Insulet’s Omnipod 5 System Gains CE Mark

Insulet’s Omnipod 5 automated insulin delivery system has CE mark certification for treatment of patients aged two years and older with type 1 diabetes.

The tubeless closed loop system integrates with the Dexcom G6 continuous Glucose Monitoring (CGM) system to automatically adjust insulin and help protect against high and low glucose levels.

The Omnipod 5 system receives a CGM value and trend every five minutes and predicts where the patient’s glucose level will be 60 minutes into the future. It then increases, decreases or pauses insulin delivery based on the user’s glucose target, the company said.

Insulet plans to launch the system in several countries that accept the CE mark starting in mid-2023.