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

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.

Key Words::

• Analytical quality
• diabetes mellitus
• plasma glucose
• point-of-care
• self-testing

Acknowledgements

This article is the result of The Arctic Experience, a course in scientific writing organized by the Nordic Association for Clinical Chemistry and the Scandinavian Journal of Clinical & Laboratory Investigation. The authors would like to thank Tor-Arne Hagve, Sverre Sandberg, Ulf-Håkan Stenman, Elvar Theodorsson, Axel Brock, Anders Kallner, Olav Klingenberg and Sverre Landaas for their support during the course. Last but not least we are deeply indebted to Torny Bjerketvedt and SKUP for carrying out the actual study.

Declaration of interest: The authors report no conflict of interest. The authors alone are responsible for the content and writing of the paper.