Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06962735
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older as of the index date
* Clinical diagnosis of T1D or T2D ≥ one year
* Using either MDI or CSII therapy
* Initiated a FreeStyle Libre® isCGM device between January 1, 2018 and July 31, 2023 (isCGM cohort)
* Switched from a FreeStyle Libre® 1 or Libre 2® isCGM device to a Dexcom® G5 or G6 CGM device between April 1, 2018 and July 31, 2023 (rtCGM cohort)
* Baseline HbA1c ≥7.0% for primary objective with rtCGM cohort
* Baseline HbA1c ≥8.0% for key secondary objective comparing rtCGM cohort to isCGM cohort
* Known rtCGM/isCGM start date (month and year)
* Exclusive use of isCGM for ≥ 3 months
* ≥ one HbA1c value up to 6 months (± 6 weeks) prior to index date (HbA1c value must be after isCGM initiation and no more than 6 weeks after the index date)
* ≥ one HbA1c value 6-12 months (± 6 weeks) following the index date
* Informed consent for their medical record data to be used for research purposes
Exclusion Criteria:
* Have a prior history of rtCGM within 12 months of the index date
* Are pregnant at the time of isCGM initiation or time of switch to rtCGM
* Used the isCGM or rtCGM for \< 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06962735
Study Brief:
Protocol Section:
NCT06962735