Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Completed · Not applicable · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02181127

Run by

Massachusetts General Hospital

People needed

31

Starts

2014-11-01

Expected to finish

2017-04-01

Last updated by the study team

2019-01-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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