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Type 1 Diabetes REst for Metabolic Health

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 19 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether longer sleep and an earlier body clock can improve heart and blood sugar health in teens with type 1 diabetes who get too little sleep. It compares one month of usual sleep with one month of at least one extra hour in bed each night, evening melatonin, and morning light therapy.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • High school students ages 14–19.
  • Have had type 1 diabetes for at least 1 year.
  • Use an insulin pump or another automatic insulin delivery system.
  • Usually sleep 7 hours or less on school nights, measured with an activity tracker.
  • Have a body mass index (BMI, a measure of weight for height) at or above the 50th percentile, or a parent with a BMI of 30 or higher.
  • Are in a later stage of puberty (Tanner stage 4 or 5), based on breast development in girls or testicle size in boys.

Who can't join

  • Have a diagnosed sleep disorder, or a high screening score for sleep apnea, which causes breathing pauses during sleep.
  • Regularly take medicines that affect sleep, such as stimulants, certain mental health medicines, melatonin, or other sleep aids.
  • Regularly take medicines that affect how the body responds to insulin, such as steroids that act throughout the body or extra diabetes medicines.
  • Have an HbA1c of 12% or higher. This test measures average blood sugar over time.
  • Had a severe illness or diabetic ketoacidosis (DKA, a dangerous buildup of acids in the blood) within the past 60 days.
  • Have an IQ below 70, or a severe mental illness that affects sleep or the ability to take part.
  • Work night shifts or have other duties that would prevent following the study's sleep plan.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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