Improving T2DM Detection Using Spot cHbA1c Test (DM-REACH)

Improving T2DM Detection Among At-Risk Individuals - Effectiveness of Active Opportunistic Screening Using Spot Capillary-HbA1c Test - a Cluster Randomized Controlled Trial (DM-REACH)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Pre-diabetes
• Intervention / Treatment: Procedure: POC-cHbA1c testing

Detailed Description

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

1. To determine the difference in the proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (conventional vHbA1c testing).
2. To evaluate the uptake rate of the POC-cHbA1c test relative to the vHbA1c test among at-risk public primary care patients in Hong Kong.

Secondary Objectives

1. To determine the proportion of subjects with high-risk HbA1c concentration (i.e. HbA1c≥5.6%) among the studied at-risk group.
2. To compare the difference in uptake rate of confirmatory OGTT test between intervention and control groups.
3. To calculate the number-needed-to-screen to detect one more case with T2DM using POC-cHbA1c testing compared to vHbA1c testing.
4. The proportion of patients who refuse to join the study (among all eligible subjects).

Hypotheses:

1. A greater proportion of T2DM patients will be detected in the intervention group (POC-cHbA1c testing) than in the control group (vHbA1c).
2. Uptake rate of POC-cHbA1c testing will be higher than vHbA1c testing among the studied population.
3. Uptake rate of confirmatory OGTT among screened positive patients (i.e. HbA1c ≥5.6%) in the intervention group will be higher than for those in the control group.

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.

• Study Type: Interventional
• Enrollment (Actual): 852
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Lek Yuen General Out-Patient Clinic
  • Hong Kong, Hong Kong
    • Aberdeen Jockey Club General Out-Patient Clinic
  • Hong Kong, Hong Kong
    • Kwun Tong Community Health Centre
  • Hong Kong, Hong Kong
    • Li Po Chun General Out-Patient Clinic
  • Hong Kong, Hong Kong
    • Ma On Shan Family Medicine Centre
  • Hong Kong, Hong Kong
    • Sai Ying Pun Jockey Club General Out-patient Clinic
  • Hong Kong, Hong Kong
    • Tseung Kwan O (Po Ning Road) General Out-patient Clinic
  • Hong Kong, Hong Kong
    • Yau Ma Tei Jockey Club Specialist Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Non-diabetic patient;
• Aged ≥ 45 years;
• Family history of DM in a first-degree relative;
• History of Gestational DM;
• Hypertension (i.e. Systolic Blood Pressure (BP) ≥140mmHg, Diastolic BP ≥90mmHg or on therapy for hypertension);
• History of pre-diabetes (i.e. impaired fasting glucose with fasting glucose concentration between 5.6-6.9 mmol/L, impaired glucose tolerance with 2-hour post challenge plasma glucose concentration between 7.8-11.0 mmol/L or HbA1c between 5.6-6.4%);
• Hyperlipidemia (i.e. total cholesterol ≥ 5.2 mmol/L, triglycerides ≥ 1.7 mmol/L or on therapy);
• Obesity (i.e. for Chinese subjects, body mass index (BMI) ≥ 25 kg/m2).

Exclusion Criteria:

• Known history of T2DM or on hypoglycaemic treatment;
• Received T2DM screening within 12-months;
• Women who are pregnant or breast-feeding at recruitment;
• Active thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment;
• History of blood donation or blood transfusion within 3 months prior to recruitment;
• Patients who are taking systemic steroid therapy or iron supplement at recruitment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	36 months
Uptake rate	The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of high-risk HbA1c concentration	The proportion of subjects with high-risk HbA1c concentration ≥5.6% among the studied at-risk group	36 months
Difference in uptake rate of OGTT	The difference in the uptake rate of confirmatory OGTT between intervention and control groups	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	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)	36 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong; Food and Health Bureau, Hong Kong
• Investigators: Principal Investigator: Linda Chan, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2022
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Screening; Point-of-Care Testing; Hemoglobin-A1c
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: UW21-363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No