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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT06740435
Eligibility Criteria:
Inclusion Criteria:
* adults 18 years or older
* Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
* HbA1c greater than or equal to 8% based on most recent value at time of recruitment
* Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
* Patient must use insulin
* Patients must have \>2 comorbid chronic health conditions
* Be able to provide informed consent
* Reside in Pennsylvania
Exclusion criteria:
* Age over 80 based on date of birth in electronic medical record
* Visit with an endocrinologist in the prior 1 years
* Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
* Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
* Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
* ESRD N18.6
* Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
* Type 1 diabetes: E10.X
* Gestational diabetes: O24.X, E08.X
* Other diabetes: E09.X, E13.2
* Pregnant or planning to become pregnant in next 6 months
* Currently enrolled in another diabetes management intervention study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06740435
Study Brief:
Protocol Section:
NCT06740435