standard Deviation 1.62	6.80 g/kg/day Standard Deviation 1.70

SECONDARY outcome

Timeframe: Day 1

Population: All randomized participants who completed both periods of the study.

Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Unscheduled Infusion Set Changes Fell out	1 unscheduled infusion set changes	0 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Failure	0 unscheduled infusion set changes	1 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Pain	1 unscheduled infusion set changes	0 unscheduled infusion set changes

SECONDARY outcome

Timeframe: Days 1-5

Population: All randomized participants who completed both periods of the study.

Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Unscheduled Infusion Set Changes Fell out	7 unscheduled infusion set changes	1 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Failure	2 unscheduled infusion set changes	5 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Pain	3 unscheduled infusion set changes	0 unscheduled infusion set changes

SECONDARY outcome

Timeframe: Days 2-5

Population: All randomized participants who completed both periods of the study.

Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Unscheduled Infusion Set Changes Fell out	6 unscheduled infusion set changes	1 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Failure	2 unscheduled infusion set changes	4 unscheduled infusion set changes
Number of Unscheduled Infusion Set Changes Pain	2 unscheduled infusion set changes	0 unscheduled infusion set changes

SECONDARY outcome

Timeframe: Day 1, Days 1-5 and Days 2-5

Population: All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.

Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Bionic Pancreas Local Infusion Site Reactions Day 1	1 infusion site reactions	—
Number of Bionic Pancreas Local Infusion Site Reactions Days 1 to 5	3 infusion site reactions	—
Number of Bionic Pancreas Local Infusion Site Reactions Days 2 to 5	2 infusion site reactions	—

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 in each period

Population: All randomized participants who completed both periods of the study.

Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores from Day 1 to Day 5 were calculated

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Mean Nausea Index Score Using a Visual Analogue Scale (VAS) Day 1	1.1 cm Standard Deviation 2.2	0.9 cm Standard Deviation 2.2
Mean Nausea Index Score Using a Visual Analogue Scale (VAS) Days 1 to 5	1.3 cm Standard Deviation 2.0	1.4 cm Standard Deviation 1.8
Mean Nausea Index Score Using a Visual Analogue Scale (VAS) Days 2 to 5	1.4 cm Standard Deviation 2.3	1.5 cm Standard Deviation 1.8

SECONDARY outcome

Timeframe: Day 1, Days 1-5 and Days 2-5

Population: All randomized participants who completed both periods of the study.

A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Severe Hypoglycemic Events Day 1	0 severe hypoglycemic events	0 severe hypoglycemic events
Number of Severe Hypoglycemic Events Days 1 to 5	0 severe hypoglycemic events	0 severe hypoglycemic events
Number of Severe Hypoglycemic Events Days 2 to 5	0 severe hypoglycemic events	0 severe hypoglycemic events

SECONDARY outcome

Timeframe: 5 days

Population: All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.

Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period Insulin Pump: Loss of Wireless Connectivity	4.9 percentage of time Standard Deviation 2.5	—
Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period Glucagon Pump: Loss of Wireless Connectivity	6.1 percentage of time Standard Deviation 3.1	—

SECONDARY outcome

Timeframe: 5 days

Population: All randomized participants who completed both periods of the study.

Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Time Without CGM Monitoring Data	4.2 percentage of time Standard Deviation 1.9	5.1 percentage of time Standard Deviation 1.9

SECONDARY outcome

Timeframe: 5 days

Population: All randomized participants who completed both periods of the study.

The change in body weight collected at Day 5 of each period relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Change From Baseline in Body Weight	0.07 kg Standard Deviation 0.63	0.28 kg Standard Deviation 0.81

SECONDARY outcome

Timeframe: Day 1, Days 1-5, and Days 2-5 in each period

Population: All randomized participants who completed both periods of the study.

Reliability index was calculated as the percentage of time values were actually recorded by CGM.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Reliability Index Day 1	95.3 percentage of time Standard Deviation 3.76	95.1 percentage of time Standard Deviation 2.28
Reliability Index Days 1 to 5	95.4 percentage of time Standard Deviation 2.0	93.1 percentage of time Standard Deviation 3.0
Reliability Index Days 2 to 5	95.8 percentage of time Standard Deviation 1.9	95.0 percentage of time Standard Deviation 1.9

SECONDARY outcome

Timeframe: 5 days

Population: Data was not collected and analyzed to this level of detail.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 days

Population: All randomized participants who completed both periods of the study.

The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 Participants Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Number of Unscheduled CGM Sensor Changes	3 CGM sensor changes	5 CGM sensor changes

SECONDARY outcome

Timeframe: 5 days

Population: All participants who completed both periods of the study. Results are reported for the Usual Care period only.

The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period	0 percentage of participants	—

SECONDARY outcome

Timeframe: 5 days

Population: All participants who completed both periods of the study. Results are reported for the Usual Care period only.

The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.

Outcome measures

Measure	Bionic Pancreas n=19 Participants Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Percentage of Participants Using Pramlintide During the Usual Care Period	0 percentage of participants	—

Adverse Events

Bionic Pancreas

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bionic Pancreas n=19 participants at risk Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.	Usual Care n=19 participants at risk Usual Care diabetes management in a diabetes camp environment including a nurse or nursing student assigned to each cabin and review and adjustment of the insulin regimen daily by a physician or nurse practitioner, all participants using the participant's own insulin pump and a continuous glucose monitor if they use one as part of their usual care, for 5 days.
Investigations Hyperketonemia	0.00% 0/19 • 5 days for each arm	26.3% 5/19 • 5 days for each arm
Gastrointestinal disorders Vomiting in mouth	5.3% 1/19 • 5 days for each arm	5.3% 1/19 • 5 days for each arm
Nervous system disorders Headache	5.3% 1/19 • 5 days for each arm	0.00% 0/19 • 5 days for each arm
Gastrointestinal disorders Stomachache	5.3% 1/19 • 5 days for each arm	0.00% 0/19 • 5 days for each arm
Gastrointestinal disorders Nausea	73.7% 14/19 • 5 days for each arm	57.9% 11/19 • 5 days for each arm
General disorders Infusion site pain	15.8% 3/19 • 5 days for each arm	0.00% 0/19 • 5 days for each arm
General disorders Infusion site redness	10.5% 2/19 • 5 days for each arm	0.00% 0/19 • 5 days for each arm
General disorders Infusion site itching	10.5% 2/19 • 5 days for each arm	0.00% 0/19 • 5 days for each arm

Additional Information

Dr. Steven J. Russell

Massachusetts General Hospital

Phone: 617.726.1848

Email: sjrussell@partners.org

Results disclosure agreements

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