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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT04862858
Eligibility Criteria:
Inclusion Criteria:
Patient
* Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
* ≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
* Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
* Age 18-85 years at time of identification
* Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)
Provider
* Primary care providers of the identified patients
Exclusion Criteria:
Patients
* ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
* Any hospice or long-term care residence
* ≥1 code for pregnancy/childbirth
* Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
* Patients without an attributed primary care provider
* Patients on do not contact lists
* Patients without valid addresses and telephone numbers
* Patients with ≥1 diagnosis for type 1 diabetes pre-identification
Primary care providers
* Providers on do not contact lists
* Providers without valid fax/mailing address and phone number
* Providers with \<3 or \>50 eligible patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04862858
Study Brief:
Protocol Section:
NCT04862858