Recruiting

T1DREaMSleep and Circadian Health in Adolescents with Type 1 Diabetes

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What is being tested

Sleep Health and Circadian Timing Intervention

Behavioral
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 14 to 19 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactAngel Bernard, BS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 12, 2025

Actual date on which the first participant was enrolled.

This study focuses on adolescents with type 1 diabetes who experience poor sleep health and late internal body clock timing. These conditions are linked to increased heart and blood vessel problems, which are major concerns for people with type 1 diabetes. Since heart disease risk starts early and current treatment options are limited, the study aims to see if better sleep habits and adjusting the body's internal clock can improve heart and metabolic health in these teenagers. Participants in the study are adolescents with type 1 diabetes who usually sleep less than seven hours on school nights. Over the course of the study, participants will follow a sleep and circadian intervention that includes spending an extra hour in bed each night, taking melatonin in the evening, and having light therapy in the morning. These changes will occur over one month, and researchers will compare the results to a month of the participants' typical sleep schedule. The study will evaluate changes in how well the body uses insulin, controls blood sugar, and supports healthy blood vessels.

Official TitleMechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes
NCT06627504
Principal SponsorUniversity of Colorado, Denver
Study ContactAngel Bernard, BS
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
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);
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7 exclusion criteria prevent from participating
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%;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Children's Hospital Colorado

Aurora, United StatesOpen Children's Hospital Colorado in Google Maps
Recruiting
One Study Center