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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Richard Pratley, MD · PRINCIPAL_INVESTIGATOR · AdventHealth
Who to contact
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What this trial measures
- 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.