Type 1 Diabetes REst for Metabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorUniversity of Colorado, Denver
About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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%;
Trial design
Treatments tested in this trial
- Sleep Health and Circadian Timing Intervention
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov