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

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.