Evaluation of OneTouch Verio^®, a new blood glucose self-monitoring system for patients with diabetes

Abstract

Introduction. Self-monitoring of blood glucose (SMBG) is important in diabetes management. Reliable and user-friendly instruments are essential. OneTouch Verio^® is a new blood glucose concentration-measuring system designed to be used by patients with diabetes and healthcare professionals. The objective of the present study was to evaluate the analytical performance of the OneTouch Verio^®. Method. The OneTouch Verio^® was evaluated by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP) according to a protocol based on ISO 15197 and the American Diabetes Association (ADA) quality goals. Blood samples were collected and measured on the OneTouch Verio^® by laboratory personnel and patients with diabetes (n = 91, randomized into groups receiving personal training or mail instructions for the OneTouch Verio^® system). Results were compared to a validated routine method, imprecision and bias were calculated. User-friendliness was evaluated with a questionnaire. Results. Quality specifications for blood glucose concentration monitoring systems according to ISO 15197 were fulfilled. The mean coefficients of variation (CV%) of repeatability was 3.4% when tested by laboratory personnel and within the goal of imprecision suggested by ADA. Mean CV% of repeatability for patient self-monitoring was 5.0% and 5.1% in the training- and the mail group, respectively. Total error was 6.4–10.0%. The OneTouch Verio^® showed no hematocrit interference or variation between strip lots. Conclusion. The OneTouch Verio^® displayed sufficient analytical quality and satisfactory user-friendliness. It is suitable for point-of-care testing of blood glucose concentration when handled by patients and healthcare professionals.

Key Words::

• Blood glucose self-monitoring
• diabetes mellitus
• point-of-care system
• validation
• blood glucose

Acknowledgements

The authors would like to thank SKUP and especially Sverre Sandberg and Grete Monsen for the opportunity to use the data from the evaluation of the OneTouch Verio^® meter. Thanks to Tor-Arne Hagve, Jens Petter Berg, Axel Brock, Elvar Theodorsson, Anders Kallner, Sverre Sandberg, Kjetil Retterstøl, Olav Klingenberg and Holger Jon Møller for encouragement and supervision during the writing process at the Course in Manuscript Writing and Publication in Finse, February 2012. Finally a special thanks to Anders Kallner for helping us to complete the manuscript in Stockholm April 2012.

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