Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Inclusion Criteria:

- Age 21 years or older with type 1 diabetes for at least one year.

- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression
will be allowed if well controlled).

- Self-reported frequency of documented hypoglycemia (BG < 60 mg/dl) of at least 2 times
per week

- Partial hypoglycemic unawareness (inconsistent symptoms with BG < 50 mg/dl) or
hypoglycemic unawareness (minimal or no symptoms with BG < 50 mg/dl)

Exclusion Criteria:

- Unable to provide informed consent.

- Unable to comply with study procedures.

- Current participation in another diabetes-related clinical trial other than one that
is primarily observational in nature.

- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the
immediate future, or sexually active without use of contraception

- History of cystic fibrosis, pancreatitis, or other pancreatic disease other than type
1 diabetes

- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).

- Any known liver or biliary disease including cirrhosis, alcoholic liver disease,
non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral
hepatitis.

- Congestive heart failure (established history of CHF, paroxysmal nocturnal dyspnea, or
orthopnea).

- Acute illness or exacerbation of chronic illness at the time of the study.

- Seizure disorder or history of hypoglycemic seizure in the last 1 year

- History of pheochromocytoma. Fractionated metanephrines will be tested in patients
with history increasing the risk for a catecholamine secreting tumor:

- Untreated or inadequately treated mental illness (indicators would include symptoms
such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the
last year).

- Current alcohol abuse (intake averaging > 3 drinks daily in last 30 days) or substance
abuse (any use within the last 6 months of controlled substances without a
prescription).

- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be
susceptible to RF interference.

- History of adverse reaction to glucagon (including allergy) besides nausea and
vomiting.

- Unwilling or unable to completely avoid acetaminophen during the study period.

- Any factors that, in the opinion of the principal investigator, would interfere with
the safe completion of the study procedures.