Trial Outcomes & Findings for The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas (NCT NCT01833988)
NCT ID: NCT01833988
Last Updated: 2017-09-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
1 week
Results posted on
2017-09-08
Participant Flow
Participant milestones
| Measure |
Bionic Pancreas Then Usual Care
Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.
In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between.
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Usual Care Then Bionic Pancreas
Subjects were campers or counselors between the ages of 12 and 21 years who had at least a 1-year history of type 1 diabetes mellitus and were receiving insulin pump therapy.
In a random cross over design, subjects were assigned to either intervention (5 days on bionic pancreas) or standard care (5 days on insulin pump) with a 2 day washout period in between.
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|---|---|---|
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Overall Study
STARTED
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16
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16
|
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Overall Study
COMPLETED
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16
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16
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total number of participants was 32. Half were allocated to each of the 2 arms and then switched to the other arm in a random cross over design so that data was obtained from each participant for each of the 2 arms.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=32 Participants
The bionic pancreas (closed loop) will be compared to usual care (subject's own insulin pump) in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a two day washout period in between.
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|---|---|
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Age, Continuous
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16 years
STANDARD_DEVIATION 3 • n=5 Participants
|
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Sex: Female, Male
All study participants · Female
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16 Participants
n=5 Participants • Total number of participants was 32. Half were allocated to each of the 2 arms and then switched to the other arm in a random cross over design so that data was obtained from each participant for each of the 2 arms.
|
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Sex: Female, Male
All study participants · Male
|
16 Participants
n=5 Participants • Total number of participants was 32. Half were allocated to each of the 2 arms and then switched to the other arm in a random cross over design so that data was obtained from each participant for each of the 2 arms.
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Region of Enrollment
United States
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32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.
|
138 mg/dL
Standard Deviation 18
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157 mg/dL
Standard Deviation 27
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PRIMARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm
|
6.1 percentage of time
Standard Deviation 4.5
|
7.6 percentage of time
Standard Deviation 7.3
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SECONDARY outcome
Timeframe: 1 weekPopulation: This data was not analysed to prevent bias. This information would have been misleading (unscheduled BG checks were performed to confirm a low BG mostly). Overall CGM trend, incidence/duration of hypoglycemia and BG trend during and after exercise is separately analyzed under other secondary outcomes.
Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 2-5Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl
|
29 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 2-5Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period
|
75 percentage of days
Standard Deviation 21.5
|
49.3 percentage of days
Standard Deviation 36.2
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SECONDARY outcome
Timeframe: Day 1-5Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements
|
97 events
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210 events
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SECONDARY outcome
Timeframe: 1 weekPopulation: Fraction of time \< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, \> 180 mg/dl, \> 250 mg/dl
Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
<70 mg/dl
|
2.7 percentage of time
Standard Deviation 2.2
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5.3 percentage of time
Standard Deviation 4.6
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
70-120 mg/dl
|
39.4 percentage of time
Standard Deviation 8.2
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29.9 percentage of time
Standard Deviation 12.3
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
70-180 mg/dl
|
73.3 percentage of time
Standard Deviation 9.0
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63.8 percentage of time
Standard Deviation 13.3
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
>180 mg/dl
|
24.0 percentage of time
Standard Deviation 8.5
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30.9 percentage of time
Standard Deviation 15.0
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
>250 mg/dl
|
7.6 percentage of time
Standard Deviation 5.6
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10.8 percentage of time
Standard Deviation 8.7
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SECONDARY outcome
Timeframe: 1 weekPopulation: Data on exercise not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: Individual data during exercise was not analyzed. No episodes of severe hypoglycemia were observed on bionic pancreas and only 1 episode of severe hypoglycemia occurred in usual care arm (insulin pump)
Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise
|
0 Participants
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1 Participants
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SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)
Mean CGMG on Day 1
|
169.2 mg/dl
Standard Deviation 31.3
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156 mg/dl
Standard Deviation 37.0
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Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)
Mean CGMG day 2-5
|
142 mg/dl
Standard Deviation 12
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158 mg/dl
Standard Deviation 27
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SECONDARY outcome
Timeframe: Day 2-5Day 2-5
Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)
|
142 mg/dl
Standard Deviation 12
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158 mg/dl
Standard Deviation 27
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SECONDARY outcome
Timeframe: 1 weekPopulation: This outcome was not analyzed as we feel that the outcome "percentage of time \<70mg/dl" is an equivalent indicator of hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: This outcome was not analyzed as we feel that the outcome "percentage of time \<50mg/dl" is a n equivalent indicator of severe hypoglycemia instead of area over the curve, and can be used to compare outcomes with other studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl
|
26 Participants
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17 Participants
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SECONDARY outcome
Timeframe: 1 weekPopulation: Data was not collected to measure this outcome
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: Data not obtained for exercise period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekDifference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges. %\<70 70-120 70-180 %\>180 %\>250
Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
<70
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2.2 Standard deviation of mean values
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4.6 Standard deviation of mean values
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
70-120
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8.2 Standard deviation of mean values
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12.3 Standard deviation of mean values
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
70-180
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9.0 Standard deviation of mean values
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13.3 Standard deviation of mean values
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
>180
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8.5 Standard deviation of mean values
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15.0 Standard deviation of mean values
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.
