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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 Montréal (IRCM, Montreal, Canada).
Hypothesis: Faster acting Aspart (FiAsp) will be non-inferior to insulin Aspart for hypoglycemic risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspart - 60-minutes postprandial exercise | Active Comparator |
| |
| Aspart - 120-minutes postprandial exercise | Active Comparator |
| |
| FiAsp - 60-minutes postprandial exercise | Active Comparator |
| |
| FiAsp - 120-minutes postprandial exercise | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin FiAsp | Drug | An insulin bolus of FiAsp will be given 5 minutes before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Remi Rabasa-Lhoret | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Montreal | Quebec | H2W 1R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39069599 | Derived | Molveau J, Myette-Cote E, Tagougui S, Taleb N, St-Amand R, Suppere C, Bourdeau V, Heyman E, Rabasa-Lhoret R. Assessing the influence of insulin type (ultra-rapid vs rapid insulin) and exercise timing on postprandial exercise-induced hypoglycaemia risk in individuals with type 1 diabetes: a randomised controlled trial. Diabetologia. 2024 Nov;67(11):2408-2419. doi: 10.1007/s00125-024-06234-0. Epub 2024 Jul 29. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Aspart | Drug | An insulin bolus of Aspart will be given 5 minutes before breakfast |
|
| 60-minutes postprandial exercise | Other | A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast |
|
| 120-minutes postprandial exercise | Other | A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast |
|
| 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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |