BACKGROUND: The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published. METHODS: In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied. RESULTS: The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors. It is expected that, for regulatory purposes, this document will stipulate that the error grid version for type 1 diabetes should be applied with the caveat that only the A zone represents acceptable accuracy. CONCLUSIONS: It remains to be seen by how much the new error grid, which is currently being developed by the Food and Drug Administration/Diabetes Technology Society/American Diabetes Association/The Endocrine Society/Association for Advancement of Medical Instrumentation, will deviate from the Parkers error grid.
BACKGROUND: The Parkes error grid, which was developed in 1994, presented performance zones for blood glucose (BG) monitors with borders that were not mathematically specified at the time the grid was published. METHODS: In this article, we (1) review the history of the Parkes error grid, (2) present the never-before-published exact coordinates and specifications of the grid so that others may produce an exact replica of the original grid, and (3) discuss our suggestions how this metric should be applied. RESULTS: The new ISO15197:2013 guideline for system accuracy assessment of BG meters for patient self-measurement incorporates use of this metric for defining acceptable accuracy of BG monitors. It is expected that, for regulatory purposes, this document will stipulate that the error grid version for type 1 diabetes should be applied with the caveat that only the A zone represents acceptable accuracy. CONCLUSIONS: It remains to be seen by how much the new error grid, which is currently being developed by the Food and Drug Administration/Diabetes Technology Society/American Diabetes Association/The Endocrine Society/Association for Advancement of Medical Instrumentation, will deviate from the Parkers error grid.
Authors: Andreas Pfützner; Michael Mitri; Petra B Musholt; Daniela Sachsenheimer; Marcus Borchert; Andrew Yap; Thomas Forst Journal: Curr Med Res Opin Date: 2012-03-21 Impact factor: 2.580
Authors: David C Klonoff; Courtney Lias; Robert Vigersky; William Clarke; Joan Lee Parkes; David B Sacks; M Sue Kirkman; Boris Kovatchev Journal: J Diabetes Sci Technol Date: 2014-06-13
Authors: Andreas Pfützner; Filiz Demircik; Valeria Kirsch; Johannes Pfützner; Stephanie Strobl; Mina Hanna; Jan Spatz; Anke H Pfützner Journal: J Diabetes Sci Technol Date: 2019-04-11
Authors: Andreas Pfützner; Stephanie Strobl; Filiz Demircik; Lisa Redert; Johannes Pfützner; Anke H Pfützner; Alexander Lier Journal: J Diabetes Sci Technol Date: 2018-02-16