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

Massachusetts General Hospital32 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Bi-hormonal Bionic PancreasDEVICE

Automated blood glucose control via a closed-loop bionic pancreas device.

Usual CareOTHER

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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.

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

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)

Data from ClinicalTrials.gov

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