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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
720
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.
Research staff will use standardised glucometers and test strips to measure fingerstick random blood glucose. Test results will be provided on site.
The First People's Hospital of Dali
Dali, Yunnan, China
Detection rate of T2DM
Time frame: 1 week
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.