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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT06627504
Eligibility Criteria:
Inclusion Criteria:
* High school students between the ages of 14-19 years;
* Diagnosed with T1D for ≥1 year;
* Using an insulin pump or other automated insulin delivery system;
* Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
* With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
* Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
Exclusion Criteria:
* Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure
* Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
* Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
* HbA1c ≥12%;
* Severe illness or DKA within 60 days;
* IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
* Night-shift employment or other obligations that would preclude adherence to the intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
19 Years
Study:
NCT06627504
Study Brief:
Protocol Section:
NCT06627504