FDA批准用于1型糖尿病患者的新型闭环胰岛素输送系统

2019-12-15 佚名 cnBeta.COM

据外媒The Verge报道,美国食品药品管理局(FDA)周五批准了一种新型闭环胰岛素输送系统的使用,该系统可以使糖尿病患者自定义治疗方法并自动调整胰岛素水平。它将在2020年1月抵达患者手中。名为Control-IQ的技术由Tandem Diabetes Care制造,并与血糖传感器和胰岛素泵连接,以根据1型糖尿病患者的血糖水平自动增加,减少或停止胰岛素的输送。1型糖尿病患者无法产生自己的胰岛素

据外媒The Verge报道,美国食品药品管理局(FDA)周五批准了一种新型闭环胰岛素输送系统的使用,该系统可以使糖尿病患者自定义治疗方法并自动调整胰岛素水平。它将在2020年1月抵达患者手中。



名为Control-IQ的技术由Tandem Diabetes Care制造,并与血糖传感器和胰岛素泵连接,以根据1型糖尿病患者的血糖水平自动增加,减少或停止胰岛素的输送。1型糖尿病患者无法产生自己的胰岛素来调节血糖(又称葡萄糖),因此他们每天都需要从外部来源获取胰岛素。当前,许多糖尿病患者必须手动调整和重新调整他们整天接收的胰岛素量。使用这种称为闭环系统的设备,用户可以改为依靠设备根据需要进行调整。

根据最近发表在《新英格兰医学杂志》杂志上的一篇论文,一项为期六个月的临床试验显示,使用Control-IQ和Tandem的t:slim X2胰岛素泵的1型糖尿病患者的高血糖或低血糖病例少于手动调节胰岛素的人。这些患者还花费更多时间在目标范围内血糖水平。

其他闭环系统也已获得FDA批准。该软件的一个主要区别在于它被认为是“可互操作的”。这意味着用户不会被Tandem Diabetes Care锁定使用产品。他们可以使用其他获得FDA批准的传感器和泵来构建个性化系统。

Control-IQ目前可以与Tandem Diabetes Care的t:slim X2胰岛素泵一起使用,该泵于2019年2月被批准可互操作,而Dexcom Inc的G6连续血糖监测仪于2018年被指定为可互操作。

如果软件系统确定用户的血糖水平过高,它也可以自动提供正确剂量的速效胰岛素。这使其与市场上其他闭环系统区分开来,后者提供连续的低剂量胰岛素(称为基础剂量),以保持血糖水平稳定,但不会自动提供校正剂量。医疗设备公司Medtronic拥有市场上第一个闭环系统,现在正在测试其设备的附加功能。

使用Tandem的t:slim X2胰岛素泵的用户将在2020年1月免费自动升级到新系统。

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    2020-01-09 baoya
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    2020-07-21 bugit
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    2019-12-16 misszhang

    谢谢MedSci提供最新的资讯

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