Phase 3CompletedNCT05205928

Semaglutide with AID: randomized crossover trial

What this study tests

A small double-blind crossover trial in adults with T1D found that semaglutide improved glucose time in range alongside automated insulin delivery. Twenty-eight people were randomized and 24 completed both treatment periods.

Editorial review: 2026-09-16. What was checked and what remains uncertain.

Registry checked: 2026-09-16. Registry’s own update: 2025-01-22.

Latest dated source in the citation list: 2025-01-10. This is the source’s date, not a new review of every claim.

Trial status, labels and access can change between reviews.

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?: Adults with T1D using an insulin pump; the full registry lists metabolic, device and safety criteria. This completed Canadian study is not enrolling. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results: During the final four weeks of each treatment period, time in 70–180 mg/dL (3.9–10.0 mmol/L) was 4.8 percentage points higher with semaglutide than placebo (P=0.006). Two episodes of euglycemic ketosis occurred on semaglutide, without acidosis. No severe hypoglycemia occurred on semaglutide; the full paper reports one event during placebo titration associated with CGM malfunction.[^paper]Read the result sources and their limitations →
Important harms: Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval: Study regions: Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?: Read this trial’s review notes for the checks completed and what remains unresolved. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo) — 4 weeks

The full picture

What the study asks

Who it involves

Adults with T1D using an insulin pump; the full registry lists metabolic, device and safety criteria. This completed Canadian study is not enrolling. This is a summary; the full registry lists additional criteria.¹

Design and timing

The registry lists 28 participants (actual enrollment). Primary completion: 2024-04-15 (actual). Study completion: 2024-06-30 (actual). Estimated dates can change and do not mean results are available.¹

Evidence and limits

During the final four weeks of each treatment period, time in 70–180 mg/dL (3.9–10.0 mmol/L) was 4.8 percentage points higher with semaglutide than placebo (P=0.006). Two episodes of euglycemic ketosis occurred on semaglutide, without acidosis. No severe hypoglycemia occurred on semaglutide; the full paper reports one event during placebo titration associated with CGM malfunction.²

A short crossover trial cannot determine rare adverse events or long-term outcomes. Ketosis without marked hyperglycemia is a relevant safety signal even though DKA did not occur in this study.

ClinicalTrials.gov. NCT05205928. Record checked 16 September 2026; last update posted 2025-01-22. https://clinicaltrials.gov/study/NCT05205928 ↩ ↩²
Pasqua MR et al. Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial. Nature Medicine, 10 January 2025. https://www.nature.com/articles/s41591-024-03463-z ↩

Sources

[1]Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care (NCT05205928) · registry — Protocol and current registry status checked 16 September 2026.
[2]Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial · peer-reviewed · 2025-01-10