Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China

July 25, 2026 updated by: William Chi Wai Wong, The University of Hong Kong

Effectiveness and Cost-Effectiveness of Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, Yunnan, China: A Cluster Randomised Controlled Trial

This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China, and to improve treatment adherence and self-management among people with diabetes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a cluster randomised controlled trial conducted in rural Dali, Yunnan, China, to evaluate the effectiveness and cost-effectiveness of point-of-care capillary HbA1c testing (POC-cHbA1c) for screening type 2 diabetes among high-risk individuals. The study will involve six township health centres in rural Dali. The intervention group will receive immediate on-site POC-cHbA1c testing, while the control group will undergo fingerstick RBG testing, with both groups having confirmatory vHbA1c testing for validation. Primary outcome is the detection rates of T2DM, while secondary outcomes include the detection rate of pre-diabetes, sensitivity, specificity, and economic evaluations such as the incremental cost-effectiveness ratio (ICER). The findings are intended to inform optimized screening strategies in rural settings, potentially leading to earlier diagnosis, better treatment adherence, and improved health outcomes in rural populations at high risk of diabetes.

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Levon Yongle Zhan, PhD
  • Phone Number: 852-25185656
  • Email: levon@hku.hk

Study Locations

  • China
    • Yunnan
      • Dali, Yunnan, China, 671000
        • The First People's Hospital of Dali
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or above;
  • Permanent residents of Dali City who have lived locally for at least six consecutive months;
  • Registered as rural residents;
  • No known history of diabetes;
  • Meet at least one of the high-risk criteria for T2DM specified in the Chinese Guidelines for the Prevention and Treatment of Diabetes issued by the Chinese Diabetes Society;
  • Able to understand the study information and provide written informed consent.

Exclusion Criteria:

  • Known history of T2DM or currently receiving glucose-lowering treatment;
  • HbA1c testing with a clear result within the past three months, or completion of standardised diabetes screening within the past six months;
  • Pregnant or breastfeeding at the time of recruitment;
  • Active thyroid disease or other active endocrine disorders at recruitment, such as Cushing's syndrome or acromegaly;
  • Known haemoglobinopathy, severe anaemia, recent acute blood loss, or history of blood transfusion or blood donation within the past three months;
  • Currently receiving treatment that may substantially affect interpretation of HbA1c, such as erythropoietin therapy or recent high-dose iron therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
POC-cHbA1c + vHbA1c
Diagnostic test: POC-cHbA1c
Research staff will use quality-certified POC HbA1c devices to perform finger-prick capillary HbA1c testing for participants. Testing will be completed on site and results will be provided immediately.
Active Comparator: Control group
Fingerstick RBG + vHbA1c
Diagnostic test: Fingerstick RBG
Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection rate of T2DM
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection rate of pre-diabetes
Time Frame: 1 week
1 week
Sensitivity and specificity
Time Frame: 1 week
1 week
Number needed to screen
Time Frame: 1 week
1 week
Incremental cost-effectiveness ratio
Time Frame: 3 months and 6 months
3 months and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of diabetes self-management
Time Frame: 3 months and 6 months
The level of diabetes self-managment will be calculated as a score using the Summary of Diabetes Self-Care Activities - 6 items (SDSCA-6).
3 months and 6 months
Venous HbA1c levels
Time Frame: 3 months and 6 months
3 months and 6 months
Treatment-related adverse event
Time Frame: 3 months and 6 months
Hypoglycaemia, anxiety and depression, etc.
3 months and 6 months
Level of satisfaction with the screening method
Time Frame: 3 months and 6 months
The level of satisfaction with the screening method will be evaluated using a 5-point Likert item (very disappointed, disappointed, neutral, satisfied, very satisfied).
3 months and 6 months
Proportion of treatment adherence
Time Frame: 3 months and 6 months
Treatment adherence will be measured by the Medication Adherence Report Scale - 5 items, MARS-5
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: William Chi Wai Wong, MD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 28, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 25, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYYLL-2026021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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