Abstract
Objective For patients with diabetes, regular self-monitoring of blood glucose (SMBG) is essential to ensure adequate glycemic control. Therefore, accurate and reliable blood glucose measurements with SMBG systems are necessary. The international standard ISO 15197 describes requirements for SMBG systems, such as limits within which 95% of glucose results have to fall to reach acceptable system accuracy. The 2013 version of this standard sets higher demands, especially regarding system accuracy, than the currently still valid edition. ISO 15197 can be applied by manufacturers to receive a CE mark for their system. Research design and methods This study was an accuracy evaluation following ISO 15197:2013 section 6.3 of two recently updated SMBG systems (Contour * and Contour TS; Bayer Consumer Care AG, Basel, Switzerland) with an improved algorithm to investigate whether the systems fulfill the requirements of the new standard. For this purpose, capillary blood samples of approximately 100 participants were measured with three test strip lots of both systems and deviations from glucose values obtained with a hexokinase-based comparison method (Cobas Integra † 400 plus; Roche Instrument Center, Rotkreuz, Switzerland) were determi...Continue Reading
References
Feb 8, 1986·Lancet·J M Bland, D G Altman
Aug 11, 2000·Diabetes Care·J L ParkesB H Ginsberg
Jul 24, 2007·Clinical Oncology : a Journal of the Royal College of Radiologists·M W R Reed
Feb 16, 2010·Diabetes Technology & Therapeutics·Guido FreckmannCornelia Haug
Jun 2, 2010·Journal of Diabetes Science and Technology·Marc D Breton, Boris P Kovatchev
Feb 10, 2011·Journal of Diabetes Science and Technology·Joy FrankJoan Lee Parkes
Sep 2, 2011·Journal of Diabetes Science and Technology·Bern HarrisonSolveig Halldorsdottir
Dec 20, 2011·Diabetes Technology & Therapeutics·Cornelius TackAndreas Pfützner
Jul 4, 2012·Nutrition, Metabolism, and Cardiovascular Diseases : NMCD·M FranciosiA Nicolucci
Jul 14, 2012·Swiss Medical Weekly·Thomas ZuegerEmanuel R Christ
Apr 10, 2013·Journal of Diabetes Science and Technology·Erwin S BudimanAnsgar Resch
Aug 6, 2013·Journal of Diabetes Science and Technology·Oliver SchnellEva Wintergerst
Dec 20, 2013·Journal of Diabetes Science and Technology·Guido FreckmannCornelia Haug
May 31, 2014·Journal of Diabetes Science and Technology·Daniel A FinanRamakrishna Venugopalan
May 31, 2014·Journal of Diabetes Science and Technology·Christoph HasslacherIsabel Platten
Nov 2, 2014·Diabetes Technology & Therapeutics·Rebekah J WalkerLeonard E Egede
Jan 7, 2015·Journal of Diabetes Science and Technology·David C KlonoffUNKNOWN Error Grid Panel
Apr 16, 2015·Journal of Diabetes Science and Technology·Guido FreckmannLutz Heinemann
Apr 16, 2015·Journal of Diabetes Science and Technology·Manuela LinkGuido Freckmann
Jun 26, 2015·Diabetes Technology & Therapeutics·Guido FreckmannCornelia Haug
Sep 4, 2015·Journal of Diabetes Science and Technology·David A Simmons
Citations
Apr 27, 2017·Journal of Diabetes Science and Technology·Stefan PleusGuido Freckmann
Jan 16, 2018·Advanced Healthcare Materials·Hyunjae LeeDae-Hyeong Kim
Oct 31, 2018·Diabetes Technology & Therapeutics·Fraya KingDavid C Klonoff
Jun 16, 2017·Journal of Diabetes Science and Technology·John B WelshDavid Price
Feb 23, 2017·Diabetes Technology & Therapeutics·Guido FreckmannCornelia Haug
Sep 18, 2018·Journal of Diabetes Science and Technology·Gary H Thorpe