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NCT07325201 · ClinicalTrials.gov registry record · Phase 2
Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring
A Phase 2 study, sponsored by HealthPartners Institute.
- Not yet
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT07325201 is a Phase 2 study that has not yet begun recruiting, run by HealthPartners Institute. The registered enrollment target is 80 participants.
The verdict
NCT07325201, a Phase 2 study, has not yet begun recruiting, sponsored by HealthPartners Institute.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants with mild to moderate chronic kidney disease and those with normal renal function in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous glucose monitoring (CGM) and continuous ketone monitoring (CKM) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors. 4. Gather information on how participants and clinicians like and use the CGM/CKM reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on the usefulness of CGM/CKM reports
Interventions
- DRUG Sotagliflozin initiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07325201
The ClinicalTrials.gov registry entry for NCT07325201 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HealthPartners Institute, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sotagliflozin initiation is the first listed.
NCT07325201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07325201 about?
NCT07325201 is a clinical study titled "Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring". The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The ma...
What is the current status of trial NCT07325201?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-06. Estimated completion is 2028-08.
What interventions are being tested in trial NCT07325201?
The interventions under investigation include: Sotagliflozin initiation (DRUG).
Who is sponsoring clinical trial NCT07325201?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
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