A new plug-in attachment for the iPhone and iPod Touch called the iBGStar incorporates a blood glucose meter that allows users to view and analyze readings in ‘real time’.
The compact device attaches to the iPhone/iPod touch’s dock connector and uses the iDevice to perform computational functions and display results – although the iBGStar also functions as a stand-alone blood glucose meter and includes a backlit display to provide a blood glucose level readout without being connected to an iPhone/iPod touch.
When connected, however, the device automatically syncs data with the iBGStar Diabetes Manager App to keep track of blood glucose, carbs intake and insulin dose that can easily be shared with healthcare professionals. The app also allows users to input specific notes for personalized information to help analyze patterns and variations to make better-informed diabetes-related decisions.
Developed by Sanofi-aventis and AgaMatrix, the iBGStar boasts AgaMatrix’s proprietary Dynamic Electrochemistry technology to perform precise glucose measurements. According to the companies, this technology extracts a spectrum of information from the blood that is inaccessible to traditional electrochemical methods, by taking a time-varying input signal and processing it to compensate for many of the interfering factors that can often distort blood glucose results.
The iBGStar was unveiled at the Association for the Study of Diabetes (EASD) in Stockholm, Sweden, where it was billed as the world’s first attachment for an iPhone/iPod that is a standalone medical device. Due to the FDA’s arcane rules, however, the device cannot be classified as a medical device without an FDA 510(k) clearance in the U.S. – something that may not be forthcoming for some time. This means the iBGStar and similar mobile computing devices with potential medical uses can only be sold for non medical uses only.
Sanofi-aventis plans to release both the iBGStar device and the iBGStar App in early 2011. The device itself is expected to cost around US$80, with the app to be available as a free download from the App Store. The company is also examining the possibility of expanding the iBGStar connectivity to other smartphones in the future.
