Medtronic Diabetes announces world's first approval for MiniMed 780G System with Simplera Sync disposable, all-in-one sensor.

Medtronic plc announced CE (Conformité Européenne) Mark approval for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks or overtape.

Simplera Sync features an improved user experience with a simple, two-step insertion process and is half the size of previous Medtronic sensor. The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.

With both Simplera Sync sensor and the Guardian 4 sensor, no fingersticks are required.

The MiniMed 780G system with Simplera Sync sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S. Simplera Sync sensor is designed to leverage Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM. The Simplera CGM for integrated use with the InPen smart insulin pen received CE Mark in September 2023.

"A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycemia). Prolonged hyperglycemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children," Robert Vigersky, M.D., Chief Medical Officer, Medtronic Diabetes, Professor of Medicine, Uniformed Services University of the Health Sciences "With its responsive algorithm, the MiniMed 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs. The system takes on more of the work involved in diabetes management and helps alleviate mental burden."

The MiniMed 780G system is Medtronic's most advanced insulin delivery system, automatically adjusting and correcting glucose levels every 5 minutes. It's the world's only system with a Meal Detection feature that is designed to reduce post-meal hyperglycemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world's only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes.