Not Yet RecruitingPhase 2

Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring

United States80 participantsStarted 2026-06

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Males and females; Ages 18-75. * Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening. * Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)). * Most recent eGFR ≥30 (and within prior 12 months). * HbA1c \<10%. 8) Have had ≥1 primary or specialty ambulatory visit(s) in the past year in the HealthPartners care system. * Have never been prescribed SGLT2i medications. * Must be willing and able to wear a CGM/CKM device and willing to follow the study protocol. * Must be able to read and speak English. * Use of adequate contraception for the duration of the study be the women of childbearing potential. * Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). Exclusion Criteria: * Pregnancy, lactation, planning to become pregnant or unwillingness to be on contraception during the trial. * Any form of diabetes other than T1D. * Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months. * Chronic systemic corticosteroids (\>4 consecutive weeks) within 6…

What they're measuring

Change in % time in ketone range >1.5/mmol/L

Timeframe: Baseline 3 months to 3 months following sotagliflozin initiation

Number of episodes of diabetic ketoacidosis

Timeframe: 3 months following sotagliflozin initiation

Trial details

NCT IDNCT07325201

SponsorHealthPartners Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Kelsea Forrester, Dietitian

1-952-993-2755 kelsea.forrester@parknicollet.com