No associated adverse events; software update expected by end of April, implying ~eight-week pause; Horizon’s launch pushed from 2H20 to “early 2021”
Insulet announced this morning that it has paused the Omnipod Horizon pivotal trial due to a “software anomaly” and will resume the trial once the issue is resolved. According to the press release, the issue could result in the hybrid closed loop system utilizing an incorrect CGM reading to adjust insulin delivery. On a positive note, the software bug is “rare” and has not been attributed to any adverse events. Insulet expects a software patch to become available by the end of April, implying an ~eight-week pause in the trial. The delay will also push back the planned launch of Horizon from the end of 2020 to “early 2021.” Importantly, the bug does not affect the validity of the data collected to-date: “about 8,000 patient days” as of last week’s earnings call.
The issue was detected at one of Horizon’s trial sites and Insulet is emphasizing that the decision to pause the trial is a proactive one. We had a chance to speak with Insulet’s Medical Director Dr. Trang Ly, who said patient and provider response to the pause has been “incredibly understanding” and that she didn’t expect the anomaly to cause any drop-outs. While the delay is temporarily disappointing, we commend Insulet for its priority as always on patient safety and its move to quickly identify and investigate the issue. When Insulet rolls out the update, trial participants will have to go to their clinic sites to receive the update. Interestingly, Tandem experienced a similar CGM-related software bug in the Control-IQ pivotal almost exactly one year ago; that bug was patched in three to four weeks through Tandem’s Device Updater.
Insulet planned to share pre-pivotal data at ADA 2020 – according to Dr. Ly, this is still on track and we hope this will continue to be the case. The timeline for publication or read-out for the full pivotal results is still unclear. As a reminder, the pivotal trial for Horizon began at the end of December and includes patients (n=240) from 6-70 years of age.
The software anomaly is a reminder of how difficult it is to build a fully functional AID system and prepare for all unexpected or “edge” cases. Insulet and Dexcom have been working together for years, but of course, products are unlikely to be perfect on their first iteration. Insulet announced plans to integrate Abbott’s FreeStyle Libre 2 with Omnipod Horizon last week, and we’ll be watching closely to see how quickly/easily a new CGM can be integrated into Horizon, while still ensuring safety and reliability.
--by Ani Gururaj, Albert Cai, and Kelly Close