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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03761251
Eligibility Criteria:
Inclusion Criteria:
* age 10-13 years
* diagnosis of T1DM
* duration of T1DM for at least one year
* fluency in English
* two recent consecutive HbA1c values 8.0 - 13%
Exclusion Criteria:
* clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment
* current participation in another study that may impact glycemic control
* regular usage of a continuous glucose monitor
* HbA1c \> 13% (because these individuals may need a more intensive intervention than this is intended to provide).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
13 Years
Study:
NCT03761251
Study Brief:
Protocol Section:
NCT03761251