Insulet's Omnipod 5 Cleared by FDA

The FDA has cleared the first tubeless automated insulin delivery system with a smartphone app control.

The FDA has cleared Insulet’s Omnipod 5 automated insulin delivery system, marking the first such clearance of a tubeless system with smart phone control, according to a company statement.

The device, which integrates with the Dexcom G6 continuous glucose monitoring (CGM) system, is now approved for those age 6 and up who have type 1 diabetes (T1D).

In addition to the Dexcom G6, the Omnipod 5 system includes a tubeless pod with SmartAdjust technology and a mobile app integrated with the SmartBolus Calculator. The app can be downloaded on a smartphone or patients can use a special controller which will be provided free-of-charge upon filling their first prescription.

The announcement comes after favorable efficacy and safety data were published in July 2021. A single-arm multicenter prospective study found that among 235 participants with T1D, use of the Omnipod 5 resulted in reduced glycated hemoglobin levels and improved time in range in both adults and children.

The system will launch via the pharmacy channel while the company plans to release Omnipod 5 in a limited market to incorporate learnings; the system is expected to become broadly available shortly after this release.

“Authorization of the Insulet Omnipod 5 is a huge win for the T1D community. As the first tubeless hybrid closed loop system to receive FDA clearance, this is a critical step forward in making day-to-day life better for people living with the disease,” JDRF International, a nonprofit that funds T1D research, said in a statement.

The system works by submitting a Dexcom CGM value and trend to SmartAdjust every 5 minutes. This measure is used to predict glucose levels 60 minutes into the future, and the system adjusts insulin delivery accordingly using the patient’s desired customized glucose target.

“Until we find cures, we will continue to support the development of new technologies and treatments to improve blood sugar management to ensure people with T1D can live healthier and more manageable lives,” JDRF said.

More details regarding the clearance will be announced during Insulet’s 4th quarter earnings call, scheduled to take place on February 23, 2022.

The Omnipod insulin pump first received FDA clearance in 2005, while in 2020 it was announced both Abbott and Dexcom would partner with Insulet to improve diabetes management technology.