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Clinical Trial Details

Trial ID: L6572
Source ID: NCT02411578
Associated Drug: G-Pen Mini™ (Glucagon Injection)
Title: Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02411578/results
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: G-Pen Mini™ (glucagon injection)|OTHER: Glucose Tablets
Outcome Measures: Primary: Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment, 30 minutes | Secondary: 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 120 Minutes|CGM Mean Glucose, Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period, 3 weeks|CGM Time in Range, Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period, 3 weeks|CGM Time Below 70, Percentage of time \<70 mg/dL from CGM data computed over entire 3 weeks of treatment period, 3 weeks|CGM Coefficient of Variation, Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period, 3 weeks
Sponsor/Collaborators: Sponsor: Jaeb Center for Health Research | Collaborators: Xeris Pharmaceuticals
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-09
Completion Date: 2016-05
Results First Posted: 2017-10-23
Last Update Posted: 2020-03-03
Locations: University of Colorado/Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States|Yale University of Medicine, New Haven, Connecticut, 06510, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
URL: https://clinicaltrials.gov/show/NCT02411578