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 (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.
 



Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Most Popular

Related Articles

By mapping out the epigenomic landscape of rheumatoid arthritis, scientists hope to gain insight on disease origins as well as new cell signaling pathways.
Diets high in foods such as vegetables, fruit, and healthy fats found to lower the risk of death from all causes, cardiovascular disease, and cancer.
A new report has found mortality rates for 5 of the 12 leading causes of death in the United States have increased since 2000.
Company Profile >
Contributors >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2018
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$