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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT05911256
Eligibility Criteria:
Inclusion Criteria:
* Age 25-75.
* History of T2DM \> 1 year.
* Speak English or Spanish.
* A1c ≥ 8% (within past 6 months) - with reduction if necessary based on recruitment.
* eGFR (estimated glomerular filtration rate) \> 30.
* Willingness to use continuous glucose monitoring (CGM) and work with a community health worker (including home visits) and clinical pharmacist.
Exclusion Criteria:
* Plans for weight reduction surgery or prescription weight loss medication (specific for weight loss, not GLP-1).
* Current, recent, or planned use of CGM.
* Current use of steroids.
* Abuse of illicit drugs.
* Pregnancy (or planned pregnancy).
* Specific comorbidities (e.g., recent MI, TIA, CVA, malignancy, hemoglobinopathy, severe hypoglycemia, etc.).
* Psychiatric disorder that may limit ability to perform study tasks
* Skin changes that preclude use of sensor or allergy to adhesive.
* Planning to leave geographic area within 12 months or distance from clinical site \> 20 miles.
* Participation in another study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT05911256
Study Brief:
Protocol Section:
NCT05911256