Medtronic’s Diabetes Monitoring Device Gains FDA Approval

Medtronic’s Diabetes Monitoring Device Gains FDA Approval

- April 4, 2018

The Guardian Connect monitoring system, a small wireless device for people with diabetes, has been approved by the Food & Drug Administration. According to its manufacturer, Medtronics, the GCM system is the first smart standalone system to help people with diabetes stay ahead of high and low glucose events.

Here’s how it works. The Guardian Sensor 3 is attached to the skin. It takes regular blood samples to test for sugar levels, transmitting the readings to the patient’s smartphone. The Guardian Connect App can be used to access the latest and all the previous readings, and to understand trends in relation to one’s activities and eating habits.

According to a report in Medgadget, “when glucose levels go beyond pre-defined limits, the app can sound alerts and send out messages to family and caretakers. The physician can access the data via Medtronic’s CareLink system, which compiles the readings into charts and reports.”

Watson and AI are part of the approach. People using the Guardian Connect system will also have exclusive access to the groundbreaking Sugar.IQ (TM) smart diabetes assistant. With artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how an individual’s glucose levels respond to their food intake, insulin dosages, daily routines, and other factors.

Despite the proven benefits and advances in technology, only a minority of insulin-using people with diabetes currently use continuous glucose monitors (GCM), notes Dr. Timothy Bailey, Director of the AMCR Institute.

“Newer sensors paired with intelligent algorithms that help both predict and understand glucose excursions, particularly hypoglycemia, will make diabetes safer and more comprehensive for people who inject insulin. Greater utilization of smarter GCM systems promises to allow our patients to achieve more glycemic time-in-range and to further reduce the risk of hypoglycemia.”

In addition, according to Medtronic, the system uses predictive algorithms to let patients know of high chances for unwanted events. Medtronic says that sometimes the system provides up to an hour’s warning and that in a study, 98.5 percent of hypoglycemic events were alerted by the system.

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