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106 CHAPTER 5 Modeling the SMBG measurement error
[8] Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M,
Bailey TS, Nichols JH, Kohn MA. Investigation of the accuracy of 18 marketed blood
glucose monitors. Diabetes Care 2018;41(8):1681e8.
[9] Ramljak S, Lock JP, Schipper C, Musholt PB, Forst T, Lyon M, Pfu ¨tzner A. Hematocrit
interference of blood meters for patient self-monitoring. Journal of Diabetes Science
and Technology 2013;7(1):179e89.
[10] Schmid C, Haug C, Heinemann L, Freckmann G. System accuracy of blood glucose
monitoring systems: impact of use by patients and ambient conditions. Diabetes Tech-
nology and Therapeutics 2013;15(10):889e96.
[11] Lam M, Louie RF, Curtis CM, Ferguson WJ, Vy JH, Truong AT, Sumner SL, Kost GJ.
Short-term thermal-humidity shock affects point-of-care glucose testing: implications
for health professionals and patients. Journal of Diabetes Science and Technology
2014;8(1):83e8.
[12] Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability
of test strips and accuracy assessment of systems for self-monitoring of blood glucose
according to ISO 15197. Journal of Diabetes Science and Technology 2012;6(5):
1076e86.
[13] Rodbard D. Characterizing accuracy and precision of glucose sensors and meters. Jour-
nal of Diabetes Science and Technology 2014;8(5):980e5.
[14] Klaff LJ, Brazg R, Hughes K, Tideman AM, Schachner HC, Stenger P, Pardo S,
Dunne N, Parkes JL. Accuracy evaluation of Contour Next compared with five blood
glucose monitoring systems across a wide range of blood glucose concentrations occur-
ring in a clinical research setting. Diabetes Technology and Therapeutics 2015;17(1):
1e8.
[15] International Organization for Standardization. In vitro diagnostic test systems e re-
quirements for blood-glucose monitoring systems for self-testing in managing diabetes
mellitus. ISO 15197:2003.
[16] International Organization for Standardization. In vitro diagnostic test systems e re-
quirements for blood-glucose monitoring systems for self-testing in managing diabetes
mellitus. ISO 15197:2013.
[17] U.S. Department of Health and Human Services, U.S. Food and Drug Administration.
Self-monitoring blood glucose test systems for over-the-counter use: guidance for in-
dustry and food and drug administration staff. 2016. Available from: https://www.fda.
gov/downloads/ucm380327. [Accessed 5 January 2019].
[18] Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-
monitoring of blood glucose systems: clinical considerations for patients and providers.
Journal of Diabetes Science and Technology 2013;7(1):144e52.
[19] Heinemann L, Zijlstra E, Pleus S, Freckmann G. Performance of blood glucose meters
in the low-glucose range: current evaluations indicate that it is not sufficient from a clin-
ical point of view. Diabetes Care 2015;38:e139e40.
[20] Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Ho ¨gel J, Haug C. Accuracy
evaluation of four blood glucose monitoring systems in unaltered blood samples in the
low glycemic range and blood samples in the concentration range defined by ISO
15197. Diabetes Technology and Therapeutics 2015;17(9):625e34.
[21] Viceconti M, Cobelli C, Haddad T, Himes A, Kovatchev B, Palmer M. In silico assess-
ment of biomedical products: the conundrum of rare but not so rare events in two case
studies. Proceedings e Institution of Mechanical Engineers, Part H 2017;231(5):
455e66.