Recruiting

Sleep & Circadian

Sponsor:

University of Colorado, Denver

Code:

NCT06627504

Conditions

Type 1 Diabetes (T1D)

Sleep Health

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

Sleep Health and Circadian Timing Intervention

Study Details

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).

Conditions

Type 1 Diabetes (T1D)

Sleep Health

Study ID

NCT06627504

Start date

Aug 12, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep Health and Circadian Timing Intervention

Participants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses.

no intervention: Typical Sleep

Participants will be asked to sleep on their usual schedule.

Interventions

Sleep Health and Circadian Timing Intervention

Participants will be prescribed a sleep schedule that allows them to obtain at least 1h more time in bed compared to their typical school week schedule. In addition, participants will be provided with pharmaceutical-grade exogenous melatonin and instructed to take 500mcg 2 hours before their scheduled bedtime. They will also be asked reduce evening light exposure starting 2 hours before bedtime by limiting household lights and dimming electronics. In the mornings, participants will be exposed to bright light for 30 minutes after waking by wearing provided ReTimer light therapy glasses.

Primary outcome measure

  • Insulin Sensitivity [ Time Frame: Baseline (following 1 month typical sleep) and following 1 month intervention ]
  • Cardiovascular Function [ Time Frame: Baseline (following 1 month typical sleep) and following 1 month intervention ]
  • Glycemic Control [ Time Frame: Baseline (following 1 month typical sleep) and following 1 month intervention ]

Central Contacts and Locations

Central contacts

Angel Bernard, BS

720-777-3491angel.bernard@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Angel Bernard, BS

720-777-3491angel.bernard@childrenscolorado.org

Principal Investigator:

Stacey L Simon, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-03.