Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT07186660
Brief 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.
Detailed 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 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:
NCT07186660
Study Brief:
Protocol Section:
NCT07186660