Simplera™ continuous glucose monitor receives CE mark

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Medtronic, a global leader in healthcare technology, proudly announced the CE (Conformité Européenne) mark approval for its innovative Simplera™ all-in-one disposable continuous glucose monitor (CGM).

This device features a two-step insertion process, eliminating the need for adhesive tape. Simplera™ has been designed to provide a comprehensive solution that seamlessly integrates with Medtronic’s smart insulin pen, InPen™. This CGM monitor offers real-time personalized dosing guidance, significantly simplifying diabetes management for patients.

Gradual launch at the 59th EASD annual meeting

Medtronic has announced that the gradual launch of Simplera™ will take place at the 59th annual meeting of the European Association for the Study of Diabetes (EASD), scheduled from October 2nd to October 6th, 2023, in Hamburg, Germany. This event represents a milestone in the fight against diabetes, granting patients access to an advanced glucose monitoring solution.

Personalized guidance for Worry-Free living

Dr. Sandra Schlüter, an endocrinologist in Germany and AGDF Executive, emphasized the importance of Simplera™: “Patients with diabetes can feel overwhelmed by the vast number of decisions they must make daily. As a physician, I appreciate Medtronic’s ability to introduce this solution as it provides real-time personalized guidance to help patients stay in control. For example, when it detects someone is having a meal and their glucose levels are trending high, it alerts the individual to facilitate diabetes management and ensure peace of mind.”

Simplifying diabetes management with advanced algorithms

Que Dallara, EVP and President of Medtronic Diabetes, highlighted, “Despite the rapid adoption of CGM over the last decade, fewer than 30% of individuals on MDI therapy using CGM achieve glycemic goals, underscoring a significant unmet need. We are excited to help more people reach their goals with our advanced algorithm in InPen™, powered by our smallest and most convenient CGM to date. This latest addition of a Smart MDI solution to our comprehensive portfolio demonstrates our commitment to meeting people where they are on their diabetes journey with simplified solutions that make life with diabetes easier.”

Compatible across the family and operating systems

Simplera™ is suitable for children aged 2 and up and is compatible with both iOS and Android devices. However, it’s important to note that Simplera™ is not currently FDA-approved and is limited to experimental use in the United States. Medtronic’s automated insulin delivery (AID) system integrated with this next-generation sensor is currently under CE mark review and is not yet available for commercial use in the United States or Europe.

About smart MDI: A revolution in diabetes management

The Medtronic Smart MDI system is the first to seamlessly integrate real-time CGM with a smart insulin pen powered by an adjustable algorithm that provides personalized dosing recommendations. InPen™, combined with the new Simplera™ CGM, provides users with valuable information that reduces guesswork and complicated manual calculations, thus simplifying and enhancing diabetes management.

Medtronic Diabetes’ Commitment to Worry-Free Living

Medtronic Diabetes aims to alleviate the burden of diabetes, enabling people to live life on their terms with the most advanced diabetes technology and always-on support when and how they need it. For over 40 years, they have pioneered unique innovations and are dedicated to designing the future of diabetes management through next-generation sensors (CGM), smart dosing systems, and the power of data science and artificial intelligence, always putting the customer experience at the forefront of their efforts.

For more information about Medtronic’s diabetes business, visit the Medtronic Diabetes website.