The company is correcting an issue that could result in the system using an incorrect glucose value that has the potential to impact insulin delivery, according to the company. Insulet says the issue is rare but could affect insulin delivery and, as a result, would be pausing the study until the issue is fixed.
No adverse events have been reported due to the software issue.
“Patient safety is our number one priority,” senior VP and medical director Trang Ly said in a news release. “While we are disappointed to pause the trial, we are proud of how we were able to proactively and swiftly diagnose the issue and come to this decision. The experience highlights the benefits of our significant investment in mobile and cloud technology, which enable our engineers to monitor enormous amounts of information in real-time from the Omnipod Horizon clinical trials. This information allowed us to quickly identify, investigate, and decide to correct the issue. The enthusiasm from our trial participants has been overwhelmingly positive and we are excited for what Omnipod Horizon will offer our customers.”
The company expects the software update to be completed by the end of April. The study being paused will modestly impact the timing of bringing the Horizon to the market. Insulet now expects the device to hit the market in early 2021.