Literature DB >> 30328716

Why the Details of Glucose Meter Evaluations Matters.

Jan S Krouwer1.   

Abstract

In an article in the Journal of Diabetes Science and Technology, Macleod and coworkers describe an evaluation of LifeScan glucose meters that focus on the effects of sample types and comparison methods. They make a valid point that these factors influence the accuracy observed in evaluations and recommend the comparison method be the one recommended by the manufacturer for the sample type in the intended use statement. Yet, the recommended comparison method is not a reference method. The accuracy hierarchy of definitive, reference, and field methods originally described by Tietz should remind one that virtually all glucose meter evaluations use commercially available field methods as the comparison method. Finally, one should not neglect the FDA adverse event database as a way to assess glucose meter performance.

Entities:  

Keywords:  MAUDE; YSI; definitive method; evaluation; glucose meter; reference method

Mesh:

Substances:

Year:  2018        PMID: 30328716      PMCID: PMC6501532          DOI: 10.1177/1932296818803113

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


  5 in total

1.  Analysis of the performance of the CONTOUR® TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients?

Authors:  Martha E Lyon; Andrew W Lyon
Journal:  J Diabetes Sci Technol       Date:  2011-01-01

2.  The chronic injury glucose error grid: a tool to reduce diabetes complications.

Authors:  Jan S Krouwer; George S Cembrowski
Journal:  J Diabetes Sci Technol       Date:  2014-10-14

3.  A model for a comprehensive measurement system in clinical chemistry.

Authors:  N W Tietz
Journal:  Clin Chem       Date:  1979-06       Impact factor: 8.327

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

Authors:  Kirsty Macleod; Laurence B Katz; Hilary Cameron
Journal:  J Diabetes Sci Technol       Date:  2018-08-07

5.  Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician.

Authors:  Svein Skeie; Geir Thue; Kari Nerhus; Sverre Sandberg
Journal:  Clin Chem       Date:  2002-07       Impact factor: 8.327

  5 in total
  1 in total

1.  Analyse Accuracy of Glucose Monitors without any Dedicated Software Package.

Authors:  Himel Mondal; Shaikat Mondal
Journal:  Indian J Endocrinol Metab       Date:  2022-08-04
  1 in total

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