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Melatonin may boost brain and blood sugar health in teens with diabetes

NCT ID NCT07592442

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether taking a melatonin supplement (3 mg each night for 6 months) could improve sleep, thinking skills, and blood sugar control in 70 adolescents with type 1 diabetes. Half received melatonin and half received a placebo. The researchers measured changes in blood sugar time-in-range, sleep quality, and executive function (like focus and planning). The goal was to see if this simple hormone supplement could help manage some common diabetes-related challenges.

What this could mean

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

Active substance
melatonin (3 mg tablet once daily)
What this could lead to
If it works, melatonin could become a simple, low-cost add-on to help teens with type 1 diabetes sleep better, think more clearly, and manage blood sugar more effectively.
What could go wrong
This is a small, completed trial with only 70 participants. Melatonin is not a diabetes treatment on its own, and any benefits may be modest or not apply to all teens. Long-term effects are unknown.

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

70 people

The number who actually took part.

Started

Nov 2024

Finished

Jan 2026

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

12 to 18 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: * Adolescents with T1DM according to the ISPAD 2022 guidelines (Couper et al., 2021) * Age: 12-18 years old. Exclusion Criteria: * Adolescents with other types of diabetes e.g. MODY, type 2 diabetes. * Adolescents with associated neurophsyciatric diseases e.g autism, ADHD * Adolescentswith other comorbidities e.g Auto immune throid disease,liver dysfunction

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Conditions

The condition(s) this trial relates to.

insomnia type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 diabetes (T1D)

Contacts and locations

Locations

  • Ain shams university

    Cairo, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.