How Should Blood Glucose Meter System Analytical Performance Be Assessed?

Journal of Diabetes Science and Technology

Volumn 10, Issue 1, 2016, Pages 178-184

  Simmons, David A ^a  

^a BAYER CORPORATION   (United States)

Author keywords

accuracy; blood glucose monitoring system; performance; precision

Indexed keywords

BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; ERROR; GLUCOSE BLOOD LEVEL; HEALTH IMPACT ASSESSMENT; HUMAN; MATHEMATICAL ANALYSIS; MATHEMATICAL PARAMETERS; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; RISK FACTOR; ANALYSIS; DEVICES; STANDARDS;

GLUCOSE BLOOD LEVEL;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; HUMANS;

EID: 85009135395     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/1932296815598599     Document Type: Review

References (19)

1. UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352 (9131): 837-853.
2. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329 (14): 977-986.
3. Boyd JC, Bruns DE,. Quality specifications for glucose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem. 2001; 47 (2): 209-214.
4. Raine CH III, Schrock LE, Edelman SV, et al. Significant insulin dose errors may occur if blood glucose results are obtained from miscoded meters. J Diabetes Sci Technol. 2007; 1 (2): 205-210.
5. Virdi NS, Mahoney JJ,. Importance of blood glucose meter and carbohydrate estimation accuracy. J Diabetes Sci Technol. 2012; 6 (4): 921-926.
6. Raine CH III, Pardo S, Parkes JL,. Predicted blood glucose from insulin administration based on values from miscoded glucose meters. J Diabetes Sci Technol. 2008; 2 (4): 557-562.
7. Bailey T, Klaff LJ, Wallace JF, et al. Fundamental importance of reference glucose analyzer accuracy for evaluating the performance of blood glucose monitoring systems (BGMSs). Diabetes. 2015; 64 (suppl 1): A239.
8. Neese JW, Duncan P, Bayse D, et al. Development and evaluation of a hexokinase/glucose-6-phosphate dehydrogenase procedure for use as a national glucose reference method. HEW Publication No (CDC) 77-8330 HEW USPHS, Centers for Disease Control and Prevention; 1976.
9. Stockl D, Dewitte K, Thienpont LM,. Validity of linear regression in method comparison studies: is it limited by the statistical model or the quality of the analytical input data? Clin Chem. 1998; 44 (11): 2340-2346.
10. International Organization for Standardization. ISO 15197:2003(E): In vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization; 2003.
11. International Organization for Standardization. ISO 15197:2013(E): In vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization; 2013.
12. Bland JM, Altman DG,. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986; 1 (8476): 307-310.
13. Klonoff DC, Lias C, Vigersky R, et al. The surveillance error grid. J Diabetes Sci Technol. 2014; 8 (4): 658-672.
14. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL,. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987; 10 (5): 622-628.
15. 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 (8): 1143-1148.
16. Pfutzner A, Klonoff DC, Pardo S, Parkes JL,. Technical aspects of the Parkes error grid. J Diabetes Sci Technol. 2013; 7 (5): 1275-1281.
17. American Diabetes Association. Standards of medical care in diabetes-2015. Diabetes Care. 2015; 38 (suppl): S1-S93.
18. Tack C, Pohlmeier H, Behnke T, et al. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012; 14 (4): 330-337.
19. DeGroot MH,. Probability and Statistics. Menlo Park, CA: Addison-Wesley; 1975.