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NCT05626725: AIDE-1
Safety and Effectiveness of Automated Insulin Delivery (AID) Systems in Physically Active Adults With Type 1 Diabetes
trial testing Automated insulin delivery system in Type 1 Diabetes in 76 participants. Completed in 31 August 2025.
31 July 2025
Quick facts
| Lead sponsor | Institut de Recherches Cliniques de Montreal |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 76 |
| Start date | 1 December 2022 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 August 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Automated insulin delivery system
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Institut de Recherches Cliniques de Montreal — full company profile →
Who can join
18 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05626725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Institut de Recherches Cliniques de Montreal trials
Trials by the same sponsor.
- NCT07322380 — Feasibility and Adoption of a Screening Program for T1D Relatives in Canada · NA · not yet recruiting
- NCT07475962 — Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes · not yet recruiting
- NCT06683391 — Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living With Type 1 Diabetes · NA · recruiting
- NCT05821322 — Blood Glucose Target Before and During Exercise in Adults With Type 1 Diabetes Using an Artificial Pancreas · NA · terminated
- NCT05449678 — Low cArbohydraTe dIeT and aUtomated Insulin Delivery System for Type 1 DiabetEs · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05626725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut de Recherches Cliniques de Montreal
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05626725.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing