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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Steven J. Russell, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01833988
First received: April 13, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Device: Bi-hormonal Bionic Pancreas
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in percentage of subjects with mean BG < 154 mg/dl [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in number of hypoglycemic events as determined from HemoCue measurements [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in mean BG during exercise [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in number of hypoglycemic episodes and nadir BG during exercise [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in mean continuous glucose monitoring glucose (CGMG) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in percentage of subjects with mean CGMG < 154 mg/dl [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in percentage of study days with mean CGMG < 154 mg/dl [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in mean CGMG in the four hour period following meals [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in mean CGMG during exercise [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in number of incidents of hypoglycemia and nadir CGMG during exercise [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in number of hypoglycemic events at night as determined from HemoCue measurements [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in mean CGMG at night [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in standard deviation of CGMG values (glycemic variability) at night [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in number of carbohydrate interventions for hypoglycemia at night [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
  • Difference between closed-loop and open-loop in total number of grams of carbohydrate taken for hypoglycemia at night [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Mean absolute relative deviation (MARD) of CGMG vs. scheduled HemoCue BG measurements in closed-loop and usual care periods [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Difference between closed-loop and open-loop in mean insulin total daily dose [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-hormonal Bionic Pancreas
Bi-hormonal Bionic Pancreas
Device: Bi-hormonal Bionic Pancreas
Automated blood glucose control via a closed-loop bionic pancreas device.
Other Name: Boston University Bionic Pancreas
Active Comparator: Usual Care
Usual Care
Other: Usual Care
Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833988

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Boston University
Investigators
Principal Investigator: Steven J Russell, MD PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven J. Russell, MD, PhD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01833988     History of Changes
Other Study ID Numbers: 2013p000561
Study First Received: April 13, 2013
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
bionic pancreas
artificial pancreas
insulin
glucagon
continuous glucose monitoring (CGM)
outpatient
insulin pump
pediatrics
children
camp
summer camp

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014