Medtronic gets CE Mark for smartphone-connected CGM

By Jonah Comstock

Medtronic has received a CE Mark for its Guardian Connect mobile continuous glucose monitor (CGM) and app. The company will begin selling the system in select countries in Europe, Asia, and Latin America in Q2 2017 and expects to receive FDA clearance to launch the device in the US around that same time.

The Dublin, Ireland-based company already has an FDA and CE cleared connected CGM called Minimed Connect, but that system is for users of both a Medtronic CGM and the company's insulin pump. A Medtronic spokesperson explained the difference between the two systems in an email to MobiHealthNews.

"While the MiniMed Connect system and Guardian Connect systems both display diabetes data on mobile apps, there are a few key differences," they wrote. "In particular: The MiniMed Connect system is intended for people who are on Medtronic MiniMed 530G insulin pumps integrated with CGM in the US, while the Guardian Connect system is a standalone CGM system intended for people on insulin injections, initially outside the US. The MiniMed Connect app displays some key pump information, such as active insulin, in addition to CGM information. The Guardian Connect system also allows people to track activities related to their diabetes, such as meal intake, exercise and insulin intake."

Guardian Connect, which was demoed and announced at an event back in the fall of 2014, is in some ways Medtronic's answer to Dexcom Share, the rival company's connected CGM that got its FDA clearance in October 2014 and launched shortly thereafter. Not only can the user of Guardian Connect check their insulin level on their smartphone, they can also have the device send text message alerts about high or low blood glucose to a care partner of their choosing, or upload the data into Medtronic's CareLink diabetes therapy management platform.

"Having continuous, real-time access to glucose values and being alerted to important trends and events is key for people with diabetes," Annette Brüls, president of Diabetes Service and Solutions at Medtronic, said in a statement. "With our new Guardian Connect system, we've continued to innovate so we can deliver these insights for people with diabetes on insulin injection therapy. Guardian Connect is also compatible with our CareLink diabetes therapy management platform and arms healthcare providers, their patients and care partners with actionable data to help improve day-to-day diabetes management and make long-term therapy adjustments. Expanding our solutions to help more people with diabetes no matter where they are on the care continuum is central to our goal of transforming diabetes care for greater freedom and better health."

Initially, the app will be iOS only, but Medtronic is working on an Android version. Medtronic is also working on getting FDA clearance to eventually launch the device in the US as well.