Type 1 Diabetes REst for Metabolic Health

ConditionsType 1 Diabetes (T1D)Sleep 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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Sleep Health and Circadian Timing Intervention
Behavioral
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Sleep Health and Circadian Timing InterventionExperimental treatment 1 intervention

Group B: Typical SleepNo intervention 0 interventions

Trial outcomes

Primary outcomes

Insulin Sensitivity

Steady-state glucose infusion rate (M) normalized to free fat mass (FFM) and to steady-state insulin (M/I, \[mg/kg FFM/min\]/insulin) measured with hyperinsulinemic euglycemic clamp

Time frame