FDA批准无需进行手指点刺的血糖监测

2017-12-30 MedSci MedSci原创

美国监管机构批准了首款用于糖尿病患者的连续血糖监测仪,无需进行手指点刺测试。目前的模型要求用户每天测试两滴血液以校准或调整检测仪。手指的疼痛和测试的成本使许多人不愿密切关注他们的血糖,而这是控制胰岛素使用和调整饮食所需要的。FDA周三批准了雅培公司的新型自由式血糖监测系统,它通过一个小传感器连接到上臂。病人们通过阅读器,查看当前血糖水平和过去8小时的变化。美国3000万糖尿病患者中,大多数人使用标


美国监管机构批准了首款用于糖尿病患者的连续血糖监测仪,无需进行手指点刺测试。目前的模型要求用户每天测试两滴血液以校准或调整检测仪。

手指的疼痛和测试的成本使许多人不愿密切关注他们的血糖,而这是控制胰岛素使用和调整饮食所需要的。

FDA周三批准了雅培公司的新型自由式血糖监测系统,它通过一个小传感器连接到上臂。病人们通过阅读器,查看当前血糖水平和过去8小时的变化。

美国3000万糖尿病患者中,大多数人使用标准血糖仪,每天需要进行多个手指点刺,且只显示当前血糖水平。约有345,000名美国人使用更准确的连续血糖监测装置。

但如果大多数人不用手指测试校准,也可能会得到不准确的读数,Timothy Bailey说,他帮助测试了自由式血糖监测系统。

加利福尼亚州高级代谢护理和研究所所长Bailey说:"我们能够安全地降低血糖。" 他从各种糖尿病设备制造商那里获得咨询费用。

过高的血糖水平会损伤器官,导致心脏病,中风,失明和截肢。非常低的血糖会引起惊厥,意识混乱和意识丧失。

雅培的设备被批准用于1型或2型糖尿病的成人,应该在几个月内即可在药房买到。这家位于芝加哥附近的公司没有透露阅读器或传感器的价格。

雅培的系统不能与胰岛素泵一起使用,胰岛素泵是一种针对皮肤的设备,使用者可以根据需要注射胰岛素,但公司正在计划改进,最终实现这一功能。

竞争对手Medtronic今年春天推出了一种装置,胰岛素泵会自动对传感器记录的血糖变化做出反应,并根据需要保存或注射胰岛素。


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    2018-11-13 bugit
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    2017-12-30 惠映实验室

    学习了.谢谢.

    0

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    2017-12-30 15121100f4m

    很棒的东东.听同事说用过***不菲.不过按着中国目前的限这个限那个.这个好东东肯定在中国没有市场.

    0

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    2017-12-30 thlabcde

    好资料学习了!

    0

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    2017-12-30 明月清辉

    谢谢分享.学习了

    0

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    2017-12-30 深海的鱼

    学习学习学习

    0