Point-of-care Capillary HbA1c Testing for Type 2 Diabetes Screening Among At-risk Individuals in Rural Dali, China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POC-cHbA1c, Fingerstick RBG.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Pre-diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Diagnostic test POC-cHbA1c
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. - Diagnostic test Fingerstick RBG
Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.
Primary outcome measures
- Detection rate of T2DM [Time frame: 1 week]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 1 center
- The First People's Hospital of Dali — Dali
Identifiers
NCT: NCT07718867 · SYYLL-2026021