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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT05268250
Eligibility Criteria:
Inclusion Criteria:
* child age between 8-12 years, physician confirmed T1D diagnosis,
* either the child or the parent or both the child and parent report diabetes distress levels at or above clinical cut-points,
* child is on an intensive insulin regimen (pump or MDI).
Exclusion Criteria:
* children on a conventional insulin regimen, children and/or parents who do not report diabetes distress levels at or above the clinical cut-points,
* children who have an allergy or sensitivity to the adhesive and/or skin preparation used for CGM, children with a comorbid chronic condition (e.g., renal disease),
* children and parents who do not speak English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
65 Years
Study:
NCT05268250
Study Brief:
Protocol Section:
NCT05268250