CBT-I to improve blood sugar and sleep in older adults with type 2 diabetes and insomnia.

The Impact of Cognitive Behavioral Therapy for Insomnia (CBT-I) on Glycemic Control in Older Type 2 Diabetes (T2D) Comorbid With Insomnia

This project will test whether cognitive behavioral therapy for insomnia (CBT-I) can improve blood sugar control, sleep, mood, and thinking in older Hong Kong Chinese adults with type 2 diabetes and insomnia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Chinese University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT04831385 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial will compare a program of cognitive behavioral therapy for insomnia (CBT-I) to usual care in Hong Kong Chinese adults aged 60 and older who have type 2 diabetes and insomnia. Eligible participants must have HbA1c 7.1–10% and an ISI score >10 and will be screened to exclude cognitive impairment, major depression, current hypnotic use, and other sleep‑affecting conditions. CBT-I will incorporate standard elements such as cognitive therapy, stimulus control, sleep restriction, sleep hygiene, and relaxation delivered by trained clinicians. Primary and secondary outcomes include changes in glycemic control (HbA1c), objective and subjective sleep measures, psychological symptoms, and cognitive function.

Who should consider this trial

Good fit: Ideal candidates are Hong Kong Chinese adults aged 60 or older with type 2 diabetes (HbA1c 7.1–10%), insomnia (ISI > 10), able to give consent, and not taking hypnotics or having major cognitive or psychiatric disorders.

Not a fit: Patients with significant cognitive impairment, major depression or other psychiatric disorders, current use of hypnotic or psychotropic medications, shift work, or chronic medical conditions that themselves disturb sleep are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, CBT-I could improve blood sugar control and sleep without adding hypnotic drugs, potentially reducing medication risks and improving quality of life.

How similar studies have performed: CBT-I has strong randomized-trial and meta-analysis evidence for improving sleep outcomes, but its direct effects on glycemic control in older adults with type 2 diabetes remain largely untested.

Eligibility criteria

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.

Where this trial is running

Hong Kong

• 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 (Recruiting)

Study contacts

• Study coordinator: Alice Kong, MD

Conditions Diabetes Mellitus, Type 2; Insomnia