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Can a sleep therapy program help control blood sugar in older diabetes patients?

NCT ID NCT04831385

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether cognitive behavioral therapy for insomnia (CBT-I) can improve blood sugar control in older Chinese adults with type 2 diabetes and insomnia. The trial compares CBT-I to usual care in 214 participants aged 60 and older. They will measure changes in HbA1c, sleep quality, mood, and thinking over time.

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), a structured program that changes sleep habits and thoughts
What this could lead to
If CBT-I helps, it could offer a non-drug way to improve blood sugar and sleep in older adults with type 2 diabetes and insomnia.
What could go wrong
This is a single study in one ethnic group, so results may not apply to everyone. CBT-I requires effort and may not work for all sleep problems.

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

214 people

The number who actually took part.

Started

May 2022

Finished

Jul 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

60 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: 1. Aged ≥60 years; 2. T2D with suboptimal glycemic control defined as HbA1c 7.1-10%; 3. Chinese ethnicity; 4. Comorbid with insomnia having ISI score \>10; 5. Able and willing to give informed written consent Exclusion criteria: 1. Cognitive impairment (HK-MoCA score of ≤22); 2. Depression (GDS-15 score \>8) and other psychiatric disorders e.g. generalized anxiety disorder, restless leg syndrome, schizophrenia to be elucidated by history from research nurse and questionnaires; 3. Benign prostatic hypertrophy by history and/or elevated PSA and any other chronic medical condition that is likely to affect sleep e.g. chronic pain; 4. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep; 5. Cerebrovascular accidents, vascular dementia, or any condition that are known to affect cognitive function; 6. Shift workers; 7. Haemoglobinopathies, renal failure, need of regular blood transfusion or any other conditions which will affect the validity of HbA1c in measurement of glycemia; 8. Any condition, as judged by the investigators, as ineligible to participate in this study.

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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 mellitus type 2 Insomnia

Contacts and locations

Locations

  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital

    Hong Kong, Hong Kong

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