RECRUITING

Type 1 Diabetes REst for Metabolic Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-08-12
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06627504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * High school students between the ages of 14-19 years;
  2. * Diagnosed with T1D for ≥1 year;
  3. * Using an insulin pump or other automated insulin delivery system;
  4. * Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);
  5. * With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
  6. * Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
  1. * 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
  2. * Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);
  3. * Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);
  4. * HbA1c ≥12%;
  5. * Severe illness or DKA within 60 days;
  6. * IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
  7. * Night-shift employment or other obligations that would preclude adherence to the intervention.

Contacts and Locations

Study Contact

Angel Bernard, BS
CONTACT
720-777-3491
angel.bernard@childrenscolorado.org

Principal Investigator

Stacey L Simon, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Stacey L Simon, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-12
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-08-12
Study Completion Date2029-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes (T1D)
  • Sleep Health