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CKM For Safe Use of SGLT2i in Type 1 Diabetes

NCT07211802 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-10-08

No results posted yet for this study

Summary

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.

Conditions

  • Type 1 Diabetes (T1D)

Interventions

DRUG

Sotagliflozin Low Dose

200 mg Sotagliflozin, once daily for 6 weeks

DRUG

Sotagliflozin High Dose

400 mg Sotagliflozin, once daily for 6 weeks

DEVICE

Dual Continuous Glucose and Ketone Monitor

Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Abbott

    collaborator INDUSTRY

  • Lexicon Pharmaceuticals

    collaborator INDUSTRY

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

    collaborator NIH

  • University of California, San Diego

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2030-07-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211802 on ClinicalTrials.gov