Accuracy assessment of two novel systems for self-monitoring of blood glucose following ISO 15197:2013

Journal of Diabetes Science and Technology

Volumn 8, Issue 4, 2014, Pages 906-908

  Pleus, Stefan ^a   Schmid, Christina ^a   Link, Manuela ^a   Baumstark, Annette ^a   Haug, Cornelia ^a   Stolberg, Erhard ^a   Freckmann, Guido ^a  

^a UNIVERSITY OF ULM   (Germany)

Author keywords

Accuracy; Blood glucose; ISO 15197; Self monitoring of blood glucose; SMBG system

Indexed keywords

GLUCOSE BLOOD LEVEL;

BLOOD GLUCOSE MONITORING; COMPARATIVE STUDY; DEVICES; EVALUATION STUDY; GLUCOSE BLOOD LEVEL; HUMAN; REPRODUCIBILITY; STANDARD; STANDARDS;

BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; HUMANS; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS;

EID: 84905904928     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/1932296814536030     Document Type: Letter

References (6)

1. In vitro diagnostic test systems-Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013.
2. In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. DIN EN ISO 15197:2003.
3. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1(8476):307-310.
4. Scandinavian evaluation of laboratory equipment for primary health care, SKUP. Accu-Chek Aviva-Meter and test strips designed for glucose self-measurement and measurements by health care professionals. Available at: http://www.skup.nu/. Accessed November 18, 2013.
5. Scandinavian evaluation of laboratory equipment for primary health care, SKUP. Accu-Chek Performa-Meter and test strips designed for self-measurement and measurements by health care professionals. Available at: http://www.skup.nu/. Accessed November 18, 2013.
6. Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012;6(5):1076-1086.