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斯里兰卡目前使用的血糖仪的准确性和精密度评估。

Evaluation of the accuracy and precision of glucometers currently used in Sri Lanka.

作者信息

Liyanage J H, Dissanayake H A, Gamage K K K, Keerthisena G S P, Ihalagama I R H S, Weeratunga P N, Wijesundara W A, Wijetunga W M U A, Subasinghe S, Tilakaratne T A D, Katulanda G W, Katulanda P

机构信息

Diabetes Research Unit, Department of Clinical Medicine, Faculty of Medicine, Colombo, Sri Lanka.

Department of Clinical Medicine, Faculty of Medicine, Colombo, Sri Lanka.

出版信息

Diabetes Metab Syndr. 2019 May-Jun;13(3):2184-2188. doi: 10.1016/j.dsx.2019.05.011. Epub 2019 May 22.

DOI:10.1016/j.dsx.2019.05.011
PMID:31235155
Abstract

AIMS

Life threatening macrovascular and microvascular complications of diabetes can be minimized by effective glycaemic control. Self monitoring of blood glucose with glucometers is recognized as a cost effective strategy to improve glycaemic control. However accuracy and precision of glucometers will determine the effectiveness of this strategy. We aimed to evaluate accuracy and precision of commonly used glucometers in Sri Lanka.

MATERIALS AND METHODS

An observational study was conducted in a tertiary care setting including patients with diabetes and healthy volunteers. Eight commonly used glucometers were used. Blood glucose was measured in 50 participants (16 healthy volunteers, 34 patients with diabetes) in finger prick capillary blood using glucometers and venous blood using standard laboratory methods, and were compared to determine accuracy. Repeated measurements from same glucometer with a single finger prick were made and compared to determine precision.

RESULTS

Only one glucometer showed insignificant difference to venous plasma glucose values. Only one glucometer met ADA recommended bias of <5%. None of the glucometers fell within the ISO recommendations for accuracy.

CONCLUSION

Majority of commonly used glucometers in Sri Lanka do not meet the ADA recommendations and ISO standards for accuracy and precision. However their variations are unlikely to make significant adverse impact on patient management.

摘要

目的

通过有效的血糖控制可将糖尿病危及生命的大血管和微血管并发症降至最低。使用血糖仪进行血糖自我监测被认为是改善血糖控制的一种具有成本效益的策略。然而,血糖仪的准确性和精密度将决定该策略的有效性。我们旨在评估斯里兰卡常用血糖仪的准确性和精密度。

材料与方法

在一个三级护理机构中进行了一项观察性研究,纳入糖尿病患者和健康志愿者。使用了八种常用血糖仪。对50名参与者(16名健康志愿者、34名糖尿病患者)采用血糖仪测量手指针刺毛细血管血中的血糖,并采用标准实验室方法测量静脉血中的血糖,通过比较来确定准确性。对同一血糖仪在同一手指针刺处进行重复测量并比较以确定精密度。

结果

只有一种血糖仪与静脉血浆葡萄糖值的差异不显著。只有一种血糖仪符合美国糖尿病协会(ADA)推荐的偏差<5%的标准。没有一种血糖仪的准确性符合国际标准化组织(ISO)的建议。

结论

斯里兰卡大多数常用血糖仪不符合ADA关于准确性和精密度的建议以及ISO标准。然而,它们的差异不太可能对患者管理产生重大不利影响。

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