>250
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5.6 Standard deviation of mean values
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8.7 Standard deviation of mean values
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SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
<70
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2.1 Standard deviation of mean values
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5.4 Standard deviation of mean values
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
70-120
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12.3 Standard deviation of mean values
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17.1 Standard deviation of mean values
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
70-180
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8.5 Standard deviation of mean values
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16.9 Standard deviation of mean values
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
>180
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7.6 Standard deviation of mean values
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19.8 Standard deviation of mean values
|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)
>250
|
3.4 Standard deviation of mean values
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10.9 Standard deviation of mean values
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SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.
|
141 mg/dl
Standard Deviation 20
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162 mg/dl
Standard Deviation 37
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SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
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Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night
|
4.1 percentage of time
Standard Deviation 6.1
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4.4 percentage of time
Standard Deviation 6.7
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SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
<70
|
2.4 percentage of time
Standard Deviation 2.1
|
5.0 percentage of time
Standard Deviation 5.4
|
|
Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
70-120
|
51.5 percentage of time
Standard Deviation 12.3
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27.4 percentage of time
Standard Deviation 17.1
|
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Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
70-180
|
84.6 percentage of time
Standard Deviation 8.5
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65.9 percentage of time
Standard Deviation 16.9
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Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
>180
|
13.0 percentage of time
Standard Deviation 7.6
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29.8 percentage of time
Standard Deviation 19.8
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Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)
>250
|
2.8 percentage of time
Standard Deviation 3.4
|
8.6 percentage of time
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Day 2-5Day 2-5
Outcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night
|
124 mg/dl
Standard Deviation 11
|
157 mg/dl
Standard Deviation 36
|
SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
<70 mg/dl
|
2.6 percentage of time
Standard Deviation 2.5
|
4.0 percentage of time
Standard Deviation 5.3
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
70-120 mg/dl
|
55.3 percentage of time
Standard Deviation 13.7
|
28.3 percentage of time
Standard Deviation 17.3
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
70-180 mg/dl
|
86.9 percentage of time
Standard Deviation 8.1
|
66.7 percentage of time
Standard Deviation 19.9
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
>180 mg/dl
|
10.5 percentage of time
Standard Deviation 7.0
|
29.3 percentage of time
Standard Deviation 22.0
|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night
>250 mg/dl
|
1.8 percentage of time
Standard Deviation 2.5
|
9.5 percentage of time
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 1 weekPopulation: This outcome was not analyzed as we feel that the outcome "percentage of time \<70mg/dl at nightime" is an equivalent indicator of overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: This outcome was not analyzed as we feel that the outcome "percentage of time \<50mg/dl at nightime" is an equivalent indicator of severe overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia
|
97 number of interventions
|
210 number of interventions
|
SECONDARY outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night
|
29 interventions
|
48 interventions
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekOutcome measures
| Measure |
Bionic Pancreas
n=32 Participants
|
Control
n=32 Participants
|
|---|---|---|
|
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose
|
0.82 unit/kg/day
Standard Deviation 0.16
|
0.79 unit/kg/day
Standard Deviation 0.17
|
Adverse Events
Bionic Pancreas
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bionic Pancreas
n=32 participants at risk
|
Control
n=32 participants at risk
|
|---|---|---|
|
Endocrine disorders
Episodes of Severe Hypoglycemia
|
0.00%
0/32
|
3.1%
1/32
|
|
Endocrine disorders
Transient hyperketonemia
|
9.4%
3/32
|
9.4%
3/32
|
|
Endocrine disorders
Nausea
|
3.1%
1/32
|
0.00%
0/32
|
|
Endocrine disorders
Vomiting
|
6.2%
2/32
|
0.00%
0/32
|
Additional Information
Dr. Steven J. Russell
Massachusetts General Hospital Diabetes Research Center
Phone: 617.726.1848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place