Medtronic (NYSE:MDT) said today that its Guardian Connect continuous glucose monitoring system won FDA approval for people with diabetes ages 14 to 75.
The medtech titan touted its system as the first connected standalone CGM designed to help people with diabetes avoid high and low glucose events.
Using Medtronic’s Guardian Sensor 3, the system alerts its users of potential high or low glucose events up to 60 minutes in advance. In one study, the Guardian Connect accurately alerted patients to 98.5% of all hypoglycemic events, according to Medtronic.
Caregivers and partners can track glucose levels for their loved ones in real-time or choose to receive text alerts. Users also have access to Medtronic’s Sugar.IQ smart diabetes assistant, which uses AI technology from IBM Watson Health to continually analyze how a person’s blood sugar responds to food, insulin and their daily routine.
Medtronic expects the system to be available in the first quarter of Medtronic’s 2019 fiscal year – between May and July of 2018.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors,” Dr. Timothy Bailey, director of the AMCR Institute, said in prepared remarks. “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 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 of Medtronic’s diabetes service & solutions business, added. “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.”
Medtronic 670g is a Terrific advancement in diabetes management. Surprisingly and despite fda approval the 760g cgm system is not approved for coverage through Medicare leaving seniors over 65 without coverage for these very expensive cgm sensors.
I would like to see an article discussing this issue.