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Clinical Trials/NCT02181127
NCT02181127CompletedNot Applicable

Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia

Massachusetts General Hospital2 sites in 1 country31 target enrollmentStarted: November 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
2
Primary Endpoint
Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Time Frame: From t=0 to study stop after 2 weeks

Secondary Outcomes

  • 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)
  • Mean CGMG During Exercise(2 weeks)
  • Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values(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)
  • Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime(2 weeks)
  • Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime(2 weeks)
  • Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl(2 weeks)
  • Number of Study Days With Mean BG < 154 mg/dl(2 weeks)
  • Number of Carbohydrate Interventions for Hypoglycemia(from t=0 to study stop after 2 weeks)
  • Total Number of Grams of Carbohydrate Taken for Hypoglycemia(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)
  • Count of Subjects With Mean CGMG < 154mg/dl(from t=0 to study stop after 2 weeks)
  • Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements(from t=0 to study stop after 2 weeks)
  • Number of All BG Values Less Than 70 mg/dl(from t=0 to study stop after 2 weeks)
  • Insulin Total Daily Dose(from t=0 to study stop after 2 weeks)
  • Mean BG During Exercise(2 weeks)
  • Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl(2 weeks)
  • Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)(2 weeks)
  • Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)(2 weeks)
  • • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise(2 weeks)
  • • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)(2 weeks)
  • Total Glucagon Dosing (mcg/kg/24 Hours)(from t=0 to study stop after 2 weeks)
  • Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)(2 weeks)
  • Episodes of Nausea Per Day on Glucagon vs Placebo(from t=0 to study stop after 2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Steven J. Russell, MD, PhD

Assistant Professor of Medicine

Massachusetts General Hospital

Study Sites (2)

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