Abbott has received CE Mark clearance for the second generation of its Freestyle Libre device, which will allow the company to make the device available to users in Europe. It will be rolled out gradually in Europe starting in the next few weeks, and it will be offered as the same price as the first generation device.

Freestyle Libre 1, which has been available in Europe since 2014, is a fully disposable CGM system consisting of a tiny insertable sensor and a patch about the size of a quarter worn on the arm for up to 14 days. The patch records glucose data every 15 minutes. Using a special reader or a smartphone app, the wearer can scan the patch with NFC technology, checking their glucose painlessly as often as they want. In addition to the current reading, a scan gives eight hours of historical data and trend information. 

The new generation of the device adds Bluetooth LE in addition to NFC as a means for the patch to communicate. This will allow the device to deliver alerts when the wearers glucose gets dangerously high or low.

Why it matters

“The common use case that you’ll hear about that really motivated this the most strongly is, during the overnight period, if you’re fully asleep, you’re not scanning your sensor and you may not be waking up to do that,” Joel Goldsmith, senior director of digital platforms at Abbott told MobiHealthNews. “So you only want to do that if there’s a pending event that might require you to do it. So this now will operate autonomously and it will motivate you through three different types of alarms that are built in.”

The third alarm, in addition to alarms for high and low glucose, is an alarm for signal loss that tells the user when the sensor isn’t communicating with the reader.

The device will be offered at the same price as the first generation device and presumably will be reimbursable in the same countries where the first Freestyle Libre is — 31 countries including France, Germany and the UK.

What’s the trend

The Freestyle Libre has been hailed as a revelation for people with diabetes because it provides some of the same benefits as a CGM but is smaller, less intrusive and less expensive. But it still can’t do everything that a larger CGM like those from Dexcom and Medtronic can do. Alarms are a big part of that, and this update should make Libre even more competitive with other CGMs.

Notably, Abbott’s Freestyle Libre line is years ahead in Europe of where it is in the US, due to the difficulties of FDA clearance. Since Freestyle Libre 1 only came to the US last fall and still lacks some of the functionality of the European version (notably, it can be read by only a special reader, not a smartphone), it’s likely the States will have to wait a bit for the Libre 2.

“When we first offered Freestyle Libre in Europe, that was three or four years before we offered it in the US,” Goldsmith said. “Would we have gladly offered it in the US at the same time? Of course. But there are differences in the regulatory processes, and that’s just a reality that we accept and know how to operate within.”