Insulet, the global leader in tubeless insulin pump technology with its Omnipod Insulin Management System, today announced that it plans to pause the pivotal study of the Omnipod Horizon Automated Glucose Control System to correct a software anomaly. The identified anomaly could result in the system using an incorrect glucose value which has the potential to impact insulin delivery. The issue is rare, but because of the potential to affect insulin delivery, the Company will pause the study until the anomaly is corrected. No adverse events have been reported due to this issue.
“Patient safety is our number one priority,” said Dr. Trang Ly MBBS FRACP PhD, Senior Vice President, Medical Director. “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 updated software will be available by the end of April 2020. The study pause will modestly impact the timing of bringing Horizon to market, which is now anticipated to happen in early 2021.
Source: Company Press Release
