Type 1 Diabetes REst for Metabolic Health (T1DREaM)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Sleep Health; Type 1 Diabetes (T1D)
• Intervention / Treatment: Behavioral: Sleep Health and Circadian Timing Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angel Bernard, BS; Phone Number: 720-777-3491; Email: angel.bernard@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Angel Bernard, BS; Phone Number: 720-777-3491; Email: angel.bernard@childrenscolorado.org
      • Principal Investigator: Stacey L Simon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Health and Circadian Timing Intervention; 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; 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.
No Intervention: Typical Sleep; Participants will be asked to sleep on their usual schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation	Laboratory values of hs-CRP, IL-6, and TNF-alpha	Baseline (following 1 month typical sleep) and following 1 month intervention
Adipokines	Laboratory values of leptin and adiponectin	Baseline (following 1 month typical sleep) and following 1 month intervention
Cortisol	Laboratory values of cortisol	Baseline (following 1 month typical sleep) and following 1 month intervention

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Stacey L Simon, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 24-1490; R01HL174735 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All fully deidentified raw and processed/scored data will be shared.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No