A large drop of blood was placed on the strip and, after 60 seconds, was washed away. In 1965, Ames developed the first blood glucose test strip, the Dextrostix, using glucose oxidase. Glucose was oxidized, and the amount of glycosuria was proportional to the color of the heated solution. The cumbersome methodology of heating became more convenient in 1945 with the development of Clinitest (Ames, Elkhart, IN), which featured a modified copper reagent tablet. The most important development in the commercialization of urine glucose testing came in 1908, when Benedict developed a copper reagent for urine glucose, which was used, with some modifications, for more than 50 years ( 1). Seven-year surveillance of the clinical performance of a blood glucose test strip product.Attempts to quantify glucose in the urine date back to the mid-1800s and laid the foundation for modern diabetes care.
Global Brand Equity Insights Study, February 2015 Patients who have questions are encouraged to get in touch with OneTouch® Customer Care at 1-80 so we can work with them to provide answers. As we are always evaluating ways to further ensure product quality, LifeScan’s clinical and R&D teams are working to evaluate and understand the DTS results. In fact, the April issue of the Journal of Diabetes Science and Technology features a study detailing the OneTouch Verio® BGMS platform’s seven years of proven accuracy across more than 70,000 clinical data points.
Newest blood glucose meters 2015 iso#
Both products meet the International Organization for Standardization (ISO) standard for accuracy, with the OneTouch Verio® BGMS designed to meet the requirements of ISO 15197:2013 and the OneTouch® Ultra®2 designed to meet ISO 15197:2003. These products are continually assessed in our OneTouch® post-market surveillance program, which includes clinical testing as well as complaint capture, to ensure that all products – including those in the DTS study – continue to meet FDA performance requirements and specifications.
we stand by the accuracy and the efficacy of our OneTouch® products – used by more than 20 million people around the world and recommended by more endocrinologists, primary care physicians, and pharmacists than any other brand. Joan Parkes, a co-author of the study, expressed her hope that manufacturers would support DTS in doing more of these studies.Īt LifeScan, Inc. It’s not clear if DTS will get funding to run this study on an ongoing basis, ensuring the meters on the market are accurate and reliable. (Indeed, Abbott had one meter pass and one meter fail). This study was funded by Abbott but developed and run independently. On the other hand, it is encouraging that two store-brand “value” meters, Walmart’s ReliOn Confirm (Micro) and CVS’ Advanced, showed great accuracy in this study. It is not yet clear how the FDA (or even Medicare) will respond to the reports of particularly low-accuracy meters such as the Advocate Redi-Code+ and the GmateSmart, which have been criticized for inaccuracy before. According to market share data from the US government, about 68% of the Medicare mail orders for BGMs in 2016 were for meters that did not pass the DTS standards. The results may be particularly frustrating for those on Medicare. It should be noted that the study's standards for accuracy were even higher than FDA standards. The FDA looks at company-reported trials when it reviews new meters this study took an independent look, purchasing the meters directly through retailers and testing them rigorously at respected research centers. While all of these meters received FDA clearance at some point, this study shows that not all are equivalent in terms of accuracy.
Newest blood glucose meters 2015 full#
Get the full data and all the accuracy information here. True Track from HDI/Nipro (Trividia) – 81%Īdvocate Redi-Code+ from Diabetic Supply of Suncoast – 76%
True Result from HDI/Nipro (Trividia) – 88% Walmart ReliOn Confirm (Micro) from Arkray – 97% The devices that passed were:Ĭontour Next from Ascensia (formerly Bayer) – 100% The results were troubling: only six out of the 18 devices met the DTS passing standard for meter accuracy – within 15% or 15 mg/dl of the laboratory value in over 95% of trials. These FDA-cleared meters were purchased through retail outlets and tested rigorously at three study sites in over 1,000 people (including 840 people with diabetes). The rigorous study tested the accuracy of 18 popular blood glucose meters (BGM) used in the US. The Diabetes Technology Society (DTS) recently revealed long-awaited results from its Blood Glucose Monitor System (BGMS) Surveillance Program. Results from the Diabetes Technology Society’s Blood Glucose Meter Surveillance Program identifies only six out of 18 meters that passed.
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