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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Despite recent medical and technological advances, optimal glycemic control (time in range; TIR) and prevention of hypoglycemia remain significant challenges for people living with type 1 diabetes (T1DM). Automated insulin delivery systems (AIDs) combine an insulin pump coupled via an algorithm with a continuous glucose monitor (CGM), allowing constant adjustment of insulin doses according to blood glucose levels. Despite the significant improvement in blood glucose parameters and quality of life with these systems, they are not available to everyone and more and more people with diabetes are resorting to home-made or do-it-yourself (DIY) systems to access this technology. DIY systems are not approved or regulated by Health Canada, despite the growing interest. There have been no studies looking at this type of system in active people living with DbT1, including the risk of exercise-induced hypoglycemia. The primary objective of this study is to evaluate the safety and efficacy of IDA systems in physically active individuals living with type 1 diabetes.This is a real-life observational study in people with commercial IDA (control group) and IDA-DIY. This study includes only one inclusion visit (which may be virtual) and the observation period is 6 weeks. Participants will be required to wear their own artificial pancreas system and give us access to blood glucose and insulin data at the end of the study. They will be required to wear a watch to record physical activity (FitBit). We will ask them to complete information about their diet at least twice a week for a whole day (Keenoa application). Finally, participants will be asked to complete a physical activity diary to complete data (carbohydrates in prevention of activity, insulin suspension, hypoglycemia during or after exercise, etc.).

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

• Males and females aged ≥ 18 years old.

• 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.)

• Using automated insulin delivery systems (Commercial or DIY) for at least 3 months.

• Willing to share CGM data and insulin pump data with the research team. This access will be limited to the study period.

• Exercising at least twice weekly (Questionnaire assessment MAQ) or willing to exercise at least twice weekly during the study period.

• Willing to share physical activity tracker data with the research team and if applicable, data about the menstrual cycle.

Locations
Other Locations
Canada
Institut de Recherches Cliniques de Montréal (IRCM)
RECRUITING
Montreal
Contact Information
Primary
Valérie Boudreau, PhD
valerie.boudreau@ircm.qc.ca
5149875643
Backup
Joséphine Molveau, Msc
josephine.molveau@ircm.qc.ca
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Observationnal cohort
Patients with type 1 diabetes and using an AID system.
Sponsors
Leads: Institut de Recherches Cliniques de Montreal
Collaborators: University of Alberta

This content was sourced from clinicaltrials.gov