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.
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 they are tolerating the study drug/placebo. * Return the study CGM, ketone meter, and remaining supplies, etc. at the end of the study. * Notify the study team of any illness, injury, hypoglycemic or hyperglycemic events during the study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
University of Virginia
Charlottesville, Virginia, United States
RECRUITINGGlucose Time-in-Range
Glucose time 70-180 mg/dL
Time frame: 12 weeks
Total Daily Insulin Dose
Units of insulin per day
Time frame: 12 weeks
Glucose Time-above-Range
Glucose time \>180 mg/dL
Time frame: 12 weeks
Glucose Time-Below-Range
Glucose time \<70 mg/dL
Time frame: 12 weeks
Hemoglobin A1c
measure of glycemic control
Time frame: 12 weeks
Insulin Sensitivity
M-value from euglycemic insulin clamp
Time frame: 12 weeks
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