Not provided
Not provided
Not provided
Not provided
The protocol did not work.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Alberta | OTHER |
Not provided
Not provided
Not provided
Not provided
Despite major technological advances in type 1 diabetes (artificial pancreas), the management of hypoglycemia remains a major challenge, especially during and after physical activity. The primary outcome is to determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in people with type 1 diabetes (PWT1D) using do-it-yourself automated insulin delivery (DIY-AID) systems. Three glycemic thresholds to be applied 60 minutes before physical activity will be tested in 32 people on AID-DIY: 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. Each participant will perform 3 sessions of moderate aerobic physical activity (ergocycle) at 60% of vo2peak with a different glycemic target each time (random order). Plasma glucose will be measured every 20 minutes before and during physical activity, and blood glucose measured by continuous glucose reading (DEXCOM) for 24 hours post-intervention. Once the best glycemic target is selected, participants could come to the research center for 1 or 2 more voluntary interventions to test the threshold during 1) fasting exercise and 2) late luteal phase of the menstrual cycle.
This study follows a randomized, cross-over design and aims to test tree temporary BG targets (8.3, 8.8 and 9.3 mmol/L), resulting in 3 intervention visits per participants. A total of 32 participants will be recruited and randomized for this study.
Intervention visit:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporary target of 8.3 mmol/L | Active Comparator | Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention. |
|
| Temporary target of 8.8 mmol/L | Experimental | Temporary target set 60 minutes before the intervention |
|
| Temporary target of 9.3 mmol/L | Experimental | Temporary target set 60 minutes before the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity trial intervention | Other | 60 minutes aerobic ergocyle exercice at 60% VO2 Peak |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma glucose during exercise | To determine the temporary blood glucose (BG) target to be set 60 minutes before aerobic exercise in PWT1D using DIY-AID systems which will be associated with the smallest change in glucose during exercise by testing the targets of 8.3 (current target for commercial AID systems), 8.8, and 9.3 mmol/L. | 60 minutes (during exercice) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range during exercice: menstrual cycle phases | Volunteer participants will return in the luteal phase of the menstrual cycle to repeat the intervention at the glycemic threshold targeted during the primary outcome. | 60 minutes (during exercice) |
| Time in range (during fasting exercice) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Remi Rabasa-Lhoret, MD, PhD | IRCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Montreal | Quebec | H2W1R7 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The intervention will be repeated at the glycemic threshold targeted during the primary outcome |
| 60 minutes (during exercice) |
| Number of hypoglycemic episodes | number of hypoglycemic episodes (plasma glucose < 4.0 mmol/L) during exercise. | 60 minutes (during exercice) |
| Number of participants who required oral treatment during exercise | Number of participants who required oral treatment during exercise for: a) plasma glucose value < 4.5 mmol/L and b) plasma glucose value < 4.0 mmol/L. | 60 minutes (during exercice) |
| Lowest plasma glucose | Lowest plasma glucose level during exercise | 60 minutes (during exercice) |
| Plasma glucose at 60 minutes | plasma glucose level at the end of exercise | 60 minutes |
| Carbohydrate consumption (g) | amount of carbohydrate (CHO) needed to increase glucose value | 60 minutes (during exercice) |
| Insulin on board (units) | Insulin on board or active insulin at exercise onset (Units will be collected on insulin pump) from start to finish | 60 minutes (during exercice) |
| Plasma insulin | plasma insulin changes from exercise start to finish (uU/mL) | 60 minutes (during exercice) |
| Percent time in range, in hypoglycemia and in hyperglycemia | Percentage of time < 3.0 mmol/L, between 3.0-3.9 mmol/L, between 3.9-10.0 mmol/L, between 10.1-13.9 mmol/L, and > 13.9 mmol/L post-exercice until 6 am | 6 hours post-exercice |
| Percent time in range, in hypoglycemia and in hyperglycemia | Percentage of time < 3.0 mmol/L, between 3.0-3.9 mmol/L, between 3.9-10.0 mmol/L, between 10.1-13.9 mmol/L, and > 13.9 mmol/L post-exercice until 6 am | midnight to 6 am |
| Mean CGM glucose | post-exercice until 6 am | 24 hours post-exercice |
| Glucose variability | post-exercice until 6 am; assessed by the CGM standard deviation | midnight to 6 am |
| Coefficient of variation | post-exercice until 6 am; assessed by the coefficient of variation | midnight to 6 am |
| Coefficient of variation | post-exercice until 6 am; assessed by the coefficient of variation | 24 hours post-exercice |
| Glucose variability | post-exercice until 6 am; assessed by the CGM standard deviation | 24 hours post-exercice |
| Number of participants requiring an oral treatment for hypoglycemia | Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am. | midnight to 6 am |
| Number of participants requiring an oral treatment for hypoglycemia | Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am. | 24 hours post-exercice |
| Hypoglycemia with treatment | Total number of hypoglycemia episodes requiring treatment | 24 hours post-exercice |
| Hypoglycemia with treatment | Total number of hypoglycemia episodes requiring treatment | midnight to 6 am |
| Carbohydrate needed (g) | total amount of carbohydrate (CHO) needed to treat hypoglycemic events. | midnight to 6 am |
| Carbohydrate needed (g) | total amount of carbohydrate (CHO) needed to treat hypoglycemic events. | 24 hours post-exercice |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |