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To prevent hypoglycemia during prolonged exercise (>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing ~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full snack given before exercise | Active Comparator | A snack containing ~0.5g of carbohydrates per kilogram of body weight will be given 5 minutes before exercise |
|
| Distributed snack over exercise period | Active Comparator | A snack containing ~0.5g of carbohydrates per kilogram of body weight distributed this way will be given: ~40% given 5 minutes before exercise, ~30% after 20 minutes of exercise and the last ~30% after 40 minutes of exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Participants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of capillary glucose levels spent between 4-10 mmol/L | This time frame corresponds to the exercise period and the 1 hour following it | This outcome will be measured over 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of sensor glucose levels spent between 4-10 mmol/L | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) | |
| Percentage of time of glucose levels spent below 4 mmol/L |
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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 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33632598 | Derived | Goulet-Gelinas L, Saade MB, Suppere C, Fortin A, Messier V, Taleb N, Tagougui S, Shohoudi A, Legault L, Henderson M, Rabasa-Lhoret R. Comparison of two carbohydrate intake strategies to improve glucose control during exercise in adolescents and adults with type 1 diabetes. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1238-1246. doi: 10.1016/j.numecd.2020.12.011. Epub 2020 Dec 17. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D062410 | Snacks |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Snack | Other | Full snack or Distributed snack |
|
| This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Decrease in glucose levels | Difference between glucose level at the start of the exercise and the lowest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise. | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Increase in glucose level | Difference between glucose level at the start of the exercise and the highest glucose level from the start of the exercise until 1) the end of the exercise and 2) 1 hour after the end of the exercise. | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Number of participants with an exercise-induced hypoglycemia below 4 mmol/L | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Number of participants with an exercise-induced hypoglycemia below 3.5 mmol/L | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Number of participants requiring an oral treatment for hypoglycemia | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Total number of hypoglycemia episodes requiring treatment | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Percentage of time of glucose levels spent above 10 mmol/L | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Mean time (minutes) to the first hypoglycemic event | This outcome will be measured for the exercise period only (60 minutes) |
| Mean glucose levels | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Standard deviation of glucose levels | This outcome will be measured for the exercise period only (60 minutes) and for the exercise period and the hour following the exercise (120 minutes) |
| Percentage of time of glucose levels between 4 and 10 mmol/L | Dinner time will be up to the patient. | From the end of the exercise period to dinner time. |
| Percentage of time of glucose levels between 4 and 10 mmol/L | From the end of the exercise period to midnight (7.5 hours) |
| Percentage of time of glucose levels between 4 and 10 mmol/L | From midnight to 6:00 next morning (6 hours) |
| Percentage of time of glucose levels between 4 and 10 mmol/L | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| Percentage of time of glucose levels spent below 4 mmol/L | Dinner time will be up to the patient. | From the end of the exercise period to dinner time |
| Percentage of time of glucose levels spent below 4 mmol/L | From the end of the exercise period to midnight (7.5 hours) |
| Percentage of time of glucose levels spent below 4 mmol/L | From midnight to 6:00 next morning (6 hours) |
| Percentage of time of glucose levels spent below 4 mmol/L | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| Percentage of time of glucose levels spent above 10 mmol/L | Dinner time will be up to the patient | From the end of the exercise period to dinner time |
| Percentage of time of glucose levels spent above 10 mmol/L | From the end of the exercise period to midnight (7.5 hours) |
| Percentage of time of glucose levels spent above 10 mmol/L | From midnight to 6:00 next morning (6 hours) |
| Percentage of time of glucose levels spent above 10 mmol/L | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| Number of participants requiring treatment for hypoglycemia | Dinner time will be up to the patient | From the end of the exercise period to dinner time |
| Number of participants requiring treatment for hypoglycemia | From the end of the exercise period to midnight (7.5 hours) |
| Number of participants requiring treatment for hypoglycemia | From midnight to 6:00 next morning (6 hours) |
| Number of participants requiring treatment for hypoglycemia | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| Number of hypoglycemic episodes requiring treatment | Dinner time will be up to the patient | From the end of the exercise period to dinner time |
| Number of hypoglycemic episodes requiring treatment | From the end of the exercise period to midnight (7.5 hours) |
| Number of hypoglycemic episodes requiring treatment | From midnight to 6:00 next morning (6 hours) |
| Number of hypoglycemic episodes requiring treatment | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| Mean glucose levels | Dinner time will be up to the patient | From the end of the exercise period to dinner time |
| Mean glucose levels | From the end of the exercise period to midnight (7.5 hours) |
| Mean glucose levels | From midnight to 6:00 next morning (6 hours) |
| Mean glucose levels | From the end of the exercise period to 6:00 next morning (13.5 hours) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |