A New Test Strip Technology Platform for Self-Monitoring of Blood Glucose

Abstract

In the management of diabetes, accuracy of devices used for self-monitoring of blood glucose (SMBG) is critical because SMBG results can affect patient diabetes-related health outcomes. A new blood glucose monitoring system (BGMS) platform has been developed that is based on the new CONTOUR ® NEXT (CN) test strip. This BGMS platform uses a proprietary electron mediator and algorithm to minimize errors at different steps in the testing process, thus minimizing outliers and significantly improving accuracy from prior-generation blood glucose meter systems. As demonstrated by questionnaire results from clinical studies with the new BGMS platform, accuracy and ease of use are important considerations for people with diabetes and their health care professionals when selecting an SMBG device. This article provides an overview of laboratory studies and clinical trials in the hands of lay users involving the performance of the portfolio of blood glucose meters that uses the new test strip. Each BGMS in the platform, which includes the CONTOUR XT (CONTOUR NEXT EZ in the United States), CONTOUR NEXT LINK, CONTOUR NEXT USB, and CN systems, demonstrated advanced accuracy both in the laboratory and in the hands of subjects (people with diabetes) and trained health care professionals. All systems met and exceeded International Organization for Standardization accuracy criteria (both ISO 15197:2003 and ISO 15197:2013). Each system in the new BGMS platform delivers advanced accuracy, which is essential to people who utilize SMBG for improved management.

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

“…It has been demonstrated that this BGMS fulfills the standards as laid out in ISO 15197 section 6.3, including the more stringent requirements introduced in 2013. 6,7,18 Noteworthy comparative studies reported good performance of CXT-BGMS when ISO 15197:2013 accuracy limits were applied. 16,17,19 In a recent multicenter study conducted in 21 hospitals under routine conditions using 2100 leftover blood samples, 20 CXT-BGMS results were remarkably congruent with the present data.…”

“…Samples were exclusively collected in tubes containing lithium heparin. Samples with hematocrit results outside the CXT-BGMS range (>70%) 7 were considered nonevaluable. Blood glucose levels were measured using the CXT-BGMS, and the local, available hexokinase method (Dimension® Vista 1500, Siemens AG, Erlangen.…”

System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method

“…System accuracy and other performance data of the systems investigated have also been reported in other studies. [9][10][11][12][13][14][15][16][17][18][19] However, in our study, each system was evaluated by using 2 established comparison methods/systems, a GOD-based method/YSI 2300 STAT Plus glucose analyzer and a HK-based method/cobas c111 analyzer; the use of 2 methods allows for an investigation of possible impacts of the used comparison method/system on system accuracy.…”

Impact of Xylose on Glucose-Dehydrogenase-Based Blood Glucose Meters for Patient Self-Testing

“…Xylose has on the other hand been identified as a potential interfering substance in blood glucose meters employing glucose-dehydrogenase based strip technologies. 10,11 According to our knowledge, the extent of this effect has not been explored in a comparative investigation yet.…”

“…This situation has to be considered, when selecting blood glucose meters for patient self-testing of blood glucose, as blood glucose strip technologies based on glucosidehydrogenase have been identified to be subject to interference by xylose. 10,11 No or only very limited data exist about the real potential risk for wrong readings for patients consuming xylose containing food. It may be useful to quantify the influence of xylose on glucose meter readings to be able to define educational needs, if applicable.…”