Evaluating the Appropriate Blood Glucose Target Before and During Moderate Intensity Aerobic Exercise in Adults With Type 1 Diabetes Using Do-it-yourself Automated Insulin Delivery (AID) Systems (the GUARDIA [GlUcose tARget DIY-AID] Trial)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 (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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Males and females aged between 18 and 65 years old.

• 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.)

• Treatment using DIY-AID system for 3 months.

• Own a smartphone or tablet to use the mobile application: Keenoa, Fitbit App

• Using Dexcom G6 and willing to share CGM data with the research team.

• Using rapid- (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.

• HbA1c \< 8.5%.

Locations
Other Locations
Canada
Institut de recherches cliniques de Montréal
RECRUITING
Montreal
Contact Information
Primary
Valérie Boudreau, PhD
valerie.boudreau@ircm.qc.ca
514 987-5643
Backup
Roxane St-Amand, Mec
roxane.st-amand@ircm.qc.ca
514 987-5500
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 32
Treatments
Active_comparator: Temporary target of 8.3 mmol/L
Current commercial artificial pancreas thresholds. Temporary target set 60 minutes before the intervention.
Experimental: Temporary target of 8.8 mmol/L
Temporary target set 60 minutes before the intervention
Experimental: Temporary target of 9.3 mmol/L
Temporary target set 60 minutes before the intervention
Related Therapeutic Areas
Sponsors
Leads: Institut de Recherches Cliniques de Montreal
Collaborators: University of Alberta

This content was sourced from clinicaltrials.gov