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持续葡萄糖监测系统的临床性能评估:范围审查和报告建议
Guido Freckmann1,2, Manuel Eichenlaub2, Delia Waldenmaier2
1IFCC Scientific Division - Working Group on Continuous Glucose Monitoring.
Journal of diabetes science and technology
|August 21, 2023
概括
评估连续血糖监测 (CGM) 系统显示了重要的设计变化. 这次审查强调了研究方法和报告中的不一致性,阻碍了结果的比较,并强调了标准化的需要.
科学领域:
- 临床化学 临床化学
- 医疗器械评估 医疗器械评估
- 糖尿病 技术 技术
背景情况:
- 持续血糖监测 (CGM) 系统的临床性能比较具有挑战性,因为研究设计和结果呈现方式各异.
- 在CGM评估中缺乏对这种设计变化的全面分析.
- 本研究解决了了解临床绩效评估方法的异质性的需要.
研究的目的:
- 从2002年到2022年进行临床CGM性能评估的范围审查.
- 量化不同研究设计元素的流行程度,包括受试者群体,比较方法,测试程序和统计准确度措施.
- 在现有的CGM性能研究中发现不一致性和报告差距.
主要方法:
- 发表的临床CGM性能评估 (2002-2022) 的范围审查.
- 系统量化研究设计参数变化:受试者特征,参考方法选择,测试协议和统计分析.
- 对研究设计的关键方面报告完整性的分析.
主要成果:
- 在几乎所有评估的研究设计方面都观察到显著的变化.
- 在对比 (参考) 方法的选择和特征方面存在特别的异质性.
- 对于关键的研究设计元素,报告细节不足往往会阻碍对CGM绩效结果的明智解释.
结论:
- 目前临床CGM绩效评估的现状标志着大量的变化和不充分的报告.
- 提供了建议,以加强研究设计,CGM使用,比较方法,测试程序和统计分析的报告.
- 这一审查是制定标准化CGM绩效评估程序的基础,以提高可比性和可靠性.
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