FDA Approves Smart Continuous Glucose

Monitoring System
Officials with the FDA have approved Medtronic’s continuous glucose monitoring (CGM)
system (Guardian Connect) for use by individuals living with diabetes, according to a company
press release.

The Guardian Connect System is indicated for patients aged 14 to 75 years old with diabetes.
According to the press release, the product is the first standalone CGM system that can alert
patients of potential high or low glucose events up to 60 minutes in advance.

The approval is based on a clinical study that demonstrated the system’s ability to accurately
alert patients of 98.5% of hypoglycemic events while using Medtronic’s advanced glucose
sensor, Guardian Sensor 3. The Guardian Connect system gives caregivers the opportunity to
track glucose in real-time or receive text alerts.

Additionally, the system offers access to the Sugar.IQ smart diabetes assistant, an artificial
technology product from IBM Watson Health, which continually analyzes how an individual’s
glucose levels respond to their food intake, insulin dosages, daily routines, and other factors.

“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,” Timothy Bailey, director of the AMCR Institute
and clinical associate professor at University of California, San Diego, said in the press release.
“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 System will be available in the first quarter of Medtronic’s fiscal year
2019, according to the press release.

Article By-
MR. TARUN KUMAR PANCHAL
AP62046