FDA Approves Guardian™ Connect CGM System

I am excited to announce that the Food and Drug Administration (FDA) has approved our Guardian Connect continuous glucose monitoring (CGM) system for use in the United States. To hear more about this important milestone, watch my video message.

The Guardian™ Connect system is the first smart standalone CGM system to help people with diabetes — ages 14 to 75 years — stay ahead of high and low glucose events. With smart CGM, we are predicting future high and low glucose events up to 60 minutes in advance along with providing exclusive access to the groundbreaking Sugar.IQ™ smart diabetes assistant. With artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how an individual’s glucose levels respond to their food intake, insulin dosages, daily routines, and other factors. * The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.

The Guardian Connect is the first and only standalone CGM system approved to send continuous sensor glucose data directly from the sensor transmitter to a smartphone, without requiring an additional receiver. The system uses Guardian Sensor 3, our newest and most advanced sensor from Medtronic — and the only sensor approved by the FDA to also control a hybrid closed loop insulin delivery system (MiniMed™ 670G system).

The Guardian Connect system also give customers access to the full Medtronic ecosystem. For the first time, patients on MDI and their physicians will have access to advanced diabetes management algorithms, CareLink™ therapy management, and unparalleled service and support.

Together, the Guardian Connect system and the Sugar.IQ™ diabetes assistant can turn difficult-to-determine patterns into personalized, actionable** insights that help people with diabetes keep glucose levels in their target range.

We are excited to expand our diabetes technology portfolio to address more people with diabetes, helping them to live with greater freedom and experience better health with our clearly smarter way to outsmart diabetes.

* Based on information provided by the user. 

**The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices.  All therapy adjustments should be based on measurements obtained using a home blood glucose meter and not on values provided by the system.

Important Safety Information

The Guardian Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices, and is not recommended for people who are unwilling or unable to perform a minimum of two meter blood glucose tests per day, or for people who are unable or unwilling to maintain contact with their healthcare professional. The system requires a functioning mobile electronic device with correct settings. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at http://www.medtronicdiabetes.com/support/download-library/user-guides and http://www.medtronicdiabetes.com/importantsafetyinformation.

The Sugar.IQ assistant is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices.  All therapy adjustments should be based on measurements obtained using a home blood glucose meter and not on values provided by the system.

Values at  70 mg/dL. Guardian Sensor 3 data from Summary of Safety and Efficacy Data. Dexcom G5 data from product User Guide. With threshold and predictive alerts (for Guardian Connect system).

 

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