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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT06176495
Eligibility Criteria:
Inclusion Criteria for Participants with Diabetes:
* Adult patients 18 years or older
* Patients with an established DM diagnosis
* Patients with a recent HbA1c level with no recent changes in treatment regimen
* Recent HbA1c \> 7 but less than 9
* Patients who are on oral antidiabetic medications or basal insulin (intermediate, long acting, ultra long acting insulin)
* Patients who are adherents to the American University of Beirut Health Insurance Plan (AUB-HIP)
* Patients who have visited the Family Medicine Primary Care Clinics at American University of Beirut Clinics in the past 12 months.
* Patients with smart mobile phones and/or access to WhatsApp services
* Patients who can speak and read Arabic or English or live with someone who can read for them
* Patients with available family members involved in their care (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).
* Willingness to participate in the study
Exclusion Criteria for participants with Diabetes:
* Young patients below 18 years
* Patients who are on non basal insulin/bolus therapy
* Adults with cognitive impairment
* Adults with functional dependence and no assisting family member or caregiver
* Pregnant and Postpartum patients
* Patients with terminal or critical diseases (e.g., cancer; advanced heart, lung, liver, and kidney disease; Human immunodeficiency virus infection and Acquired immune deficiency syndrome and etc.)
* Patients with severe hearing or visual impairment
* Patients who can't read or have difficulty reading and do not live with someone who can read for them
* Patients who will have any of their medications modified throughout the study process will be excluded from the study as well
* Patients with a positive depression (PHQ 2) and/or anxiety (GAD 2) screening results who will be asked to follow up with their primary physician
Inclusion Criteria for Family Member Caregivers:
* Age 18 years or older
* Designated or selected by the participating patient with diabetes.
* Not diagnosed with DM
* Can read and write
* No visual or hearing impairments
* Involved in the participant's diabetes or general care and has an influence on the participant's lifestyle behaviors or medical insurance (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).
* Access to the WhatsApp service
* Willingness to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06176495
Study Brief:
Protocol Section:
NCT06176495