Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197

Freckmann, Guido; Pleus, Stefan; Link, Manuela; Baumstark, Annette; Schmid, Christina; Högel, Josef; Haug, Cornelia

doi:10.1089/dia.2015.0043

Cited by 32 publications

(36 citation statements)

References 35 publications

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“…6,7,18 Noteworthy comparative studies reported good performance of CXT-BGMS when ISO 15197:2013 accuracy limits were applied. 16,17,19 In a recent multicenter study conducted in 21 hospitals under routine conditions using 2100 leftover blood samples, 20 CXT-BGMS results were remarkably congruent with the present data. The ISO accuracy limits and CEG results similarities corroborate the generalizability of the performance data of the CXT-BGMS in different hospital environments.…”

Section: Discussionsupporting

confidence: 88%

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Ottiger

Gygli

Huber

et al. 2016

J Diabetes Sci Technol

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This study assesses and demonstrates that CONTOUR® XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBÄK) and Swiss (QUALAB) quality control guidelines for point-of-care testing (POCT) and fulfills the ISO15197:2013 accuracy limits criteria under the routine conditions of a hospital point-of care setting. This single-center study was conducted in Switzerland using 105 venous blood samples from hospitalized patients. Each sample was tested in comparison to the hexokinase reference method. Compliance with POCT guidelines was assessed by daily BGMS measurements using control solutions. Accuracy of CXT-BGMS according to ISO limits was 98.41%. All control measurements were within the limits defined by RiliBÄK (within ± 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within ± 10% of target values).

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Section: Discussionsupporting

confidence: 88%

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Ottiger

Gygli

Huber

et al. 2016

J Diabetes Sci Technol

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“…Several published studies have compared BGM brands and models by name during headto-head testing (56,57,136,(145)(146)(147)(148). For clinicians and consumers, MARD provides an excellent measure of accuracy and precision when evaluating a BGM (134).…”

Section: Iso Standardsmentioning

confidence: 99%

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

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“…Accuracy of the systems was also analyzed by calculating mean absolute relative deviations, which is presented in a current publication. 8 The results of the bias analysis and regression analysis are shown in Table 4. Regarding the results obtained by using the manufacturers' comparison method, the relative bias of individual lots ranged from -6.2% (system 3) to +4.7% (system 2).…”

Section: Resultsmentioning

confidence: 99%

System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method

Link¹,

Schmid²,

Pleus³

et al. 2015

J Diabetes Sci Technol

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The accuracy of blood glucose (BG) measurement results obtained with systems for self-monitoring of blood glucose (SMBG) by people with diabetes is crucial for adequate therapeutic decisions. Requirements for SMBG systems, for example, acceptable system accuracy, are established in the International Organization for Standardization (ISO) standard 15197. Manufacturers often provide evidence of conformity with this standard to obtain the Conformité Européenne (CE) mark for their system; in the European Union this mark, is a minimum requirement for being marketed. Background: The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek® Aviva, Contour®XT, GlucoCheck XL, GlucoMen® LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used.

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Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197

Cited by 32 publications

References 35 publications

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method

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