CE Mark for Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process – Medtronic

Medtronic plc announced CE (Conformité Européenne) Mark approval for its new all-in-one, disposable Simplera continuous glucose monitor (CGM) featuring a simple, two-step insertion process.

The company’s newest no-fingerstick sensor does not require over tape and is seamlessly integrated with the InPen smart insulin pen, which provides real-time, personalized dosing guidance to help simplify diabetes management. Medtronic will begin a phased launch at the European Association for the Study of Diabetes (EASD) 59th Annual Meeting in Hamburg, Germany on Oct. 2-6, 2023.

“Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets — highlighting a significant unmet need. We’re excited to help more people to reach their goals with our advanced algorithm in InPen powered by our smallest and most comfortable CGM to-date,” said Que Dallara, EVP and President, Medtronic Diabetes. “This newest addition of a Smart MDI solution to our holistic portfolio demonstrates our commitment to meeting people where they are in their diabetes journey with simplified solutions that help make life with diabetes easier”.

The sensor is half the size of Medtronic’s last CGM, the Guardian 4, while also being easier to apply than its predecessor—via a two-step insertion process, using the included applicator tool—and is completely disposable. Plus, unlike the Guardian 4 sensor, the Simplera device adheres to the back of a user’s arm without requiring any additional tape or adhesive to keep it in place. The flatter, simplified sensor more closely resembles Dexcom and Abbott’s offerings, though Simplera’s seven-day wear period is the shortest of the three compared to the Dexcom G7’s 10-day span and Abbott FreeStyle Libre 3’s 14-day period. The CGM’s European rollout will happen in phases, according to Medtronic, with the phased launch kicking off at the European Association for the Study of Diabetes annual meeting in Germany early next month.