国内首个！雅培瞬感2代获得中国iCGM批准

上观新闻09-18

雅培今天宣布，瞬感2代获得了中国国家药品监督管理局（NMPA）集成式持续葡萄糖监测系统（iCGM）的批准，成为国内首个且目前唯一获此批准的动态血糖仪。　　该认证代表着动态血糖监测领域的更高标准，集成式持续葡萄糖监测系统（iCGM）不仅仅是帮助跟踪糖值变化趋势，其核心价值在于：测量结果可用于成人糖尿病患者糖尿病治疗的辅助决策。　　作为持续葡萄糖监测领域的重要标准，iCGM对全血糖区间准确度及安全性...

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Abbott Instantaneous 2nd Generation Receives Approval from China's iCGM","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IHI":0.6,"PJP":0.6,"ABT":1.5,"TMED":0.6},"content_text":"雅培今天宣布，瞬感2代获得了中国国家药品监督管理局（NMPA）集成式持续葡萄糖监测系统（iCGM）的批准，成为国内首个且目前唯一获此批准的动态血糖仪。　　该认证代表着动态血糖监测领域的更高标准，集成式持续葡萄糖监测系统（iCGM）不仅仅是帮助跟踪糖值变化趋势，其核心价值在于：测量结果可用于成人糖尿病患者糖尿病治疗的辅助决策。　　作为持续葡萄糖监测领域的重要标准，iCGM对全血糖区间准确度及安全性提出了严苛的要求，能够为患者和医疗专业人士提供更可靠的血糖数据，也为未来与自动胰岛素给药系统等智能设备的集成应用奠定基础。　　中国国家药品监督管理局在《持续葡萄糖监测系统注册审查指导原则（2023年修订版）》中新增iCGM分类标准。近年来，iCGM也相继被纳入国内糖尿病管理、心血管疾病患者血糖管理、基层临床应用等多个专家共识及行业规范，正逐步成为推动糖尿病规范化诊疗的重要标准。　　对患者而言，糖尿病是一种需要长期管理的慢性病，和疾病共处的时候，许多患者往往忽视一些真正影响生命健康的关键时刻，例如夜间低血糖、药物调整以及血糖剧烈波动等。在这些关键时刻，每一次糖值变化都可能影响治疗决策和健康结果。　　瞬感2代通过更为精准安全的持续监测葡萄糖变化，为患者和医疗专业人士提供值得信赖的数据支持，帮助做出更加精准的健康管理决策。　　雅培糖尿病业务大中华区总经理李婧表示：“此次获批是对瞬感2代产品性能和临床价值的高度认可。作为中国首个符合iCGM批准的动态血糖仪品牌，我们将持续推动血糖监测技术的不断创新，帮助患者实现更精准的血糖管理，实现更好地健康获益。”（文章来源：上观新闻）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.50.1","shortVersion":"4.50.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2668942096","isCrawlerRequest":true}