由最新的國際標準規格看血糖機精準的必要性與影響檢測準確的因素

Confounding Factors for Accuracy- Lesson from the Latest International Standard of Self-monitoring Blood Glucose System

黃莉棋(Li-Chi Huang) ； 陳瑜忻(Yu-Hsin Chen) ； 李治中(Chih-Chung Lee) ； 林慶齡(Ching-Ling Lin)

《內科學誌》 27卷5期 (2016/10) Pp. 239-247

https://doi.org/10.6314/JIMT.2016.27(5).03

摘要

現今全球約有 4.15 億名糖尿病患，預估至 2040 年會有高達 6.42 億的病患，糖尿病已是重要的公共衛生課題。糖尿病治療的目標是控制血糖的穩定並減少併發症，而自我血糖監測(self-monitoring of blood glucose) 是糖尿病控制相當重要的環節。近期的研究證實自我血糖監測確實能有效提升第二型糖尿病患者的血糖穩定。根據ISO 15197 對血糖機精準度要求的標準由原有2003 年版本修改為2013 年版本，並規定業界需在 2016 年全面落實，以及美國 FDA2014 年公告更嚴格的血糖機檢測準確度(accuracy) 草案，顯示國際上對血糖機檢測精準度的重視。然而，血糖機檢測的精準性會被許多因素影響，如：人為操作不當、不同反應酶檢測化學特性、藥物干擾等。藉由選擇符合最新國際規範的血糖機，並避免相關干擾因素的影響，才能正確的讓病患進行自我血糖監測。此外，提升病患本身對糖尿病的認知、醫療院所提供良好的衛教諮詢以及強化家屬的共同參與，都是幫助病患達成理想血糖控制的要素。

關鍵字

自我血糖監測(Self-monitoring of blood glucose) ； 準確度(Accuracy) ； 血糖機(Glucose meters) ； 糖尿病(Diabetes mellitus)

並列摘要

Currently there are approximately 415 million diabetic patients worldwide, and are expected to reach 642 million by 2024, implying that diabetes mellitus is a crucial global health concern. Goal of diabetes treatment is to reduce the risk of diabetic complications and ensure stable blood glucose control. SMBG (self-monitoring of blood glucose) is an essential link of good diabetes control. Recent studies provided new evidence that SMBG can effectively improve blood glucose stability in type 2 diabetes patients. The ISO 15197 standard requirements for the accuracy of blood glucose monitoring system had been renewed to the 2013 version, and mandate that it to be fully implemented by the industry in 2016. In 2014, the US FDA also announced a draft for new standard of blood glucose monitoring system. This suggested that the international standard for the accuracy of blood glucose monitoring system had been strengthened. However, the accuracy of self-monitoring of blood glucose system is affected by many confounding factors, such as inappropriate manipulation, different chemical properties of the reaction enzyme system, drug interference. By selecting a blood glucose monitoring system that qualified with the latest international standard, and properly avoiding those confounding factors of accuracy should made self-monitoring of blood glucose more reliable and useful for diabetic patients. Furthermore, patient's self-awareness, effective and efficient counselling from a qualified institute, and strengthening family support all are essential to ensure good diabetic control.