Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ket… (NCT07325201) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in % time in ketone range >1.5/mmol/L
Timeframe: Baseline 3 months to 3 months following sotagliflozin initiation
2
Number of episodes of diabetic ketoacidosis
Timeframe: 3 months following sotagliflozin initiation