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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05116319

Enrollment

1901

Registered

2021-11-11

Start date

2022-02-01

Completion date

2023-10-31

Last updated

2024-02-07

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

Conditions

Diabetes Mellitus

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.

Interventions

DIAGNOSTIC_TESTpoint-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%

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

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