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关于在拉丁美洲标准化CGM评估指标的共识声明:专家的方法
Mauro Scharf1, Karen Feriz2, Carlos Yepes3
1Pediatric Endocrinology Unit, Centro de Diabetes Curitiba, Hospital Nossa Senhora das Graças, Curitiba, Brazil. mauroscharf@gmail.com.
Diabetology & metabolic syndrome
|July 22, 2025
概括
拉丁美洲需要标准化指标来评估持续血糖监测 (CGM) 设备. 这种共识建立了准确性,验证和监测的专家建议,以确保患者安全并改善糖尿病护理.
科学领域:
- 内分泌学 在内分泌学.
- 医疗器械规则 医疗器械规则
- 糖尿病 技术 技术
背景情况:
- 拉丁美洲缺乏用于持续血糖监测 (CGM) 设备评估的标准化性能标准.
- 这导致市场上有不符合基本质量,准确性,可靠性或安全标准的CGM设备.
- 可靠和准确的CGM系统对于糖尿病管理至关重要,为检测和预测葡萄糖水平事件提供关键数据,并确保患者的安全.
研究的目的:
- 建立一个基于共识的专家建议框架,用于评估拉丁美洲的CGM技术.
- 定义CGM设备性能,准确性和安全性的关键指标和标准.
- 解决迫切需要与国际最佳实践调整监管的迫切需要.
主要方法:
- 使用了经过修改的Delphi方法,涉及来自拉丁美洲的内分泌学家,儿科内分泌学家和糖尿病学家.
- 专家参与多轮调查和讨论,以达成对关键CGM特征和验证协议的共识.
- 定量和定性数据分析为CGM评估制定了强有力的建议.
主要成果:
- 一个专家小组在拉丁美洲当前的CGM法规中发现了重大差距.
- 制定了12个关键建议和一个检查清单,以使区域标准与全球最佳实践保持一致,重点关注准确度值,临床验证和市场后监测.
- 重点放在患者教育,医疗保健提供者的参与和可访问性上,以改善CGM的采用和可用性.
结论:
- 迫切需要标准化指标来评估整个拉丁美洲的CGM设备.
- 实施标准化的准确性要求,严格的验证协议和加强患者教育对于确保设备可靠性至关重要.
- 这些措施将改善临床结果,提高患者安全,并促进该地区糖尿病管理的更公平的医疗保健环境.
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