Literature DB >> 24351185

Assessing the analytical performance of systems for self-monitoring of blood glucose: concepts of performance evaluation and definition of metrological key terms.

Oliver Schnell1, Rolf Hinzmann, Bernd Kulzer, Guido Freckmann, Michael Erbach, Volker Lodwig, Lutz Heinemann.   

Abstract

Reliability of blood glucose (BG) measurements is a prerequisite for successful diabetes management. Publications on the evaluation of self-monitored glucose values, however, are frequently characterized by a confusion in terminology. We provide an inventory of key terms such as accuracy, trueness, precision, traceability, calibration, and matrix effect to avoid future misunderstanding. Definitions are taken from the metrological literature and international norms and explained in a language intended for nonspecialists in metrology. The terms are presented in light of the need to apply generally accepted definitions. In addition, a description of requirements and components for a sound evaluation of BG measurement systems is presented. These factors will also enable improvement in future comparisons of study results.
© 2013 Diabetes Technology Society.

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Year:  2013        PMID: 24351185      PMCID: PMC3876337          DOI: 10.1177/193229681300700619

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  27 in total

1.  Setting performance goals and evaluating total analytical error for diagnostic assays.

Authors:  Jan S Krouwer
Journal:  Clin Chem       Date:  2002-06       Impact factor: 8.327

2.  A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose.

Authors:  J L Parkes; S L Slatin; S Pardo; B H Ginsberg
Journal:  Diabetes Care       Date:  2000-08       Impact factor: 19.112

3.  Guidelines on diabetes, pre-diabetes, and cardiovascular diseases: executive summary. The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European Association for the Study of Diabetes (EASD).

Authors:  Lars Rydén; Eberhard Standl; Małgorzata Bartnik; Greet Van den Berghe; John Betteridge; Menko-Jan de Boer; Francesco Cosentino; Bengt Jönsson; Markku Laakso; Klas Malmberg; Silvia Priori; Jan Ostergren; Jaakko Tuomilehto; Inga Thrainsdottir; Ilse Vanhorebeek; Marco Stramba-Badiale; Peter Lindgren; Qing Qiao; Silvia G Priori; Jean-Jacques Blanc; Andrzej Budaj; John Camm; Veronica Dean; Jaap Deckers; Kenneth Dickstein; John Lekakis; Keith McGregor; Marco Metra; João Morais; Ady Osterspey; Juan Tamargo; José Luis Zamorano; Jaap W Deckers; Michel Bertrand; Bernard Charbonnel; Erland Erdmann; Ele Ferrannini; Allan Flyvbjerg; Helmut Gohlke; Jose Ramon Gonzalez Juanatey; Ian Graham; Pedro Filipe Monteiro; Klaus Parhofer; Kalevi Pyörälä; Itamar Raz; Guntram Schernthaner; Massimo Volpe; David Wood
Journal:  Eur Heart J       Date:  2007-01       Impact factor: 29.983

4.  Statistical tools to analyze continuous glucose monitor data.

Authors:  William Clarke; Boris Kovatchev
Journal:  Diabetes Technol Ther       Date:  2009-06       Impact factor: 6.118

5.  Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems.

Authors:  R Dybkaer
Journal:  Eur J Clin Chem Clin Biochem       Date:  1995-12

6.  Evaluating clinical accuracy of systems for self-monitoring of blood glucose.

Authors:  W L Clarke; D Cox; L A Gonder-Frederick; W Carter; S L Pohl
Journal:  Diabetes Care       Date:  1987 Sep-Oct       Impact factor: 19.112

7.  Approved IFCC recommendation on reporting results for blood glucose (abbreviated).

Authors:  Paul D'Orazio; Robert W Burnett; Niels Fogh-Andersen; Ellis Jacobs; Katsuhiko Kuwa; Wolf R Külpmann; Lasse Larsson; Andrzej Lewenstam; Anton H J Maas; Gerhard Mager; Jerzy W Naskalski; Anthony O Okorodudu
Journal:  Clin Chem       Date:  2005-09       Impact factor: 8.327

8.  Precision of glucose measurements in control sera by isotope dilution/mass spectrometry: proposed definitive method compared with a reference method.

Authors:  O Pelletier; C Arratoon
Journal:  Clin Chem       Date:  1987-08       Impact factor: 8.327

9.  Veterans Affairs Cooperative Study on glycemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Affairs Cooperative Study in Type II Diabetes.

Authors:  C Abraira; J A Colwell; F Q Nuttall; C T Sawin; N J Nagel; J P Comstock; N V Emanuele; S R Levin; W Henderson; H S Lee
Journal:  Diabetes Care       Date:  1995-08       Impact factor: 19.112

10.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group.

Authors: 
Journal:  Lancet       Date:  1998-09-12       Impact factor: 79.321

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  9 in total

1.  Analysis of "Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations".

Authors:  Gary H Thorpe
Journal:  J Diabetes Sci Technol       Date:  2018-09-15

Review 2.  Performance of Cleared Blood Glucose Monitors.

Authors:  David C Klonoff; Priya Prahalad
Journal:  J Diabetes Sci Technol       Date:  2015-06-08

3.  7(th) Annual Symposium on Self-Monitoring of Blood Glucose (SMBG), May 8-10, 2014, Helsinki, Finland.

Authors:  Christopher G Parkin; Anita Mlinac; Rolf Hinzmann
Journal:  Diabetes Technol Ther       Date:  2014-09-11       Impact factor: 6.118

4.  A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range.

Authors:  Eric Zijlstra; Lutz Heinemann; Annelie Fischer; Christoph Kapitza
Journal:  J Diabetes Sci Technol       Date:  2016-11-01

5.  The YSI 2300 Analyzer Replacement Meeting Report.

Authors:  Julia Han; Lutz Heinemann; Barry H Ginsberg; Shridhara Alva; Matthias Appel; Stephan Bess; Kong Y Chen; Guido Freckmann; Dennis R Harris; Matthias Hartwig; Rolf Hinzmann; David Kerr; Jan Krouwer; Linda Morrow; James Nichols; Andreas Pfützner; Stefan Pleus; Mark Rice; David B Sacks; Kevin Schlueter; Hubert W Vesper; David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2020-03-16

6.  A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.

Authors:  Sonia R Chandnani; C D Ramakrishna; Bhargav A Dave; Pankaj S Kothavade; Ashok S Thakkar
Journal:  J Clin Diagn Res       Date:  2017-05-01

Review 7.  Interferences and Limitations in Blood Glucose Self-Testing: An Overview of the Current Knowledge.

Authors:  Michael Erbach; Guido Freckmann; Rolf Hinzmann; Bernhard Kulzer; Ralph Ziegler; Lutz Heinemann; Oliver Schnell
Journal:  J Diabetes Sci Technol       Date:  2016-08-22

8.  Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.

Authors:  Guido Freckmann; Jochen Mende; Stefan Pleus; Delia Waldenmaier; Annette Baumstark; Nina Jendrike; Cornelia Haug
Journal:  J Diabetes Sci Technol       Date:  2021-03-24

9.  Assessment of analytical performance of glucose meter in pediatric age group at tertiary care referral hospital.

Authors:  Mohit Vijay Rojekar; Vandana Kumawat; Jayesh Panot; Surekha Khedkar; Arati Adhe-Rojekar
Journal:  J Diabetes Metab Disord       Date:  2017-09-13
  9 in total

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