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Clinical Accuracy of Blood Glucose Meters
Development of blood glucose meter validation
As listed below, protocols to validate blood glucose meters independently were initiated by the American Diabetes Association in 1987. Several organisations, including the FDA, the Canadian Standards Association, and the US based Clinical and Laboratory Standards Institute (or the National Committee for Clinical Laboratory Standards as it was known prior to 2005) also developed validation criteria, many of which were revised. Apart from the 2013 CLSI standard, most of these have since been either withdrawn or superseded. The ISO, in conjunction with CEN, developed a draft standard 15197 in 2000, which was finalised in 2002 and revised in 2003 and 2013. The most recent call for new validation procedures has been made by Klonoff et al in 2015. [2]
Error Grids
Error grid analysis, to quantify the potential harm of error levels in blood glucose meters for self-measurement, as against reference measurements, was first postulated by Clarke et al in 1987 with the grid, described in the paper, becoming known as the Clarke Error Grid. [3] Parkes et al. published an alternative Consensus Error Grid, also known as the Parkes Error Grid, in 2000 [4] and this now forms part of ISO 15197:2013. Klonoff et al described a Surveillance Error Grid in 2014 [5].
  1. International Diabetes Federation. IDF Diabetes Atlas, 6th Edition, 2014 Update [Internet]. Brussels: IDF; 2015 [Updated 2015 Mar 07; Cited 2015 Jul 03].
  2. Klonoff DC, Lias C, Beck S, Parkes JL, Kovatchev B, Vigersky RA, Arreaza-Rubin G, Burk RD, Kowalski A, Little R, Nichols J, Petersen M, Rawlings K, Sacks DB, Sampson E, Scott S, Seley JJ, Slingerland R, Vesper HW. Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol. J Diabetes Sci Technol. 2016 May 3;10(3):697-707. doi: 10.1177/1932296815614587. Epub 2015 Oct 18. PMID: 26481642.
  3. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622–8. doi: 10.2337/diacare.10.5.622. PMID: 3677983. Download here.
  4. Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-8. doi: 10.2337/diacare.23.8.1143. PMID: 10937512. Download here.
  5. Klonoff DC, Lias C, Vigersky R, Clarke W, Parkes JL, Sacks DB, Kirkman MS, Kovatchev B; Error Grid Panel. The surveillance error grid. J Diabetes Sci Technol. 2014;8(4):658-72. doi: 10.1177/1932296814539589. PMID: 25562886. Download here.