Type 1 Diabetes REst for Metabolic Health

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Type 1 Diabetes REst for Metabolic Health study, is exploring how improving sleep health can help adolescents with type 1 diabetes (T1D). Researchers have noticed that not getting enough sleep, especially going to bed late, can negatively affect heart and metabolic health in young people with T1D. The study aims to see if sleeping more—by extending bedtime and using light therapy in the morning—can improve important health measures like insulin sensitivity and blood sugar control. This study will involve high school students aged 14 to 19 who usually sleep less than 7 hours on school nights and have been diagnosed with T1D for more than a year.

To participate, individuals need to be using an insulin pump or an automated insulin delivery system and may have a higher risk for obesity. However, those with sleep disorders, certain medical conditions, or specific medications that affect sleep will not be eligible. During the trial, participants will try this new sleep routine for one month and compare their health results to another month of their usual sleep schedule. This is an exciting opportunity to potentially improve health while also addressing sleep habits in teenagers with T1D!

Gender

ALL

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.