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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Sleep education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-65 years Type 2 diabetes mellitus Chinese ethnicity Able and willing to give informed written consent Sleep deprived, defined as subjective sleeping time <6 hours per day Exclusion Criteria: Type 1 diabetes mellitus Known history of psychiatric disorders (e.g. depression, anxiety, dementia) Sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (OSA), circadian rhythm sleep disorder) Concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain) Concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep. Any condition, as judged by the investigators, as ineligible to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br> | |
| Experimental: sleep education program<br> | Behavioral: Sleep education<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  | 12 months | 
| insulin resistance | HOMA_IR | 12 months | 
| body weight |  | 12 months | 
| blood pressure |  | 12 months | 
| lipid profile |  | 12 months | 
| sleep duration |  | 12 months |