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EGV1 自我监测血糖系统的临床性能。

The clinical performance of the EGV1 self-monitoring blood glucose system.

机构信息

Wei-Gong Memorial Hospital, Miaoli, Taiwan.

出版信息

Clin Chim Acta. 2012 Jul 11;413(13-14):1039-44. doi: 10.1016/j.cca.2011.12.012. Epub 2012 Jan 14.

DOI:10.1016/j.cca.2011.12.012
PMID:22266375
Abstract

BACKGROUND

The novel technique of blood volume detection can improve the reliability and accuracy of a self-monitoring blood glucose system. Self-management of diabetes can be improved, and the glycemic range can be efficiently controlled.

METHODS

A total of 153 patients with diabetes mellitus participated in the clinical study. The accuracy, blood volume detection, interference, and altitude effect of the EGV1 self-monitoring blood glucose system were evaluated and compared among the fingerstick, alternative site testing, and venous blood.

RESULTS

The EGV1 self-monitoring blood glucose system with fingertip demonstrated an excellent correlation with venous blood (linear regression analysis: slope=1.01, intercept=-0.8972 mg/dl, r(2)=0.96), and with other brands of glucose systems (linear regression analysis: slope=0.99, intercept=+3.5632 mg/dl, r(2)=0.94). The Clarke error grid analysis indicated that the results of fingertip and alternative sites were in the acceptable zones, A and B. The system required 0.6 ul of a blood sample to obtain an accurate reading, and was unaffected by several interferents and altitude.

CONCLUSIONS

The EGV1 self-monitoring blood glucose system using various blood samples demonstrated acceptable accuracy and reliability compared to the laboratory reference and other self-monitoring blood glucose systems.

摘要

背景

新型血量检测技术可提高自我监测血糖系统的可靠性和准确性。有助于改善糖尿病的自我管理,高效控制血糖范围。

方法

共有 153 例糖尿病患者参与了这项临床研究。评估并比较了 EGV1 自我监测血糖系统在指血、替代部位检测和静脉血中的准确性、血量检测、干扰和海拔效应。

结果

指尖的 EGV1 自我监测血糖系统与静脉血(线性回归分析:斜率=1.01,截距=-0.8972mg/dl,r(2)=0.96)和其他品牌的血糖仪(线性回归分析:斜率=0.99,截距=+3.5632mg/dl,r(2)=0.94)具有极好的相关性。Clarke 误差网格分析表明,指尖和替代部位的结果处于可接受区域 A 和 B。该系统仅需 0.6ul 的血样即可获得准确读数,并且不受多种干扰物和海拔的影响。

结论

与实验室参考和其他自我监测血糖系统相比,使用各种血样的 EGV1 自我监测血糖系统具有可接受的准确性和可靠性。

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