N/A N=22 Randomized Triple-blind Treatment

Closed-Loop Glucagon Administration For Hypoglycemia Treatment

Type 1 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02181127 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl — 1015; 4375.68 mg/dl/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Glucagon-only Bionic Pancreas (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl	1015; 4375.68	—
SECONDARY Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime	3.92; 1.50; 7.94; 10.25	—
SECONDARY Number of Hypoglycemic Episodes With CGMG < 50 mg/dl	1.73; 5.0	—
SECONDARY Number of Hypoglycemic Episodes With CGMG < 60 mg/dl	4.14; 8.86	—
SECONDARY Number of Hypoglycemic Episodes With CGMG < 70 mg/dl	8.95; 12.68	—
SECONDARY 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	3.11; 8.73; 33.32; 30.53; 68.91; 61.89	—
SECONDARY Count of Subjects With Mean CGMG < 154mg/dl	13; 11	—
SECONDARY Mean CGMG During Exercise	—	—
SECONDARY Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime	—	—
SECONDARY Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values	15.20	—
SECONDARY Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements	0.73; 2.59	—
SECONDARY Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime	—	—
SECONDARY Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl	—	—
SECONDARY Number of All BG Values Less Than 70 mg/dl	1.45; 4.23	—
SECONDARY Number of Study Days With Mean BG < 154 mg/dl	4.4; 4.2	—
SECONDARY 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	—	—
SECONDARY Mean BG During Exercise	—	—
SECONDARY • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise	—	—
SECONDARY Number of Carbohydrate Interventions for Hypoglycemia	1.25; 1.89	—
SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia	23.90; 36.29	—
SECONDARY Insulin Total Daily Dose	38.7; 37.0	—
SECONDARY • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)	—	—
SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)	—	—
SECONDARY Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)	—	—
SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)	—	—
SECONDARY Total Glucagon Dosing (mcg/kg/24 Hours)	6.84; 9.8	—
SECONDARY Episodes of Nausea Per Day on Glucagon vs Placebo	1.1; 0.4	—

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02181127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.