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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05854069
Eligibility Criteria:
Inclusion Criteria:
PERSONS WITH DIABETES
* Ages 18-24
* Have a diagnosis of T1D and has been taking insulin for at least one year
* Comfortable sending and receiving texts
* Can speak, read, and write in English
* Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
* Using a continuous glucose monitor (CGM)
SUPPORT PERSONS
* Age 18 or older
* Can speak, read, and write in English or Spanish
* Comfortable sending and receiving texts
Exclusion Criteria:
PERSONS WITH DIABETES
* Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
* Plans to live outside the country during the study period
SUPPORT PERSONS
* Shares a phone with the person with diabetes
* Plans to live outside of the country during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
24 Years
Study:
NCT05854069
Study Brief:
Protocol Section:
NCT05854069