Evaluating automated insulin delivery systems in active adults with type 1 diabetes

An Observational Study to Assess the Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults with Type 1 Diabetes in Free-living Conditions (AIDE-1)

This study tests how well automated insulin delivery systems work for active adults with type 1 diabetes and if they help manage blood sugar levels during exercise.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut de Recherches Cliniques de Montreal (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05626725 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of automated insulin delivery (AID) systems in adults with type 1 diabetes who are physically active. It focuses on individuals using either commercial or do-it-yourself AID systems for at least three months. The research aims to understand how these systems perform in managing blood glucose levels during exercise and to evaluate the risk of exercise-induced hypoglycemia. Participants will share their continuous glucose monitor and insulin pump data with the research team throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults who are using automated insulin delivery systems and exercise regularly.

Not a fit: Patients who do not understand French or English or are not currently using automated insulin delivery systems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance glycemic control and reduce the risk of hypoglycemia for physically active adults with type 1 diabetes.

How similar studies have performed: While there is growing interest in automated insulin delivery systems, this specific focus on physically active adults and DIY systems is relatively novel and has not been extensively studied.

Eligibility criteria

Inclusion Criteria:

1. Males and females aged ≥ 18 years old.
2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year. (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
3. Using automated insulin delivery systems (Commercial or DIY) for at least 3 months.
4. Willing to share CGM data and insulin pump data with the research team. This access will be limited to the study period.
5. Exercising at least twice weekly (Questionnaire assessment MAQ) or willing to exercise at least twice weekly during the study period.
6. Willing to share physical activity tracker data with the research team and if applicable, data about the menstrual cycle.

Exclusion Criteria:

1. Do not understand French or English
2. Anticipated therapeutic change (including change of insulin type \[switching to biosimilar is acceptable\] and/or type of CGM sensor) between admission and end of the study.
3. Anticipated need to use acetaminophen (dose above 1g every 6 hours) or vitamin C (dose above 500mg DIE) between admission and end of the study.
4. Pregnancy (ongoing or current attempt to become pregnant).
5. Breastfeeding.
6. Uncontrolled thyroid disease (recent less than 5 months TSH should be in target range and treatment stable for at least 6 weeks).
7. Severe hypoglycemic episode within two weeks of screening.
8. Severe hyperglycemic episodes requiring hospitalization in the last 3 months
9. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®).
10. Current use of adjunct therapy such as SGLT-2 inhibitors or GLP_1 receptor analog unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed in case of off-label SGLT2 usage.
11. Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).
12. Physically inactive participants (see inclusion criteria #5).
13. People with professional activities involving night shifts, as it may influence glycemic profiles differently compared to people working days and sleeping nights.
14. In the opinion of the investigator, a participant who is unable or unwilling to complete the study (e.g., recent injury, foot wound, etc.).

Where this trial is running

Montreal, Quebec

• Institut de Recherches Cliniques de Montréal (IRCM) — Montreal, Quebec, Canada (RECRUITING)

Study contacts

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

Conditions: Type 1 Diabetes