Type 1 Diabetes REst for Metabolic Health

NCT ID: NCT06627504

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2029-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sleep Health and Circadian Timing Intervention

Intervention Type: BEHAVIORAL

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.

Typical Sleep

Participants will be asked to sleep on their usual schedule.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey L Simon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angel Bernard, BS

Role: CONTACT

angel.bernard@childrenscolorado.org

720-777-3491

Facility Contacts

Angel Bernard, BS

Role: primary

angel.bernard@childrenscolorado.org

720-777-3491

Other Identifiers

R01HL174735

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1490

Identifier Type: -

Identifier Source: org_study_id