RecruitingNot ApplicableNCT06627504

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


Sponsor

University of Colorado, Denver

Enrollment

50 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 14 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study explores whether improving sleep in teenagers with type 1 diabetes can improve blood sugar control and metabolic health. Participants are teens who already use an insulin pump and tend to sleep less than 7 hours on school nights, and the study tests strategies to help them sleep longer. **You may be eligible if...** - You are a high school student between 14 and 19 years old with type 1 diabetes (diagnosed at least 1 year ago) - You use an insulin pump or automated insulin delivery system - You typically sleep 7 hours or less on school nights - You are overweight or have a family history of obesity **You may NOT be eligible if...** - You have been diagnosed with a sleep disorder (like insomnia or sleep apnea) - You regularly take medications that affect sleep - You have other significant health conditions that affect insulin sensitivity or sleep Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSleep 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.


Locations(1)

Children's Hospital Colorado

Aurora, Colorado, United States

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NCT06627504


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