The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
BMJ Open. 2024 Jan 30;14(1):e076011. doi: 10.1136/bmjopen-2023-076011.
Diabetes mellitus (DM) is an important health issue that affects the ageing population. China has the largest geriatric population and the largest number of diabetes cases in the world. This poses a significant challenge for healthcare providers and policymakers. Haemoglobin A1C (HbA1c), which is one of the diagnostic criteria for diabetes, is affected by many factors such as pregnancy, age, race and anaemia. Glycated albumin (GA) is not influenced by factors that affect HbA1c concentrations, although it has been used in the diagnosis of diabetes in a few people. The aim of this study protocol is to determine reference intervals (RIs) of HbA1c and GA for the diagnosis of older adults with diabetes in China and to assess the optimal cut-off values for these parameters from a health economic perspective.
This cross-sectional survey study will recruit 1278 community-dwelling older adults aged 60-89 in Chengdu City. The data collection process will involve a questionnaire survey, a comprehensive physical examination and the collection of blood samples for laboratory testing. Data analyses will be conducted on the pooled sample and stratified by gender, age or other demographic features if necessary. Rates will be compared using the χ2 test or Fisher test and receiver operating characteristic (ROC) curves will be used to identify the most effective threshold values for HbA1c and GA for diagnosing diabetes among older adults in China.
The study protocol was approved by the ethics review board of the Bioethics Subcommittee of West China Hospital, Sichuan University (Approval No. 1705 in 2022). The study's results will be disseminated through peer-reviewed journals and scientific conferences.
ChiCTR2300070831.
糖尿病（DM）是一个重要的健康问题，影响着老年人口。中国拥有世界上最大的老年人口和最多的糖尿病病例。这对医疗保健提供者和政策制定者来说是一个重大挑战。糖化血红蛋白（HbA1c）是糖尿病的诊断标准之一，受妊娠、年龄、种族和贫血等多种因素的影响。糖化白蛋白（GA）不受影响 HbA1c 浓度的因素影响，尽管它已在少数人中用于糖尿病的诊断。本研究方案的目的是确定中国老年糖尿病患者 HbA1c 和 GA 的参考区间（RI），并从健康经济学角度评估这些参数的最佳截断值。
这是一项横断面调查研究，将在成都市招募 1278 名 60-89 岁的社区居住的老年人。数据收集过程将包括问卷调查、全面体检和采集血样进行实验室检测。如果必要，将对汇总样本进行数据分析，并按性别、年龄或其他人口统计学特征进行分层。率的比较将使用 χ2 检验或 Fisher 检验，受试者工作特征（ROC）曲线将用于确定 HbA1c 和 GA 在中国老年人中诊断糖尿病的最有效阈值。
本研究方案已获得四川大学华西医院生物伦理委员会伦理审查分委员会（2022 年第 1705 号）的批准。研究结果将通过同行评议期刊和科学会议传播。
ChiCTR2300070831。
