Medtronic Revamps Its Continuous Glucose Monitor Platform

Medtronic Diabetes has received approval from the US Food and Drug Administration (FDA) for a new continuous glucose monitoring (CGM) device and has also partnered with Abbott Diabetes Care for a future CGM device to work with Medtronic products.

On July 29, 2024, the FDA approved Medtronic’s Simplera CGM device, designed to integrate with the company’s Smart Multiple Daily Injection system with InPen. Medtronic plans to submit to the FDA the app for that system to enable the InPen integration. Also pending is FDA’s approval of the company’s Simplera Sync sensor, designed to integrate with the MiniMed 780G hybrid closed-loop insulin delivery system (Automated Insulin Delivery).

The accuracy of the Simplera and Simplera Sync sensors, assessed as mean absolute relative difference compared with a reference standard, will be the same as in the currently available Guardian 4 sensor.

Medtronic also announced a partnership with Abbott Diabetes Care for that company to manufacture sensors similar to their Libre CGM device but sold exclusively by Medtronic to work with their automated insulin delivery and multiple daily injection products. The current Medtronic Guardian CGM devices will be phased out in the United States.

At least initially after launch, all three new sensors will be available. Physicians will need to write a prescription for the most appropriate one for a given patient, Medtronic Chief Medical Officer Robert Vigersky, MD, told Medscape Medical News.

He called the Abbott collaboration “very important because it is the first partnership we’ve established that brings a second sensor made by someone else to our ecosystem. Medtronic hasn’t traditionally partnered with others in the industry, but we think this will provide the best experience for our patients.”

Both the Simplera and Simplera Sync sensors were CE Marked in Europe and launched earlier in 2024. The company anticipates additional global submissions.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape Medical News, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X: @MiriamETucker.