Closed-Loop Glucagon Administration For Hypoglycemia Treatment

NCT ID: NCT02181127

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-04-30

Brief Summary

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glucagon-only Bionic Pancreas (active)

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.

Group Type: ACTIVE_COMPARATOR

Glucagon-only Bionic Pancreas

Intervention Type: DEVICE

A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.

Glucagon-only Bionic Pancreas (placebo)

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.

Group Type: PLACEBO_COMPARATOR

Glucagon-only Bionic Pancreas

Intervention Type: DEVICE

A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.

Interventions

Glucagon-only Bionic Pancreas

A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.

Intervention Type: DEVICE

Other Intervention Names

Boston University Bionic Pancreas

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Russell, MD, PhD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven J Russell, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Related Links

http://bionicpancreas.org

Information about this and related studies

Other Identifiers

2013P001663/MGH

Identifier Type: -

Identifier Source: org_study_id