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NCT Number: NCT06627504

Type 1 Diabetes REst for Metabolic Health

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).

Recruiting

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Angel Bernard, BS

CONTACT

[email protected]

720-777-3491

Stacey L Simon, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Insulin Sensitivity

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Steady-state glucose infusion rate (M) normalized to free fat mass (FFM) and to steady-state insulin (M/I, [mg/kg FFM/min]/insulin) measured with hyperinsulinemic euglycemic clamp

  2. Cardiovascular Function

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Value of central aortic stiffness from cardiovascular MRI

  3. Glycemic Control

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Value of mean sensor glucose assessed with continuous glucose monitor

Secondary outcomes

  1. Inflammation

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Laboratory values of hs-CRP, IL-6, and TNF-alpha

  2. Adipokines

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Laboratory values of leptin and adiponectin

  3. Cortisol

    Time frame: Baseline (following 1 month typical sleep) and following 1 month intervention

    Laboratory values of cortisol

Study contacts

Contact information is provided by the study sponsor or research team.

Angel Bernard, BS

CONTACT

[email protected]

720-777-3491

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes

Acronym: T1DREaM

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 4, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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