Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Institut de Recherches Cliniques de Montreal
Updated on 6 March 2021
diabetes
insulin
treatment regimen
hemoglobin a1c
glycosylated hemoglobin
hypoglycaemic
hypoglycemia
hypoglycemic agents
hypoglycemic drugs
fiasp

Summary

Hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (T1D). For postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. The impact of faster acting Aspart (FiAsp) pharmacokinetic on hypoglycemic risk has not yet been explored. This study will explore two different timings for exercise onset.

Objective: To compare the impact of rapid-acting insulin Aspart and faster acting Aspart (FiAsp) on glucose reduction during exercise.

Design: This study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin Aspart, and 2) FiAsp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. The insulin used and the timing of the exercise will be randomized. This project will be conducted at Institut de recherches cliniques de Montral (IRCM, Montreal, Canada).

Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.

Details
Condition Diabetes Mellitus, Insulin dependent diabetes mellitus, Autoimmune disease, Diabetes Mellitus, Type 1, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), type 1 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus
Treatment Insulin Aspart, Insulin FiAsp, 60-minutes postprandial exercise, 120-minutes postprandial exercise
Clinical Study IdentifierNCT03659799
SponsorInstitut de Recherches Cliniques de Montreal
Last Modified on6 March 2021

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