Type 2 DiabetesNCT07718867
Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China
A study testing POC-cHbA1c and Fingerstick RBG in people with Type 2 Diabetes and Pre-diabetes, run by The University of Hong Kong at 1 site in China.
Trial summary
This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Pre-diabetes
- What is being tested?
- POC-cHbA1c and Fingerstick RBG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above;
- Permanent residents of Dali City who have lived locally for at least six consecutive months;
- Registered as rural residents;
- No known history of diabetes;
- Meet at least one of the high-risk criteria for T2DM specified in the Chinese Guidelines for the Prevention and Treatment of Diabetes issued by the Chinese Diabetes Society;
- Able to understand the study information and provide written informed consent.
Who cannot join
- Known history of T2DM or currently receiving glucose-lowering treatment;
- HbA1c testing with a clear result within the past three months, or completion of standardised diabetes screening within the past six months;
- Pregnant or breastfeeding at the time of recruitment;
- Active thyroid disease or other active endocrine disorders at recruitment, such as Cushing's syndrome or acromegaly;
- Known haemoglobinopathy, severe anaemia, recent acute blood loss, or history of blood transfusion or blood donation within the past three months;
- Currently receiving treatment that may substantially affect interpretation of HbA1c, such as erythropoietin therapy or recent high-dose iron therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First People's Hospital of Dali
Dali, Yunnan, 671000
Libo Yang, BMed, 0872-2121378, 448925216@qq.com
About this study
Official title: Effectiveness and Cost-Effectiveness of Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, Yunnan, China: A Cluster Randomised Controlled Trial
This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China, and to improve treatment adherence and self-management among people with diabetes.
Read the detailed description
This is a cluster randomised controlled trial conducted in rural Dali, Yunnan, China, to evaluate the effectiveness and cost-effectiveness of point-of-care capillary HbA1c testing (POC-cHbA1c) for screening type 2 diabetes among high-risk individuals. The study will involve six township health centres in rural Dali. The intervention group will receive immediate on-site POC-cHbA1c testing, while the control group will undergo fingerstick RBG testing, with both groups having confirmatory vHbA1c testing for validation. Primary outcome is the detection rates of T2DM, while secondary outcomes include the detection rate of pre-diabetes, sensitivity, specificity, and economic evaluations such as the incremental cost-effectiveness ratio (ICER). The findings are intended to inform optimized screening strategies in rural settings, potentially leading to earlier diagnosis, better treatment adherence, and improved health outcomes in rural populations at high risk of diabetes.
- Conditions
- Type 2 Diabetes, Pre-diabetes
- Being tested
- POC-cHbA1c, Fingerstick RBG
- Keywords
- POCT, HbA1c, Diabetes screening, Effectiveness, Cost-effectiveness, Rural China, Cluster randomised controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC-cHbA1cDiagnostic test
Research staff will use quality-certified POC HbA1c devices to perform finger-prick capillary HbA1c testing for participants. Testing will be completed on site and results will be provided immediately.
Fingerstick RBGDiagnostic test
Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | POC-cHbA1c + vHbA1c Receives: Diagnostic Test: POC-cHbA1c |
| Control group | Active comparator | Fingerstick RBG + vHbA1c Receives: Diagnostic Test: Fingerstick RBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of T2DM
Measured: 1 week
Secondary outcomes (4)
Detection rate of pre-diabetes
Measured: 1 week
Sensitivity and specificity
Measured: 1 week
Number needed to screen
Measured: 1 week
Incremental cost-effectiveness ratio
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start28 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Chi Wai Wong, The University of Hong Kong
- Investigators
- William Chi Wai Wong, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718867
- Sponsor's protocol ID
- SYYLL-2026021
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-Effectiveness of Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, Yunnan, China: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07718867
- Acronym / sponsor ID
- SYYLL-2026021
- Conditions
- Type 2 Diabetes, Pre-diabetes
- Keywords
- POCT, HbA1c, Diabetes screening, Effectiveness, Cost-effectiveness, Rural China, Cluster randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (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.
This project aims to compare Point-of-care capillary HbA1c (POC-cHbA1c) testing and fingerstick random blood glucose (RBG) testing in terms of type 2 diabetes detection rate and cost-effectiveness, in order to optimise current screening strategies for rural populations at high risk of diabetes in rural Dali, China, and to improve treatment adherence and self-management among people with diabetes.
Detailed description
This is a cluster randomised controlled trial conducted in rural Dali, Yunnan, China, to evaluate the effectiveness and cost-effectiveness of point-of-care capillary HbA1c testing (POC-cHbA1c) for screening type 2 diabetes among high-risk individuals. The study will involve six township health centres in rural Dali. The intervention group will receive immediate on-site POC-cHbA1c testing, while the control group will undergo fingerstick RBG testing, with both groups having confirmatory vHbA1c testing for validation. Primary outcome is the detection rates of T2DM, while secondary outcomes include the detection rate of pre-diabetes, sensitivity, specificity, and economic evaluations such as the incremental cost-effectiveness ratio (ICER). The findings are intended to inform optimized screening strategies in rural settings, potentially leading to earlier diagnosis, better treatment adherence, and improved health outcomes in rural populations at high risk of diabetes.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: POC-cHbA1cPOC-cHbA1c + vHbA1c |
| Control group | Active comparator | Diagnostic Test: Fingerstick RBGFingerstick RBG + vHbA1c |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or above;
- Permanent residents of Dali City who have lived locally for at least six consecutive months;
- Registered as rural residents;
- No known history of diabetes;
- Meet at least one of the high-risk criteria for T2DM specified in the Chinese Guidelines for the Prevention and Treatment of Diabetes issued by the Chinese Diabetes Society;
Key exclusion criteria (6 listed)
- Known history of T2DM or currently receiving glucose-lowering treatment;
- HbA1c testing with a clear result within the past three months, or completion of standardised diabetes screening within the past six months;
- Pregnant or breastfeeding at the time of recruitment;
- Active thyroid disease or other active endocrine disorders at recruitment, such as Cushing's syndrome or acromegaly;
- Known haemoglobinopathy, severe anaemia, recent acute blood loss, or history of blood transfusion or blood donation within the past three months;
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-cHbA1cResearch staff will use quality-certified POC HbA1c devices to perform finger-prick capillary HbA1c testing for participants. Testing will be completed on site and results will be provided immediately. | Diagnostic test | Intervention group |
| Fingerstick RBGResearch staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site. | Diagnostic test | Control group |
Primary outcome
Detection rate of T2DM
Time frame: 1 week
4 secondary outcomes
Detection rate of pre-diabetes
Time frame: 1 week
Sensitivity and specificity
Time frame: 1 week
Number needed to screen
Time frame: 1 week
Incremental cost-effectiveness ratio
Time frame: 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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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.
William Chi Wai Wong, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC-cHbA1c and Fingerstick RBG in people with Type 2 Diabetes and Pre-diabetes, run by The University of Hong Kong at 1 site in China.
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 6 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Levon Yongle Zhan, PhD (852-25185656, levon@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of T2DM (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.