Type 1 Diabetes REst for Metabolic Health

NCT06627504 | Recruiting DMC

• 2 other identifiers: 24-1490R01HL174735
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 1 Diabetes (T1D); Sleep Health

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline (following 1 month typical sleep) and following 1 month intervention

• Cardiovascular Function

  Value of central aortic stiffness from cardiovascular MRI

  Baseline (following 1 month typical sleep) and following 1 month intervention

• Glycemic Control

  Value of mean sensor glucose assessed with continuous glucose monitor

  Baseline (following 1 month typical sleep) and following 1 month intervention

Secondary Outcomes (3)

• Inflammation

  Baseline (following 1 month typical sleep) and following 1 month intervention

• Adipokines

  Baseline (following 1 month typical sleep) and following 1 month intervention

• Cortisol

  Baseline (following 1 month typical sleep) and following 1 month intervention

Study Arms (2)

Sleep Health and Circadian Timing Intervention

EXPERIMENTAL

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.

Behavioral: Sleep Health and Circadian Timing Intervention

Typical Sleep

NO INTERVENTION

Participants will be asked to sleep on their usual schedule.

Interventions

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.

Sleep Health and Circadian Timing Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stacey L Simon, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Bernard, BS

CONTACT

720-777-3491; angel.bernard@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: August 12, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Access to the data will be made at the end of the grant award or when a publication has been submitted. Once the data are submitted, the archive will control the long-term persistence of the data set.

Locations

US (1)