Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHealthPartners Institute

About this trial

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 no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable. 4. Gather information on how participants and clinicians like and use the DGK 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 their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).

Eligibility criteria

Qualifiers

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.

Disqualifiers

Pregnant, lactating, or 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.

Trial design

Treatments tested in this trial

  • Sotagliflozin initiation

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

HealthPartners Institute

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator