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FDA approves smart CGM system

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The FDA has approved the first smart continuous glucose monitoring system designed to alert patients with diabetes of potential hypoglycemia or hyperglycemia up to 60 minutes in advance, Medtronic announced in a press release.

The Guardian Connect CGM, indicated for people with diabetes aged 14 to 75 years, features the Sensor 3, also used in Medtronic’s hybrid closed-loop system, and was shown to accurately alert patients of 98.5% of hypoglycemic events. Care partners can use the system to track glucose readings in real-time or receive glucose readings via text alerts.

"Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors," 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. 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."

People using the Guardian Connect system will also have exclusive access to the Sugar.IQ smart diabetes assistant, employing artificial intelligence technology from IBM Watson Health. Sugar.IQ assistant continually analyzes how an individual's glucose level responds to their food intake, insulin dosages and daily routines, according to the release.

"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," Annette Brüls, president, Diabetes Service and Solutions at Medtronic, said in the release. "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."

The Guardian Connect system is scheduled to be available in the first quarter of Medtronic's fiscal year 2019 (between May and July 2018).