NCT05116319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,901

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

October 20, 2021

Last Update Submit

February 5, 2024

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Office blood pressure

    baseline

  • Body mass index

    baseline

Study Arms (1)

Chinese people with no known history of diabetes

Diagnostic Test: point-of-care HbA1c

Interventions

point-of-care HbA1cDIAGNOSTIC_TEST

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%

Chinese people with no known history of diabetes

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General Chinese population

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of public health and primary care

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 11, 2021

Study Start

February 1, 2022

Primary Completion

August 29, 2023

Study Completion

October 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

HK(1)