Improving T2DM Detection Using Spot cHbA1c Test

Summary

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.

Conditions

• Diabetes Mellitus
• Pre-diabetes

Interventions

PROCEDURE

POC-cHbA1c testing

The point-of-care HbA1c instrument employed in this study will be the Cobas b 101 (Roche Diagnostics, Switzerland) diagnostic test system. A capillary blood sample will be obtained by dermal puncture of a fingertip using a disposable lancet and resorbed in the specially marked area of the Cobas b 101 test disc. The disc will be inserted in the autoanalyzer. Test results displayed in both % and mmol/l will be available within 10 minutes.

Sponsors & Collaborators

• Hospital Authority, Hong Kong

  collaborator OTHER_GOV

• Food and Health Bureau, Hong Kong

  collaborator OTHER_GOV

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Linda Chan · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-11

Primary Completion

2023-12-12

Completion

2023-12-12

Countries

• Hong Kong

Study Locations