Restoring sleep and circadian timing to improve metabolic health in teens with type 1 diabetes.

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

This trial will test whether extending nightly time in bed by an hour plus evening melatonin and morning light can improve insulin sensitivity, blood sugar control, and vascular health in high-school teens (14–19) with type 1 diabetes who usually sleep less than seven hours on school nights.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 14 Years to 19 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06627504 on ClinicalTrials.gov

What this trial studies

Adolescents with type 1 diabetes who habitually sleep less than seven hours on school nights will compare one month of a sleep-and-circadian intervention to one month of their usual school-week sleep. The intervention combines at least one hour longer time in bed each night with evening melatonin and morning light therapy to advance circadian timing. Outcomes include changes in insulin sensitivity, glycemic control, and vascular function measured after each month, with sleep tracked by actigraphy. Participants must use an insulin pump or automated delivery system and meet puberty and obesity-risk criteria specified by the protocol.

Who should consider this trial

Good fit: High-school students aged 14–19 with type 1 diabetes for at least one year who use an insulin pump or automated insulin delivery, get less than seven hours sleep on school nights, are in Tanner stage 4–5, and have above-average weight or a parental history of obesity.

Not a fit: Patients with diagnosed sleep disorders, regular use of sleep-altering medications (including melatonin or stimulants), use of medications that affect insulin resistance, very high HbA1c (≥12%), or recent severe illness/DKA are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve insulin sensitivity, blood sugar control, and blood-vessel health in teens with type 1 diabetes and potentially reduce early cardiovascular risk.

How similar studies have performed: Observational work links poor sleep and late circadian timing to cardiometabolic risk and small experimental studies of sleep extension or circadian shifting have shown metabolic benefits, but this specific combined intervention in adolescents with type 1 diabetes is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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);
* With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg/m2);
* Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

* 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%;
* Severe illness or DKA within 60 days;
* IQ\<70 or severe mental illness impacting sleep or ability to participate in the study;
* Night-shift employment or other obligations that would preclude adherence to the intervention.

Where this trial is running

Aurora, Colorado

• Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Stacey L Simon, PhD — University of Colorado, Denver
• Study coordinator: Angel Bernard, BS

Conditions Type 1 Diabetes; Sleep Health