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

Sensitivity and Specificity of Guidelines' Recommendations and Existing Predictive Models to Detect Undiagnosed Diabetes Mellitus or Prediabetes in a Chinese Population

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: point-of-care HbA1c

• Study Type: Observational
• Enrollment (Actual): 1901

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of public health and primary care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General Chinese population

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese people with no known history of diabetes	Diagnostic test: point-of-care HbA1c; The Afinion2™ (Abbott, Oslo, Norway), will be used for the current study as it is recently validated. According to American Diabetes Association (ADA), pre-diabetes (pre-DM) is diagnosed if HbA1c is 5.7-6.4% and diabetes (DM) is diagnosed if HbA1c is ≥6.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point-of-care (POC) HbA1c	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%.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office blood pressure	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	baseline
Body mass index	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	baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 30, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CREC-202103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will share data upon researchers' reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No