Insulet ((PODD)) announced an update on their ongoing clinical study.
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Insulet Corporation has launched a post-market registry study titled ‘Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes.’ The study aims to gather real-world evidence on the safety and effectiveness of the Omnipod 5 System, a device designed to manage Type 1 Diabetes in both children and adults. This study is significant as it seeks to provide comprehensive data on the system’s performance in everyday settings.
The intervention being tested is the Omnipod 5 System, a tubeless insulin delivery device that works in conjunction with the Dexcom G6® Continuous Glucose Monitoring System. Its purpose is to automatically deliver insulin based on continuous glucose monitoring, thereby improving diabetes management.
The study is observational, following a cohort model with a prospective time perspective. It does not involve random allocation or masking, focusing instead on collecting data from users who are transitioning to or starting with the Omnipod 5 System.
The study began on November 10, 2023, with an estimated completion date in 2025. The primary completion date is not specified, but the last update was submitted on May 14, 2025. These dates are crucial for tracking the study’s progress and anticipating when results might influence the market.
This study could have significant implications for Insulet’s stock performance and investor sentiment, as positive results may enhance the company’s market position in the diabetes management sector. Competitors in the industry will likely monitor these developments closely, given the potential impact on market dynamics.
The study is currently ongoing, with further details available on the ClinicalTrials portal.