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Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unannounced exercise | Active Comparator | The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given. |
|
| Announced exercise with pre-meal full bolus | Active Comparator | The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given |
|
| Announced exercise with reduced insulin bolus | Active Comparator | The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60-minute exercise | Other | Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose levels spent below 3.9 mmol/L | From 9:30 to 11:30 (120 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative decrease in glucose levels during exercise compared to pre-breakfast levels | Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise | From 8:00 to 10:50 (170 minutes) |
| Number of patients experiencing exercise-induced hypoglycemia requiring treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi 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 |
|---|---|---|---|
| 32740723 | Derived | Tagougui S, Taleb N, Legault L, Suppere C, Messier V, Boukabous I, Shohoudi A, Ladouceur M, Rabasa-Lhoret R. A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: announced (with or without bolus reduction) vs unannounced exercise strategies. Diabetologia. 2020 Nov;63(11):2282-2291. doi: 10.1007/s00125-020-05244-y. Epub 2020 Aug 1. |
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|
| Insulin pump | Device | Patient's insulin pump will be used to infuse insulin. |
|
| Dexcom G4 Platinum glucose sensor | Device | The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels. |
|
| Insulin | Drug | Patient's usual fast-acting insulin analog will be used. |
|
| Single-hormone closed-loop strategy | Other | Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates. |
|
| From 9:30 to 10:30 (60 minutes) |
| Decremental area under the curve from the start of the exercise | From 9:30 to 11:00 (90 minutes) |
| Percentage of time of plasma glucose levels spent below 3.9 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent below 3.3 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent below 2.8 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent above 10 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent above 13.9 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Percentage of time of plasma glucose levels spent above 16.7 mmol/L | From 9:30 to 10:30 (60 minutes) |
| Mean plasma glucose levels | From 8:00 to 11:30 (210 minutes) |
| Standard deviation of glucose levels | From 8:00 to 11:30 (210 minutes) |
| Coefficient of variation of glucose levels | From 8:00 to 11:30 (210 minutes) |
| Mean time (minutes) to the first hypoglycemic event | From 9:30 to 10:30 (60 minutes) |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D007332 | Insulin Infusion Systems |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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