Amy H. Chu

A new test strip technology platform for self-monitoring of blood glucose.

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 New Blood Glucose Monitoring System in the Hands of Intended Users

BACKGROUND This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs). SUBJECTS AND METHODS In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS. HCPs performed fingersticks (using a Tenderlett(®) lancing device [International Technidyne Corp., Edison, NJ]) and venipunctures on subjects and tested both capillary and venous samples from subjects on the BGMS. All BGMS results were compared with Yellow Springs Instruments (YSI) (YSI Life Sciences, Inc., Yellow Springs, OH) laboratory results. Analytical accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., within ± 15 mg/dL or ± 20% of the YSI results for samples with glucose concentrations < 75 mg/dL and ≥ 75 mg/dL, respectively) and more stringent criteria (i.e., within ± 15 mg/dL or ± 15% of the YSI results for samples with glucose concentrations < 100 mg/dL and ≥ 100 mg/dL, respectively). RESULTS Overall, 98.9% (180/182) of subject Microlet2 capillary fingerstick results, 99.5% (182/183) of HCP Tenderlett capillary fingerstick results, and 100% (186/186) of venous results met current ISO criteria and more stringent criteria. The average hematocrit was 44%, with values ranging from 32% to 52%. CONCLUSIONS Test results from both capillary fingerstick and venous samples with a new BGMS in development met current accuracy guidelines as well as proposed tighter criteria.