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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Detection rate of T2DM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
Fingerstick RBG + vHbA1c
干预措施: Fingerstick RBG (Diagnostic Test)
Intervention group
POC-cHbA1c + vHbA1c
干预措施: POC-cHbA1c (Diagnostic Test)
结局指标
主要结局
Detection rate of T2DM
时间窗: 1 week
次要结局
- Incremental cost-effectiveness ratio(3 months and 6 months)
- Detection rate of pre-diabetes(1 week)
- Sensitivity and specificity(1 week)
- Number needed to screen(1 week)
研究者
William Chi Wai Wong
Clinical Professor
The University of Hong Kong