Impact of Sleep Education Program on Glycemic Control in Hong Kong Chinese Type 2 Diabetic Patients

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01881724

Enrollment

264

Registered

2013-06-20

Start date

2013-05-31

Completion date

2017-12-31

Last updated

2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

This is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.

Detailed description

Patients will be identified from the Diabetes Mellitus and Endocrine Centre of Prince of Wales Hospital and Yao Chung Kit Diabetes Assessment Centre, The Chinese University of Hong Kong. All participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.Eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.

Interventions

BEHAVIORALSleep education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Aged 18-65 years 2. Type 2 diabetes mellitus 3. Chinese ethnicity 4. Able and willing to give informed written consent 5. Sleep deprived, defined as subjective sleeping time \<6 hours per day

Exclusion criteria

1. Type 1 diabetes mellitus 2. Known history of psychiatric disorders (e.g. depression, anxiety, dementia) 3. Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder) 4. Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain) 5. Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep. 6. Any condition, as judged by the investigators, as ineligible to participate in this study

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	12 months

Secondary

Measure	Time frame	Description
insulin resistance	12 months	HOMA\_IR
body weight	12 months	—
fasting plasma glucose	12 months	—
lipid profile	12 months	—
sleep duration	12 months	—
blood pressure	12 months	—

Countries

China, Hong Kong

Contacts

Primary ContactAlice Kong, FRCP

alicekong@cuhk.edu.hk(852)26323307

Backup ContactTracy Cheng, RN

tracycheng@cuhk.edu.hk(852)26323663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026