Medtronic’s Guardian Connect CGM Gets FDA Approval

DUBLIN, IRELAND – Medtronic’s Guardian Connect continuous glucose monitoring system (CGM) has received FDA approval, expanding CGM options for people living with diabetes from the most recent Dexcom G5 and Abbott’s Freestyle Libre system. It is “the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events” as it transmits directly to the iPhone without using another receiver.

The standalone CGM is comprised of three parts: a thin sensor, a small plastic transmitter attached to the sensor and the Guardian Connect app on a compatible iOS device. The Guardian Connect system is designed to help people, aged 14 to 75, using multiple daily injections (MDIs), and is the only one on market to give alerts for potential high or low glucose events up to 60 minutes in advance. “The FDA approval of the Guardian Connect system fills a key gap that exists in diabetes treatment today – how to predict dangerous glucose highs and lows so they can be potentially avoided,” said Annette Brüls, President, Diabetes Service and Solutions at Medtronic. “With predictive alerts and the Sugar.IQ assistant, the Guardian(TM) Connect system enables people to proactively manage their diabetes, so they can focus on living their life, not constantly worrying about their glucose levels.” The CGM uses the Using Guardian(TM) Sensor 3, the same sensor used in Medtronic’s 670G hybrid closed-loop system. In studies, it was found that the system accurately alerted patients of 98.5 percent of hypoglycemic events.2 Benefits of the Guardian Connect system include: Customized 1 hour predictive alerts – from 10 minutes up to 1 hour ahead gives you time to respond

– from 10 minutes up to 1 hour ahead gives you time to respond Free 24-hour SMS alerts (and up to 5 care people)

(and up to 5 care people) Easy to share blood glucose readings with family and friends

blood glucose readings with family and friends Reduced risks of hypoglycemia and more time “in-range”

and more time “in-range” Sleek design – marketed for an active lifestyle, half the weight of other real-time CGM systems on the market

– marketed for an active lifestyle, half the weight of other real-time CGM systems on the market Water proof – can be submerged for up to 2.4 meters (7.5 feet) for 10-minute periods

– can be submerged for up to 2.4 meters (7.5 feet) for 10-minute periods Access to the Sugar.IQ system – smart diabetes assistant that looks at what affects BGLs

– smart diabetes assistant that looks at what affects BGLs Rechargeable, re-useable, long-life technology The Guardian Connect does not work with Insulin Pumps, however, automatic syncing shares easy to interpret data with your healthcare professional.

Available soon, the Guardian Connect system is believed to hit markets by July 2018, and as early as May 2018.

People using the Guardian Connect system will also have exclusive access to the groundbreaking Sugar.IQ(TM) smart diabetes assistant, empowering them to further address the daily challenges of diabetes. 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 factors3. Together with the Guardian Connect system, the Sugar.IQ assistant can turn difficult-to-determine patterns into personalized, actionable insights that help people with diabetes keep glucose levels in their target range.

About Continuous Glucose Monitoring (CGM)

A CGM is a small wearable device that tracks your glucose throughout the day and night, notifying you of highs and lows so you can take control of your levels.

he CGM can be placed in several areas of your body, depending on what is most comfortable for the user. The most popular places for a CGM tend to be around the stomach, back of the arms and legs. Avoid spots where your body naturally bends a great deal, where clothing might cause irritation or be a burden.

The process of inserting the CGM is easy and virtually painless. For seven days (longer if you are able to keep the adhesive for sticking), you can have direct access to your blood sugars throughout the day and night.

The CGM consists of three basic parts:

wireless display device (or receiver) – has a screen where you can check your current glucose level, look at past data over a span of 24 hours, and get trends about whether glucose is likely to go up or down, and how fast.

– has a screen where you can check your current glucose level, look at past data over a span of 24 hours, and get trends about whether glucose is likely to go up or down, and how fast. transmitter – is the small piece that fits onto the sensor and sends glucose information data wirelessly to your display device.

– is the small piece that fits onto the sensor and sends glucose information data wirelessly to your display device. sensor – is inserted just underneath the skin, is thinner than a needle and roughly half an inch long. The sensor remains in the skin for several days, detecting glucose information.

About the Diabetes Group at Medtronic

Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.



About Medtronic

Medtronic plc, headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Resources

1 Smart CGM predicts future high and low sensor glucose events and provides access to additional algorithms and insights that can inform users of clinically relevant glucose patterns. 2 Guardian Connect system Instructions for Use (IFU). With a sensor glucose limit of 70 mg/dL, with calibration every 12 hours, both predictive and threshold alerts “On,” within 30 minutes; abdomen sensor insertion. The correct detection rate for arm inserted sensor is 96.7 percent; with the same settings and conditions.

Read the press release here.