The purpose of this study is to determine if a small dose of glucagon (mini-dose glucagon) is effective for the treatment of non-severe hypoglycemia in adults with type 1 diabetes (T1D).
There are three phases included in this study: (1) Pre-crossover Trial Run-in Phase, (2) Randomized Clinical Trial (RCT) Crossover Trial Phase, and (3) Post-Crossover Trial Extension Phase. 1. Run-in Phase: Prior to commencing the crossover trial, study enrollment will begin with a 2 week run-in phase to assess hypoglycemia eligibility and compliance. 2. Crossover Trial Phase: The Crossover Trial Phase will consist of two (3-week) periods. The Crossover Trial Phase will include up to 24 participants who complete these study periods. Participants who do not complete both periods or who do not have at least one event during both periods may be replaced. During the Crossover Trial Phase participants will be randomized into two groups: (1) Group A will use mini-dose glucagon in period 1 and oral glucose tablets in period 2 and (2) Group B will use oral glucose tablets in period 1 and mini-dose glucagon in period 2. Each group with follow the applicable treatment arm according to their randomized group. 3. Extension Phase: The Post-Crossover Trial phase will commence upon completion of the second 3-week period of the Crossover Trial Phase. Participants will have a 3 week phase during which time they will decide whether to use mini-dose glucagon or glucose tablets to treat each non-severe hypoglycemic event or to prevent hypoglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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)
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)
University of Colorado/Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Yale University of Medicine
New Haven, Connecticut, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment
Time frame: 30 minutes
Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level
Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time frame: 60 Minutes
CGM Maximum Glucose, Event Level
Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time frame: 60 Minutes
CGM Mean Glucose, Event Level
Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time frame: 60 Minutes
CGM Time in Range, Event Level
Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time frame: 60 Minutes
CGM Time Below 70 mg/dL, Event Level
Percentage of time \<70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event
Time frame: 60 Minutes
CGM Minimum Glucose, Event Level
Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Time frame: 120 Minutes
CGM Maximum Glucose, Event Level
Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time frame: 120 Minutes
CGM Mean Glucose, Event Level
Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time frame: 120 Minutes
CGM Time in Range, Event Level
Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time frame: 120 Minutes
CGM Time Below 70 mg/dL
Percentage of time \<70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event
Time frame: 120 Minutes
CGM Mean Glucose
Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period
Time frame: 3 weeks
CGM Time in Range
Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time frame: 3 weeks
CGM Time Below 70
Percentage of time \<70 mg/dL from CGM data computed over entire 3 weeks of treatment period
Time frame: 3 weeks
CGM Coefficient of Variation
Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period
Time frame: 3 weeks