Kabadi U M, Kabadi M, O'Connell K M
Carl T. Hayden V.A. Medical Center, Phoenix, USA.
Diabetes Res. 1994;26(1):25-32.
This study determined the accuracy and precision of the MediSense Companion 2 Blood Glucose Monitoring System in the hands of newly trained patients, after individual training. 101 subjects attending a diabetes clinic at a Veterans Affairs Medical Center participated in the study. Subjects were individually trained in the use of the Companion 2 system. They performed 10 practice control solution tests prior to two capillary blood glucose tests. Venous blood was collected within 15 minutes for comparative laboratory analysis. The comparisons were performed by both the linear regression and the total Grid analysis. The correlation between the first capillary blood glucose test results and the laboratory values was highly significant (r = 0.94, p = 0.0001). Total Error Analysis also revealed that the Systematic Error (SE), Random Error (RE) and Total Error (TE) were all well within the acceptable norms at two glucose levels of 5.5 mmol/(100 mg/dL) and 11.1 mmol/L (200 mg/dL); (SE < 15%, RE < 10% and TE < 15%). Therefore, this study demonstrates that Companion 2 provides precise and accurate values during capillary blood glucose testing by newly trained subjects following intensive individual training.
本研究测定了经过个体培训后，新接受培训的患者使用美迪生Companion 2血糖监测系统的准确性和精密度。101名在退伍军人事务医疗中心糖尿病门诊就诊的受试者参与了该研究。受试者接受了使用Companion 2系统的个体培训。他们在进行两次毛细血管血糖检测之前先进行了10次对照溶液测试。在15分钟内采集静脉血用于实验室对比分析。采用线性回归和总网格分析进行对比。首次毛细血管血糖检测结果与实验室值之间的相关性非常显著（r = 0.94，p = 0.0001）。总误差分析还显示，在5.5 mmol/（100 mg/dL）和11.1 mmol/L（200 mg/dL）这两个血糖水平下，系统误差（SE）、随机误差（RE）和总误差（TE）均完全在可接受范围内；（SE < 15%，RE < 10%且TE < 15%）。因此，本研究表明，经过强化个体培训后，新接受培训的受试者在进行毛细血管血糖检测时，Companion 2能提供精确且准确的值。
