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中國首款自主研發的"14天、免校準、實時"持續葡萄糖監測系統成功獲批
格隆匯 11-04 19:53

11月4日,從國家藥監局網站獲悉,由微泰醫療器械(杭州)股份有限公司自主研發的,國內首款"14天、免校準、實時"持續葡萄糖監測系統AiDEX G7正式獲批上市。

同時獲悉,微泰AiDEX G7已在2020年9月獲得歐洲CE註冊證書,也是全球範圍內第二家獲批的免校準實時持續葡萄糖監測系統,標誌着中國科技公司通過自身努力成功打破國外技術壁壘,躋身成為持續葡萄糖監測領域的領先者。

AiDEX G7臨牀研究結果已發表在《Journal of Diabetes Science and Technology》(糖尿病科學與技術)期刊上。此研究的受試人數為國內最多,其結果顯示,與靜脈血蔘考值相比AiDEX CGMS的平均相對誤差絕對值(MARD)為 9.08%,性能國際領先。

截止2020年數據,中國是全球糖尿病第一大國,患病人數已突破1.298億,另有超過3億人處於糖尿病前期。血糖監測一直是糖尿病管理的基礎。傳統指血血糖測試,只能體現測試當時的血糖數值,而這種獨立時間點的血糖監測,極易忽略血糖波動時的高低血糖真實情況,不利於血糖控制的整體達標率。

AiDEX G7可連續14天使用,實時監測患者血糖變化,形成一條能完整反應血糖變化趨勢的曲線,為患者血糖控制方案調整提供全面及時的數據支撐,有效提高控糖達標率。其免校準的使用方式,可以免去患者扎手指的痛苦,大大提高使用依從性。

另外從微泰醫療器械(杭州)股份有限公司網站上了解到該公司還有中國第一款,也是唯一一款獲批的貼敷式胰島素泵,可模擬生理胰島素分泌模式,實現血糖控制目標,未來可以實現與剛獲批的免校準實時持續葡萄監測系統配合,形成閉環人工胰腺,為廣大糖尿病患者提供更智能、跟便捷、更全面糖尿病管理服務。

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