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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Bionic Pancreas Then Usual Care   Usual Care Then Bionic Pancreas
STARTED   16   16 
COMPLETED   16   16 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cross over design, 16 participants in each arm and then switched to second arm after a 1 day washout period.

Reporting Groups
  Description
All Study 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.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Mean (Standard Deviation)
 16  (3) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
All study participants   
Female      16  50.0% 
Male      16  50.0% 
[1] 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 
[Units: Participants]
 
United States   32 


  Outcome Measures

1.  Primary:   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.   [ Time Frame: 1 week ]

2.  Primary:   Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm   [ Time Frame: 1 week ]

3.  Secondary:   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.   [ Time Frame: 1 week ]

4.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl   [ Time Frame: Day 2-5 ]

5.  Secondary:   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   [ Time Frame: Day 2-5 ]

6.  Secondary:   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   [ Time Frame: Day 1-5 ]

7.  Secondary:   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)   [ Time Frame: 1 week ]

8.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise   [ Time Frame: 1 week ]

9.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise   [ Time Frame: 1 week ]

10.  Secondary:   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)   [ Time Frame: 1 week ]

11.  Secondary:   Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)   [ Time Frame: Day 2-5 ]

12.  Secondary:   Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)   [ Time Frame: 1 week ]

13.  Secondary:   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)   [ Time Frame: 1 week ]

14.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl   [ Time Frame: 1 week ]

15.  Secondary:   Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals   [ Time Frame: 1 week ]

16.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise   [ Time Frame: 1 week ]

17.  Secondary:   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.   [ Time Frame: 1 week ]

18.  Secondary:   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)   [ Time Frame: 1 week ]

19.  Secondary:   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.   [ Time Frame: 1 week ]

20.  Secondary:   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   [ Time Frame: 1 week ]

21.  Secondary:   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)   [ Time Frame: 1 week ]

22.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night   [ Time Frame: Day 2-5 ]

23.  Secondary:   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   [ Time Frame: 1 week ]

24.  Secondary:   Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night   [ Time Frame: 1 week ]

25.  Secondary:   Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night   [ Time Frame: 1 week ]

26.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia   [ Time Frame: 1 week ]

27.  Secondary:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night   [ Time Frame: 1 week ]

28.  Other Pre-specified:   Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose   [ Time Frame: 1 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: sjrussell@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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