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Can better sleep help tame diabetes? new study tests CBT for insomnia

NCT ID NCT07062406

Symptom relief Sponsor: Tulane University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This pilot study will test whether a 6-week program of cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and blood sugar control in 30 adults aged 40+ with type 2 diabetes and chronic insomnia. Participants are randomly assigned to CBT-I or usual care, and outcomes like HbA1c and insomnia severity are measured after 3 months. The goal is to see if this approach is practical and effective in primary care clinics serving high-risk communities in Louisiana.

What this could mean

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

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If it works, this could point toward a practical way to improve both sleep and blood sugar control in people with type 2 diabetes.
What could go wrong
This is a very small pilot study with only 30 participants, so results may not apply widely. It also relies on patients sticking with 6 therapy sessions, which may be challenging.

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 30 people

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

Started

Sep 2026

Expected to finish

Jun 2027

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

40 years and older

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: * aged 40 or older * receive primary care from participating clinic * diagnosis of type 2 diabetes * most recent hemoglobin A1c (HbA1c) \>7% within the past year * Insomnia Severity Index (ISI) score ≥15 * able to speak English Exclusion Criteria: * diagnosed or self-reported sleep apnea * pregnant or planning to become pregnant during the study period * having a psychiatric or medical condition that would interfere with the ability to complete study procedures * participating in another diabetes clinical trial * living in same household as another participant * required to work night shifts

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Conditions

The condition(s) this trial relates to.

insomnia type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes type 2 Insomnia

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

  • Southeast Community Health Systems

    RECRUITING

    Zachary, Louisiana, 70791, United States

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