基于葡萄糖氧化酶的血糖试纸在极端氧分压下的临床准确性。

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM
Steven Setford, Stuart Phillips, Hilary Cameron, Mike Grady
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引用次数: 0

摘要

背景:基于葡萄糖氧化酶(GOx)的血糖监测仪(BGM)会受到应用样本中氧分压(Po2)的影响。在生理上具有代表性的葡萄糖和氧分压范围内,关于未经处理的毛细管指尖血液样本中氧分压的定量影响,目前仅有有限的临床数据:作为血糖仪制造商对基于 GOx 的市售血糖仪测试条持续进行的上市后监控计划的一部分,收集了临床准确性数据。数据集包括 29 901 个成对的血糖仪-比较器读数和来自 975 名受试者的 5 428 份血样的相应 Po2 值:线性回归计算的偏差范围为 5.22%(+0.72% [低 Po2:45 mm Hg] 至-4.5% [高 Po2:105 mm Hg]);偏差以 75 mm Hg 的绝对值计算,低 Po2 时的线性回归偏差为 +3.14%,而高于标称水平(>75 mm Hg)时对偏差的影响可忽略不计(回归斜率:+0.002%)。在评估低血糖(180 毫克/分升)、低血氧饱和度和高血氧饱和度条件下的血糖监测性能时,在这一小部分受试者中,线性回归偏差从 +1.52% 到 -5.32% 不等,在 2.Conclusions 条件下没有读数记录:这项大规模临床研究对来自不同糖尿病人群的未经人工操作的指尖毛细血管血液进行了检测,研究数据表明,血糖仪对 Po2 的敏感性明显低于已发表的研究,而这些研究主要基于实验室,需要对等分静脉血中的氧含量进行人工操作。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Accuracy of a Glucose Oxidase-Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure.

Background: Glucose oxidase (GOx)-based blood glucose monitors (BGMs) are influenced by the partial pressure of oxygen (Po2) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po2 in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po2 ranges.

Method: Clinical accuracy data were collected as part of a BGM manufacturer's ongoing post-market surveillance program for a commercially available GOx-based BGM test-strip. The data set comprised 29 901 paired BGM-comparator readings and corresponding Po2 values from 5 428 blood samples from a panel of 975 subjects.

Results: A linear regression-calculated bias range of 5.22% (+0.72% [low Po2: 45 mm Hg] to -4.5% [high Po2: 105 mm Hg]); biases calculated as absolute at <100 mg/dL glucose was found. Below the nominal Po2 of 75 mm Hg, a linear regression bias of +3.14% was calculated at low Po2, while negligible impact on bias (regression slope: +0.002%) was observed at higher than nominal levels (>75 mm Hg). When evaluating BGM performance under corner conditions of low (<70 mg/dL) and high (>180 mg/dL) glucose, combined with low and high Po2, linear regression biases ranged from +1.52% to -5.32% within this small group of subjects and with no readings recorded at <70 mg/dL glucose at low and high Po2.

Conclusions: Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po2 sensitivity of the BGM to be markedly lower than published studies, which are mainly laboratory-based, requiring artificial manipulation of oxygen levels in aliquots of venous blood.

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来源期刊
Journal of Diabetes Science and Technology
Journal of Diabetes Science and Technology Medicine-Internal Medicine
CiteScore
7.50
自引率
12.00%
发文量
148
期刊介绍: The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.
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