protocolSection identificationModule nctId: NCT06382363, orgStudyIdInfo id: UW21-363, briefTitle: Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT, acronym: DM-REACH, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Hospital Authority, Hong Kong, collaborators name: Food and Health Bureau, Hong Kong, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes Mellitus, conditions: Pre-diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 776, type: ESTIMATED, armsInterventionsModule interventions name: POC-cHbA1c testing, outcomesModule primaryOutcomes measure: Proportional difference in detection of T2DM, primaryOutcomes measure: Uptake rate, secondaryOutcomes measure: Proportion of high-risk HbA1c concentration, secondaryOutcomes measure: Difference in uptake rate of OGTT, secondaryOutcomes measure: Number-needed-to-screen to detect one more T2DM case, secondaryOutcomes measure: Proportion of patients who refuse to join the study, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aberdeen Jockey Club General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Kwun Tong Community Health Centre, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Lek Yuen General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Li Po Chun General Out-Patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Ma On Shan Family Medicine Centre, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Sai Ying Pun Jockey Club General Out-patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Tseung Kwan O (Po Ning Road) General Out-patient Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Yau Ma Tei Jockey Club Specialist Clinic, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Linda Chan, role: CONTACT, phone: 25185657, email: lmjchan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False