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[用于1型糖尿病患者自我血糖监测的血糖仪性能]

[Performance of glucometer used for self-monitoring blood glycaemia in type 1 diabetic patients].

作者信息

Mira Giane Sprada, Candido Lys Mary Bileski, Yale Jean François

机构信息

Departamento de Nutrição, Universidade Federal do Paraná, Rua Prof. Lothário Meissner 632, 80210-170 Curitiba, PR, Brasil.

出版信息

Arq Bras Endocrinol Metabol. 2006 Jun;50(3):541-9. doi: 10.1590/s0004-27302006000300018.

Abstract

This prospective study assessed the minimum volume of blood, the precision and the accuracy of capillary glycaemia obtained with the use of a digital glucometer. A total of 108 diabetic individuals were enrolled, teenagers and adults of both genders, from the Diabetes Clinic of the Royal Victoria Hospital, McGill University, Canada, in 6 months. Glycaemia monitoring was performed using an AccuCheck Compact (Roche) glucometer. For the volume, 6 samples of blood were tested, on three glucometers, using a crossover design (432 results). For accuracy, 100 samples of venous and arterial blood, measured with the glucometer and on a clinical laboratory were compared. For precision, 2 samples of venous blood and solution controls were repeatedly tested. Results demonstrated that a volume of 3.0 microL of capillary blood is sufficient for reproducible results. Measurements of venous and capillary glycaemia did not differ statistically when obtained with the glucometer or from a clinical laboratory (p > 0.05). Comparison of capillary glycaemia measured with the glucometer with venous and capillary glycaemia obtained from the laboratory resulted in a correlation coefficient of 0.9819 and 0.9842, respectively. These observations confirm the accuracy and precision of the tested glucometer. The establishment of a minimum digital punction of 3 microL may have positive impact upon the compliance to auto-monitoring routines.

摘要

这项前瞻性研究评估了使用数字血糖仪获取毛细血管血糖时所需的最小血量、精密度和准确性。在6个月内,从加拿大麦吉尔大学皇家维多利亚医院糖尿病诊所招募了总共108名糖尿病患者,包括青少年和成年人,男女皆有。使用AccuCheck Compact(罗氏)血糖仪进行血糖监测。对于血量,采用交叉设计在三台血糖仪上对6份血样进行了检测(共432个结果)。对于准确性,比较了用血糖仪测量的100份静脉血和动脉血样本与临床实验室测量结果。对于精密度,对2份静脉血样本和溶液对照进行了重复检测。结果表明,3.0微升毛细血管血的血量足以获得可重复的结果。用血糖仪测得的静脉血糖和毛细血管血糖与临床实验室测得的结果在统计学上无差异(p>0.05)。血糖仪测得的毛细血管血糖与实验室测得的静脉血糖和毛细血管血糖的相关系数分别为0.9819和0.9842。这些观察结果证实了所测试血糖仪的准确性和精密度。确定3微升的最小数字采血体积可能对自我监测程序的依从性产生积极影响。

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