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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05116319
• Other study ID #: CREC-202103
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1901
• Est. completion date: October 31, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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%

Locations

Country	Name	City	State
Hong Kong	School of public health and primary care	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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