A comprehensive evaluation of the performance of the test strip technology for OneTouch Verio glucose meter systems

Diabetes Technology and Therapeutics

Volumn 14, Issue 8, 2012, Pages 701-709

  Bailey, Timothy ^a   Chang, Anna ^b   Rosenblit, Paul D ^c   Jones, Loretta ^d   Teft, Gillian ^e   Setford, Steven ^e   Mahoney, John ^d  

^a AMCR Institute Inc   (United States)

^b John Muir Physician Network Clinical Research Center   (United States)

^c Diabetes/Lipid Management and Research Center   (United States)

^d LifeScan Inc   (United States)

^e LifeScan Scotland Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE;

ACCURACY; ADULT; ALTITUDE; ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; BLOOD GLUCOSE METER; CLINICAL EVALUATION; CONTROLLED STUDY; FEMALE; GLUCOSE BLOOD LEVEL; GLUCOSE TOLERANCE TEST; HEALTH CARE PERSONNEL; HEMATOCRIT; HUMAN; HUMIDITY; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL; REFERENCE VALUE; REPRODUCIBILITY; TEMPERATURE SENSITIVITY; TEST STRIP;

ALGORITHMS; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; CALIFORNIA; CLINICAL LABORATORY TECHNIQUES; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; FEMALE; HEMATOCRIT; HUMANS; MALE; PHARMACIES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84864663289     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2011.0260     Document Type: Article

References (18)

1. American Diabetes Association: Standards of medical care in diabetes-2011. Diabetes Care 2011;34(Suppl 1):S11-S61.
2. Ginsberg BH: Factors affecting blood glucose monitoring: sources of errors in measurement. J Diabetes Sci Technol 2009;3:903-913.
3. Klonoff DC: Regulatory controversies surround blood glucose monitoring devices. J Diabetes Sci Technol 2010;4:231-235.
4. Hodges AM, Chatelier RC: Improved glucose measurements using a thin layer cell and tri-pulse electrochemical detection. Clin Chem 2008;54:1934.
5. 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;10:419-439.
6. Lee-Davey J, Alexander, Raja P: Clinical patterns of low blood glucose identified by a pattern algorithm may predict increased risk of severe hypoglycemia in the following 24-hour period [abstract]. Diabetes Technol Ther 2011;13:264-265.
7. Tsujimura S, Kojima S, Kano K, Ikeda T, Sato M, Sanada H, Omura H: Novel FAD-dependent glucose dehydrogenase for a dioxygen-insensitive glucose biosensor. Biosci Biotechnol Biochem 2006;70:654-659.
8. Teodorczyk M, Cardosi M, Setford S: Hematocrit compensation in electrochemical blood glucose monitoring systems. J Diabetes Sci Technol 2012;6:648-655.
9. 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: International Organization for Standardization, 2003.
10. Clinical and Laboratory Standards Institute: Interference Testing in Clinical Chemistry, Approved Guideline, 2nd ed. Publication number CLSI EP07-A2. Wayne, PA: Clinical and Laboratory Standards Institute, 2005.
11. Davies D: Kinetics of icodextrin. Perit Dial Int 1994;14(Suppl 2):S45-S50.
12. Mayo Clinic: Tolazamide (Oral Route). www.mayoclinic .com/health/drug- information/DR602751/DSECTION =proper-use (accessed January 19, 2012).
13. Pastore A, Massoud R, Motti C, Lo Russo A, Fucci G, Cortese C, Federici G: Fully automated assay for total homocysteine, cysteine, cysteinylglycine, glutathione, cysteamine, and 2-mercaptopropionylglycine in plasma and urine. Clin Chem 1998;44:825-832.
14. Klonoff DC: The Food and Drug Administration is now preparing to establish tighter performance requirements for blood glucose monitors. J Diabetes Sci Technol 2010;4: 499-504.
15. Breton MD, Kovatchev BP: Impact of blood glucose selfmonitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Technol 2010;4:562-570.
16. Burtis CA, Ashwood ER, eds.: Tietz Textbook of Clinical Chemistry, 2nd ed. Philadelphia: W.B. Saunders Co., 1994.
17. Craig RM, Murphy P, Gibson TP, Quintanilla A, Chao GC, Cochrane C, Patterson A, Atkinson AJ Jr: Kinetic analysis of d-xylose absorption in normal subjects and in patients with chronic renal failure. J Lab Clin Med 1983;101:496-506.
18. Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS: Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care 2011;34:262-267.