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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

Tracking Information
First Submitted Date  ICMJE April 13, 2013
First Posted Date  ICMJE April 17, 2013
Results First Submitted Date  ICMJE September 10, 2015
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date September 8, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2013)
  • Difference in average blood glucose (BG) between closed-loop and open-loop periods as determined from all scheduled HemoCue measurements with mean evenly weighted across the daytime and nighttime hours. [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in the percentage of the above subset of BG values less than 70 mg/dl. [ Time Frame: 1 week ]
Change History Complete list of historical versions of study NCT01833988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • 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 ]
    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.
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise [ Time Frame: 1 week ]
  • 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 ]
  • 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 ]
  • Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG) [ Time Frame: Day 2-5 ]
    Day 2-5
  • 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 ]
  • 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 ]
  • 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 ]
  • Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals [ Time Frame: 1 week ]
  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise [ Time Frame: 1 week ]
  • 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 ]
    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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night [ Time Frame: Day 2-5 ]
    Day 2-5
  • 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 ]
  • 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 ]
  • 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 ]
  • Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia [ Time Frame: 1 week ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2013)
  • Difference between closed-loop and open-loop 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 ]
  • Difference between closed-loop and open-loop in percentage of the above subset of BG values less than 70 mg/dl. [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in average BG as determined from the pre-meal, pre-snack, before bed, 12:00 AM, and 3:45 AM HemoCue measurements (nine measurements per day) [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in the percentage of the above subset of BG values between the closed-loop control and usual care periods less than 70 mg/dl. [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in percentage of subjects with mean BG < 154 mg/dl [ Time Frame: 1 week ]
  • Difference in the percentage of study days with mean BG < 154 mg/dl over the duration of the closed-loop period vs. the usual care period [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of hypoglycemic events as determined from HemoCue measurements [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in fraction of time 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 ]
  • Difference between closed-loop and open-loop in mean BG during exercise [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of hypoglycemic episodes and nadir BG during exercise [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in mean BG and likelihood of hypoglycemia on nights after a period of exercise > 30 minutes vs. nights after days without exercise [ Time Frame: 1 week ]
  • Difference of outcome measures on day 1 vs. remaining days (days 2-5) and on day 1-2 vs. on remaining days (days 3-5) in closed-loop and usual care periods [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in mean continuous glucose monitoring glucose (CGMG) [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of CGMG events < 70 mg/dl (episodes separated by < 15 minutes will be considered a single episode) and nadir for each [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop 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) [ Time Frame: 1 week ]
  • 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 ]
  • Difference between closed-loop and open-loop in area over the curve and below 50 mg/dl (measure of total hypoglycemia exposure) [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in percentage of subjects with mean CGMG < 154 mg/dl [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in percentage of study days with mean CGMG < 154 mg/dl [ Time Frame: 1 week ]
  • Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in mean CGMG during exercise [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of incidents of hypoglycemia and nadir CGMG during exercise [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability) [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in standard deviation of CGMG values at night (11:00 PM to 7:00 AM) [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in average BG as determined from all HemoCue measurements taken during the daytime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring. [ Time Frame: 1 week ]
  • 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 ]
  • Difference between closed-loop and open-loop in percentage of the above subset of BG values at night less than 70 mg/dl. [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of hypoglycemic events at night as determined from HemoCue measurements [ Time Frame: 1 week ]
  • 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 ]
  • Difference between closed-loop and open-loop in mean CGMG at night [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of CGMG events < 70 mg/dl (episodes separated by < 15 minutes will be considered a single episode) and nadir for each during nighttime hours [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop 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 ]
  • 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 ]
  • 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 ]
  • Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability) at night [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia at night [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia at night [ Time Frame: 1 week ]
Current Other Pre-specified Outcome Measures
 (submitted: July 19, 2017)
Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose [ Time Frame: 1 week ]
Original Other Pre-specified Outcome Measures
 (submitted: April 13, 2013)
  • Mean absolute relative deviation (MARD) of CGMG vs. scheduled HemoCue BG measurements in closed-loop and usual care periods [ Time Frame: 1 week ]
  • Difference between closed-loop and open-loop in mean insulin total daily dose [ Time Frame: 1 week ]
  • Fraction of time bionic pancreas not functioning properly due to: system crash, communication problem (continuous glucose monitor), communication problem (pumps), pump malfunction, tubing occlusion, infusion set failure) [ Time Frame: 1 week ]
  • Difference of outcome measures on day 1 vs. remaining days (days 2-5) and on day 1-2 vs. on remaining days (days 3-5) for both closed-loop and usual care [ Time Frame: 1 week ]
 
Descriptive Information
Brief Title  ICMJE The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
Official Title  ICMJE The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps
Brief Summary This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers both insulin and glucagon can improved glycemic control vs. usual care for young people with type 1 diabetes 12-20 in a diabetes camp environment.
Detailed Description The bionic pancreas will be compared to usual care 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 one day washout period in between.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Device: Bi-hormonal Bionic Pancreas
    Automated blood glucose control via a closed-loop bionic pancreas device.
    Other Name: Boston University Bionic Pancreas
  • Other: Usual Care
    Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.
Study Arms  ICMJE
  • Experimental: Bi-hormonal Bionic Pancreas
    Bi-hormonal Bionic Pancreas
    Intervention: Device: Bi-hormonal Bionic Pancreas
  • Active Comparator: Usual Care
    Usual Care
    Intervention: Other: Usual Care
Publications * Russell SJ, El-Khatib FH, Sinha M, Magyar KL, McKeon K, Goergen LG, Balliro C, Hillard MA, Nathan DM, Damiano ER. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014 Jul 24;371(4):313-325. doi: 10.1056/NEJMoa1314474. Epub 2014 Jun 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2013)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 12-20 years with type 1 diabetes for at least one year.
  • Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment.
  • Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion).

Exclusion Criteria:

  • Unable to provide informed assent
  • Unable to comply with study procedures.
  • Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.
  • Total daily dose (TDD) of insulin that is > 2 units/kg.
  • Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception
  • Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is < 50 mg/dl)
  • End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).
  • History of prolonged QT or arrhythmia
  • History of congenital heart disease or current known cardiac disease
  • Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study.
  • Seizure disorder or history of hypoglycemic seizures or coma in the last five years
  • Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation.
  • Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference.
  • Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications.
  • History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
  • Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study.
  • History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight
  • History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
  • Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01833988
Other Study ID Numbers  ICMJE 2013p000561
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Steven J. Russell, MD, PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Boston University
Investigators  ICMJE
Principal Investigator: Steven J Russell, MD PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP