Closed-Loop Glucagon Administration For Hypoglycemia Treatment

NCT02181127 | Completed Results DMC

• 1 other identifier: 2013P001663/MGH
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

bionic pancreas; artificial pancreas; insulin; glucagon; continuous glucose monitoring (CGM); outpatient; insulin pump; glucagon pump

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl

  From t=0 to study stop after 2 weeks

Secondary Outcomes (26)

• Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime

  2 weeks

• Number of Hypoglycemic Episodes With CGMG < 50 mg/dl

  From t=0 to study stop after 2 weeks

• Number of Hypoglycemic Episodes With CGMG < 60 mg/dl

  from t=0 to study stop after 2 weeks

• Number of Hypoglycemic Episodes With CGMG < 70 mg/dl

  from t=0 to study stop after 2 weeks

• Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl

  from t=0 to stud stop after 2 weeks

Study Arms (2)

Glucagon-only Bionic Pancreas (active)

ACTIVE COMPARATOR

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.

Device: Glucagon-only Bionic Pancreas

Glucagon-only Bionic Pancreas (placebo)

PLACEBO COMPARATOR

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.

Device: Glucagon-only Bionic Pancreas

Interventions

Glucagon-only Bionic Pancreas DEVICE

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

Also known as: Boston University Bionic Pancreas

Glucagon-only Bionic Pancreas (active); Glucagon-only Bionic Pancreas (placebo)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Information about this and related studies

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Dr Steven J Russell
• Organization: Massachusetts General Hospital

sjrussell@partners.org

617-726-1848

Study Officials

• Steven J Russell, MD PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: July 3, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: April 1, 2017
• Last Updated: January 10, 2019
• Results First Posted: December 26, 2016

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)