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Sleep more, sugar less? new study tests sleep as a diabetes tool for teens

NCT ID NCT04213547

What the study statuses mean

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study explores the link between sleep duration and blood sugar control in adolescents aged 12-20 with type 2 diabetes. Researchers will first measure sleep and blood sugar in 67 teens, then test a program using Fitbits and text messages to encourage longer sleep in 15 teens who sleep less than 8 hours. The goal is to see if better sleep can improve glycemic control.

What this could mean

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

Active substance
sleep extension intervention (behavioral, using Fitbit and text messaging)
What this could lead to
If successful, this could show that improving sleep helps teens with type 2 diabetes manage their blood sugar better.
What could go wrong
This is a small, early-stage study with only 90 participants, so results may not apply to everyone. The sleep intervention is short-term and may not lead to lasting changes.

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 90 people

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

Started

Sep 2020

Expected to finish

Jul 2028

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

12 to 20 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: Aim 1 for child: 1. Subjects age 12-20 2. Diagnosed with T2DM by standard laboratory criteria without pancreatic autoimmunity 3. Low probability of obstructive sleep apnea (OSA) assessed via validated sleep survey 4. Subjects will be included if they are taking T2DM treatments (i.e., diet modification, Metformin and/or insulin) 5. Parental/guardian permission and child assent Aim 1 for parent: 1\. Parent or legal guardian of child that meets inclusion criteria for Aim 1. Aim 2 for child: 1. Completed Aim 1 evaluation 2. Average sleep duration \< 8 hours per night as determined by actigraphy in Aim 1 3. HbA1c ≤ 10% as HbA1c \>10 correlates to poor adherence 4. Adherence \> 80% Focus group for child: 1. Subjects aged 12-20 2. Diagnosed with type 2 diabetes without pancreatic autoimmunity Exclusion Criteria: Aim 1 for child: 1. Non-English speaking subject (as questionnaires used are validated in English) 2. Institutionalized patients as sleep duration will not be of their own accord, and therefore is not generalizable to the rest of the adolescent T2DM population. 3. Patients with other forms of Diabetes Mellitus (e.g. Type 1 Diabetes) 4. Behavioral disorders that may affect data collection (e.g. autism spectrum disorder) will be determined on a case-by-case basis. These include patients that are unable to answer questionnaires on their own, participate in a sleep diary, wear devices and/or understand incentives. 5. Oral or IV steroid treatment within the past month 6. Females with known pregnancies as these patients will not be generalizable to the rest of the adolescent T2DM population and pregnancy may alter sleep duration. 7. Subjects with known hyperthyroidism, pain syndrome, or serious medical condition that can affect sleep. 8. Subjects with hemoglobinopathies that affect hemoglobin A1c measurement. 9. Unable to obtain point-of-care hemoglobin A1c in clinic on date of recruitment 10. Known diagnosis of obstructive sleep apnea or other sleep disorder Aim 1 for Parent: 1. Non-English speaking subject (as questionnaires used are validated in English) 2. Parent/guardians with cognitive disorders that may affect data collection (determined on a case-by-case basis) Aim 2 for child: 1\. Do not own a smart phone or tablet Focus group for child: 1. Non-English speaking subject (as focus group will be conducted in English) 2. Lack of access to a computer, tablet or smartphone that can accommodate participation in video conferencing

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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