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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01833988
Recruitment Status : Completed
First Posted : April 17, 2013
Results First Posted : August 11, 2017
Last Update Posted : September 8, 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: Bi-hormonal Bionic Pancreas
Other: Usual Care
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bionic Pancreas Then Usual Care Usual Care Then Bionic Pancreas
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
Cross over design, 16 participants in each arm and then switched to second arm after a 1 day washout period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
16  (3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
All study participants Number Analyzed 32 participants
Female
16
  50.0%
Male
16
  50.0%
[1]
Measure Analysis Population Description: 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.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: mg/dL
138  (18) 157  (27)
2.Primary Outcome
Title Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Standard Care (Insulin Pump)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of time
6.1  (4.5) 7.6  (7.3)
3.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bionic Pancreas
Hide Arm/Group Description:

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 1 day washout period in between.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl
Hide Description [Not Specified]
Time Frame Day 2-5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
29
  90.6%
14
  43.8%
5.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Day 2-5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of days
75  (21.5) 49.3  (36.2)
6.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Day 1-5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: events
97 210
7.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Fraction of time < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of time
<70 mg/dl 2.7  (2.2) 5.3  (4.6)
70-120 mg/dl 39.4  (8.2) 29.9  (12.3)
70-180 mg/dl 73.3  (9.0) 63.8  (13.3)
>180 mg/dl 24.0  (8.5) 30.9  (15.0)
>250 mg/dl 7.6  (5.6) 10.8  (8.7)
8.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data on exercise not collected
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   3.1%
10.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: mg/dl
Mean CGMG on Day 1 169.2  (31.3) 156  (37.0)
Mean CGMG day 2-5 142  (12) 158  (27)
11.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)
Hide Description Day 2-5
Time Frame Day 2-5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: mg/dl
142  (12) 158  (27)
12.Secondary Outcome
Title Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Count of Participants
Unit of Measure: Participants
26
  81.3%
17
  53.1%
15.Secondary Outcome
Title Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected to measure this outcome
Arm/Group Title All Study Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not obtained for exercise period
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title 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.
Hide Description

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 70–120 70–180 %>180 %>250

Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: Standard deviation of mean values
<70 2.2 4.6
70-120 8.2 12.3
70-180 9.0 13.3
>180 8.5 15.0
>250 5.6 8.7
18.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: Standard deviation of mean values
<70 2.1 5.4
70-120 12.3 17.1
70-180 8.5 16.9
>180 7.6 19.8
>250 3.4 10.9
19.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: mg/dl
141  (20) 162  (37)
20.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of time
4.1  (6.1) 4.4  (6.7)
21.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bi-hormonal Bionic Pancreas Usual Care
Hide Arm/Group Description:

Bi-hormonal Bionic Pancreas

Bi-hormonal Bionic Pancreas: Automated blood glucose control via a closed-loop bionic pancreas device.

Usual Care

Usual Care: Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of time
<70 2.4  (2.1) 5.0  (5.4)
70-120 51.5  (12.3) 27.4  (17.1)
70-180 84.6  (8.5) 65.9  (16.9)
>180 13.0  (7.6) 29.8  (19.8)
>250 2.8  (3.4) 8.6  (10.9)
22.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night
Hide Description Day 2-5
Time Frame Day 2-5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: mg/dl
124  (11) 157  (36)
23.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage of time
<70 mg/dl 2.6  (2.5) 4.0  (5.3)
70-120 mg/dl 55.3  (13.7) 28.3  (17.3)
70-180 mg/dl 86.9  (8.1) 66.7  (19.9)
>180 mg/dl 10.5  (7.0) 29.3  (22.0)
>250 mg/dl 1.8  (2.5) 9.5  (12.5)
24.Secondary Outcome
Title Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Study Participants
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: number of interventions
97 210
27.Secondary Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Measure Type: Number
Unit of Measure: interventions
29 48
28.Other Pre-specified Outcome
Title Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose
Hide Description [Not Specified]
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: unit/kg/day
0.82  (0.16) 0.79  (0.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bionic Pancreas Control
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Bionic Pancreas Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bionic Pancreas Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (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 Control
Affected / at Risk (%) Affected / at Risk (%)
Total   6/32 (18.75%)   4/32 (12.50%) 
Endocrine disorders     
Episodes of Severe Hypoglycemia  0/32 (0.00%)  1/32 (3.13%) 
Transient hyperketonemia  3/32 (9.38%)  3/32 (9.38%) 
Nausea  1/32 (3.13%)  0/32 (0.00%) 
Vomiting  2/32 (6.25%)  0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Steven J. Russell
Organization: Massachusetts General Hospital Diabetes Research Center
Phone: 617.726.1848
Responsible Party: Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01833988     History of Changes
Other Study ID Numbers: 2013p000561
First Submitted: April 13, 2013
First Posted: April 17, 2013
Results First Submitted: September 10, 2015
Results First Posted: August 11, 2017
Last Update Posted: September 8, 2017