An interventional study of POC-cHbA1c testing in Diabetes Mellitus and Pre-diabetes, sponsored by The University of Hong Kong. Completed at 8 sites in Hong Kong. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Screening
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.
Aim:
This pragmatic cluster randomized controlled trial aims to determine the effectiveness of active opportunistic screening using point-of-care capillary HbA1c (POC-cHbA1c) testing compared to venous HbA1c (vHbA1c) testing in improving T2DM detection among at-risk public primary care patients, to estimate the impact of such a screening strategy in the real-world setting. The ultimate goal would be to fill the current preventive care gap and reduce the burden of undiagnosed T2DM in Hong Kong.
Objectives:
Primary Objectives
Secondary Objectives
Hypotheses:
Data analysis:
Descriptive statistics will be used to summarize patients' characteristics in the intervention (POC-cHbA1c testing) group and control (vHbA1c testing) group. The difference in characteristics between groups will be assessed by independent t-tests for continuous variables or Chi-square tests for categorical variables. The uptake rate of POC-cHbA1c testing and vHbA1c testing will be reported. The difference in the proportion of T2DM detected between groups will also be compared using a Chi-squared test. The number-needed-to-screen to identify one additional patient with DM will be calculated. To take cluster effect into account, a mixed effect logistic model will be used to evaluate the effect of the intervention on the uptake rate by treating the clinic as a random effect and adjusting for the patients' characteristics. All statistical analyses will be performed using Stata. All significance tests will be two-tailed and findings with a p-value less than 0.05 will be considered statistically significant.
Potential problem:
Missing data will be handled by using multiple imputation. The chained equation method will be used to impute each missing value five times, adjusted for all baseline covariates and outcomes. The same analysis method will be adopted for each of the five imputed datasets, and the results will be pooled using Rubin's rule. Complete case analysis will also be conducted to confirm the results by multiple imputation analysis.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 852 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subjects in the control group will be offered a free venous HbA1c test. Consistent with current practice at GOPCs, the venous sampling will be scheduled on a separate clinic visit at a set time within 1-2 weeks of recruitment. Test results will be available within one week. The subject will be informed via phone call regarding his/her DM risk, and if his/her HbA1c≥5.6%, he/she will be scheduled for a confirmatory OGTT within 2-4 weeks, ideally at the same clinic.
Subjects in the intervention group will be offered a free POC-cHbA1c test to screen for hyperglycemia. The test will be performed on-site (i.e. during the same clinic visit of recruitment). Test results will be available within 10 minutes and the subject will be immediately informed of his/her DM risk, and for those with HbA1c≥5.6%, a confirmatory OGTT will be arranged on-site, scheduled within 2-4 weeks and ideally at the same clinic.
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.
Proportional difference in detection of T2DM
The difference in proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (vHbA1c testing)
Time frame: 36 months
Uptake rate
The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants
Time frame: 36 months
Proportion of high-risk HbA1c concentration
The proportion of subjects with high-risk HbA1c concentration ≥5.6% among the studied at-risk group
Time frame: 36 months
Difference in uptake rate of OGTT
The difference in the uptake rate of confirmatory OGTT between intervention and control groups
Time frame: 36 months
Number-needed-to-screen to detect one more T2DM case
The number-needed-to-screen for POC-cHbA1c to detect one more case with T2DM compared to vHbA1c testing
Time frame: 36 months
Proportion of patients who refuse to join the study
The proportion of patients who refuse to join the study (among all eligible subjects)
Time frame: 36 months
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong