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

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ClinicalTrials.gov Identifier: NCT02105324
Recruitment Status : Completed
First Posted : April 7, 2014
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Device: Bionic Pancreas
Other: Usual Care
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bionic Pancreas Then Usual Care Usual Care Then Bionic Pancreas
Hide Arm/Group Description 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 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 Title: Period 1
Started 9 10
Completed 9 10
Not Completed 0 0
Period Title: Period 2
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title All Randomized Participants
Hide Arm/Group Description All randomized participants who completed both periods of the study.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
19
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
9.8  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
13
  68.4%
Male
6
  31.6%
1.Primary Outcome
Title Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5
Hide Description Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.
Time Frame Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter (mg/dL)
136.8  (10.8) 167.4  (30.6)
2.Primary Outcome
Title Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5
Hide Description 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.
Time Frame Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
1.2  (1.1) 2.8  (1.2)
3.Secondary Outcome
Title Mean CGMG Values
Hide Description Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.
Time Frame Day 1 and Days 1-5 in each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1 153.6  (19.7) 179.2  (37.8)
Days 1 to 5 140.6  (12.0) 169.9  (27.6)
4.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Day 1
Hide Description 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).
Time Frame Day 1 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dL (2.8 mmol/L) 0.2  (0.6) 1.0  (2.6)
< 70 mg/dL (3.9 mmol/L) 1.8  (2.0) 3.7  (4.5)
70-180 mg/dL (3.9 to 10.0 mmol/L) 71.6  (11.7) 52.1  (21.3)
> 180 mg/dL (10.0 mmol/L) 26.6  (11.3) 44.2  (23.4)
5.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5
Hide Description 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).
Time Frame Days 1 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dl (2.8 mmol/L) 0.4  (0.4) 1.1  (0.8)
< 70 mg/dl (3.9 mmol/L) 2.7  (1.8) 5.6  (2.5)
70-180 mg/dl (3.9 to 10.0 mmol/L) 78.8  (7.4) 56.5  (13.9)
> 180 mg/dL (10.0 mmol/L) 18.5  (6.6) 37.9  (15.4)
6.Secondary Outcome
Title Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5
Hide Description 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).
Time Frame Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
< 50 mg/dl (2.8 mmol/L) 0.4  (0.5) 1.1  (0.8)
< 70 mg/dl (3.9 mmol/L) 2.9  (2.1) 6.1  (2.8)
70-180 mg/dl (3.9 to 10.0 mmol/L) 80.6  (7.4) 57.6  (14.0)
> 180 mg/dL (10.0 mmol/L) 16.5  (6.4) 36.3  (15.7)
7.Secondary Outcome
Title Percentage of Participants With Mean CGMG Glucose <154 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 57.9 15.8
Days 1 to 5 84.2 36.8
Days 2 to 5 94.7 42.1
8.Secondary Outcome
Title Percentage of Participants With Mean CGMG Glucose <169 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 89.5 36.8
Days 1 to 5 94.7 57.9
Days 2 to 5 100 68.4
9.Secondary Outcome
Title Percentage of Participants With Mean CGMG Glucose <183 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 89.5 57.9
Days 1 to 5 100 68.4
Days 2 to 5 100 73.7
10.Secondary Outcome
Title Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Hide Description 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.
Time Frame Days 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: times below threshold
<70 mg/dl 9.4  (5.8) 9.4  (5.1)
<60 mg/dl 4.4  (3.3) 6.3  (3.0)
<50 mg/dl 1.9  (1.9) 3.1  (2.1)
11.Secondary Outcome
Title Mean Plasma Glucose Values
Hide Description 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.
Time Frame Day 1, Days 1 to 5, and Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 1 137.2  (20.1) 169.7  (32.2)
Days 1 to 5 136.8  (7.2) 176.4  (25.2)
Days 2 to 5 135.8  (5.4) 178.8  (27.4)
12.Secondary Outcome
Title Percentage of Time With Plasma Glucose Values by Ranges on Day 1
Hide Description 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).
Time Frame Day 1 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of values
< 70 mg/dL (3.9 mmol/L) 4.4  (0.1) 3.7  (0.07)
< 60 mg/dL (3.3 mmol/L) 0.9  (0.4) 2.8  (0.06)
< 50 mg/dL (2.8 mmol/L) 0  (0) 0.9  (0.04)
13.Secondary Outcome
Title Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5
Hide Description 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).
