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Are Blood Glucose Meters Accurate? New Data on 18 Meters

By Jeemin Kwon and Adam Brown

Results from the Diabetes Technology Society’s Blood Glucose Meter Surveillance Program identifies only six out of 18 meters that passed. Did yours make the cut?

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The Diabetes Technology Society (DTS) recently revealed long-awaited results from its Blood Glucose Monitor System (BGMS) Surveillance Program. The rigorous study tested the accuracy of 18 popular blood glucose meters (BGM) used in the US. 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 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.

The devices that passed were:

The devices that failed were:  

Get the full data and all the accuracy information here.

While all of these meters received FDA clearance at some point, this study shows that not all are equivalent in terms of accuracy. 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. It should be noted that the study's standards for accuracy were even higher than FDA standards. 

The results may be particularly frustrating for those on Medicare. 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. 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.

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.

This study was funded by Abbott but developed and run independently. (Indeed, Abbott had one meter pass and one meter fail). 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. Dr. Joan Parkes, a co-author of the study, expressed her hope that manufacturers would support DTS in doing more of these studies.

Company statements:

At LifeScan, Inc. 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[1], and pharmacists[2] than any other brand. 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. 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. 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[3].  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. Patients who have questions are encouraged to get in touch with OneTouch® Customer Care at 1-800-227-8862 so we can work with them to provide answers.


[1] Global Brand Equity Insights Study, February 2015

[2] U.S. News and World Report, June 13, 2017 http://health.usnews.com/wellness/articles/2017-06-13/pharmacists-picks-top-recommended-health-products

[3] Setford, et al. Seven-year surveillance of the clinical performance of a blood glucose test strip product. Journal of Diabetes Science and Technology (2017) 1-8

 

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