NCT07421518

Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors

Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: AdventHealth Translational Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Type 1 Diabetes
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	SGLT-2 inhibitor (Sotagliflozin)	Participants will be asked to take the SGLT-2 inhibitor.
OTHER	Insulin withdrawal test (IWT)	An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study