Pfützner Andreas, Hermanns Norbert, Schröder Stefan, Wegenstein Margarethe, Larbig Martin, Mondok Agnes, Forst Thomas, Haak Thomas
Institut für klinische Forschung und Entwicklung, Mainze.
Swiss Med Wkly. 2002 Jun 29;132(25-26):351-7. doi: 10.4414/smw.2002.09991.
The aim of this study was to evaluate possible differences in the results of blood glucose testing with the Soft-Sense blood glucose monitoring system (Abbott MediSense, Wiesbaden, Germany; not yet available in Switzerland) using different sites for drawing whole blood samples.
In total, 66 patients participated in the study. Blood glucose measurements were performed with the Soft-Sense device taking capillary blood from the forearm and the fingertip. The results were compared with blood glucose measurements by means of a laboratory reference method using blood from the fingertips.
276 blood glucose data sets could be obtained and were used for the examination of the accuracy of blood glucose measurements at both different sites. Blood glucose results obtained from the arm with Soft-Sense correlated well and were nearly parallel with the results achieved from the fingertip with a laboratory reference method (regression analysis: slope = 0.981; intercept = 0.045 mmol/l (0.819 mg/dl); correlation coefficient r = 0.943). Error grid analysis showed 99.2% of the measurements within clinically acceptable zones A and B. In addition, finger stick measurements done with the Soft-Sense device and the reference method revealed a strong correlation (regression analysis: slope = 0.959; intercept = -0.042 mmol/l (0.748 mg/dl); correlation coefficient r = 0.972). Error grid analysis showed 98.9% of all blood glucose readings within clinically acceptable zones A and B. Mean absolute percent deviations were 9.3+/- 8.1% for the finger tests and 11.2+/- 8.7% for the arm tests. If blood glucose values exceeded 11.1 mmol/l (200 mg/dl), measurements revealed from the forearm were slightly lower than the measurements obtained from the fingertips.
The results indicate that the automated blood glucose monitoring device Soft-Sense provides accurate results independent of the measuring site. As with other alternate site testing devices, nearly painless blood collection at the forearm might help to increase patients readiness to perform more frequent measurements by self blood glucose monitoring, which is a known prerequisite of improved blood glucose control.
本研究的目的是评估使用Soft-Sense血糖监测系统（德国威斯巴登的雅培医疗传感公司；瑞士尚未上市）在不同部位采集全血样本进行血糖检测时结果可能存在的差异。
共有66名患者参与了该研究。使用Soft-Sense设备从前臂和指尖采集毛细血管血进行血糖测量。将结果与采用实验室参考方法使用指尖血进行的血糖测量结果进行比较。
共获得276组血糖数据集，并用于检验两个不同部位血糖测量的准确性。使用Soft-Sense从手臂获得的血糖结果相关性良好，并且与采用实验室参考方法从指尖获得的结果几乎平行（回归分析：斜率 = 0.981；截距 = 0.045 mmol/L（0.819 mg/dL）；相关系数r = 0.943）。误差网格分析显示99.2%的测量值处于临床可接受的A区和B区。此外，使用Soft-Sense设备和参考方法进行的指尖采血测量显示出很强的相关性（回归分析：斜率 = 0.959；截距 = -0.042 mmol/L（0.748 mg/dL）；相关系数r = 0.972）。误差网格分析显示98.9%的血糖读数处于临床可接受的A区和B区。手指检测的平均绝对百分比偏差为9.3±8.1%，手臂检测为11.2±8.7%。如果血糖值超过11.1 mmol/L（200 mg/dL），从前臂获得的测量值略低于从指尖获得的测量值。
结果表明，自动血糖监测设备Soft-Sense提供的结果准确，与测量部位无关。与其他替代部位检测设备一样，在前臂几乎无痛采血可能有助于提高患者通过自我血糖监测进行更频繁测量的意愿，这是改善血糖控制的一个已知前提条件。
