the summer camp study: blood glucose control with a bi-hormonal bionic endocrine pancreas

Conditions: Type 1 Diabetes

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.

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.

Eligibility 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.

Keywords: bionic pancreas artificial pancreas insulin glucagon continuous glucose monitoring (cgm) outpatient insulin pump pediatrics children camp summer camp