Abbott’s FreeStyle InsuLinx Touchscreen Blood Glucose Meter Gets FDA Clearance for Sale in the US, sans Bolus Calculator

Touchscreens have changed how hundreds of millions of people use cell phones and have enabled the rise of the tablet computer; now, a touchscreen blood glucose meter is on its way to the US. The FDA cleared the new FreeStyle InsuLinx in March, and Abbott Diabetes Care plans to make it available “in the coming months.” We think this is an exciting approval that will result in less “hassle factor” for data input, collection, and analysis. The meter will be similar to the version of the FreeStyle InsuLinx that has been a hit with patients in Europe since last spring (and in Canada since last fall), but with two major differences. One is that the US version doesn’t have a built-in bolus calculator to help patients with their mealtime insulin injections. Presumably, the bolus calculator – cool as it is – would have taken a long time to get through the FDA, which has stricter requirements for medical devices than European regulatory agencies. Instead the US FreeStyle InsuLinx allows users to record, but not calculate, their rapid- and long-acting insulin doses. The other difference is that the US version of the meter will use specific FreeStyle InsuLinx-branded test strips; however, the new strips appear to us to be very similar in design and look to the popular FreeStyle Lite line of test strips used in some of Abbott’s other meters. The new name is due mainly to regulatory requirements, as we understand it.

For our deep dive into the FreeStyle InsuLinx’s touchscreen interface, its insulin-logging ability, its new FreeStyle Auto-Assist data management software, and more, please see this month’s test drive. And for background on other upcoming, touchscreen-enabled diabetes devices, see the new now nexts on Tandem’s t:slim insulin pump in diaTribe #38 and on Cellnovo’s online-enabled pump/meter in diaTribe #36. –JS/AB