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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT07325201
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin initiation — DRUG
    All patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR \>60%) and who have moderate or no CKD (eGFR \>60) will be offered the option to increase sotagliflozin to 400mg/d. The decision to increase sotagliflozin dose will be a shared decision between the study subject and the study investigators. All other participants will continue taking 200 mg sotagliflozin daily. After completing all study visits, all participants will stop taking sotagliflozin and continue care with their healthcare provider(s).

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Sotagliflozin
    In this single arm trial, all patients will be started on sotagliflozin at a dose of 200mg/d. After 3 months of sotagliflozin 200 mg/d, patients who do not achieve good glycemic control (TIR \>60%) and who have moderate or no CKD (eGFR \>60) will be offered the option to increase sotagliflozin to 400mg/d. All other participants will continue taking 200 mg sotagliflozin daily.

Primary Outcome Measure

Change in % time in ketone range >1.5/mmol/L [ Time Frame: Baseline 3 months to 3 months following sotagliflozin initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
International Diabetes CenterMinneapolisMinnesota55416
Rebecca Passi
[email protected]
952-993-3452

Find similar trials in Minneapolis, MN

By condition
Chronic kidney diseaseType 1 diabetes
By specialty
NephrologyKidney diseaseEndocrinology
By research site
International Diabetes Center· Minneapolis, MN

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