NCT06382363: DM-REACH

Improving T2DM Detection Using Spot cHbA1c Test

Completed NA Last updated 5 July 2024

What this trial tests

NA trial testing POC-cHbA1c testing in Diabetes Mellitus in 852 participants. Completed in 12 December 2023.

Timeline

11 June 2022

Primary endpoint
12 December 2023

12 December 2023

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	852
Start date	11 June 2022
Primary completion	12 December 2023
Estimated completion	12 December 2023
Sites	8 locations across Hong Kong

Drugs / interventions tested

• POC-cHbA1c testing

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Pre-diabetes — all drugs for Pre-diabetes →

Sponsor

The University of Hong Kong

Who can join

45 and older, any sex, with Diabetes Mellitus or Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.

Design: Pragmatic cluster randomized controlled trial.

Setting: 8 public primary care clinics in Hong Kong.

Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.

Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.

Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.

Secondary outcomes include number-needed-to-screen to detect one more T2DM case.

Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.

Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving type 2 diabetes detection among at-risk individuals - comparing the effectiveness of active opportunistic screening using spot capillary-HbA1c testing and venous HbA1c testing: a cluster randomized controlled trial.
   Chan L, Yu EYT, Wan EYF, Wong SYS, et al · · 2025 · cited 1× · PMID 40165254 · DOI 10.1186/s12916-025-04007-z