Insulet said it plans to pause a pivotal clinical study of its upcoming wearable insulin pump due to an anomaly in the device’s software.
The company said the computer bug could cause the automated Omnipod Horizon diabetes system to use an incorrect blood glucose value in its calculations for a person’s insulin delivery. No adverse events have been reported due to the issue, which Insulet described as a rare occurrence.
“Patient safety is our number one priority,” said Trang Ly, Insulet’s medical director and senior vice president. “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,” Ly said in a statement. “This information allowed us to quickly identify, investigate and decide to correct the issue.”
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Insulet said it plans to deliver a software update to correct the problem by the end of April. It also expects the temporary hold to push back the Omnipod Horizon’s market release, now slated for early 2021 instead of the second half of 2020.
The company recently announced collaborations with Abbott and Dexcom, which aim to connect their respective continuous glucose monitoring systems with Insulet’s tubeless insulin pump to form an integrated, hybrid closed-loop delivery device.
Controlled via a smartphone, the system is designed to use glucose data from the wireless sensors to guide a predictive algorithm for background insulin doses, while the app can be used to deliver fast-acting boluses.