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Clinical Trial Details

Trial ID: L5535
Source ID: NCT03659799
Associated Drug: Insulin Fiasp
Title: Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Insulin FiAsp|DRUG: Insulin Aspart|OTHER: 60-minutes postprandial exercise|OTHER: 120-minutes postprandial exercise
Outcome Measures: Primary: Decrease in plasma glucose levels during exercise, Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of the exercise, 60 minutes (exercise period) | Secondary: Percentage of time of plasma glucose levels spent below 4 mmol/L, 60 minutes (exercise period)|Decremental area under the curve of plasma glucose levels, 60 minutes (exercise period)|Area under the curve of plasma glucose levels below 4 mmol/L, 60 minutes (exercise period)|Number of patients with an exercise-induced hypoglycemia below 3.9 mmol/L, 60 minutes (exercise period)|Number of patients with an exercise-induced hypoglycemia below 3.3 mmol/L, 60 minutes (exercise period)|Number of patients requiring an oral treatment for hypoglycemia, 60 minutes (exercise period)|Total number of hypoglycemia episodes requiring treatment, 60 minutes (exercise period)|Percentage of time of plasma glucose levels spent above 10 mmol/L, 60 minutes (exercise period)|Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L, 60 minutes (exercise period)|Mean time (minutes) to the first hypoglycemic event, 60 minutes (exercise period)|Amount of carbohydrates needed to treat a hypoglycemic event, 60 minutes (exercise period)|Change in oxyhemoglobin in the vastus lateralis, 60 minutes (exercise period)|Changes in deoxyhemoglobin in the vastus lateralis, 60 minutes (exercise period)|Changes in total hemoglobin in the vastus lateralis, 60 minutes (exercise period)|Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L, 90 minutes after the end of exercise|Percentage of time of plasma glucose levels spent below 4 mmol/L, 90 minutes after the end of exercise|Percentage of time of plasma glucose levels spent above 10 mmol/L, 90 minutes after the end of exercise|Area under the curve of plasma glucose levels below 4 mmol/L, 90 minutes after the end of exercise|Number of patients requiring an oral treatment for hypoglycemia, 90 minutes after the end of exercise|Total number of hypoglycemia episodes requiring treatment, 90 minutes after the end of exercise|Total amount of carbohydrates needed to treat hypoglycemic events, 90 minutes after the end of exercise|Area under the curve of plasma glucose levels, 4.5 hours (entire protocol period)|Total number of hypoglycemia episodes requiring treatment, 4.5 hours (entire protocol period)|Total amount of carbohydrates needed to treat hypoglycemic events, 4.5 hours (entire protocol period)
Sponsor/Collaborators: Sponsor: Institut de Recherches Cliniques de Montreal
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-04-12
Completion Date: 2023-03-30
Results First Posted:
Last Update Posted: 2023-09-01
Locations: Institut de recherches cliniques de Montréal, Montréal, Quebec, H2W 1R7, Canada
URL: https://clinicaltrials.gov/show/NCT03659799