NCT06627504Recruiting
Type 1 Diabetes REst for Metabolic Health
Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 12 Aug 2025
- Primary completion date
- 31 May 2029
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 1 diabetes
- NCT number
- NCT06627504
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 12 Aug 2025 to the primary completion date, 31 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
- Severe illness or DKA within 60 days;
- IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
Lab values
- HbA1c ≥12%;
Other
- Night-shift employment or other obligations that would preclude adherence to the intervention.
Who the study is looking for
- 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.
Age in the registry: 14 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.