Boettcher Claudia, Dost Axel, Wudy Stefan A, Flechtner-Mors Marion, Borkenstein Martin, Schiel Ralf, Weitzel Dieter, Bechtold-Dalla Pozza Susanne, Wolf Johannes, Holl Reinhard W
1 Division of Paediatric Endocrinology & Diabetology, Centre of Child and Adolescent Medicine, Justus Liebig University , Giessen, Germany .
Diabetes Technol Ther. 2015 Apr;17(4):275-82. doi: 10.1089/dia.2014.0262. Epub 2014 Dec 30.
AIMS/HYPOTHESIS: This study investigated the accuracy of blood glucose meters for self-monitoring and its influence on glycated hemoglobin (HbA1c) levels and the frequency of hypoglycemic coma.
Self-measured and simultaneously obtained laboratory blood glucose values from 9,163 patients with type 1 diabetes <18 years of age in the German/Austrian Diabetes Prospective Documentation Initiative registry were analyzed by investigating their compliance with the International Organization for Standardization (ISO) criteria (versions 2003 and 2013) and by error grid analyses. Regression models elucidated effects on glucose control and hypoglycemia rates.
Depending on the respective subgroup (defined by sex, age, duration of diabetes, mode of insulin therapy), 78.7-94.7% of the self-monitoring of blood glucose (SMBG) values met the old and 79.7-88.6% met the new ISO criteria. In Clarke and Parkes error grid analyses, the percentages of SMBG values in Zone A ranged between 92.8% and 94.6% (Clarke) and between 92.2% and 95.0% (Parkes). The patient group with SMBG devices measuring "far too low" (compared with the laboratory-obtained glucose levels) presented with a higher HbA1c level than those measuring "far too high," "too high," "identical/almost identical," or "too low" (based on quintiles of deviation). Performing "far too high" was associated with the highest rate of hypoglycemic coma in comparison with the other deviation quintiles.
This study showed that current SMBG devices fulfilled neither the previous nor the new ISO criteria. Large deviations of the SMBG values from the "true" glucose levels resulted in higher HbA1c levels and markedly increased rates of hypoglycemic events.
目的/假设：本研究调查了自我监测血糖仪的准确性及其对糖化血红蛋白（HbA1c）水平和低血糖昏迷频率的影响。
通过调查德国/奥地利糖尿病前瞻性文档倡议登记处9163例18岁以下1型糖尿病患者的自我测量血糖值和同时获得的实验室血糖值是否符合国际标准化组织（ISO）标准（2003版和2013版）以及进行误差网格分析。回归模型阐明了对血糖控制和低血糖发生率的影响。
根据各自的亚组（按性别、年龄、糖尿病病程、胰岛素治疗方式定义），78.7% - 94.7%的自我血糖监测（SMBG）值符合旧标准，79.7% - 88.6%符合新ISO标准。在克拉克和帕克斯误差网格分析中，A区SMBG值的百分比在92.8%至94.6%之间（克拉克）和92.2%至95.0%之间（帕克斯）。与测量“过高”“过高”“相同/几乎相同”或“过低”（基于偏差五分位数）的患者组相比，使用SMBG设备测量“过低”（与实验室获得的血糖水平相比）的患者组HbA1c水平更高。与其他偏差五分位数相比，测量“过高”与最高的低血糖昏迷发生率相关。
本研究表明，当前的SMBG设备既不符合先前的ISO标准，也不符合新的ISO标准。SMBG值与“真实”血糖水平的较大偏差导致更高的HbA1c水平和低血糖事件发生率显著增加。
