新一代罗康全整合型血糖仪的准确度分析

Accuracy of Newer-generation Home Blood Glucose Meter in Patients with IGR and Newly-diagnosed Type 2 Diabetes Mellitus

目的评价新一代自我血糖检测仪——罗康全整合型血糖仪(ACCU-CHEKIntegra,Roche Diagnostics GmbH,Germany)在糖调节受损(impaired glucose regulation,IGR)和初发2型糖尿病患者自我血糖检测中的准确度。方法采用横断面研究的方法,对109例初发2型糖尿病或IGR患者进行口服葡萄糖耐量试验(oral glucose tolerance test,OGTT)的同时,在±2 min内用罗康全整合型血糖仪测定指尖毛细血管血糖,而后比较毛细血管血糖(capillary blood glucose,CBG)和静脉血浆血糖(venous plasma glucose,VPG)数值差异,以VPG为参考值,评价该血糖仪的准确度。用绝对差值的中位数(median AD)、绝对差值的相对数的中位数(median RAD)评价其准确度;用Clarke误差表格分析指尖血CBG和VPG的一致性;用线性回归方法分析CBG值与VPG值的相关性;用敏感度、特异度评估血糖仪对高血糖检测的准确度和特异度。结果共收集到292对CBG-VPG值。93.49%的CBG值符合ISO家用血糖仪检测标准,median AD为7.2 mg/dL,median RAD为4.76%;误差表格分析显示100%位于A区和B区;CBG值与VPG值在整体水平上具有较好的相关性(r=0.984,P=0.000),检测高血糖的敏感度和特异度分别为94.6%和95.7%。结论罗康全整合型血糖仪具有良好的准确度,能较准确地反映血糖的真实水平。

Objective To evaluate the accuracy of newer-generation home blood glucose meter（Accu-Check Integra） in patients with impaired glucose regulation（IGR） and newly-diagnosed type 2 diabetes mellitus.Methods A cross-sectional study was performed on 109 cases with newly-diagnosed type 2 diabetes or IGR who were asked to take oral glucose tolerance test（OGTT）,while paired samples,that were Accu-Check Integra in capillary blood glucose（CBG） and laboratory glucose in venous plasma glucose（VPG）,were taken simultaneously.Taking VPG as the reference value,the accuracy of the home glucose meter was assessed according to the international standardization organization（ISO）,including,the accuracy was studied by means of Median absolute difference（Median AD） and Median absolute relative difference（Median RAD）,the consistency of CBG and VPG was studied by Clarke Error Grid analysis,the correlation of CBG and VPG was analyzed according to liner regression analysis,and the sensitivity and specificity for hyperglycemia were also calculated.Results There were 292 VPG values paired with CBG values,among which 93.49% of CBG values met ISO home glucose meter criteria,the median AD was 7.2 mg/dL,and the median RAD was 4.76%.Paired glucose measurements from the Accu-Check Integra meter and laboratory glucose measurement demonstrated that 100% of paired points in the overall subject population fell in zones A and B of the Clarke Error Grid.The CBG value was well correlated to VPG value in the overall level,and the sensitivity and specificity were 94.6% and 95.7% respectively for hyperglycemia.Conclusion The newer-generation home blood glucose meter（Accu-Check Integra） demonstrates a high degree of accuracy,and it can precisely report the real value of blood glucose.