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Sotagliflozin with Continuous Glucose and Ketone Monitoring for Type 1 Diabetes

This study is investigating if wearing a special device that continuously monitors both your blood sugar (glucose) and ketones can help reduce side effects when taking sotagliflozin for type 1 diabetes. Sotagliflozin is being tested at two doses, 200 mg and 400 mg daily. The study aims to see if this monitoring device helps keep your ketone levels from getting too high (above 0.6 mmol/L) over 6 weeks. You may be able to join if you are over 18 years old and have type 1 diabetes. The current recruitment status is unclear, and the study plans to enroll 52 participants.

Study design
This is a single-site, double-blind, random-order, cross-over study involving 52 participants with type 1 diabetes. Participants will be divided into groups based on their insulin delivery method (Hybrid Closed Loop pumps or Multiple Daily Injections) and will receive both 200mg and 400mg doses of sotagliflozin for 6 weeks each, with a 2-week break in between.
What's involved
Participants will take sotagliflozin daily for two 6-week periods, separated by a 2-week break. They will also wear a dual continuous glucose and ketone monitor.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, measuring BHB Time Above 0.6mmol/L, are assessed at 6 weeks for each dose of sotagliflozin.

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NCT07211802

CKM For Safe Use of SGLT2i in Type 1 Diabetes

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
University of California, San Diego
~52 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Sotagliflozin Low DoseSotagliflozin High DoseDual Continuous Glucose and Ketone Monitor

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BHB Time Above 0.6mmol/L - 200mg
Measured over 6 weeks
+1 more outcome measured

Conditions

Type 1 Diabetes (T1D)

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Who to contact

Program Manager, MS
[email protected]
858-246-2169
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

ADA Level 3 Definition - A severe hypoglycemic event characterized by altered mental or physical status requiring the assistance for treatment of hypoglycemia, irrespective of glucose level; 10. History of multiple (≥3 infections) genital mycotic infections within 6 months of screening; 11. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits; 12. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

What this trial measures

  • BHB Time Above 0.6mmol/L - 200mg6 weeks

    Beta hydroxybutyrate (BHB) time \> 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.

  • BHB Time Above 0.6mmol/L - 400mg6 weeks

    Beta hydroxybutyrate (BHB) time \> 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.