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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT03428932
Eligibility Criteria:
Inclusion Criteria:
* Be at least 14 and not yet 18 years old
* Must have been diagnosed with T1D prior to 5 years old but after 6 months
* For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
* Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
* Be in puberty
Exclusion Criteria:
* History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
* ADD/ADHD and/or on stimulant medication
* Any known genetic or medical problem that could impair brain development
* Abnormalities of the brain/nervous system, visual or hearing problem
* History of seizures not associated with fever before diabetes diagnosis
* Previous inpatient psychiatric treatment
* Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT03428932
Study Brief:
Protocol Section:
NCT03428932