The Food and Drug Administration approved Medtronic’s Guardian Connect continuous glucose monitoring (CGM) system for use in people with diabetes between the ages of 14 and 75 years old.
The first CGM to use artificial intelligence for this purpose, the Guardian Connect system is intended to help people with diabetes who use multiple daily injections of insulin to manage their diabetes by helping them prevent hyperglycemia and hypoglycemia, according to a statement from Medtronic.
Guardian Connect utilizes a predictive algorithm that alerts patients of significant swings in blood glucose levels up to 60 minutes prior to the event. When combined with the Guardian Sensor 3, which is placed on the abdomen to monitor blood glucose levels, the Guardian Connect system was accurate and was able to alert patients about 98.5% of hypoglycemic events, according to the results of a clinical trial . This information can also be shared and monitored with care takers and family member in real time or via text message.
Perhaps the most intriguing aspect of using the Guardian Connect system is exclusive access to the Sugar.IQ smart diabetes assistant. Utilizing artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how patient’s blood glucose levels respond to factors like food intake, insulin dosages, and daily routines. The combination of continuous monitoring and real-time analysis may be able to identify patterns and lead to personalized insights that will help patients with diabetes keep their blood glucose levels under control.
“Despite proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors,” Timothy Bailey, MD, the director of the AMCR Institute and a clinical associate professor at University of California, San Diego, said in a statement. “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,” he said.
Similar products have been approved in the last 6 months, but they have not utilized artificial intelligence and continuous analysis.
No serious adverse events were reported in the clinical trial of Guardian Connect, but less serious adverse events were observed, including gastroenteritis, upper respiratory infection, worsening of benign prostatic hyperplasia, rash, and blisters.
Guardian Connect should be available commercially sometime this summer.
