Distribution of Oxygen Partial Pressures in Native Capillary Fingertip Blood Samples From a Large Diabetes Patient Population

Setford, Steven; Phillips, Stuart; Cameron, Hilary; Grady, Mike

doi:10.1177/19322968221095055

Cited by 2 publications

(1 citation statement)

References 16 publications

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“…Ten measurements were performed on each individual sample with each reagent lot. Partial pressure of oxygen in each sample was determined and checked to be comparable to capillary blood (55–96 mmHg) [ 5 ].…”

Section: Methodsmentioning

confidence: 99%

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Pleus,

Jendrike,

Baumstark

et al. 2023

Diabetes Ther

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Introduction Sufficiently high analytical quality of blood glucose monitoring systems (BGMS) is a prerequisite for efficient diabetes therapy. In this study we assessed system accuracy, measurement repeatability, intermediate measurement precision, user performance, and the influence of hematocrit on two CE-marked blood glucose monitoring systems. For one BGMS, measurement accuracy using venous samples was additionally investigated. Methods Study procedures were based on the International Organization of Standardization (ISO) 15197:2013/EN ISO 15197:2015 (“ISO 15197”). User performance included data from 100 subjects who used one test strip lot, whereas for all other analyses three different reagent system lots were used. For system accuracy assessment, 100 capillary samples were measured in duplicate with each of three reagent system lots per system, resulting in 600 results per system. Results CareSens S Fit and CareSens H Beat both fulfilled the ISO 15197 accuracy criteria with 97.5–100% of each test strip lot’s results falling within ± 15 mg/dL or ± 15% of the results of the comparison method and 100% of results in consensus error grid (CEG) zone A for all three lots. User performance evaluation revealed sufficient accuracy in the hands of lay users although some handling errors were documented by study staff. Assessment of measurement repeatability and intermediate measurement precision is given by standard deviation (SD) (glucose levels < 100 mg/dL) and by coefficient of variation (CV) (glucose concentrations ≥ 100 mg/dL). SD was ≤ 4.1 mg/dL and CV ≤ 4.2% for measurement repeatability and SD was ≤ 2.2 mg/dL and CV ≤ 2.6% for intermediate measurement precision. In case of hematocrit influence, both BGMS complied with all three tested lots with the defined criteria. Conclusion Both BGMS analyzed in this study fulfilled the required accuracy criteria of ISO 15197. They showed high precision, good performance in the hands of lay users, and the influence of hematocrit was acceptable in the labeled range. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-023-01517-y.

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Section: Methodsmentioning

confidence: 99%

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Pleus,

Jendrike,

Baumstark

et al. 2023

Diabetes Ther

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Clinical Accuracy of a Glucose Oxidase–Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure

Setford

Phillips

Cameron

et al. 2023

J Diabetes Sci Technol

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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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Distribution of Oxygen Partial Pressures in Native Capillary Fingertip Blood Samples From a Large Diabetes Patient Population

Cited by 2 publications

References 16 publications

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Evaluation of System Accuracy, Precision, Hematocrit Influence, and User Performance of Two Blood Glucose Monitoring Systems Based on ISO 15197:2013/EN ISO 15197:2015

Clinical Accuracy of a Glucose Oxidase–Based Blood Glucose Test-Strip Across Extremes of Oxygen Partial Pressure

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