Steven Setford, Stuart Phillips, Hilary Cameron, Mike Grady
{"title":"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。","authors":"Steven Setford, Stuart Phillips, Hilary Cameron, Mike Grady","doi":"10.1177/19322968231158663","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Glucose oxidase (GOx)-based blood glucose monitors (BGMs) are influenced by the partial pressure of oxygen (Po<sub>2</sub>) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po<sub>2</sub> in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po<sub>2</sub> ranges.</p><p><strong>Method: </strong>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 Po<sub>2</sub> values from 5 428 blood samples from a panel of 975 subjects.</p><p><strong>Results: </strong>A linear regression-calculated bias range of 5.22% (+0.72% [low Po<sub>2</sub>: 45 mm Hg] to -4.5% [high Po<sub>2</sub>: 105 mm Hg]); biases calculated as absolute at <100 mg/dL glucose was found. Below the nominal Po<sub>2</sub> of 75 mm Hg, a linear regression bias of +3.14% was calculated at low Po<sub>2</sub>, 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 Po<sub>2</sub>, 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 Po<sub>2</sub>.</p><p><strong>Conclusions: </strong>Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po<sub>2</sub> 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.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531037/pdf/","citationCount":"0","resultStr":"{\"title\":\"Clinical Accuracy of a Glucose Oxidase-Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure.\",\"authors\":\"Steven Setford, Stuart Phillips, Hilary Cameron, Mike Grady\",\"doi\":\"10.1177/19322968231158663\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Glucose oxidase (GOx)-based blood glucose monitors (BGMs) are influenced by the partial pressure of oxygen (Po<sub>2</sub>) within the applied sample. Limited in-clinic data exists regarding the quantitative effect of Po<sub>2</sub> in unmanipulated capillary fingertip blood samples across physiologically representative glucose and Po<sub>2</sub> ranges.</p><p><strong>Method: </strong>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 Po<sub>2</sub> values from 5 428 blood samples from a panel of 975 subjects.</p><p><strong>Results: </strong>A linear regression-calculated bias range of 5.22% (+0.72% [low Po<sub>2</sub>: 45 mm Hg] to -4.5% [high Po<sub>2</sub>: 105 mm Hg]); biases calculated as absolute at <100 mg/dL glucose was found. Below the nominal Po<sub>2</sub> of 75 mm Hg, a linear regression bias of +3.14% was calculated at low Po<sub>2</sub>, 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 Po<sub>2</sub>, 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 Po<sub>2</sub>.</p><p><strong>Conclusions: </strong>Data from this large-scale clinical study, performed on unmanipulated fingertip capillary bloods from a diverse diabetes population, indicate Po<sub>2</sub> 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.</p>\",\"PeriodicalId\":15475,\"journal\":{\"name\":\"Journal of Diabetes Science and Technology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531037/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Diabetes Science and Technology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/19322968231158663\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/3/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Diabetes Science and Technology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/19322968231158663","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/6 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
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.
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.