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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT06695533
Eligibility Criteria:
Inclusion Criteria:
Focus group inclusion:
1. Patients: adult with diabetes and patient at the Midtown Clinic
2. Caregivers: partner, or caregiver of a patient with diabetes
3. Providers: Physician Assistant (PA), Nurse Practitioner (NP), or MD who cares for patients with diabetes
4. Diabetes educators: diabetes educator
Focus group exclusion:
1. Cannot speak/read English
2. Unwilling to participate in group discussion
3. Pregnancy
Aim 2 inclusion criteria:
1. Having type 2 diabetes which is not insulin dependent since insulin management adds another level of diabetes self-management that would confound self-efficacy scores.
2. Having a hemoglobin a1c less than 10% based on their last 3 hemoglobin a1c readings within the 2 years before the recruitment phase of the study. The ADA recommends the initiation of insulin therapy for individuals with a hemoglobin a1c above 10%, therefore the study will focus on an intervention for diabetes before insulin is likely to be part of the management plan.
3. Not having any conditions that could interfere with the accuracy of a hemoglobin a1c result: anemia, hemoglobinopathy, end-stage renal disease, chronic liver disease.
4. The ability to read a passage set at a fifth-grade literacy, a score of at least 3 on the Mini-Cog test scale which would represent a lower likelihood of dementia, and the ability to drive to medical visits.
5. Subjects will represent a diversity of age, educational level, and socioeconomic status (will use type of medical insurance as a proxy)
Aim 2 exclusion criteria:
1. Cannot speak/read English
2. Unwilling to return for a follow-up visit in 3 months
3. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06695533
Study Brief:
Protocol Section:
NCT06695533