Time Frame Days 1 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of values
< 70 mg/dL (3.9 mmol/L) 2.7  (0.03) 4.3  (0.04)
< 60 mg/dL (3.3 mmol/L) 1.1  (0.02) 2.1  (0.02)
< 50 mg/dL (2.8 mmol/L) 0.4  (0.01) 0.5  (0.01)
14.Secondary Outcome
Title Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5
Hide Description 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).
Time Frame Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of values
< 70 mg/dl (3.9 mmol/L) 2.2  (0.03) 4.4  (0.04)
< 60 mg/dL (3.3 mmol/L) 1.1  (0.02) 1.9  (0.02)
< 50 mg/dl (2.8 mmol/L) 0.4  (0.013) 0.2  (0.01)
15.Secondary Outcome
Title Percentage of Participants With Mean Plasma Glucose <154 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1 to 5, and Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 84 37
Days 1 to 5 100 16
Days 2 to 5 100 11
16.Secondary Outcome
Title Percentage of Participants With Mean Plasma Glucose <169 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1 to 5, and Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 95 58
Days 1 to 5 100 37
Days 2 to 5 100 53
17.Secondary Outcome
Title Percentage of Participants With Mean Plasma Glucose <183 mg/dL
Hide Description 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%.
Time Frame Day 1, Days 1 to 5, and Days 2 to 5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: percentage of participants
Day 1 95 68
Days 1 to 5 100 68
Days 2 to 5 100 63
18.Secondary Outcome
Title Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)
Hide Description 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.
Time Frame Days 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: times below threshold
<50 mg/dl 0.47  (0.61) 0.53  (0.61)
<60 mg/dl 1.26  (1.19) 2.11  (1.97)
<70 mg/dl 2.84  (2.39) 4.79  (3.52)
19.Secondary Outcome
Title Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care
Hide Description The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.
Time Frame Day 1, Days 1-5, and Days 2-5 of the Usual Care Period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Usual Care
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of days
Day 1 0
Days 1 to 5 0
Days 2 to 5 0
20.Secondary Outcome
Title Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL
Hide Description 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.
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: carbohydrate interventions
Day 1
1
(0 to 3)
1
(0 to 5)
Days 1 to 5
3
(0 to 8)
5
(0 to 14)
Days 2 to 5
2
(0 to 7)
3
(0 to 11)
21.Secondary Outcome
Title Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL
Hide Description 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.
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: grams of carbohydrate
Day 1
1.6
(0 to 8)
2.2
(0 to 10)
Days 1 to 5
7.3
(0 to 19)
12.7
(0 to 40)
Days 2 to 5
5.7
(0 to 16)
9.6
(0 to 31)
22.Secondary Outcome
Title Insulin Total Daily Dose
Hide Description Insulin total daily dose is reported in units per kilogram per day (U/kg/day).
Time Frame 11 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.7  (0.2) 0.66  (0.15)
Days 1 to 5 0.68  (0.14) 0.68  (0.13)
Days 2 to 5 0.68  (0.15) 0.68  (0.13)
23.Secondary Outcome
Title Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm
Hide Description Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).
Time Frame Day 1, Days 1-5, and Days 2-5 of each period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: µg/kg/day
Day 1 11.9  (5.2)
Days 1 to 5 11.1  (3.8)
Days 2 to 5 10.9  (4.0)
24.Secondary Outcome
Title Daily Basal Insulin Dose in the Bionic Pancreas Period
Hide Description 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).
Time Frame Day 1 through Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.2  (0.0)
Day 2 0.3  (0.1)
Day 3 0.3  (0.1)
Day 4 0.3  (0.0)
Day 5 0.3  (0.1)
25.Secondary Outcome
Title Daily Bolus Insulin Dose in the Bionic Pancreas Period
Hide Description 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).
Time Frame Day 1 through Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
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Participants who were randomized and began in the trial
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: U/kg/day
Day 1 0.4  (0.1)
Day 2 0.4  (0.2)
Day 3 0.4  (0.1)
Day 4 0.4  (0.1)
Day 5 0.4  (0.1)
26.Secondary Outcome
Title Carbohydrate Intake
Hide Description 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).
Time Frame Day 1, Days 1-5 and Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: g/kg/day
Day 1 5.51  (1.46) 6.09  (2.08)
Days 1 to 5 6.09  (1.53) 6.66  (1.72)
Days 2 to 5 6.24  (1.62) 6.80  (1.70)
27.Secondary Outcome
Title Number of Unscheduled Infusion Set Changes
Hide Description 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.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: unscheduled infusion set changes
Fell out 1 0
Failure 0 1
Pain 1 0
28.Secondary Outcome
Title Number of Unscheduled Infusion Set Changes
Hide Description 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.
