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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT03557151
Eligibility Criteria:
Adolescents:
* Age \> 11 years but \< 17 years at time of consent
* Diagnosis of Type 1 diabetes with duration of \> 1 year
* Most recent HbA1C or mean HbA1C over the prior year 7.5-10.0%, inclusive
* Has had at least one clinic visit for T1D at a Nemours Children's Clinic within the past year
* Is not currently participating in any other research in which treatment adherence or glycemic control are study outcomes
* No T1D clinic visits in the preceding 12 months in which two or more care providers saw the patient together
* Is not on daily oral glucocorticoid treatment
* Is considered developmentally normal by the treating clinician (not in a self- contained special education classroom or been retained in 2 or more grades)
* Is able to read/comprehend study questionnaires in English
* Is not currently undergoing treatment for a coincident medical condition that, in the opinion of the treating physician, represents a contraindication to study participation
* Family must be able to access the internet
Parents:
* Is either a biological parent or legally appointed caregiver of the child
* Is the primary diabetes caregiver of the child: and at least weekly involvement in T1D care
* Routinely accompanies child for diabetes care at Nemours
* Is willing to schedule T1D clinic visits at a specific available location in Orlando or Wilmington
* Capable of participating in conversations in English during medical visits
* Anticipates continued medical care for T1D at Nemours for a year following study enrollment
* Is able to read/comprehend study questionnaires and decision aids in English
* Does not have an open abuse/neglect case with any child protection agency over the prior 3 years
* There is no evidence of frequent changes in the adolescent's household or living arrangements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT03557151
Study Brief:
Protocol Section:
NCT03557151