Page 44 - Glucose Monitoring Devices
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40 CHAPTER 2 Analytical performance of SMBG systems
References
[1] Choudhary P, Genovese S, Reach G. Blood glucose pattern management in diabetes:
creating order from disorder. Journal of Diabetes Science and Technology 2013;7:
1575e84.
[2] 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. Journal of Diabetes Science and Technology 2010;4:562e70.
[3] 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 [Internet]. 2016. Available from:
https://www.fda.gov/downloads/ucm380327. pdf. [Accessed 23 November 2018].
[4] International Organization for Standardization. In vitro diagnostic test systemsd
requirements for blood-glucose monitoring systems for self-testing in managing dia-
betes mellitus. ISO 15197. 2013 (E).
[5] Klonoff DC, Prahalad P. Performance of cleared blood glucose monitors. Journal of
Diabetes Science and Technology 2015;9:895e910.
[6] Freckmann G, Baumstark A, Pleus S. Do the new FDA guidance documents help
improving performance of blood glucose monitoring systems compared with ISO
15197? Journal of Diabetes Science and Technology 2017;11:1240e6.
[7] Ekhlaspour L, Mondesir D, Lautsch N, et al. Comparative accuracy of 17 point-of-care
glucose meters. Journal of Diabetes Science and Technology 2017;11:558e66.
[8] Klonoff DC, Lias C, Beck S, et al. Development of the diabetes technology society
blood glucose monitor system surveillance protocol. Journal of Diabetes Science and
Technology 2016;10:697e707.
[9] Klonoff DC, Parkes JL, et al. Investigation of the accuracy of 18 marketed blood
glucose monitors. Diabetes Care August 2018;41(8):1681e8.
[10] International Organization for Standardization. In vitro diagnostic test systemsd
requirements for blood-glucose monitoring systems for self-testing in managing dia-
betes mellitus. EN ISO 15197. 2003. E.
[11] 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Self-monitoring blood glucose test systems for over-the-counter use: draft guidance for
industry and food and drug administration staff [Internet]. 2018. Available from: https://
www.fda.gov/downloads/UCM626742.pdf. [Accessed 30 December 2018].
[12] 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;23:1143e8.
[13] 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 bloo glucose
according to ISO 15197. Journal of Diabetes Science and Technology 2012;6(5):
1076e86.
[14] King F, Ahn D, Hsiao V, Porco T, Klonoff DC. A review of blood glucose monitor
accuracy. Diabetes Technology and Therapeutics December 2018;20(12):843e56.
[15] U.S. Department of Health and Human Services, U.S. Food and Drug Administration,
Statement from FDA Commissioner, Gottlieb S, Shuren J. Director of the Center for De-
vices and Radiological Health, on transformative new steps to modernize FDA’s 510(k)
program to advance the review of the safety and effectiveness of medical devices. 2018.
Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm626572.htm. [Accessed 30 December 2018].