Restoring sleep and circadian timing to improve metabolic health in teens with type 1 diabetes.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adolescents with type 1 diabetes who habitually sleep less than seven hours on school nights will compare one month of a sleep-and-circadian intervention to one month of their usual school-week sleep. The intervention combines at least one hour longer time in bed each night with evening melatonin and morning light therapy to advance circadian timing. Outcomes include changes in insulin sensitivity, glycemic control, and vascular function measured after each month, with sleep tracked by actigraphy. Participants must use an insulin pump or automated delivery system and meet puberty and obesity-risk criteria specified by the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Stacey L Simon, PhD — University of Colorado, Denver
• Study coordinator: Angel Bernard, BS
• Email: angel.bernard@childrenscolorado.org
• Phone: 720-777-3491

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.