Global leader in medical technology, services and solutions Medtronic plc has announced that it has received US Food and Drug Administration (FDA) approval for its Guardian Connect continuous glucose monitoring (CGM) system, for people with diabetes aged 14 to 75.
As the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events, it empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use CGM,” said Dr Timothy Bailey, Director of the AMCR Institute and Clinical Associate Professor, University of California, San Diego. “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 utilisation of smarter CGM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycaemia.”
Annette Brüls, President, Diabetes Service and Solutions at Medtronic, said that 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. “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,” she said.