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Sleep more, protect your heart: new study tests circadian fix for teens with type 1 diabetes

NCT ID NCT06627504

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether improving sleep and circadian timing can reduce heart disease risk in adolescents with type 1 diabetes who typically sleep less than 7 hours per night. Fifty teens will follow a one-month program that includes a longer sleep schedule, a low dose of melatonin, reduced evening light, and morning bright light. Researchers will measure changes in insulin sensitivity, blood sugar control, and blood vessel function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
melatonin (500mcg) plus behavioral sleep schedule, light reduction, and morning bright light
What this could lead to
If successful, this could point toward a simple, non-drug way to improve heart health and blood sugar control in teens with type 1 diabetes.
What could go wrong
This is a small, early-stage study with only 50 participants, so results may not apply to everyone. The intervention combines several changes, making it hard to know which part works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep health Type 1 diabetes (T1D)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

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