Type 1 Diabetes REst for Metabolic Health

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06627504
Status
Recruiting
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Conditions

  • Sleep Health
  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
14 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Health and Circadian Timing Intervention — 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.

Study Details

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).

Key Dates

Start date
Aug 12, 2025
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Insulin Sensitivity [ Time Frame: Baseline (following 1 month typical sleep) and following 1 month intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Angel Bernard, BS
[email protected]
720-777-3491
Stacey L Simon, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital Colorado· Aurora, CO

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