Evaluation of a Novel Insulin Sensitizer on Glycemic Control, Insulin Usage, and Cardiovascular Biomarkers in People With Type 1 Diabetes Who Use Closed-loop Automated Insulin Delivery
University of Virginia
Summary
The purpose of this study is to see if the study drug CIR-0602K will improve glucose time-in-range and/or lower total daily insulin dose in people with type 1 diabetes who are using closed-loop automated insulin delivery. Researchers will compare CIR-0602K to a placebo (a look-alike substance that contains no drug) to see if it achieves the investigational endpoints. If the study results show that the drug works to increase time-in-range and lower insulin doses, this will lead to further studies which may then make the drug available to the public.
Description
Participants in the study will: * Come to the Clinical Research Unit (CRU) at UVA Medical Center for 3 visits: Screening, Baseline (Admission 1) and End-of-Study (Admission 2). * Complete various tests of cardiovascular health at each visit. * Take either an experimental drug (CIR-0602K) or placebo for 12 weeks. * Wear a study CGM with their personal insulin pump for 12 weeks. * Be given a ketone meter and strips and be asked to take a fingerstick ketone reading every morning for 12 weeks. * The study team will contact the participants regularly during the study to check their health and how…
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. History of type 1 diabetes for at least one year 4. Age 18-45 years 5. HbA1c \<10% * BMI 18-35 kg/m2. Within this criterion, participants must have either BMI ≥25 or total daily insulin dose of ≥0.5 units/kg/day. * Currently utilizing closed-loop AID therapy that is compatible with Dexcom G7 CGM. * On stable regimen of non-diabetic medications for the last 6 months. * All screening labs within normal…
Interventions
- DrugCIR-0602K
mitochondrial pyruvate carrier inhibitor
- DrugPlacebo
Placebo tablet
Location
- University of VirginiaCharlottesville, Virginia