Devices & Diagnostics

Medtronic makes further moves into Type 2 diabetes with FDA approval of new CGM sensor

With the FDA approval of a new continuous glucose monitoring system with machine learning capabilities to predict highs and lows in blood-glucose levels, Medtronic makes a bigger play for type 2 diabetes patients.

Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

Medtronic’s CEO, Omar Ishrak, has long expressed a desire to expand the Irish medtech company’s footprint into the much larger type 2 diabetes market.

And over the years, the company has made strides to gain a foothold there – back in 2015, the company selected Henry Schein as the exclusive distributor of the company’s iPro2 Professional Continuous Glucose Monitoring system and iPort Advance Injection Port for type 2 diabetes patients.

And on Monday, the company announced the FDA has approved it latest CGM system – the Guardian Connect – which uses artificial intelligence technology to help both type 2 and type 1 diabetes patients beat high and low-glucose related events. The Guardian Connect uses the Guardian 3 sensor, which is the latest sensor from Medtronic and powers its hybrid closed-loop insulin pump, the 670G.

With this approval, patients get a new sensor as well as access to the Sugar.IQ smart diabetes assistant, powered by AI from IBM Watson. Through this, the system continually analyzes how blood-glucose reacts to how much they are eating, the amount of insulin being doses, their daily routines, and other factors. That along with predictive analytics allows this smart CGM system to be able to predict highs and lows and alert patients to an oncoming event.

This can apparently happen as much as 60 min in advance.

“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,” said Dr. Timothy Bailey, director of the AMCR Institute and clinical associate professor, University of California, San Diego in a Medtronic statement. “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.”

Most people with Type 2 diabetes do not continuously monitor their glucose through CGMs, rather relying entirely on finger pricks and blood glucose meters.

With the approval, the Guardian Connect CGM system will be available to patients 14 to 75 years old in the first quarter (May – July 2018) of Medtronic’s 2019 fiscal year.

Medtronic dominates the insulin pump market, which is largely targeted toward type 1 diabetes patients. Now with the introduction of a smart CGM for patients who inject insulin, the next step will be for the company to persuade them to ditch the injection for the more invasive insulin pump. And achieve better glycemic control, which is the key to peace of mind for diabetes patients.

Photo: Waldemarus, Getty Images

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