Insulin pump-maker Insulet has scored FDA 510(k) clearance for its Omnipod 5 Automated Insulin Delivery System for people ages 6 and up with Type 1 diabetes. The pump integrates with the Dexcom G6 continuous glucose monitor to automatically adjust insulin levels depending on blood glucose. It can be worn for up to 72 hours.

Users can control their pump and share data from an app if they have a compatible smartphone, or through the Omnipod 5 Controller.

The device will initially be offered through pharmacies in a limited market release before it's available more broadly.

WHY IT MATTERS

The CDC reports that 1.6 million adults ages 20 and older have diagnosed Type 1 diabetes and use insulin, and 244,000 children and teens have Type 1 diabetes.

Insulet is pitching the system as an easier method of diabetes management and insulin delivery.

"Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes," Insulet president and CEO Shacey Petrovic said in a statement. "We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users."

THE LARGER TREND

In February 2020, Insulet announced partnerships with Dexcom and Abbott, the maker of the FreeStyle Libre CGM, for its Omnipod Horizon Automated Insulin Delivery System, an older name for the Omnipod 5. At this time, the latest Omnipod only works with the G6. An Insulet spokesperson confirmed to MobiHealthNews that the company plans to integrate the FreeStyle Libre 2 into the system, though they could not comment on timing.

The company initially scored FDA clearance for its Omnipod Dash in 2018. Insulet also announced plans that year to allow users to control their pumps through Samsung Galaxy smartphones. The Omnipod 5 can be used with a Samsung Galaxy S10, though the company said it's currently working on iOS compatibility for iPhones. 

Patients using the Dash system can upgrade to the Omnipod 5 at no additional cost when coverage is available.