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| Name | Class |
|---|---|
| University of Alberta | OTHER |
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Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia.
The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks.
Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application).
Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observationnal cohort | Patients with type 1 diabetes and using an AID system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated insulin delivery system | Device | This is an outpatient prospective observational study to evaluate the effect of DIY-AID use on maintaining glucose levels in physically active adult people living with T1D. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood glucose levels from start of exercise to nadir during or up to 30 min post exercise. | nadir: the lowest point on a glucose curve | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic events (n) 120-min before, during and 120-min after recorded structured PA sessions | Number of hypoglycemic events | 6 weeks |
| Hypoglycemic events (n) during (at least 15-min) of habitual PA and 30-min after |
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Inclusion Criteria:
Exclusion Criteria:
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Type 1 diabetes using an AID system; Physically active
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, MD, PhD | IRCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recherches Cliniques de Montréal (IRCM) | Montreal | Quebec | H2W 1R7 | Canada |
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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 |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Number of hypoglycemic events
| 6 weeks |
| Time in range 120-min before, during and 120-min after recorded structured PA sessions | Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L | 6 weeks |
| Time in range during (at least 15-min) of habitual PA and 30-min after | Time (min and percentage) with glucose levels a. between 3.9 and 10.0 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L | 6 weeks |
| CHO intake 120-min before, during and 120-min after recorded structured PA sessions | Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L | 6 weeks |
| CHO intake during (at least 15-min) of habitual PA and 30-min after | Carbohydrate intake (g), timing and purpose of CHO intake prior to, during and within 30-min following PA.mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L | 6 weeks |
| Glucose variability 120-min before, during and 120-min after recorded structured PA sessions | Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels | 6 weeks |
| Glucose variability during (at least 15-min) of habitual PA and 30-min after | Glucose variability: Standard deviation (SD) and coefficient of variance (CV) of glucose levels | 6 weeks |
| Total insulin delivery 120-min before, during and 120-min after recorded structured PA sessions | Insulin delivery | 6 weeks |
| Total insulin delivery during (at least 15-min) of habitual PA and 30-min after | Insulin delivery | 6 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |