Omnipod 5, the company’s latest-generation automated insulin delivery (AID) system, became the first and only such system cleared for type 1 and type 2 diabetes last August. Insulet said at the time of its June submission to the FDA that it aimed for a launch in the U.S. in early 2025.

The small, discreet, tubeless, wearable patch pump features SmartAdjust technology that uses CGM readings to predict where glucose will be 60 minutes into the future. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.

According to the JAMA abstract, the study was constructed because of a need for additional treatment options for people with type 2 diabetes on insulin.