FDA OKs Smart Continuous Glucose Monitoring System

Officials with the FDA have approved Guardian Connect, Medtronic's continuous glucose monitoring system that can alert patients of potential high or low glucose events up to 60 minutes in advance, 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 (May 2018-July 2018), according to the press release.

Reference

Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose (CGM) System for People Living with Diabetes [news release]. Medtronic’s website. March 12, 2018.http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2337565. Accessed March 13, 2018.