2015 Accurate Blood Glucose Meter For Diabetics, View accurate blood glucose meter, FED Product Details from Zhengzhou Zhengtai Biotechnology Co., Ltd. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Comparison of a few glucose meter with their ISO 15197 version 2003 and 2013 published studies.
Good news on the blood glucose meter accuracy front: the Diabetes Technology Society (DTS) is beginning work on a surveillance program to ensure that blood glucose meters and strips that have been cleared for sale in the United States continue to meet those accuracy standards even after they’re on the market. Here’s the back story: while many people with diabetes (myself included) tend to assume that whatever number that pops up on their glucose meters is accurate, that’s not always the case. The FDA currently finds out about quality and accuracy issues either through its own regular inspections of manufacturing facilities (which are supposed to occur about once every two years, but thanks to budgetary and logistical reasons, don’t always happen that frequently – especially with foreign manufacturers), or through adverse events reported by the public, which are supposed to be passed along to the FDA by the manufacturers themselves.
Enter the Diabetes Technology Society’s Surveillance Program for Cleared Blood Glucose Monitors.
Even the FDA itself might be able to use the program’s results, potentially allowing manufacturers to make claims on product labels based on their scores, or even using the program’s results to help the agency zero in on companies and products whose accuracy appears to be headed south before adverse events occur.
Catherine Price is a freelance journalist and Type 1 diabetic whose work has appeared in The New York Times and The Best American Science Writing, among other publications. The Diabetes Media Foundation is a 501(c)(3) tax-exempt nonprofit media organization devoted to informing, educating, and generating community around living a healthy life with diabetes.


AgaMatrix® White Paper: Performance of the AgaMatrix Presto® Advanced Blood Glucose Monitoring System. First of all, the FDA allows a certain margin of error when it evaluates whether or not to clear meters for sale. The program aims to do the work that the FDA logistically and legally cannot: it will buy meters and strips off store shelves, test them for accuracy, and publish the results for the public to see. This will be useful to all parties involved – as David Klonoff, MD, founder of Diabetes Technology Society and Clinical Professor of Medicine at University of California, San Francisco explained in the program’s press release, “patients will benefit by having access to more accurate meters on the market and manufacturers committed to delivering accurate products will now have an opportunity to back up claims about quality and accuracy with proof from this independent, third-party testing program.” What’s more, payers like insurance companies and CMS (the Centers for Medicare and Medicaid Services) – which waded into the issue of accuracy with its recently implemented competitive bidding mail order program for diabetes supplies – could hypothetically use the results of the DTS program to decide which meters and strips to cover. As Courtney Lias, Director of the Division of Chemistry and Toxicology Devices at FDA (that’s the division responsible for meters and strips) explained to me, the agency is quite interested in the program and hopes to be as involved in its development as federal ethics rules allow. First, the program is still in its early stages, and currently Abbott is the only company contributing funding (note to the other manufacturers: this is a good bandwagon to get on).
Her newest book, Vitamin Complex, will be published in 2015 by Penguin Press, with support from the Alfred P. This is obviously bad from a patient perspective, but it’s also bad for the FDA itself, since there’s no easy way for the cash-strapped agency to focus its resources to the products and companies that cause the greatest concern.
With initial financial support from Abbott – the company that makes the Freestyle line of strips and meters – the program is in the process of establishing a steering committee (as well as recruiting other industry sponsors).
Second, it’s voluntary (though Klonoff is adamant about the need for it to eventually become mandatory, and many people have made similar suggestions in comments for the FDA’s draft guidance for blood glucose meters, which are currently under review – which hypothetically could lead to a regulation requiring that meters be evaluated on a regular basis post-market).


DTS is in the process of putting together a steering committee, including at least one patient advocacy group. Platten, Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards. Sasse, Accuracy study of blood glucose monitoring systems: Evaluation of the TRUEresult, OneTouch Ultra2, Ascensia Contour, FreeStyle Freedom Lite. This means that the accuracy of a meter and its strips can drift downwards over time, but still be on the market. According to DTS administrator, Yoram Tamir, the goal is to begin testing blood glucose meters in 2015.
Third, no one knows yet exactly what it will look like, or to what extent the FDA will be able to use it – let alone whether insurers or payers will recognize its value.



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