System accuracy evaluation of 27 blood glucose monitoring systems according to DIN en ISO 15197

Diabetes Technology and Therapeutics

Volumn 12, Issue 3, 2010, Pages 221-231

  Freckmann, Guido ^a   Baumstark, Annette ^a   Jendrike, Nina ^a   Zschornack, Eva ^a   Kocher, Serge ^b   Tshiananga, Jacques ^b   Heister, Frank ^b   Haug, Cornelia ^a  

^a UNIVERSITY OF ULM   (Germany)

^b Institute for Medical Informatics and Biostatistics   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; GLUCOSE OXIDASE; HEXOKINASE;

ADULT; ARTICLE; BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; BLOOD SAMPLING; CONTROLLED STUDY; GLUCOSE OXIDATION; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIORITY JOURNAL;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; FEMALE; GERMANY; HUMANS; MALE; MIDDLE AGED; REAGENT STRIPS; SELF CARE; YOUNG ADULT;

EID: 77249122160     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2009.0128     Document Type: Article

References (20)

1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Research Group. N Engl J Med 1993; 329:977-986.
2. U.K. Prospective Diabetes Study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes 1995;44:1249-1258.
3. Blonde L, Karter AJ: Current evidence regarding the value of self-monitored blood glucose testing. Am J Med 2005;118(9 Suppl 1):20-26.
4. Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM: Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care 2005;28:1510-1517. (Pubitemid 40756728)
5. Sarol JN, NicodemusNA,TanKM,Grava MB:Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966-2004). Curr Med Res Opin 2005;21:173-183.
6. Jansen JP: Self-monitoring of glucose in type 2 diabetes mellitus: a Bayesian meta-analysis of direct and indirect comparisons. Curr Med Res Opin 2006;22:671-681.
7. McGeoch G, Moore RA: Self-monitoring of blood glucose in type-2 diabetes: what is the evidence? Diabetes Metab Res Rev 2007;23:423-440.
8. Palmer AJ, Dinneen S, Gavin JR, III, Gray A, Herman WH, Karter AJ: Cost-utility analysis in a UK setting of selfmonitoring of blood glucose in patients with type 2 diabetes. Curr Med Res Opin 2006;22:861-872.
9. Schnell O, Hummel M, Weber C: Economic and clinical aspects of diabetes regarding self-monitoring of blood glucose. Diabetes Technol Ther 2008;10(Suppl 1):S72-S81.
10. American Diabetes Association: Standards of medical care in diabetes-2009. Diabetes Care 2009;32(Suppl 1):S13-S61.
11. IDF Clinical Guidelines Task Force: Global Guideline for Type 2 Diabetes. Brussels: Brussels: International Diabetes Federation, 2005.
12. DIN EN ISO 15197: In Vitro Diagnostic Test Systems- Requirements for Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus (ISO 15197:2003). European Committee for Standardization, Brussels, 2003.
13. Astles JR, Sedor FA, Toffaletti JG: Evaluation of the YSI 2300 glucose analyzer: algorithm-corrected results are accurate and specific. Clin Biochem 1996;29:27-31.
14. Bland JM, Altman DG: Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-310.
15. 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;10:622-628.
16. American Diabetes Association: Consensus statement on self-monitoring of blood glucose. Diabetes Care 1987;10: 95-99.
17. Self-monitoring of blood glucose. American Diabetes Association. Diabetes Care 1994;17:81-86.
18. Twomey PJ: Plasma glucose measurement with the Yellow Springs Glucose 2300 STAT and the Olympus AU640. J Clin Pathol 2004;57:752-754.
19. D'Orazio P, Burnett RW, Fogh-Andersen N, Jacobs E, Kuwa K, Kulpmann WR, Larsson L, Lewenstam A, Maas AH, Mager G, Naskalski JW, Okorodudu AO: Approved IFCC recommendation on reporting results for blood glucose (abbreviated). Clin Chem 2005;51:1573-1576.
20. Clarke WL: The original Clarke Error Grid Analysis (EGA). Diabetes Technol Ther 2005;7:776-779.