We need tighter regulatory standards for blood glucose monitoring, but they should be for accuracy disclosure

Journal of Diabetes Science and Technology

Volumn 4, Issue 5, 2010, Pages 1265-1268

  Ginsberg, Barry H ^a  

^a Diabetes Technology Consultants   (United States)

Author keywords

Accuracy; Blood glucose monitoring; Consumer product labeling; Regulation

Indexed keywords

ARTICLE; BLOOD; BLOOD GLUCOSE MONITORING; DIABETES MELLITUS; GLUCOSE BLOOD LEVEL; HUMAN; INTERPERSONAL COMMUNICATION; METABOLISM; MONITORING; PATIENT EDUCATION; REPRODUCIBILITY; STANDARD;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS; DISCLOSURE; HUMANS; MONITORING, PHYSIOLOGIC; PATIENT EDUCATION AS TOPIC; REPRODUCIBILITY OF RESULTS;

EID: 79952199087     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681000400528     Document Type: Note

References (11)

1. Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-monitoring of blood glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008;10(6):419-39.
2. Klonoff DC. Regulatory controversies surround blood glucose monitoring devices. J Diabetes Sci Technol. 2010;4(2):231-5.
3. Klonoff DC, Bergenstal R, Blonde L, Boren SA, Church TS, Gaffaney J, Jovanovic L, Kendall DM, Kollman C, Kovatchev BP, Leippert C, Owens DR, Polonsky WH, Reach G, Renard E, Riddell MC, Rubin RR, Schnell O, Siminiero LM, Vigersky RA, Wilson DM, Wollitzer AO. Consensus report of the coalition for clinical research - self-monitoring of blood glucose. J Diabetes Sci Technol. 2008;2(6):1030-53.
4. Ginsberg BH. Factors affecting blood glucose monitoring: sources of errors in measurement. J Diabetes Sci Technol. 2009;3(4):903-13.
5. International Organization for Standardization. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2003. http://www.iso.org/iso/catalogue- detail.htm?csnumber=26309.
6. Boyd JC, Bruns DE. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001;47(2):209-14.
7. Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance. J Diabetes Sci Technol. 2010;4(1):75-83.
8. 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(3):562-70.
9. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010;12(3):221-31.
10. The European Parliament and the Council of the European Union. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of the European Communities. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:331:0001:0037: en:PDF.
11. Anderson JL, Coury LA Jr, Leddy J. Dynamic electrochemistry: methodology and application. Anal Chem. 2000;72(18):4497-520.