CKM For Safe Use of SGLT2i in Type 1 Diabetes

Trial details

Who runs it

University of California, San Diego

Trial code

NCT07211802

Record updated

4 November 2026

Original description

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.Read full original descriptionShow less

Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes

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.

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: Any concurrent diagnosis of diabetes other than type 1 diabetes; Chronic systemic corticosteroids use ( > 4 consecutive weeks) within 6 months prior to screening; History of diabetic ketoacidosis within 3 months prior screening; 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); History of multiple (≥3 infections) genital mycotic infections within 6 months of screening; 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; 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); 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; Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening; 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; Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits.

ClinicalTrials.gov NCT07211802