Status:
COMPLETED
The Summer Camp Study: Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Boston University
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
12-20 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01833988
Start Date
April 1 2013
End Date
December 1 2014
Last Update
September 8 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114