Status:
NOT_YET_RECRUITING
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institutes of Health (NIH)
Abbott
Conditions:
Type 1 Diabetes (T1D)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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)...
Detailed Description
The study is a phase 3, single-site, double-blind, random-order, cross-over study to evaluate the use of continuous ketone monitoring (CKM) in participants with type 1 diabetes taking sotagliflozin. ...
Eligibility Criteria
Inclusion
- All individuals between the ages of \>18 years old, inclusive, at the time of screening;
- Individuals able to become pregnant must:
- be ≥1 year post-menopausal or documented as being surgically sterile, or
- agree to use two methods of contraception during the entire study and for an additional 2 weeks after the end of dosing with the investigational product;
- Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;
- Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
- Treatment with a stable insulin regimen for at least 8 weeks before screening with:
- a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or
- multiple daily insulin injections;
- Currently using a Continuous Glucose Monitoring (CGM) system;
- Hemoglobin A1c ≤10% at the time of screening;
- Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;
- Agrees and is able to wear the investigational device;
- Able to provide written informed consent approved by an Institutional Review Board (IRB).
Exclusion
- Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
- Any concurrent diagnosis of diabetes other than type 1 diabetes;
- History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
- Hypotension at screening as defined as, systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);
- Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);
- Use of glucagon-like-peptide 1 (GLP-1) analogues if not on a stable dose for \> 2 months at screening (participants can be rescreened after being on stable dose for \> 2 months). Participants on a stable dose of GLP-1 receptor antagonist (RA) and not experiencing frequent vomiting may be included.
- Chronic systemic corticosteroids use ( \> 4 consecutive weeks) within 6 months prior to screening;
- History of diabetic ketoacidosis within 3 months prior screening;
- History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
- 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;
- History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;
- Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
- 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.
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07211802
Start Date
July 1 2026
End Date
December 31 2030
Last Update
October 8 2025
Active Locations (1)
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1
UCSD - Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037