Medtronic’s Smartphone-Connected CGM System Gets FDA Approval

Medtronic guardian connect gets FDA approval

Medtronic’s Guardian Connect, a smartphone-connected continuous glucose monitoring system (CGM) for people with diabetes, has received FDA approval. This is the first standalone CGM system to help diabetics keep ahead of high and low glucose levels as it transmits directly to the iPhone without the help of any other receiver. The device will greatly benefit patients who use multiple daily injections (MDI) for their insulin.

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“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (CGM),” Dr. Timothy Bailey, director of the AMCR Institute and clinical associate professor at UC San Diego told Medtronic. “Newer sensors paired with intelligent algorithms that help to both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensible for people who inject insulin. Greater utilization of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia.”

The Guardian Connect is designed to help people aged 14-75. The system is comprised of the Guardian Sensor 3 and attached transmitter, which collects and sends glucose data through Bluetooth to the Guardian Connect app on a user’s smartphone continuously. The app can warn patients about high or low blood sugar 60 minutes in advance of a hyper – or hypoglycemic event.

The IBM Watson-powered Sugar.IQ recommendation system, included in the app, provides users personalized recommendations about diet and exercise based on their glucose readings and self-reported data.

Medtronic guardian connect gets FDA approval

Benefits of the Guardian Connect system

  • Customized predictive alerts (from ten minutes up to one hour) gives users enough time to respond
  • Blood glucose readings that are easy to share with family
  • Free SMS alerts for day and night
  • Lowered risks of hypoglycemia events
  • Sleek design and lightweight (half the weight of other real-time CGM systems).
  • Water proof (up to 7.5 feet for 10-minute periods)
  • Access to the Sugar.IQ system
  • Rechargeable, re-useable, long-life technology

The system does not work with Insulin Pumps, however, you can share data with healthcare professionals by automatic syncing.

Medtronic plans to launch Guardian Connect in the U.S. between May and July of this year. The system has been available in Europe since in July 2016.

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About Medtronic

Medtronic is one of the largest medical technology, services and solutions companies in the world. Based in Dublin, Ireland, the company is helping millions of people around the world ease pain, restore health and extend life. The company’s 84,000 employees serve hospitals, doctors and patients in 160 countries across the globe.

Find more innovative healthcare solutions at our WT | Wearable Technologies Show 2018 MEDICA on November 12-15.