GUARDIA: Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas
Study Details
Study Description
Brief Summary
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 (ergocylce) 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
- fasting exercise and 2) late luteal phase of the menstrual cycle.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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Participants will be admitted at the research center (IRCM; Montréal or Alberta) at 15:30.
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A venous catheter will be installed for plasma glucose and insulin measurements.
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At 16:00, the temporary BG target will be set in the DIY-AID system and blood sampling will begin.
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At 16:40, if glucose is < 5.5 mmol/L, 16g carbohydrate (CHO; 4 Dex4®) will be provided.
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At 16:55, a smaller sample will be taken only to verify glucose level. If glucose is < 5.5 mmol/L, 16g CHO (4 Dex4®) will be provided and exercise start will be postponed by at least 15 minutes or until glucose level is > 5.5 mmol/L. If more than three CHO intake are needed, the test will be canceled and rescheduled.
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At 17:00, exercise will be started if glucose is > 5.5 mmol/L. The exercise will consist of 60 minutes on the ergocycle at 60% of pre-determined VO2peak (moderate intensity).
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At 18:00, exercise and temporary BG target will be stopped. Blood sampling will continue for 1-hr during recovery.
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At 19:00, participant will be discharged. If glucose level is below 5.0 mmol/L, a snack of 16g CHO (4 Dex4®) will be offered. Participants will have the option to bring their dinner and eat it at the research facility before leaving if they prefer.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Temporary target of 8.3 mmol/L Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention. |
Other: Physical activity trial intervention
60 minutes aerobic ergocyle exercice at 60% VO2 Peak
|
| Experimental: Temporary target of 8.8 mmol/L Temporary target set 60 minutes before the intervention |
Other: Physical activity trial intervention
60 minutes aerobic ergocyle exercice at 60% VO2 Peak
|
| Experimental: Temporary target of 9.3 mmol/L Temporary target set 60 minutes before the intervention |
Other: Physical activity trial intervention
60 minutes aerobic ergocyle exercice at 60% VO2 Peak
|
Outcome Measures
Primary Outcome Measures
- Change in plasma glucose during exercise [60 minutes (during exercice)]
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.
Secondary Outcome Measures
- Time in range during exercice: menstrual cycle phases [60 minutes (during exercice)]
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.
- Time in range (during fasting exercice) [60 minutes (during exercice)]
The intervention will be repeated at the glycemic threshold targeted during the primary outcome
- Number of hypoglycemic episodes [60 minutes (during exercice)]
number of hypoglycemic episodes (plasma glucose < 4.0 mmol/L) during exercise.
- Number of participants who required oral treatment during exercise [60 minutes (during exercice)]
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.
- Lowest plasma glucose [60 minutes (during exercice)]
Lowest plasma glucose level during exercise
- Plasma glucose at 60 minutes [60 minutes]
plasma glucose level at the end of exercise
- Carbohydrate consumption (g) [60 minutes (during exercice)]
amount of carbohydrate (CHO) needed to increase glucose value
- Insulin on board (units) [60 minutes (during exercice)]
Insulin on board or active insulin at exercise onset (Units will be collected on insulin pump) from start to finish
- Plasma insulin [60 minutes (during exercice)]
plasma insulin changes from exercise start to finish (uU/mL)
- Percent time in range, in hypoglycemia and in hyperglycemia [6 hours post-exercice]
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
- Percent time in range, in hypoglycemia and in hyperglycemia [midnight to 6 am]
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
- Mean CGM glucose [24 hours post-exercice]
post-exercice until 6 am
- Glucose variability [midnight to 6 am]
post-exercice until 6 am; assessed by the CGM standard deviation
- Coefficient of variation [midnight to 6 am]
post-exercice until 6 am; assessed by the coefficient of variation
- Coefficient of variation [24 hours post-exercice]
post-exercice until 6 am; assessed by the coefficient of variation
- Glucose variability [24 hours post-exercice]
post-exercice until 6 am; assessed by the CGM standard deviation
- Number of participants requiring an oral treatment for hypoglycemia [midnight to 6 am]
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
- Number of participants requiring an oral treatment for hypoglycemia [24 hours post-exercice]
Number of participants requiring an oral treatment for hypoglycemia (< 3.9 mmol/L) until 6 am.
- Hypoglycemia with treatment [24 hours post-exercice]
Total number of hypoglycemia episodes requiring treatment
- Hypoglycemia with treatment [midnight to 6 am]
Total number of hypoglycemia episodes requiring treatment
- Carbohydrate needed (g) [midnight to 6 am]
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
- Carbohydrate needed (g) [24 hours post-exercice]
total amount of carbohydrate (CHO) needed to treat hypoglycemic events.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females aged between 18 and 65 years old.
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Clinical diagnosis of type 1 diabetes for 1 year. (Note: The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
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Treatment using DIY-AID system for 3 months.
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Own a smartphone or tablet to use the mobile application: Keenoa, Fitbit App
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Using Dexcom G6 and willing to share CGM data with the research team.
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Using rapid- (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
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HbA1c < 8.5%.
Exclusion Criteria:
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Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
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Restriction in PA due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.). Uncontrolled hypertension (e.g., blood pressure > 150 mmHg systolic or > 95 mmHg diastolic).
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Ongoing pregnancy or breastfeeding.
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Inability to give consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut de recherches cliniques de Montréal | Montreal | Quebec | Canada | H2W1R7 |
Sponsors and Collaborators
- Institut de Recherches Cliniques de Montreal
- University of Alberta
Investigators
- Principal Investigator: Remi Rabasa-Lhoret, MD, PhD, IRCM
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-1223