by Amy Sanghavi Shah, MD, MS

The Omnipod 5 system is an automated insulin delivery system that uses continuous glucose monitor (CGM) readings to automatically adjust basal insulin delivery. The system communicates with Dexcom’s G6 CGM while allowing users to control the system directly from their smartphone. A personalized predictive control algorithm is built into the pod, and a phone controller is used to initiate and stop the automated mode, deliver boluses, and change settings on the device.

This most recent study on the Omnipod 5 system evaluated safety and effectiveness of this system in 18 children (mean age 10 years) and 18 adults (mean age 35 years). In both age groups, at a target of 130 mg/dL, TIR70-180 increased vs. standard therapy, and decreased as the target was increased; more patients reached the TIR target vs standard therapy, and there were no serious adverse events in both groups.

One critical aspect in the pediatric population is the ability for caregivers, or children, to customize their insulin delivery to maintain optimal glycemic control, especially during exercise and following high fat meals. These results indicate that the Omnipod 5 System is able to meet that need in the youngest patients. This is relevant, since the youngest patients face unique diabetes management challenges and are frequently under studied, even though it is equally important to test these systems in patients of all ages.

The results for Omnipod 5 System are indeed promising. Omnipod is a unique system since it is a non-tethered pump. This means that the algorithm is on the pump itself, which communicates directly with the Dexcom glucose monitor without relying on a third device to remain in closed-loop mode. Moreover, both elements are waterproof. This study demonstrated that the investigational Omnipod System performed well and was safe in children and adults.