Devices & Diagnostics, Health Tech

Abbott gets FDA clearance for newest CGM

Abbott Laboratories received FDA clearance for its newest continuous glucose monitor, the FreeStyle Libre 2. The product is one of many in a growing market for CGMs.

Abbott Laboratories received FDA clearance for its FreeStyle Libre 2 continuous glucose monitor.

Abbott Laboratories received FDA clearance for its newest continuous glucose monitor, the FreeStyle Libre 2. The new device is another contender in the increasingly competitive market for diabetes management.

The FreeStyle Libre 2 is cleared both for adults and children ages 4 and up. The sensor is applied to the back of the upper arm, where it works for 14 days. No finger stick is needed to calibrate it.

The newest version of Abbott’s device added an option for users to set an alarm if their blood glucose levels get too high or too low. White with the first iteration of the FreeStyle Libre, users had to scan a sensor to view their levels, the new device transmits blood glucose data every minute using a Bluetooth signal.

The FreeStyle Libre 2 is also cleared to connect with other devices. Abbott said it was designed to be paired with a mobile app, which it will release soon in the U.S. Startup Bigfoot Biomedical is also developing a smart insulin pen cap system designed to work specifically with the FreeStyle Libre 2. Abbott led the company’s most recent $55 million funding round.

Abbott said it plans to release the FreeStyle Libre 2 in the coming weeks at pharmacies and durable medical suppliers. It will sell for the same price as Abbott’s previous system.

Its competitors include San Diego-based Dexcom, which released its Dexcom G6 CGM in 2018, and insulin pump-maker Medtronic, which reintroduced a standalone CGM in 2018.

But as the competition heats up, the broader market for CGMs is expected to grow. According to the American Diabetes Association, 34.2 million adults had diabetes in 2018. Another 1.5 million are diagnosed every year.

While the first CGMs were initially cumbersome and expensive, as they become more accessible, more patients are turning to them. According to an article published in the American Journal of Managed Care last year, the number of type 1 diabetes patients using a CGM is increasing exponentially, from 6% in 2011 to 38% in 2018.  More type 2 diabetes patients are also starting to turn to CGMs.

Photo credit: Abbott Laboratories