Insulet (PODD) announced an update on their ongoing clinical study.
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Study Overview
Insulet’s new study, officially titled “Safety and Efficacy of the Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes,” compares an upgraded automated insulin delivery system to the current Omnipod 5 device. The main goals are to see if SmartAdjust 2.0 is at least as safe and more effective in managing blood sugar for people with type 1 or type 2 diabetes under everyday use. For investors, this matters because strong results could support the next wave of product growth in a highly competitive diabetes-tech market.
Intervention/Treatment
The study tests two insulin pump systems: the Omnipod 5 SmartAdjust 2.0 System (the new version) and the existing Omnipod 5 System. Both are wearable, tubeless insulin pumps designed to automate insulin delivery and reduce the burden of daily diabetes management. SmartAdjust 2.0 adds new software features intended to fine-tune insulin dosing, improve time in range, and simplify meal dosing compared with the current Omnipod 5 platform.
Study Design
This is an interventional, randomized, cross-over study. Participants are randomly assigned to start with either SmartAdjust 2.0 or the standard Omnipod 5, use it for four weeks, then switch to the other system for another four weeks. Everyone then finishes with four to six weeks on SmartAdjust 2.0. There is no blinding; both participants and researchers know which device is used at each stage. The main purpose is treatment-focused, aiming to see which system delivers better day-to-day glucose control while maintaining safety.
Study Timeline
The study was first submitted on March 4, 2025, marking the formal start of regulatory tracking and signaling Insulet’s push to advance its next-generation platform. The trial status is listed as completed, suggesting that patient participation and device use periods have finished, with data now available for analysis. The most recent update was submitted on December 17, 2025, indicating that Insulet has refreshed trial details and likely locked or refined the dataset. No results have been posted yet, so the market is still waiting for headline efficacy and safety outcomes.
Market Implications
A positive readout from this completed study could support Insulet’s case for a commercial rollout of SmartAdjust 2.0 and help extend the Omnipod franchise lifecycle. If the new system shows clear gains in glucose control, fewer user interactions, or easier meal management, it could deepen Insulet’s competitive moat against rivals such as Tandem and Medtronic in automated insulin delivery. The lack of posted results keeps near-term sentiment cautious, but the December 2025 update signals progress and can sustain investor interest in upcoming catalysts. Strong data could justify higher growth expectations and valuation multiples for Insulet, while weaker-than-expected results would likely raise questions about the pace of innovation and share gains in a crowded diabetes tech space.
The study is completed and remains recently updated, with further details and upcoming results to be made available on the ClinicalTrials.gov portal.