Ginsberg Barry H
Diabetes Technology Consultants, Wyckoff, New Jersey 07481-1712, USA.
J Diabetes Sci Technol. 2010 Sep 1;4(5):1265-8. doi: 10.1177/193229681000400528.
Regulatory interest has focused on the accuracy of blood glucose monitoring systems. Currently, almost all systems meet the International Organization for Standardization (ISO) 15197 clinical standard (≥95% of the values within 20% of the reference for values above 75 mg/dl and within 15 mg/dl below that level). Should the systems have to meet one of the extended ISO standards of 15%, 10%, or even 5%? There is a wide variety of people with diabetes doing glucose monitoring, and the majority do not need better accuracy. Indeed, when selecting an insulin dose, the inaccuracy of the glucose reading has little effect compared with the inaccuracy in counting carbohydrates and the variability in insulin absorption. It might be far better to evaluate the accuracy in a standard method and provide the accuracy values on a standard label. Patients and health care providers could then select the monitoring system that best meets their needs.
监管机构的关注重点一直是血糖监测系统的准确性。目前，几乎所有系统都符合国际标准化组织（ISO）15197临床标准（血糖值高于75mg/dl时，≥95%的值在参考值的20%以内；低于该水平时，在15mg/dl以内）。这些系统是否应该满足ISO扩展标准中的15%、10%甚至5%的标准之一呢？进行血糖监测的糖尿病患者群体广泛，大多数人并不需要更高的准确性。实际上，在选择胰岛素剂量时，与计算碳水化合物的不准确性和胰岛素吸收的变异性相比，血糖读数的不准确性影响很小。采用标准方法评估准确性并在标准标签上提供准确性数值可能会好得多。这样患者和医疗服务提供者就可以选择最符合他们需求的监测系统。
