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Scand J Clin Lab Invest. 2012 Sep;72(5):374-9. doi: 10.3109/00365513.2012.677544.

The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients.

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1
Department of Medical Biochemistry, University of Oslo/Oslo University Hospital, Oslo, Norway. daniel@sachse-zhang.com

Abstract

BACKGROUND:

Self-monitoring of blood glucose is a cornerstone of diabetes management. The aim of this study was to evaluate the analytical quality and the ease of use of the Accu-Chek Mobile, a new glucose monitoring system designed for capillary blood testing by diabetic patients.

MATERIALS AND METHODS:

The performance of the Accu-Chek Mobile was evaluated both in the hands of a scientist and of diabetes patients. The designated comparative method was a hexokinase-based laboratory method (Architect ci8200). Diabetics (N = 88) with previous experience of self-testing were recruited for the study. Patient samples, containing glucose in concentrations mainly between ˜4 and ˜20 mmol/L, were analyzed in duplicates both on the Accu-Chek Mobile and with the comparative method. The patients answered a questionnaire about the ease of use of the meter.

RESULTS:

The meter yields reproducible readings, with an imprecision CV <5% as required by the American Diabetes Association (ADA). Of the glucose concentrations obtained by both the scientist and the patients, more than 95% of the individual results were within ± 20% of the comparative method, meeting the ISO 15197 accuracy goal, but not the stricter ± 10% ADA goal.

CONCLUSION:

Accu-Chek Mobile is a user-friendly glucometer that in a normo- and hyperglycemic range fulfils the ISO 15197 accuracy requirement, also in the hands of diabetes patients.

PMID:
22900743
DOI:
10.3109/00365513.2012.677544
[Indexed for MEDLINE]
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