Managing blood glucose levels during exercise for adults with type 1 diabetes using an artificial pancreas

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)"

This study is testing the best blood sugar levels for adults with type 1 diabetes to aim for before and during exercise using a DIY artificial pancreas.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institut de Recherches Cliniques de Montreal (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05821322 on ClinicalTrials.gov

What this trial studies

This study aims to determine the optimal blood glucose target for individuals with type 1 diabetes before and during aerobic exercise using do-it-yourself automated insulin delivery systems. A total of 32 participants will be randomized to test three different glycemic thresholds (8.3, 8.8, and 9.3 mmol/L) during three separate exercise sessions on an ergocycle. Blood glucose levels will be monitored closely before, during, and after the exercise to assess the effectiveness of each target. The study follows a randomized, cross-over design to ensure each participant experiences all conditions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a clinical diagnosis of type 1 diabetes for at least one year and using a DIY-AID system.

Not a fit: Patients with recent major complications or significant diabetes-related restrictions on physical activity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help improve exercise safety and management for patients with type 1 diabetes by identifying optimal blood glucose targets.

How similar studies have performed: Other studies have explored blood glucose management during exercise in diabetes, but this specific approach using DIY-AID systems is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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%.

Exclusion Criteria:

* Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
* 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).
* Ongoing pregnancy or breastfeeding.
* Inability to give consent.

Where this trial is running

Montreal, Quebec

• Institut de recherches cliniques de Montréal — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Remi Rabasa-Lhoret, MD, PhD — IRCM
• Study coordinator: Valérie Boudreau, PhD

Conditions: Type 1 Diabetes, Artificial pancreas, Exercice, Hypoglycemia