FDA Approves Medtronic's CGM System for Type 2 Diabetes

The device will offer real-time tracking and alerts for glucose level high and low events, as well as telemedicine capabilities.

Another day, another Medtronic device.

The US Food and Drug Administration (FDA) has approved the Ireland-based medical tech company’s Guardian Connect continuous glucose monitoring (GCM) system. The indication is Medtronic’s fifth this year, and seventeenth since 2017.

The CGM system is indicated for patients with diabetes aged 14-75 years old, and will serve as the first smart standalone system of its kind capable of keeping patients with diabetes ahead of high and low glucose events with alerts. Patients utilizing the device will also be to manage their diabetes with multiple daily injections.

The Guardian Connect alerts patients of impeding glucose events up to 1 hour in advance, through Medtronic’s predictive algorithms. In a clinical study testing the device’s efficacy, patients were accurately alerted to 98.5% of their hypoglycemic events. It improves on a field that, despite proven benefits, lacks a majority of patients using CGM systems, Timothy Bailey, MD, director of the AMCR Institute and clinical associate professor, University of California, San Diego, said in a statement.

“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,” Bailey said. “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 system also has telehealth capabilities, as it provides real-time glucose tracking capabilities and text message alerts for patients, their loved ones, or care providers. Guardian Connect users will also be able to use the “Sugar.IQ” program from IBM Watson Health — a software that analyzes patient glucose level-response to diet, insulin doses, daily routines, and other lifestyle factors.

Annette Brüls, Preisdent of the Diabetes Service and Solutions at Medtronic, said the newest approval fills a crucial gap in glucose highs and lows protection.

"With predictive alerts and the Sugar.IQ assistant, the Guardian Connect system enables people to proactively manage their diabetes, so they can focus on living their life, not constantly worrying about their glucose levels,” Brüls said.

The company's most recent FDA indication came for a device for patients with type 1 diabetes: the Guardian Sensor 3 CGM system, which the FDA allowed patients to wear on their upper arm in combination with a hybrid closed-loop system, in a decision made last month.

Medtronic intends to make the Guardian Connect system available in the first quarter of Medtronic’s 2019 fiscal year.

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