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Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems

INTRODUCTION: The aim of this study was to compare the accuracy of 5 blood glucose monitoring systems (BGMSs; CONTOUR(®)PLUS [CP], Accu-Chek(®) Active [ACA], Accu-Chek(®) Performa [ACP], FreeStyle Freedom™ [FF], OneTouch(®) SelectSimple™ [OTSS]). METHODS: Study staff tested fingerstick samples from...

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Autores principales: Dunne, Nancy, Viggiani, Maria T., Pardo, Scott, Robinson, Cynthia, Parkes, Joan Lee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575307/
https://www.ncbi.nlm.nih.gov/pubmed/26169192
http://dx.doi.org/10.1007/s13300-015-0121-3
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author Dunne, Nancy
Viggiani, Maria T.
Pardo, Scott
Robinson, Cynthia
Parkes, Joan Lee
author_facet Dunne, Nancy
Viggiani, Maria T.
Pardo, Scott
Robinson, Cynthia
Parkes, Joan Lee
author_sort Dunne, Nancy
collection PubMed
description INTRODUCTION: The aim of this study was to compare the accuracy of 5 blood glucose monitoring systems (BGMSs; CONTOUR(®)PLUS [CP], Accu-Chek(®) Active [ACA], Accu-Chek(®) Performa [ACP], FreeStyle Freedom™ [FF], OneTouch(®) SelectSimple™ [OTSS]). METHODS: Study staff tested fingerstick samples from 106 subjects aged ≥18 years using the 5 BGMSs. Some samples were modified to achieve blood glucose concentrations throughout the measuring range. The primary endpoint was comparison of the mean absolute relative difference (MARD) from the reference value (Yellow Springs Instruments [YSI]) across the overall tested glucose range. Other endpoints were MARD in the low (≤80 mg/dL [≤4.4 mmol/L]), middle (81–180 mg/dL [4.5–10.0 mmol/L]), and high (>180 mg/dL [>10.0 mmol/L]) glucose ranges, and MARD for unmodified samples in the overall glucose range. RESULTS: CONTOUR(®)PLUS had a statistically significantly lower MARD than all BGMSs across the overall tested range (27–460 mg/dL [1.5–25.5 mmol/L]) and in the high glucose range. In the low glucose range, CP had a lower MARD than all BGMSs, which was statistically significant except for ACP. For unmodified samples across the overall tested range, CP had a lower MARD than all BGMSs and was statistically significantly lower except for ACA. CONCLUSIONS: CONTOUR(®)PLUS had the lowest mean difference from the reference values (by MARD) when compared with other BGMSs across multiple glucose ranges with modified and unmodified samples. FUNDING: Bayer HealthCare LLC, Diabetes Care. Trial registration number: ClinicalTrials.gov Identifier NCT01714232. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0121-3) contains supplementary material, which is available to authorized users.
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spelling pubmed-45753072015-09-23 Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems Dunne, Nancy Viggiani, Maria T. Pardo, Scott Robinson, Cynthia Parkes, Joan Lee Diabetes Ther Original Research INTRODUCTION: The aim of this study was to compare the accuracy of 5 blood glucose monitoring systems (BGMSs; CONTOUR(®)PLUS [CP], Accu-Chek(®) Active [ACA], Accu-Chek(®) Performa [ACP], FreeStyle Freedom™ [FF], OneTouch(®) SelectSimple™ [OTSS]). METHODS: Study staff tested fingerstick samples from 106 subjects aged ≥18 years using the 5 BGMSs. Some samples were modified to achieve blood glucose concentrations throughout the measuring range. The primary endpoint was comparison of the mean absolute relative difference (MARD) from the reference value (Yellow Springs Instruments [YSI]) across the overall tested glucose range. Other endpoints were MARD in the low (≤80 mg/dL [≤4.4 mmol/L]), middle (81–180 mg/dL [4.5–10.0 mmol/L]), and high (>180 mg/dL [>10.0 mmol/L]) glucose ranges, and MARD for unmodified samples in the overall glucose range. RESULTS: CONTOUR(®)PLUS had a statistically significantly lower MARD than all BGMSs across the overall tested range (27–460 mg/dL [1.5–25.5 mmol/L]) and in the high glucose range. In the low glucose range, CP had a lower MARD than all BGMSs, which was statistically significant except for ACP. For unmodified samples across the overall tested range, CP had a lower MARD than all BGMSs and was statistically significantly lower except for ACA. CONCLUSIONS: CONTOUR(®)PLUS had the lowest mean difference from the reference values (by MARD) when compared with other BGMSs across multiple glucose ranges with modified and unmodified samples. FUNDING: Bayer HealthCare LLC, Diabetes Care. Trial registration number: ClinicalTrials.gov Identifier NCT01714232. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s13300-015-0121-3) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-07-14 2015-09 /pmc/articles/PMC4575307/ /pubmed/26169192 http://dx.doi.org/10.1007/s13300-015-0121-3 Text en © The Author(s) 2015 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Dunne, Nancy
Viggiani, Maria T.
Pardo, Scott
Robinson, Cynthia
Parkes, Joan Lee
Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title_full Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title_fullStr Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title_full_unstemmed Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title_short Accuracy Evaluation of CONTOUR(®)PLUS Compared With Four Blood Glucose Monitoring Systems
title_sort accuracy evaluation of contour(®)plus compared with four blood glucose monitoring systems
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4575307/
https://www.ncbi.nlm.nih.gov/pubmed/26169192
http://dx.doi.org/10.1007/s13300-015-0121-3
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