Page 170 - Glucose Monitoring Devices

References 171

[47] Danne T, Nimri R, Battelino T, Bergenstal RM, Close K, Devries JH, Garg S,
Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C,
Dassau E, Doyle 3rd FJ, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O,
Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Nørgaard K, Parkin CG,
Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International
consensus on use of continuous glucose monitoring. Diabetes Care 2017;40:1631e40.
PMID: 29162583.
[48] Kovatchev B, Gonder-Frederick L, Cox D, Clarke W. Evaluating the accuracy of contin-
uous glucose monitoring sensors. Diabetes Care 2004;27:1922e8.
[49] Clarke W, Cox D, Gonder-Frederick L, Carter W, Pohl S. Evaluating the clinical accu-
racy of self-blood glucose monitoring systems. Diabetes Care 1987;10:622e8.
[50] Parkes J, Slatin S, Pardo S, Ginsberg B. A new consensus error grid to evaluate the clin-
ical significance of inaccuracies in the measurement of blood glucose. Diabetes Care
2000;23:1143e5.
[51] Klonoff D, Lias C, Vigersky R, Clarke W, Parkes J, Sacks D, Kirkman S, Kovatchev B,
The Error Grid Panel. The surveillance error grid. Journal of Diabetes Science and
Technology 2014;8:658e72.
[52] Clarke W, Anderson S, Farhy L, Breton M, Gonder-Frederick L, Cox D, Kovatchev B.
Evaluating the clinical accuracy of two continuous glucose sensors using continuous
glucose-error grid analysis. Diabetes Care 2005;28:2412e7.
[53] Clarke W, Anderson S, Kovatchev B. Evaluating clinical accuracy of continuous
glucose monitoring systems: continuous glucose e error grid analysis (CG-EGA).
Current Diabetes Reviews 2008;4:193e9.
[54] Clinical and Laboratory Standards Institute (CLSI). Performance metrics for continuous
interstitial glucose monitoring; approved guideline. CLSI document POCT05-A.
Wayne, PA: CLSI; 2008.
[55] 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 International Standard 2013:15197.
[56] Self-monitoring blood glucose test systems for over-the-counter use: guidance for indus-
try and food and drug administration staff, document issued on October 11, 2016. Avail-
able from: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM380327.pdf.
[57] Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data.
Diabetes Technology and Therapeutics 2009;11(Suppl. 1):S1e10.