Improving T2DM detection among at-Risk individuals – Effectiveness of Active Opportunistic Screening using spot Capillary-HbA1c test – A cluster randomized controlled trial (DM-REACH)

Professor Chan, Linda   (Principal Investigator (PI))

Dr Ko Wai Kit   (Co-Investigator)

Dr Yu Yee Tak Esther   (Co-Investigator)

Professor Wong Samuel Yeung Shan   (Co-Investigator)

Emeritus Professor Lam Cindy Lo Kuen   (Co-Investigator)

Professor Wan Yuk Fai Eric   (Co-Investigator)

Dr Chen *Xiao*   (Co-Investigator)

Dr Chao David Vai Kiong   (Co-Investigator)

30

2021-10-01

1500000

Improving T2DM detection among at-Risk individuals – Effectiveness of Active Opportunistic Screening using spot Capillary-HbA1c test – A cluster randomized controlled trial (DM-REACH)

Diabetes mellitus, HbA1c, point-of-care testing, pre-diabetes, screening

Others - Medicine, Dentistry and Health

18191751

Health and Medical Research Fund - Full Grant

2020

On-going

Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary-Haemoglobin-A1c (POC-cHbA1c) testing, compared to conventional 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: 736 patients (92 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening for in 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 OGTT if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free conventional vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone on next working days, 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 group. Secondary outcomes include number-need-to-screen to detect one more T2DM case. Data analysis: Participants’ characteristics and test uptake rates will be summarized by descriptive statistics. Difference in 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: Greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c; due to higher screening test uptake rate among the studied population.