Insulet announced it has received FDA 510(k) clearance for major algorithm enhancements to the Omnipod 5 automated insulin delivery (AID) system, a move that could redefine the pod experience when it rolls out in the first half of 2026. The clearance covers updates centered on a new lower glucose target and changes designed to keep users in automated mode more consistently.
The biggest shift is the addition of a 100 mg/dL (5.6 mmol/L) glucose target. This expands Omnipod 5 to six target options between 100 and 150 mg/dL in 10 mg/dL increments. The wider range gives clinicians more control when tailoring therapy for users who need tighter glucose goals. Insulet says real world data shows lower targets link to higher time in range, making target selection a key part of optimizing automated insulin delivery.
New Omnipod 5 interface showing expanded target glucose options, including the 100 mg/dL option. (Source: Insulet)
The updated algorithm also helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These enhancements aim to deliver strong clinical results while improving flexibility and ease of use, that could reduce the number of interventions users have with the system each day.
At a recent investor day, Insulet released information about new updates coming to the broader Omnipod ecosystem including a new insights platform called Discover, and integratoon of the Libre 3 Plus CGM. The company also previewed early details of Omnipod 6, highlighting design improvements that build on the automation introduced with Omnipod 5. We broke down the Omnipod 6 news and what Omnipod’s future pumps and algorithm will look like beyond 2028 in our deep-dive article.
With the new FDA clearance, the Discover platform, and ongoing development of Omnipod 6, Insulet is working to strengthen its position in the AID market. Still, competition remains strong, with major players like Tandem, Beta Bionics, and Medtronic pushing forward with their own next generation tubeless systems.
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