Utilizing Continuous Ketone Monitors to Enable Safe Use of SGLT Inhibitors in Patients With Type 1 Diabetes
University of California, San Diego
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.
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. There will be 2 main groups in the study, participants on Hybrid Closed Loop insulin pumps (HCL), n=26, and participants on Multiple Daily Injections (MDI), n=26. There will also be 2 doses of sotagliflozin examined in the study, 200 milligram (mg) once daily and 400mg once daily. Therefore, there will be 4 treatment groups in the study: * MDI participants who receive 200mg sotagliflozin for 6 we…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. All individuals between the ages of \>18 years old, inclusive, at the time of screening; 2. Individuals able to become pregnant must: 1. be ≥1 year post-menopausal or documented as being surgically sterile, or 2. 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; 3. 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;…
Interventions
- DrugSotagliflozin Low Dose
200 mg Sotagliflozin, once daily for 6 weeks
- DrugSotagliflozin High Dose
400 mg Sotagliflozin, once daily for 6 weeks
- DeviceDual Continuous Glucose and Ketone Monitor
Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.
Location
- UCSD - Altman Clinical & Translational Research InstituteLa Jolla, California