US-based medical device company Insulet Corporation has announced its plans to pause its pivotal study on the Omnipod Horizon Automated Glucose Control System to correct a software glitch.
The glitch may cause the system to use an incorrect glucose value, affecting insulin delivery. The company state that the study will be on hold until the issue is solved.
Insulet Corporation have reported no adverse events due to this anomaly.
Omnipod Horizon Automated Glucose Control System utilises estimated glucose values from a Continuous Glucose Monitor (CGM) to predict future blood glucose and adjust insulin delivery.
Commenting on the latest update, Insulet senior vice president and medical director Trang Ly said: “Patient safety is our number one priority. 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.”
Insulet expects to release the updated software by the end of April.
The company state that the pause in the study will modestly impact the market launch of Horizon.
The launch is now anticipated to take place in early 2021.