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Medtronic Receives FDA Approval for Standalone Predictive CGM

Update – 6/13/2018: Medtronic has announced that it has begun shipping the Guardian Connect CGM and it is now on the market.

The Guardian Connect, a CGM designed for non-pump users, can predict highs and lows from 10 minutes to 60 minutes in advance, according to Medtronic.   

In recent years, the type 1 diabetes tech market has become dominated by two companies: Medtronic and Dexcom. Medtronic solidified its hold on the insulin pump market through its use of predictive technology to create a closed-loop insulin pump that could stop the flow of insulin when lows were predicted and automate basal insulin delivery throughout the day. Meanwhile, Dexcom gained a strong grasp of the continuous glucose monitor (CGM) market with integrated bluetooth technology and a reputation for sensor accuracy.

But now Medtronic has announced that it will bring predictive technology to the standalone CGM marketplace, a move which is likely to challenge Dexcom’s continued dominance. This past week, Medtronic announced that it had gained FDA approval for the Guardian Connect system, a standalone CGM designed for those who manage type 1 diabetes with multiple daily injections (MDI).

Here are several facts to know about the new Guardian Connect system, according to a Medtronic press release:

-It delivers readings to a smartphone every five minutes.

-It can alert a user within 10 minutes to 60 minutes if glucose readings are predicted to reach high or low targets set by the user.

-It utilizes the IBM Watson-powered Sugar.IQ app to decipher glucose trends.

-Glucose readings can be monitored by multiple users.

-It utilizes Guardian Sensor 3 sensors, which Medtronic claims are “the best sensor on the market at detecting lows.” (Some in the diabetes community have knocked Medtronic CGM technology in the past because of a perceived inferiority of Medtronic sensors.)

-Sensors are inserted into the abdomen and can be worn for up to seven days.

-The Guardian Connect has been available in the EU since 2016.

-At the moment, the Guardian Connect is strictly for use on Apple IOS smartphones, iPads, and iPods (sorry Android users).

-A release date is set for late summer.

We’ll learn more about the Guardian Sensor CGM as Medtronic continues the system’s commercial rollout; you can subscribe to Glu to receive updates on the Guardian Sensor by clicking here, if you are not already a Glu member. In the meantime, you can read the press release on FDA approval of the syste by clicking here.  


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