Ketone Monitoring for Type 1 Diabetes on SGLT-2 Inhibitors

This study is looking at how different education plans for monitoring ketones (substances produced when the body burns fat for energy) can help people with Type 1 Diabetes (T1D) who are taking a medication called sotagliflozin. Sotagliflozin is an SGLT-2 inhibitor, a type of drug that can increase the risk of diabetic ketoacidosis (DKA), a serious condition. Researchers want to see if a special education plan using continuous ketone monitoring can better prevent DKA compared to a general education plan. You might be able to join if you are 18 to 40 years old, have Type 1 Diabetes, and your HbA1c (a measure of blood sugar control) is less than 9%. The study will measure how many ketone events (when ketone levels are high) occur over 6 months to see if the special education plan is effective. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 75 participants. It will compare a special education plan with continuous ketone monitoring to a general education plan.
What's involved
Participants will be asked to take the SGLT-2 inhibitor (sotagliflozin) and will undergo an Insulin Withdrawal Test (IWT) while being monitored.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, ketone events, will be measured at 6 months.

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NCT07421518

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

Not Yet Recruiting
PHASE2Ages 18–40InterventionalPrevention
AdventHealth Translational Research Institute
~75 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:SGLT-2 inhibitor (Sotagliflozin)Insulin withdrawal test (IWT)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Measured over 6 months
Type 1 Diabetes
Type 2 Diabetes
1 sites across 1 states
Florida1
  • Richard Pratley, MD · PRINCIPAL_INVESTIGATOR · AdventHealth

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  • Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L6 months

    Number of ketone events with BOHB \> 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is \< 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.