Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
Part of paid clinical trials in Orlando, Florida.
- Sponsor
- AdventHealth Translational Research Institute
- Study ID
- NCT07421518
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Accepted
Interventions
- SGLT-2 inhibitor (Sotagliflozin) — DRUGParticipants will be asked to take the SGLT-2 inhibitor.
- Insulin withdrawal test (IWT) — OTHERAn Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.
Study Details
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Feb 2026
- Primary completion
- Apr 30, 2030
- Completion
- Apr 30, 2030
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- PREVENTION
Arms
- Other: People with Type 1 Diabetes
Primary Outcome Measure
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L [ Time Frame: 6 months ]
Central Contacts
- JaWanda Thacker407-303-7100
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AdventHealth Translational Research Institute | Orlando | Florida | 32804 | - |
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