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| Name | Class |
|---|---|
| Institut de Recherches Cliniques de Montreal | OTHER |
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It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction of insulin basal rate 40 minutes prior to exercise | Active Comparator |
| |
| Reduction of insulin basal rate 90 minutes prior to exercise | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise 1 | Other | Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in glucose levels | 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 exercise | 60 minutes (exercise period) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels spent below 4 mmol/L | 60 minutes (exercise period) | |
| Decremental area under the curve of glucose levels | 60 minutes (exercise period) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Semah Tagougui | Contact | 514-987-5500 | 3295 | semah.tagougui@ircm.qc.ca |
| Virginie Messier | Contact | 514-987-5500 | 3227 | virginie.messier@ircm.qc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Laurent Legault | Montreal Children's Hospital of the MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Recruiting | Montreal | Quebec | H2W 1R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35099281 | Derived | Tagougui S, Legault L, Heyman E, Messier V, Suppere C, Potter KJ, Pigny P, Berthoin S, Taleb N, Rabasa-Lhoret R. Anticipated Basal Insulin Reduction to Prevent Exercise-Induced Hypoglycemia in Adults and Adolescents Living with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):307-315. doi: 10.1089/dia.2021.0375. Epub 2022 Apr 27. |
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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 |
|---|---|
| D007328 | Insulin |
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Exercise 2 | Other | Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged. |
|
| Dexcom G4 Platinum | Device | The Dexcom G4 Platinum will be used to measure continuous glucose levels. |
|
| Insulin | Drug | Participant's usual fast-acting insulin analog will be used. |
|
| Insulin pump | Device | Participant's insulin pump will be used to infuse insulin. |
|
| Area under the curve of glucose levels < 4 mmol/L |
| 60 minutes (exercise period) |
| Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L | 60 minutes (exercise period) |
| Number of patients with an exercise-induced hypoglycemia < 3.5 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 glucose levels spent > 10 mmol/L | 60 minutes (exercise period) |
| Percentage of time of glucose levels spent between 4-10 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) |
| Muscle blood flow | 60 minutes (exercise period) |
| Percentage of time of glucose levels spent between 4 and 10 mmol/L | 4 hours following end of exercise |
| Percentage of time of glucose levels spent < 4 mmol/L | 4 hours following end of exercise |
| Percentage of time of glucose levels spent > 10 mmol/L | 4 hours following end of exercise |
| Area under the curve of glucose levels < 4 mmol/L | 4 hours following end of exercise |
| Number of patients requiring an oral treatment for hypoglycemia | 4 hours following end of exercise |
| Total number of hypoglycemia episodes requiring treatment | 4 hours following end of exercise |
| Total amount of carbohydrates needed to treat hypoglycemic events | 4 hours following end of exercise |
| Percentage of time of glucose levels spent between 4 and 10 mmol/L | From the end of exercise period to 6:00 next morning (11 hours) |
| Percentage of time of glucose levels spent < 4 mmol/L | From the end of exercise period to 6:00 next morning (11 hours) |
| Percentage of time of glucose levels spent > 10 mmol/L | From the end of exercise period to 6:00 next morning (11 hours) |
| Area under the curve of glucose levels < 4 mmol/L | From the end of exercise period to 6:00 next morning (11 hours) |
| Number of patients requiring an oral treatment for hypoglycemia | From the end of exercise period to 6:00 next morning (11 hours) |
| Total number of hypoglycemia episodes requiring treatment | From the end of exercise period to 6:00 next morning (11 hours) |
| Total amount of carbohydrates needed to treat hypoglycemic events | From the end of exercise period to 6:00 next morning (11 hours) |
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |