NCT06627504 Type 1 Diabetes REst for Metabolic Health
| NCT ID | NCT06627504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-12 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Stacey L Simon, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06627504 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 19 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627504 currently recruiting?
Yes, NCT06627504 is actively recruiting participants. Contact the research team at angel.bernard@childrenscolorado.org for enrollment information.
Where is the NCT06627504 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06627504 clinical trial?
NCT06627504 is sponsored by University of Colorado, Denver. The principal investigator is Stacey L Simon, PhD at University of Colorado, Denver. The trial plans to enroll 50 participants.
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