Diabetes MellitusDM-REACHNCT06382363
Improving T2DM Detection Using Spot cHbA1c Test
A study testing POC-cHbA1c testing in people with Diabetes Mellitus and Pre-diabetes, run by The University of Hong Kong at 8 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus, Pre-diabetes
- What is being tested?
- POC-cHbA1c testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 8 sitesHong Kong
- Study dates
- 11 Jun 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Hong Kong8 sites
Aberdeen Jockey Club General Out-Patient Clinic
Hong Kong
Kwun Tong Community Health Centre
Hong Kong
Lek Yuen General Out-Patient Clinic
Hong Kong
Li Po Chun General Out-Patient Clinic
Hong Kong
Ma On Shan Family Medicine Centre
Hong Kong
Sai Ying Pun Jockey Club General Out-patient Clinic
Hong Kong
Tseung Kwan O (Po Ning Road) General Out-patient Clinic
Hong Kong
Yau Ma Tei Jockey Club Specialist Clinic
Hong Kong
About this study
Official title: 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.
Read more
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.
Read the 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
- To determine the difference in the proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (conventional vHbA1c testing).
- 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
- To determine the proportion of subjects with high-risk HbA1c concentration (i.e. HbA1c≥5.6%) among the studied at-risk group.
- To compare the difference in uptake rate of confirmatory OGTT test between intervention and control groups.
- To calculate the number-needed-to-screen to detect one more case with T2DM using POC-cHbA1c testing compared to vHbA1c testing.
- The proportion of patients who refuse to join the study (among all eligible subjects).
Hypotheses:
- A greater proportion of T2DM patients will be detected in the intervention group (POC-cHbA1c testing) than in the control group (vHbA1c).
- Uptake rate of POC-cHbA1c testing will be higher than vHbA1c testing among the studied population.
- 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.
- Conditions
- Diabetes Mellitus, Pre-diabetes
- Being tested
- POC-cHbA1c testing
- Keywords
- Hemoglobin-A1c, Screening, Point-of-Care Testing
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC-cHbA1c testingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Procedure: POC-cHbA1c testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Uptake rate
The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants
Measured: 36 months
Secondary outcomes (4)
Proportion of high-risk HbA1c concentration
The proportion of subjects with high-risk HbA1c concentration ≥5.6% among the studied at-risk group
Measured: 36 months
Difference in uptake rate of OGTT
The difference in the uptake rate of confirmatory OGTT between intervention and control groups
Measured: 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
Measured: 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)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start11 Jun 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Dr. Linda Chan, The University of Hong Kong
- Investigators
- Linda Chan, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382363
- Sponsor's protocol ID
- UW21-363
- Acronym
- DM-REACH
- Status last verified
- Jul 2024
- First submitted
- 19 Apr 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan L, Yu EYT, Wan EYF, Wong SYS, Chao DVK, Ko WWK, Chen CXR, Chan PPL, Bilney EVM, Lee ES, Ng WL, Lam CLK. Improving type 2 diabetes detection among at-risk individuals - comparing the effectiveness of active opportunistic screening using spot capillary-HbA1c testing and venous HbA1c testing: a cluster randomized controlled trial. BMC Med. 2025 Mar 31;23(1):190. doi: 10.1186/s12916-025-04007-z.
PubMed 40165254
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving T2DM Detection Among At-Risk Individuals - Effectiveness of Active Opportunistic Screening Using Spot Capillary-HbA1c Test - a Cluster Randomized Controlled Trial (DM-REACH)
- ClinicalTrials.gov ID
- NCT06382363
- Acronym / sponsor ID
- DM-REACH / UW21-363
- Conditions
- Diabetes Mellitus, Pre-diabetes
- Keywords
- Hemoglobin-A1c, Screening, Point-of-Care Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong, Food and Health Bureau, Hong Kong
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- To determine the difference in the proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (conventional vHbA1c testing).
- 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
- To determine the proportion of subjects with high-risk HbA1c concentration (i.e. HbA1c≥5.6%) among the studied at-risk group.
- To compare the difference in uptake rate of confirmatory OGTT test between intervention and control groups.
- To calculate the number-needed-to-screen to detect one more case with T2DM using POC-cHbA1c testing compared to vHbA1c testing.
- The proportion of patients who refuse to join the study (among all eligible subjects).
Hypotheses:
- A greater proportion of T2DM patients will be detected in the intervention group (POC-cHbA1c testing) than in the control group (vHbA1c).
- Uptake rate of POC-cHbA1c testing will be higher than vHbA1c testing among the studied population.
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Intervention | Experimental | Procedure: POC-cHbA1c testingSubjects 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC-cHbA1c testingThe 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. | Procedure or surgery | Intervention |
Primary outcome
Proportional difference in detection of T2DM
Time frame: 36 months
The difference in proportion of T2DM detected between the intervention group (POC-cHbA1c testing) and control group (vHbA1c testing)
Uptake rate
Time frame: 36 months
The uptake rate of POC-cHbA1c testing and vHbA1c testing among consented participants
4 secondary outcomes
Proportion of high-risk HbA1c concentration
Time frame: 36 months
Difference in uptake rate of OGTT
Time frame: 36 months
Number-needed-to-screen to detect one more T2DM case
Time frame: 36 months
Proportion of patients who refuse to join the study
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 40165254Chan L, Yu EYT, Wan EYF, Wong SYS, Chao DVK, Ko WWK, Chen CXR, Chan PPL, Bilney EVM, Lee ES, Ng WL, Lam CLK. Improving type 2 diabetes detection among at-risk individuals - comparing the effectiveness of active opportunistic screening using spot capillary-HbA1c testing and venous HbA1c testing: a cluster randomized controlled trial. BMC Med. 2025 Mar 31;23(1):190. doi: 10.1186/s12916-025-04007-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Chan principal investigator
The University of Hong Kong
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC-cHbA1c testing in people with Diabetes Mellitus and Pre-diabetes, run by The University of Hong Kong at 8 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportional difference in detection of T2DM (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06382363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.