Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

References

• ADA. Standards of medical care in diabetes – 2017. Diabetes Care 2017;40(Suppl 1):S1-S135
   PubMedGoogle Scholar
• Elgart JF, Gonzalez L, Prestes M, et al. Frequency of self-monitoring blood glucose and attainment of HbA1c target values. Acta Diabetol 2016;53:57-62
   PubMed Web of Science ®Google Scholar
• Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem 2001;47:209-14
   PubMed Web of Science ®Google Scholar
• Raine CH III, Schrock LE, Edelman SV, et al. Significant insulin dose errors may occur if blood glucose results are obtained from miscoded meters. J Diabetes Sci Technol 2007;1:205-10
   PubMedGoogle Scholar
• Virdi NS, Mahoney JJ. Importance of blood glucose meter and carbohydrate estimation accuracy. J Diabetes Sci Technol 2012;6:921-6
   PubMedGoogle Scholar
• Breton MD, Kovatchev BP. Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Technol 2010;4:562-70
   PubMedGoogle Scholar
• International Organization for Standardization. In vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013. Geneva, Switzerland: International Organization for Standardization; 2013
   Google Scholar
• International Organization for Standardization. In vitro diagnostic test systems N requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013). EN ISO 15197:2015. Geneva, Switzerland: International Organization for Standardization; 2015
   Google Scholar
• Baumstark A, Jendrike N, Pleus S, et al. Evaluation of accuracy of six blood glucose monitoring systems and modeling of possibly related insulin dosing errors. Diabetes Technol Ther 2017;19:580-8
   PubMed Web of Science ®Google Scholar
• International Organization for Standardization. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. EN ISO 17511:2003. Geneva, Switzerland: International Organization for Standardization; 2003
   Google Scholar
• Bundesärztekammer. Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen. Deutsches Ärzteblatt 2014;111:1583-618
   Google Scholar
• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-10
   PubMed Web of Science ®Google Scholar
• Simmons DA. How should blood glucose meter system analytical performance be assessed? J Diabetes Sci Technol 2015;10:178-84
   PubMedGoogle Scholar
• Pardo S, Dunne N, Simmons DA. Using radar plots to demonstrate the accuracy and precision of 6 blood glucose monitoring systems. J Diabetes Sci Technol 2017;11:966-9
   PubMedGoogle Scholar
• Klonoff D, Lias C, Vigersky R, et al. The surveillance error grid. J Diabetes Sci Technol 2014;8:658-72
   PubMedGoogle Scholar
• Christiansen M, Greene C, Pardo S, et al. A new, wireless-enabled blood glucose monitoring system that links to a smart mobile device: accuracy and user performance evaluation. J Diabetes Sci Technol 2017;11:567-73
   PubMedGoogle Scholar
• Parkes JL, Slatin SL, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000;23:1143-8
   PubMed Web of Science ®Google Scholar
• Baumstark A, Pleus S, Schmid C, et al. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol 2012;6:1076-86
   PubMedGoogle Scholar
• Kristensen GB, Monsen G, Skeie S, et al. Standardized evaluation of nine instruments for self-monitoring of blood glucose. Diabetes Technol Ther 2008;10:467-77
   PubMed Web of Science ®Google Scholar
• Kristensen GB, Christensen NG, Thue G, et al. Between-lot variation in external quality assessment of glucose: clinical importance and effect on participant performance evaluation. Clin Chem 2005;51:1632-6
   PubMed Web of Science ®Google Scholar
• Littmann K, Petersen ER, Pussinen C, et al. Evaluation of OneTouch Verio, a new blood glucose self-monitoring system for patients with diabetes. Scand J Clin Lab Investig 2013;73:286-92
   PubMed Web of Science ®Google Scholar
• Freckmann G, Baumstark A, Jendrike N, et al. Accuracy evaluation of four blood glucose monitoring systems in the hands of intended users and trained personnel based on ISO 15197 requirements. Diabetes Technol Ther 2017;19:246-54
   PubMed Web of Science ®Google Scholar
• Skeie S, Thue G, Nerhus K, et al. Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem 2002;48:994-1003
   PubMed Web of Science ®Google Scholar
• Bailey T, Wallace JF, Greene C, et al. Accuracy and user performance evaluation of the Contour Next Link 2.4 blood glucose monitoring system. Clin Chim Acta 2015;448:139-45
   PubMed Web of Science ®Google Scholar
• Caswell M, Frank J, Viggiani MT, et al. Accuracy and user performance evaluation of a blood glucose monitoring system. Diabetes Technol Ther 2015;17:152-8
   PubMed Web of Science ®Google Scholar
• Bailey TS, Wallace JF, Pardo S, et al. Accuracy and user performance evaluation of a new, wireless-enabled blood glucose monitoring system that links to a smart mobile device. J Diabetes Sci Technol 2017;11:736-43
   PubMedGoogle Scholar
• Deakin S, Steele D, Clarke S, et al. Cook and chill: effect of temperature on the performance of nonequilibrated blood glucose meters. J Diabetes Sci Technol 2015;9:1260-9
   PubMedGoogle Scholar
• Nerhus K, Rustad P, Sandberg S. Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems. Diabetes Technol Ther 2011;13:883-92
   PubMed Web of Science ®Google Scholar
• Haller MJ, Shuster JJ, Schatz D, et al. Adverse impact of temperature and humidity on blood glucose monitoring reliability: a pilot study. Diabetes Technol Ther 2007;9:1-9
   PubMed Web of Science ®Google Scholar
• Müller UA, Hämmerlein A, Casper A, et al. Community pharmacy-based intervention to improve self-monitoring of blood glucose in type 2 diabetic patients. Pharmacy Practice 2006;4:195-203
   PubMedGoogle Scholar
• Bamberg R, Schulman K, MacKenzie M, et al. Effect of adverse storage conditions on performance of glucometer test strips. Clin Lab Sci 2005;18:203-9
   PubMedGoogle Scholar
• Bergenstal R, Pearson J, Cembrowski GS, et al. Identifying variables associated with inaccurate self-monitoring of blood glucose: proposed guidelines to improve accuracy. Diabetes Educ 2000;26:981-9
   PubMed Web of Science ®Google Scholar
• Bedini JL, Wallace JF, Pardo S, et al. Performance evaluation of three blood glucose monitoring systems using ISO 15197: 2013 accuracy criteria, consensus and surveillance error grid analyses, and insulin dosing error modeling in a hospital setting. J Diabetes Sci Technol 2015;10:85-92
   PubMedGoogle Scholar
• Pardo S, Dunne N, Simmons DA. Bolus insulin dose error distributions based on results from two clinical trials comparing blood glucose monitoring systems. J Diabetes Sci Technol 2017;11:970-4
   PubMedGoogle Scholar