CKM For Safe Use of SGLT2i in Type 1 Diabetes

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07211802
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin Low Dose — DRUG
    200 mg Sotagliflozin, once daily for 6 weeks
  • Sotagliflozin High Dose — DRUG
    400 mg Sotagliflozin, once daily for 6 weeks
  • Dual Continuous Glucose and Ketone Monitor — DEVICE
    Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.

Study Details

This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.

Key Dates

Start date
Jul 1, 2026
Status verified
Oct 2025
Primary completion
Jul 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A
    200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks
  • Experimental: Treatment Group B
    400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks

Primary Outcome Measure

BHB Time Above 0.6mmol/L - 200mg [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD - Altman Clinical & Translational Research InstituteLa JollaCalifornia92037
Recruiter
[email protected]
858-246-2146
Jeremy Pettus, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UCSD - Altman Clinical & Translational Research Institute· La Jolla, CA

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