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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT00945659
Eligibility Criteria:
Inclusion Criteria:
1. Age of adolescent \> 11 years and \< 17 years. This age range was chosen because families of adolescents often struggle with diabetes management. Youths \> 18 years old may be likely to leave home during the study.
2. Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
3. Duration of type 1 diabetes \> 2 years or \> 1 year with negligible stimulated c-peptide level, to exclude those with significant residual pancreatic insulin production.
4. Treatment of diabetes for the 6 months prior to enrollment must consist of an intensified regimen including either daily use of an insulin pump or 3 or more daily insulin injections with pre-meal insulin doses calculated using a correction factor that considers prevailing blood glucose levels and planned carbohydrate intake.
5. Adolescent must have established diabetes care at a participating Nemours Children's Clinic site as evidenced by at least two diabetes clinic visits within the prior 12 months.
6. Most recent HbA1C \> 7.5% and \< 10.0% or mean HbA1C over the prior 12 months within that same range.
7. Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
8. Family has working telephone service.
Exclusion Criteria:
1. Youth has not used a CGM device with real-time glucose feedback for clinical management of diabetes within the prior 6 months. Intermittent or one-time use of "blinded" CGM devices for retrospective analysis only is permissible.
2. Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
3. Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
4. Not enrolled in special education for mental retardation, autism or severe behavior disorders.
5. Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
6. Primary diabetes caregiver not diagnosed or in treatment for major depression, psychosis, bipolar disorder or substance use disorder within the 6 months prior to enrollment; Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
16 Years
Study:
NCT00945659
Study Brief:
Protocol Section:
NCT00945659