NCT07718867

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress1%
Jul 2026Dec 2027

First Submitted

Initial submission to the registry

July 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

July 28, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 13, 2026

Last Update Submit

July 25, 2026

Conditions

Type 2 DiabetesPre-diabetes

Keywords

POCTHbA1cDiabetes screeningEffectivenessCost-effectivenessRural ChinaCluster randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Detection rate of T2DM

    1 week

Secondary Outcomes (4)

  • Detection rate of pre-diabetes

    1 week

  • Sensitivity and specificity

    1 week

  • Number needed to screen

    1 week

  • Incremental cost-effectiveness ratio

    3 months and 6 months

Other Outcomes (5)

  • Proportion of treatment adherence

    3 months and 6 months

  • Score of diabetes self-management

    3 months and 6 months

  • Venous HbA1c levels

    3 months and 6 months

  • +2 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

POC-cHbA1c + vHbA1c

Diagnostic Test: POC-cHbA1c

Control group

ACTIVE COMPARATOR

Fingerstick RBG + vHbA1c

Diagnostic Test: Fingerstick RBG

Interventions

POC-cHbA1cDIAGNOSTIC_TEST

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.

Intervention group
Fingerstick RBGDIAGNOSTIC_TEST

Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Dali

Dali, Yunnan, 671000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • William Chi Wai Wong, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Levon Yongle Zhan, PhD

CONTACT

852-25185656levon@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 22, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)