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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06658067
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with type 2 diabetes mellitus
* A1c greater than or equal to 8.0 within two weeks of the time of enrollment
* On insulin for at least one year +/- other antihyperglycemics
* Ability and willingness to wear CGM for 14-day periods throughout the trial period
* Ability and willingness to comply with provider-directed adjustments to medication regimen
* Inability to afford CGM sensors
A note on Vulnerable Populations: Many of FHCHC's patients are economically disadvantaged and of minority backgrounds; the clinic's patient base may be considered to constitute a vulnerable population. As such, recruitment and enrollment will be conducted within a vulnerable population. The nature of the study requires this, and the results are intended to directly benefit this population through the potential for improved glycemic control and quality of life.
Exclusion Criteria:
* Insulin naïve
* Diabetic ketoacidosis (DKA) in previous 6 months
* End-Stage Renal Disease (ESRD)
* Contraindications to CGM use
* Active insurance plan that would provide enough of a subsidy for participant to feasibly purchase CGM sensors
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06658067
Study Brief:
Protocol Section:
NCT06658067