Type 1 Diabetes REst for Metabolic Health Study

This study is looking at whether improving sleep can help teenagers with type 1 diabetes (T1D) improve their heart health and how their body uses sugar. Researchers will have participants follow a sleep schedule that gives them at least one more hour in bed each night, along with taking 500mcg of melatonin two hours before bedtime. You might be able to join if you are a high school student between 14 and 19 years old with T1D, use an insulin pump, and typically sleep less than 7 hours on school nights. The study will measure changes in how your body responds to insulin (insulin sensitivity), how well your blood sugar is controlled (glycemic control), and your heart health (cardiovascular function) after one month of this sleep intervention. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study planning to enroll 50 participants. It will compare participants' health after a month of typical sleep to a month of increased sleep and melatonin.
What's involved
Participants will follow a prescribed sleep schedule and take melatonin for one month. Measurements of insulin sensitivity, cardiovascular function, and glycemic control will be taken at the start and end of this month.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one month after the intervention to assess changes in insulin sensitivity, cardiovascular function, and glycemic control.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06627504

Type 1 Diabetes REst for Metabolic Health

Recruiting
NAAges 14–19InterventionalTreatment
University of Colorado, Denver
~50 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Sleep Health and Circadian Timing Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin Sensitivity
Measured over Baseline (following 1 month typical sleep) and following 1 month intervention
+2 more outcomes measured
Type 1 Diabetes (T1D)
Sleep Health
1 sites across 1 states
Colorado1
  • Stacey L Simon, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.
  • Insulin SensitivityBaseline (following 1 month typical sleep) and following 1 month intervention

    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

  • Cardiovascular FunctionBaseline (following 1 month typical sleep) and following 1 month intervention

    Value of central aortic stiffness from cardiovascular MRI

  • Glycemic ControlBaseline (following 1 month typical sleep) and following 1 month intervention

    Value of mean sensor glucose assessed with continuous glucose monitor