Insulet has secured US Food and Drug Administration (FDA) clearance for an algorithm advancement within its Omnipod 5 automated insulin delivery (AID) system, setting users up with tighter insulin management.
Omnipod 5 integrates with continuous glucose monitoring (CGM) systems, including flagship products from Dexcom and Abbott, to continuously deliver insulin for three days automatically, regulating insulin and preventing abrupt changes in glucose levels.
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The new algorithm change means that Omnipod 5 users will soon be to shift their insulin target range from 100mg/dl-150mg/dl in 10mg increments, a lowering of the previous 110mg/dl-150mg/dl range.
Insulet anticipates that the Omnipod 5 algorithm update will launch in the US in H1 2026. The company highlighted that the new insulin target range aims to allow healthcare providers to tailor insulin delivery more precisely to support either those AID users seeking tighter glucose management or looking to meet specific glucose goals.
The algorithm update also means that users will be able to stay in automated mode with fewer interruptions, even during prolonged high glucose events. According to Insulet, this advancement will deliver stronger clinical results and increased flexibility for users, with fewer interruptions to their daily life.
Insulet’s executive VP and COO Eric Benjamin called the algorithm update the “most significant” advancement to Omnipod 5’s algorithm since the system’s launch in 2022.
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By GlobalDataHe said: “These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them.”
Insulet reported revenue of $706.3m in Q3 2025, up 30% from the same period in 2024. Total Omnipod revenue came in at $699.2m, reflecting a rise of 31%.
According to GlobalData analysis, the global insulin delivery market is growing at a compound annual growth rate of 6% and on course to hit a valuation of $34.68bn by 2034, up from $19.36bn in 2024.
A GlobalData market model reveals that Insulet held a 14.5% share of the US insulin pump and CGM market in 2025, putting it in third place behind Abbott and Dexcom with market share of 22.5% and 16.2%, respectively.
