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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

  5. [GetPortalCommentsPageByObjectIdResponse(id=1839566, encodeId=1906183956678, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Nov 13 02:18:00 CST 2018, time=2018-11-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540200, encodeId=57e11540200b1, content=<a href='/topic/show?id=da548984604' target=_blank style='color:#2F92EE;'>#血糖监测#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89846, encryptionId=da548984604, topicName=血糖监测)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50fd13191418, createdName=jktdtl, createdTime=Mon Jan 01 00:18:00 CST 2018, time=2018-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273883, encodeId=57302e38837c, content=学习了.谢谢., beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Dec 30 15:12:07 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273843, encodeId=7f262e38434b, content=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., beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/12/31/a88428e95e462b5a95499ced50b4325e.jpg, createdBy=60182225250, createdName=15121100f4m, createdTime=Sat Dec 30 11:11:37 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273820, encodeId=bf1f2e38209e, content=好资料学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=92191944782, createdName=thlabcde, createdTime=Sat Dec 30 10:05:13 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273809, encodeId=c5642e38094b, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Sat Dec 30 09:44:51 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273807, encodeId=85412e380797, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Sat Dec 30 09:37:21 CST 2017, time=2017-12-30, status=1, ipAttribution=)]
    2017-12-30 thlabcde

    好资料学习了!

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1839566, encodeId=1906183956678, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Tue Nov 13 02:18:00 CST 2018, time=2018-11-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1540200, encodeId=57e11540200b1, content=<a href='/topic/show?id=da548984604' target=_blank style='color:#2F92EE;'>#血糖监测#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89846, encryptionId=da548984604, topicName=血糖监测)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=50fd13191418, createdName=jktdtl, createdTime=Mon Jan 01 00:18:00 CST 2018, time=2018-01-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273883, encodeId=57302e38837c, content=学习了.谢谢., beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Sat Dec 30 15:12:07 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273843, encodeId=7f262e38434b, content=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., beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/12/31/a88428e95e462b5a95499ced50b4325e.jpg, createdBy=60182225250, createdName=15121100f4m, createdTime=Sat Dec 30 11:11:37 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273820, encodeId=bf1f2e38209e, content=好资料学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=92191944782, createdName=thlabcde, createdTime=Sat Dec 30 10:05:13 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273809, encodeId=c5642e38094b, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Sat Dec 30 09:44:51 CST 2017, time=2017-12-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=273807, encodeId=85412e380797, content=学习学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Sat Dec 30 09:37:21 CST 2017, time=2017-12-30, status=1, ipAttribution=)]
    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

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