Continuous Ketone Monitoring for Type 1 Diabetes and Kidney Disease
This study is for people aged 18-75 with type 1 diabetes and chronic kidney disease. It aims to reduce the risk of diabetic ketoacidosis (DKA), a serious complication, when using the medication sotagliflozin. All participants will start on 200mg/day of sotagliflozin. After three months, some may increase to 400mg/day if their blood sugar control isn't optimal and their kidney function is moderate or better. Researchers will measure how often ketones are elevated and the number of DKA episodes to see if this approach is successful. The study's status is unclear, and it plans to enroll 80 people.
- Study design
- This is an interventional study planning to enroll 80 participants. All participants will receive the drug sotagliflozin.
- What's involved
- Participants will start on sotagliflozin and may have their dose adjusted after three months. The study measures changes in ketone levels and DKA episodes over three months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at three months following sotagliflozin initiation.
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Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Richard Bergenstal, MD · PRINCIPAL_INVESTIGATOR · HealthPartners/Park Nicollet International Diabetes Center
Who to contact
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What this trial measures
- Change in time in ketone range >1.5/mmol/L3 months, 6 months, 9 months
- Number of episodes of diabetic ketoacidosis (DKA)6 months, 9 months