Regulatory controversies surround blood glucose monitoring devices.
作者信息
Klonoff David C
出版信息
J Diabetes Sci Technol. 2010 Mar 1;4(2):231-5. doi: 10.1177/193229681000400201.
Abstract
摘要
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Regulatory controversies surround blood glucose monitoring devices.血糖监测设备存在监管方面的争议。
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本文引用的文献
1
FDA meeting: Clinical accuracy requirements for point of care blood glucose meters.美国食品药品监督管理局会议：即时检测血糖仪的临床准确性要求
J Diabetes Sci Technol. 2010 Mar 1;4(2):496. doi: 10.1177/193229681000400234.
2
Analytical and clinical performance of blood glucose monitors.血糖仪的分析性能与临床性能
J Diabetes Sci Technol. 2010 Jan 1;4(1):84-97. doi: 10.1177/193229681000400111.
3
A review of standards and statistics used to describe blood glucose monitor performance.用于描述血糖监测仪性能的标准和统计数据综述。
J Diabetes Sci Technol. 2010 Jan 1;4(1):75-83. doi: 10.1177/193229681000400110.
4
Monte Carlo simulation in establishing analytical quality requirements for clinical laboratory tests meeting clinical needs.蒙特卡洛模拟在确定满足临床需求的临床实验室检测分析质量要求中的应用
Methods Enzymol. 2009;467:411-433. doi: 10.1016/S0076-6879(09)67016-6.
5
An analysis: hyperglycemic intensive care patients need continuous glucose monitoring-easier said than done.一项分析：高血糖重症监护患者需要持续血糖监测——说起来容易做起来难。
J Diabetes Sci Technol. 2008 Mar;2(2):201-4. doi: 10.1177/193229680800200205.
6
Therapy: Intensive glucose control in the ICU: is sugar nice?治疗：重症监护病房中的强化血糖控制：血糖水平理想吗？
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Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target?临床综述：重症患者的强化胰岛素治疗：NICE-SUGAR方案还是鲁汶血糖目标？
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N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
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