CKM for safer SGLT2 inhibitor use in type 1 diabetes
What this study tests
Randomized crossover study comparing 200 mg and 400 mg sotagliflozin in adults with T1D on injections or hybrid closed-loop therapy. Dual glucose/ketone monitoring measures ketone exposure; this design does not by itself show that monitoring prevents DKA.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-10-08.
Most recent recorded citation date: 2025-10-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults with type 1 diabetes. 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
- No results posted yet.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: United States. 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 the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Time with beta-hydroxybutyrate above0.6mmol/L during the200mg and400mg dosing periods, compared between injection and hybrid closed-loop groups
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]CKM For Safe Use of SGLT2i in Type 1 Diabetes · Trial registry · 2025-10-08