Larbig M, Forst T, Mondok A, Forst S, Pfützner A
Institut für Klinische Forschung und Entwicklung (IKFE GmbH), Mainz, Germany.
Diabetes Nutr Metab. 2003 Aug;16(4):257-61.
The aim of this study was to investigate the accuracy and reliability of the blood glucose self-monitoring system Prestige IQ (Home Diagnostics, Inc., Ft. Lauderdale, USA) in comparison to an established blood glucose reference method and four commercially available blood glucose self-monitoring devices. Over a 3-month period, 61 patients with Type 1 (T1DM) and Type 2 diabetes mellitus (T2DM) participated in this study. The patients entered the study clinic for two visits. Each visit consisted of 7 glucose determinations in samples of capillary whole blood drawn from the fingertip. The first and last measurements were determined using the laboratory reference and the mean of both readings was used as the reference value for statistical analysis. The 5 remaining glucose measurements were performed in randomized order using the 5 commercially available blood glucose devices. One hundred twenty-one data sets were generated and used to evaluate accuracy. Prestige IQ blood glucose results obtained from the fingertip agreed well with the laboratory reference (linear regression analysis: slope = 1.016; intercept = 0.4 mg/dl; SD = 13.555 mg/dl; correlation r = 0.972) and were comparable to the results generated using the other four blood glucose devices. Bland-Altman analysis for reliability confirmed that 119 out of 121 Prestige IQ results (98.3%) exhibited acceptable accuracy as defined in the new ISO/DIS guideline 15197.2 (85.1-99.2% in this area for the other devices). Error-grid-analysis shows all Prestige IQ glucose results in clinically acceptable zones A and B (95.9% in zone A and 4.1% in zone B). In conclusion, Prestige IQ showed excellent performance with clinically acceptable accuracy and reliability as compared to both the laboratory reference and the four commercially available self-monitoring blood glucose systems.
本研究旨在将Prestige IQ血糖自我监测系统（美国佛罗里达州劳德代尔堡的Home Diagnostics公司）与既定的血糖参考方法及四种市售血糖自我监测设备相比较，以调查其准确性和可靠性。在3个月的时间里，61例1型糖尿病（T1DM）和2型糖尿病（T2DM）患者参与了本研究。患者进入研究诊所进行两次就诊。每次就诊包括对从指尖采集的毛细血管全血样本进行7次血糖测定。首次和末次测量使用实验室参考方法进行，两次读数的平均值用作统计分析的参考值。其余5次血糖测量使用5种市售血糖设备按随机顺序进行。共生成121个数据集并用于评估准确性。从指尖获得的Prestige IQ血糖结果与实验室参考值吻合良好（线性回归分析：斜率 = 1.016；截距 = 0.4 mg/dl；标准差 = 13.555 mg/dl；相关系数r = 0.972），并且与使用其他四种血糖设备得出的结果相当。用于可靠性分析的Bland-Altman分析证实，121个Prestige IQ结果中有119个（98.3%）表现出符合新的ISO/DIS指南15197.2中定义的可接受准确性（该领域其他设备为85.1 - 99.2%）。误差网格分析显示，所有Prestige IQ血糖结果均处于临床可接受的A区和B区（A区为95.9%，B区为4.1%）。总之，与实验室参考方法及四种市售血糖自我监测系统相比，Prestige IQ表现出卓越性能，具有临床可接受的准确性和可靠性。
