Actively Recruiting
Type 1 Diabetes REst for Metabolic Health
Led by University of Colorado, Denver · Updated on 2025-08-26
50
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Type 1 Diabetes REst for Metabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 4 hours 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
You will not qualify if you...
- 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 insulin resistance (systemic steroids, adjunctive diabetes medications)
- Hemoglobin A1c (HbA1c) 12%
- Severe illness or diabetic ketoacidosis within 60 days
- IQ less than 70 or severe mental illness impacting sleep or ability to participate in the study
- Night-shift employment or other obligations that would prevent following the intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Angel Bernard, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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