Insulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management System after pausing the study in March due to a software anomaly.
The company paused the study about halfway through completion to correct an issue that could result in the system using an incorrect glucose value that had the potential to impact insulin delivery, according to the company. No adverse events it had been reported due to the software issue.
“We are thrilled to continue our trial,” senior VP and medical director Trang Ly said in a news release. “We have encouraging data from our clinical work to date and overwhelmingly positive feedback from participants and investigators. We are excited about what our next-generation Omnipod, Powered by Horizon, will offer people living with diabetes.”
The U.S. Dept. of Homeland Security also issued a medical advisory to warn of vulnerabilities of the Omnipod insulin management system in March. Because of the vulnerability, and attacker with access to one of the affected pump models was able to intercept or modify data while also being able to change pump settings and control insulin delivery.
Insulet expects to commercialize the next-generation Omnipod in the U.S. during the first half of 2021, pending FDA clearance.
