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References 73

[22] Freckmann G, Pleus S, Grady M, Setford S, Levy B. Measures of accuracy for contin-
uous glucose monitoring and blood glucose monitoring devices. Journal of Diabetes
Science and Technology 2019;13(3). https://doi.org/10.1177/1932296818812062.
[23] Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical ac-
curacy of systems for self-monitoring of blood glucose. Diabetes Care 1987;10(5):
622e8.
[24] Clarke WL. The original Clarke Error Grid Analysis (EGA). Diabetes Technology and
Therapeutics 2005;7(5):776e9.
[25] Kovatchev B, Anderson S, Heinemann L, Clarke W. Comparison of the numerical and
clinical accuracy of four continuous glucose monitors. Diabetes Care 2008;31(6):
1160e4.
[26] Kilo Charles S, et al. Evaluation of a new blood glucose monitoring system with auto-
calibration for home and hospital bedside use. Diabetes Research and Clinical Practice
2006;74(1):66e74.
[27] 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.
[28] Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simula-
tion modeling of errors in insulin dose. Clinical Chemistry 2001;47(2):209e14.
[29] Boyd JC, Bruns DE. Chapter 16 Monte Carlo simulation in establishing analytical qual-
ity requirements for clinical laboratory tests: meeting clinical needs. Methods in Enzy-
mology 2009;467:411e33. Academic Press.
[30] Karon BS, Boyd JC, Klee GG. Glucose meter performance criteria for tight glycemic
control estimated by simulation modeling. Clinical Chemistry 2010;56(7):1091e7.
[31] U. Food and D. Administration. Self-monitoring blood glucose test systems for over-the
counter useedraft guidance for industry and food and drug administration staff. Food;
Drug Administration; 2015.
[32] Krouwer JS. Why the details of glucose meter evaluations matters. Journal of Diabetes
Science and Technology 2019;13(3):559e60. https://doi.org/10.1177/1932296818803113.
[33] Grino M, Alitta Q, Oliver C. Response to ‘blood glucose monitoring data should be re-
ported in detail when studies about efficacy of continuous glucose monitoring systems
are published’. Journal of Diabetes Science and Technology 2019;13(1):154e5. https://
doi.org/10.1177/1932296818805749.
[34] for Standardization IO. In vitro diagnostic test systemserequirements for blood-glucose
monitoring systems for self-testing in managing diabetes mellitus. International Orga-
nization for Standardization; 2003 and 2013.
[35] Breton M, Kovatchev B. Analysis, modeling, and simulation of the accuracy of contin-
uous glucose sensors. Journal of Diabetes Science and Technology 2008;2(5):853e62.
[36] Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglyce-
mia: quantification, validation, and utilization. Diabetes Care 1987;10(5):617e21.
[37] Wild D, von Maltzahn R, Brohan E, Christensen T, Clauson P, Gonder-Frederick L.
A critical review of the literature on fear of hypoglycemia in diabetes: implications
for diabetes management and patient education. Patient Education and Counseling
2007;68(1):10e5.
[38] Anderbro T, et al. Fear of hypoglycaemia in adults with type 1 diabetes. Diabetic Med-
icine 2010;27(10):1151e8.