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

Study acronym: SCOUT-CKD
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later May 2028 → Feb 2029
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from HealthPartners Institute

Record History

  1. Primary completion pushed from May 2028 to Feb 2029 Completion pushed from Aug 2028 to Feb 2030v4 Show 1 more changeShow less
    • Completion pushed from Aug 2028 to Feb 2030
  2. Primary endpoint(s) modified Start date: Jun 2026 to Sep 2026 · Eligibility criteria expanded, about 22 words · Secondary endpoints: 10 to 20 · 3 morev3 Show 6 more changesShow less
    • Start date: Jun 2026 to Sep 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 10 to 20
    • Study description shortened, about 642 words
    • Site contact updated
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study description shortened, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07325201
Lead Sponsor HealthPartners Institute
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease, Diabetic Ketoacidosis, Ketones
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov