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Clinical Trial Details

Trial ID: L2919
Source ID: NCT03970772
Associated Drug: Glucagon Injection
Title: Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Fasting Hypoglycemia|Diabetes Mellitus, Type 1
Interventions: DRUG: Glucagon Injection|OTHER: Glucose Tablets
Outcome Measures: Primary: Changes in glucose values from baseline to 30 minute, The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events, 30 minutes | Secondary: Events approached 100 mg/dL or increased by 30 mg/dL, During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events approached 100 mg/dL or increased by 30 mg/dL, 60 Minutes|Treatment success from first dose, During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events with blood glucose concentration ≥50 mg/dl 15 minute AND ≥70 mg/dl 30 minute after the initial treatment of a hypoglycemic event, 60 Minutes|Mean Glucose Value, during hypoglycemia event by CGM, During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data, 60 Minutes|Time in Range, during hypoglycemia event by CGM, During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data., 60 Minutes|Time spend below 70 mg/dL, during hypoglycemia event by CGM, During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time \<70 mg/dL from CGM data., 60 Minutes|Minimum Glucose, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the minimum glucose value from CGM data., 60 Minutes|Maximum Glucose, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the maximum glucose value from CGM data., 60 Minutes|Mean Glucose Value, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data, 120 Minutes|Time in Range, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data, 120 Minutes|Time spend below 70 mg/dL, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time \<70 mg/dL from CGM data, 120 Minutes|Minimum Glucose, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the minimum glucose value from CGM data., 120 Minutes|Maximum Glucose, during hypoglycemia event by CGM, During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the maximum glucose value from CGM data., 120 Minutes|The proportion of completion of fasts, The proportion of completion of fasts following treatment of hypoglycemic events, 2 Weeks|Mean Glucose Value, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the mean glucose value from CGM data, 2 Weeks|Time in Range, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data, 2 Weeks|Time spend below 70 mg/dL, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \<70 mg/dL from CGM data, 2 Weeks|Time spend above 180 mg/dL, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \>180 mg/dL from CGM data, 2 Weeks|Time spend above 250 mg/dL, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time \>250 mg/dL from CGM data, 2 Weeks|Coefficient of Variation, by CGM, During the entire two weeks of intervention/comparator period, the investigators will calculate the Coefficient of Variation from CGM data, 2 Weeks
Sponsor/Collaborators: Sponsor: Qassim University
Gender: ALL
Age: ADULT
Phases:
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-04-15
Completion Date: 2019-08-15
Results First Posted:
Last Update Posted: 2021-07-15
Locations: Qassim University, Buraydah, Saudi Arabia
URL: https://clinicaltrials.gov/show/NCT03970772