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
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.
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 months before screening or planned use during the study period.
Single group
Sotagliflozin initiation
DrugAll 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).
Change in % time in ketone range >1.5/mmol/L
Number of episodes of diabetic ketoacidosis
ADA/EASD consensus on hyperglycemia definition of DKA will be used for the definition of DKA (must meet all 3 criteria: Glucose ≥200 mg/dL (11.1 mmol/L) OR prior history of diabetes; BHB concentration ≥3.0 mmol/L OR urine ketone strip 2+ or greater; pH \<7.3 and/or bicarbonate concentration \<18 mmol/L)
Change in mean ketone level
Highest ketone level observed
Number of episodes of ketosis with >=15 minutes at >1.5 mmol/L
Number of prolonged episodes of ketosis with >=120 minutes at >1.5 mmol/L
Change in A1c
Change in CGM metrics
Reduction in insulin total daily dose
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HealthPartners Institute
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