Time Frame Days 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: unscheduled infusion set changes
Fell out 7 1
Failure 2 5
Pain 3 0
29.Secondary Outcome
Title Number of Unscheduled Infusion Set Changes
Hide Description 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.
Time Frame Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: unscheduled infusion set changes
Fell out 6 1
Failure 2 4
Pain 2 0
30.Secondary Outcome
Title Number of Bionic Pancreas Local Infusion Site Reactions
Hide Description Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.
Time Frame Day 1, Days 1-5 and Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: infusion site reactions
Day 1 1
Days 1 to 5 3
Days 2 to 5 2
31.Secondary Outcome
Title Mean Nausea Index Score Using a Visual Analogue Scale (VAS)
Hide Description 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
Time Frame Day 1, Days 1-5, and Days 2-5 in each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: cm
Day 1 1.1  (2.2) 0.9  (2.2)
Days 1 to 5 1.3  (2.0) 1.4  (1.8)
Days 2 to 5 1.4  (2.3) 1.5  (1.8)
32.Secondary Outcome
Title Number of Severe Hypoglycemic Events
Hide Description A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.
Time Frame Day 1, Days 1-5 and Days 2-5
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: severe hypoglycemic events
Day 1 0 0
Days 1 to 5 0 0
Days 2 to 5 0 0
33.Secondary Outcome
Title Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period
Hide Description Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:
management, a wearable bionic pancreas system that automatically delivers insulin and glucagon using a continuous glucose monitoring (CGM) device, for 5 days.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
Insulin Pump: Loss of Wireless Connectivity 4.9  (2.5)
Glucagon Pump: Loss of Wireless Connectivity 6.1  (3.1)
34.Secondary Outcome
Title Percentage of Time Without CGM Monitoring Data
Hide Description Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
4.2  (1.9) 5.1  (1.9)
35.Secondary Outcome
Title Change From Baseline in Body Weight
Hide Description 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.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: kg
0.07  (0.63) 0.28  (0.81)
36.Secondary Outcome
Title Reliability Index
Hide Description Reliability index was calculated as the percentage of time values were actually recorded by CGM.
Time Frame Day 1, Days 1-5, and Days 2-5 in each period
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: percentage of time
Day 1 95.3  (3.76) 95.1  (2.28)
Days 1 to 5 95.4  (2.0) 93.1  (3.0)
Days 2 to 5 95.8  (1.9) 95.0  (1.9)
37.Secondary Outcome
Title List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution
Hide Description [Not Specified]
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and analyzed to this level of detail.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
38.Secondary Outcome
Title Number of Unscheduled CGM Sensor Changes
Hide Description The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed both periods of the study.
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 19
Measure Type: Number
Unit of Measure: CGM sensor changes
3 5
39.Secondary Outcome
Title Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period
Hide Description The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Usual Care period only.
Arm/Group Title Usual Care
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
0
40.Secondary Outcome
Title Percentage of Participants Using Pramlintide During the Usual Care Period
Hide Description The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed both periods of the study. Results are reported for the Usual Care period only.
Arm/Group Title Usual Care
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame 5 days for each arm
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bionic Pancreas Usual Care
Hide Arm/Group Description 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 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.
All-Cause Mortality
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bionic Pancreas Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   15/19 (78.95%)   13/19 (68.42%) 
Gastrointestinal disorders     
Vomiting in mouth *  1/19 (5.26%)  1/19 (5.26%) 
Stomachache *  1/19 (5.26%)  0/19 (0.00%) 
Nausea *  14/19 (73.68%)  11/19 (57.89%) 
General disorders     
Infusion site pain *  3/19 (15.79%)  0/19 (0.00%) 
Infusion site redness *  2/19 (10.53%)  0/19 (0.00%) 
Infusion site itching *  2/19 (10.53%)  0/19 (0.00%) 
Investigations     
Hyperketonemia *  0/19 (0.00%)  5/19 (26.32%) 
Nervous system disorders     
Headache *  1/19 (5.26%)  0/19 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven J. Russell
Organization: Massachusetts General Hospital
Phone: 617.726.1848
EMail: sjrussell@partners.org
Layout table for additonal information
Responsible Party: Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02105324     History of Changes
Other Study ID Numbers: 2014P000630
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: October 31, 2016
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017