Prediction to Detect Pre-DM/DM in a Chinese Population

Completed

• Conditions: Diabetes Mellitus
• Interventions: Diagnostic Test: point-of-care HbA1c

• Registration Number: NCT05116319
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This project will compare the sensitivity and specificity of different screening criteria or recommendations to detect pre-diabetes or diabetes mellitus in a Chinese population, using point-of-care hemoglobin A1c.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-30
• Study First Posted: 2021-11-11
• Study Start: 2022-02-01
• Primary Completion: 2023-08-29
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1901

Inclusion Criteria

• age ≥25 years old
• with no previous diagnosis of DM
• Chinese.

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Exclusion Criteria

• a history of cardiovascular diseases including any type of stroke, ischemic heart disease, atrial fibrillation, and/or peripheral vascular disease
• severe mental or physical disease or language barriers that limited data collection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chinese people with no known history of diabetes	point-of-care HbA1c	-

Primary Outcome Measures

Name	Time	Method
Point-of-care (POC) HbA1c	baseline	the measurement to diagnose pre-diabetes or diabetes; pre-DM is diagnosed if HbA1c is 5.7-6.4% and DM is diagnosed if HbA1c is ≥6.5%.

Secondary Outcome Measures

Name	Time	Method
Office blood pressure	baseline	a measurement to screen for hypertension; BP will be measured for 2 times (1-minute apart) and will be in accordance to the Hong Kong Primary Care Office guideline (e.g. the choice of cuffs and positioning). The average of the two BP readings will be used for analysis and management. Elevated BP is defined as a systolic BP (SBP) of ≥140mmHg and/or a diastolic BP (DBP) ≥90mmHg
Body mass index	baseline	a measurement for obesity. Body mass index (BMI) is calculated by weight divided by the square of height (BMI = weight (kg)/height(m)2). According the Hong Kong Centre for Health Protection, overweight and obesity are defined as a BMI of 23-24.9kg/m2 and ≥25kg/m2 respectively

Trial Locations

Locations (1)

School of public health and primary care; 🇭🇰 Hong Kong, Hong Kong