A comprehensive evaluation of strip performance in multiple blood glucose monitoring systems

Abstract

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch^® VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch^® Verio IQ™, OneTouch^® Verio Pro™, OneTouch^® Verio™, OneTouch^® VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E).

Keywords:

• accuracy
• blood glucose
• blood glucose meter
• blood glucose strips
• self-monitoring of blood glucose

Acknowledgements

The authors thank L Stewart, D Campbell, E Gilman, K Koria and B Irvine for technical assistance on the clinical evaluations. The authors also thank M MacDonald, A Salgado and the LifeScan testing staff for technical assistance on the laboratory evaluations.

Financial & competing interests disclosure

This work was funded by LifeScan, Inc. L Katz, is a full time employee of LifeScan, Inc. K Macleod, M Grady, H Cameron and S Satford are full time employees of LifeScan Scotland Ltd. A Pfützner is CEO and Medical Director of Pfützner Science & Health, Institute and has received research grants, consultancy fees and travel expenses from LifeScan, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control.

• However, blood glucose monitoring systems (BGMS) may be susceptible to error from test strip, user, environmental and pharmacological factors.

• According to guidelines described in ISO15197:2013(E), BGMS must meet standards for precision and effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing.

• Performance of five BGMS using new Verio blood glucose strip technology met or exceeded standards described in ISO15197:2013 in all four areas.

• The performance of these BGMS supports the use of this strip in clinical situations.

Notes