FDA approves the Guardian™ Connect system, the world’s first “smart cgm” to help people outsmart their diabetes

I’m thrilled to share some great news – we just received FDA approval for a new category of smart, standalone CGM, the Guardian™ Connect system! What’s more, people using this system have exclusive access to the groundbreaking Sugar.IQ™ smart diabetes assistant. 

Louis Dias recently wrote about our culture of listening at Medtronic. As we’ve listened to you, one of the things you’ve taught us is that every person’s journey with diabetes is unique and that you need different types of technologies to support you at different times during this journey. That’s why we created the Guardian™ Connect system. 

As proud as we are of our world-leading automated insulin delivery systems, we know plenty of people living with diabetes prefer multiple daily injections (MDI) to insulin pump therapy. But, for those of you on MDI we’ve also heard that you want valuable information to help you make better, more informed decisions about your diabetes so you can focus on your life. To do that, we created not just another continuous glucose monitor (CGM), but a smart standalone CGM. 

So how is Guardian™ Connect a Smart CGM? 
 

Smart monitoring with the power to predict 
 

The Guardian™ Connect system continuously measures your glucose levels and delivers them right to your smartphone every 5 minutes. More importantly, it’s the only standalone CGM system that uses smart technology to predict where your glucose levels are headed. It alerts you from 10-60 minutes in advance that you’re predicted to hit a low or high glucose threshold that you’ve previously set. This means you only receive alerts when you actually need them and allows you to take action before a low or high is likely to happen. It’s all about being proactive vs. reactive and outsmarting your highs and lows so that you can focus on living your life, not watching your glucose levels. 
 

Smart insights to keep you on track* 
 

Guardian™ Connect is the only CGM that comes with access to the Sugar.IQ™ smart diabetes assistant. Using the same supercomputer technology that can predict global weather patterns, Sugar.IQ™ analyzes your glucose, insulin, food and other data to offer you tips and insights that help you make more confident, data-backed decisions. This one-of-a-kind technology, supercharges your understanding of daily glucose patterns and the factors affecting them. Have certain foods that cause havoc on your diabetes? Are there certain days or times of the week where your glucose goes high or low? Sugar.IQ™ helps you uncover these hidden patterns so that you can confidently make small adjustments that will have a big impact on your day. 
 

Smart Glucose Sensor 
 

The Guardian™ Connect system includes the Guardian™ Sensor 3, our most advanced glucose sensor and the best sensor on the market at detecting lows. We know how worrisome lows can be and this sensor has a 96% low detection rate**, so you can worry less and do more of what you love. 

How does it work? 
 

The system consists of a small sensor you insert in your abdomen and can be worn for up to 7 days. It measures glucose levels from fluid under the skin and attaches to a slim, discreet Bluetooth® transmitter that sends readings to an app on your smartphone (initially only available for iOS users). Within the user-friendly app, you can see your glucose readings continuously and set up customizable alerts and alarms. If you like, you can also keep your loved ones connected to your care with automatic text alerts and access to our CareLink™ system.

Availability 
 

The Guardian™ Connect system and the Sugar.IQ™ smart diabetes assistant will begin shipping in the U.S. this summer. If you’d like to be first in line to receive Guardian Connect or speak with a representative, you can add your name here. The product will initially only be compatible with iOS smartphones, iPod and iPad. We’re working on Android compatibility, and will keep our community updated. 

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 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).