Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

May 31, 2016

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

G-Pen Mini™ (glucagon injection)

"1st BG check, 1st treatment~1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon~2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon~15 min later, 2nd BG check, 2nd treatment~1. BG is 60-69 mg/dl, no treatment~2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon~3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~1. BG is \>=70, no treatment~2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~(150 µg of glucagon per syringe)"

OTHER

Glucose Tablets

"1st BG check, 1st treatment~1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates~2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates~15 min later, 2nd BG check, 2nd treatment~1. BG is 60-69 mg/dl, no treatment~2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates~3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~30 minutes later, 3rd BG check, 3rd treatment~1. BG is \>=70, no treatment~2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon~(5 grams of fast-acting carbohydrates (D-Glucose) per tablet)"

Trial Locations (5)

13210

SUNY Upstate Medical University, Syracuse

19104

University of Pennsylvania, Philadelphia

80045

University of Colorado/Barbara Davis Center for Diabetes, Aurora

06510

Yale University of Medicine, New Haven

02215

Joslin Diabetes Center, Boston

Sponsors
All Listed Sponsors
collaborator

Xeris Pharmaceuticals

INDUSTRY

lead

Jaeb Center for Health Research

OTHER