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Status unknownNCT01881724Updated Jun 20, 2013

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

An interventional study of Sleep education in Type 2 Diabetes Mellitus, sponsored by Chinese University of Hong Kong. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-06-20.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 264 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
264 participants (estimated)

Study arms

  • No intervention
    Usual Care
  • Experimental
    sleep education program

    Behavioral: Sleep education

Interventions

  • BehavioralSleep education
06

What researchers measure

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: 12 months

Secondary outcomes

  1. fasting plasma glucose

    Time frame: 12 months

  2. insulin resistance

    HOMA_IR

    Time frame: 12 months

  3. body weight

    Time frame: 12 months

  4. blood pressure

    Time frame: 12 months

  5. lipid profile

    Time frame: 12 months

  6. sleep duration

    Time frame: 12 months

07

Study locations

1 of 2 sites recruiting
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong, China
    Recruiting
  • Clinical Trial Centre, The Chinese University of Hong Kong, Prince of Wales Hospital
    Hong Kong, Hong Kong, Hong Kong
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01881724
Lead sponsor
Chinese University of Hong Kong
Responsible party
Alice Pik Shan KONG (Associate Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jun 20, 2013
Start date
May 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2017 (estimated)
Last update
Jun 20, 2013

Study contacts

Alice Kong, FRCP
Contact
alicekong@cuhk.edu.hk
(852)26323307
Tracy Cheng, RN
Contact
tracycheng@cuhk.edu.hk
(852)26323663
Alice PS Kong, FRCP
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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