Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Mass General Brigham

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Glucagon-only Bionic Pancreas

Study type: Interventional

Funder types: Other

Identifiers

NCT02181127

2013P001663/MGH

Details and patient eligibility

About

This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

Glucagon-only Bionic Pancreas (active)

Active Comparator group

Description:

Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.

Treatment:

Device: Glucagon-only Bionic Pancreas

Glucagon-only Bionic Pancreas (placebo)

Placebo Comparator group

Description:

Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.

Treatment:

Device: Glucagon-only Bionic Pancreas