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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05541120
Eligibility Criteria:
Inclusion Criteria:
* Be enrolled in Living Well with Diabetes education program
* Have an HbA1c% ≥ 8 in the prior 6 months
* Be capable of providing consent
* Be adults (age 18 or over)
Exclusion Criteria:
* Primarily managed by endocrinology for their diabetes (\> 1 visit with endocrinology in the previous 12 months)
* Incarcerated
* PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
* Diagnosed with type 1 diabetes
* Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
* Pregnant
* Have previously participated in the Living Well with Diabetes/Virtual Diabetes Self-Management Program
* Have previously used a remote patient monitoring device for diabetes management
* Have a diagnosis of dementia or other clinical diagnosis that would impair participation capacity
* Currently participating in any other clinical trial regarding diabetes care or management
* Currently enrolled in hospice
* Currently residing in a long term care or rehabilitation facility
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05541120
Study Brief:
Protocol Section:
NCT05541120