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

Mass General Brigham

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Device: Bi-hormonal Bionic Pancreas

Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01833988

2013p000561

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

12 to 20 years old

Volunteers

No Healthy Volunteers

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.