At the ongoing meeting of Association for the Study of Diabetes (EASD) in Stockholm, Sweden, Sanofi-aventis unveiled the world’s first attachment to iPhone and iPod that is a standalone medical device. The plug-in, dubbed iBGStar, was developed by Sanofi-aventis and AgaMatrix, the company we profiled 
last year for its efforts to develop a connectivity package for iPhone and its own glucose meters. The iBGStar device not only relies on the iPhone to perform computational functions and display results, as well as to enter them into iBGStar Diabetes Manager logging software, it also sports AgaMatrix’s proprietary Dynamic Electrochemistry technology to perform glucose measurements. Dynamic Electrochemistry is a technology that essentially takes a time-varying input signal and processes it to deliver much richer digital output with more precise glucose measurements. Without giving out too many details, Sanofi-aventis says that this new method “compensates for many interfering factors that can often distort blood glucose results, helping to ensure accurate and reliable blood glucose readings.” Along with iBGStar for iPhone, Sanofi has also unveiled a new glucose meter called BGStar® that also relies on Dynamic Electrochemistry.
More from the press release:
BGStar® and iBGStar™ have been designed by listening to the needs and desires of people with diabetes. Both products aim to integrate convenient, accurate and easy-to-use blood glucose management with decision-making support in everyday lives of people with diabetes. The ultra-compact iBGStar™ can be plugged into an iPhone® or iPod touch® and displays results on a full-color, touch screen. It can also be used separately for on-the-go testing. The specially-designed and simple iBGStar™ Diabetes Manager App will allow data to be easily managed and communicated to healthcare professionals.
Along with iBGStar™, sanofi-aventis’ BGStar® is based on the patented Dynamic Electrochemistry® technology ensuring accurate and reliable blood glucose readings and both devices do not require coding. BGStar® has various feedback features including alerts, programmable reminder alarms and positive feedback to indicate what the results mean. A large, backlit display allows results to be quickly and easily viewed, managed and discussed. In addition, the iBGStar™ product range offers users access to a full service telephone hotline and other support services so people with diabetes can feel more confident to take charge of their lives.
“Blood glucose values recorded for immediate and future analysis, forming a complete record, are the basis of well-informed decision making,” stated Prof. Thomas Haak, chief physician at the diabetes clinic Bad Mergentheim Germany. “Specifically designed devices, which fit conveniently into a patient’s daily lifestyle, resulting in blood glucose self-monitoring at the recommended level, will improve diabetes management.”
“Blood glucose values recorded for immediate and future analysis, forming a complete record, are the basis of well-informed decision making,” stated Prof. Thomas Haak, chief physician at the diabetes clinic Bad Mergentheim Germany. “Specifically designed devices, which fit conveniently into a patient’s daily lifestyle, resulting in blood glucose self-monitoring at the recommended level, will improve diabetes management.”Thanks to FDA’s arcane pre-internet rules, iBGStar still requires FDA 510(k) clearance in the US, and the clearance might not be coming any time soon, since the iPhone is not a medically approved device. As we have noted before, “US FDA and other regulatory agencies are far behind the times that we live in, so they have no current policies to deal with the proliferation of mobile computing devices and their potential uses in medicine. Hence, none of the iPhone applications and attachments are classified as medical devices, so they are sold for non medical uses only.”
More from Amy Tenderich at DiabetesMine…
Press release (.pdf)…
Product page: iBGStar …
Technology page: Dynamic Electrochemistry …
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