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Sleep therapy may cut diabetes risk in prediabetes patients

NCT ID NCT06067139

Disease control Sponsor: Kaiser Permanente 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether cognitive behavioral therapy for insomnia (CBT-I) can help lower blood sugar levels in people with prediabetes. About 300 adults with both prediabetes and insomnia will receive either CBT-I or a patient education program. The main goal is to see if improving sleep leads to better glucose control and reduced diabetes risk.

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 non-drug way to lower diabetes risk by improving sleep in people with prediabetes.
What could go wrong
This is a relatively small trial (300 people) testing a behavioral intervention, so results may not apply to everyone. The effect on blood sugar may be modest or not clinically significant.

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 300 people

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

Started

Aug 2023

Expected to finish

Dec 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

22 to 79 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: * Age ≥ 22 years and \< 80 years of age * Prediabetes * Insomnia * Regular access to device with internet access * Adequate data at baseline Exclusion Criteria: * BMI \> 40 kg/m2 * Sleep comorbidities detected in medical record or via medical history * Shift work or significant, externally imposed irregular sleep schedule * moderate to severe OSA by home sleep apnea test as part of trial protocol * Received a full course of CBT-I in the last 12 months * Current use of medication with glycemic effects: * History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin) * Recent history of bariatric surgery or planning bariatric surgery in the next year * Current or recent use of weight loss meds * Unstable sleep medication regimen (recent change to schedule or dosage) * Significant comorbidity that may interfere with CBT-I uptake or increase risks * Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction * High risk of falls * Epilepsy * Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use) * Significant alcohol or substance use disorder * Active or recent history of eating disorder, recent weight change of \>10% * Women: pregnancy (current or planned), breastfeeding, \< 1 year postpartum * Use of hydroxyurea * Extensive skin changes or adhesive allergy making CGM sensor use problematic

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Conditions

The condition(s) this trial relates to.

insomnia prediabetes syndrome sleep disorder, initiating and maintaining sleep type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Diabetes mellitus type 2 Prediabetic state Sleep initiation and maintenance disorders

Contacts and locations

Locations

  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227, United States

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