Insulet Completes Key Omnipod 5 SmartAdjust 2.0 Study, Setting Up Next Growth Phase

Insulet (PODD) announced an update on their ongoing clinical study.

Study Overview

Insulet’s latest clinical study, titled “Safety and Effectiveness of the Omnipod® 5 SmartAdjust 2.0 System in Individuals With Type 1 and Type 2 Diabetes,” tested a new version of its automated insulin delivery system in people aged 2 to 70 with diabetes. The goal was to confirm that the updated SmartAdjust 2.0 software and hardware can manage blood sugar safely and effectively across a wide patient group. The study is important because it supports expansion of Insulet’s technology beyond type 1 diabetes and helps validate the next software upgrade for its Omnipod platform.

Intervention/Treatment

The study evaluated the Omnipod 5 SmartAdjust 2.0 (SA2.0) System, an insulin delivery device designed to work with a continuous glucose monitor. The system automatically adjusts insulin dosing based on real-time glucose readings to keep levels in range with less manual effort. Insulet aims to improve day-to-day control and reduce the burden of diabetes management for both type 1 and type 2 users.

Study Design

This was an interventional study with one group only. All enrolled participants used the Omnipod 5 SA2.0 System; there was no comparison or placebo group. The study was open-label, meaning both participants and investigators knew which device was used. The main purpose was treatment-focused: to see how well the system works and how safe it is when used in everyday life by people with diabetes.

Study Timeline

The study was first submitted on August 1, 2024, signaling the formal start of the clinical process and regulatory tracking. The trial has now reached “Completed” status, meaning participant follow-up and data collection are finished. While the primary completion and final completion dates are not listed, the most recent update on January 20, 2026, shows that Insulet has refreshed the record, likely reflecting final data lock or protocol status. Results have not yet been submitted, so investors should expect a later data readout or publication.

Market Implications

The completion of this study is a constructive step for Insulet (PODD). Positive safety and effectiveness data for SmartAdjust 2.0 could support software upgrades, labeling expansion, and deeper adoption of Omnipod 5 among both type 1 and type 2 users. This may strengthen Insulet’s position against rivals in automated insulin delivery and “closed-loop” systems, including Medtronic and Tandem Diabetes Care, and help defend its premium valuation in the diabetes tech space. In the near term, the update mainly boosts confidence in Insulet’s innovation pipeline; more meaningful stock impact will likely depend on the strength of the forthcoming results and any regulatory milestones that follow.

The study is now completed and recently updated, with further details available on the ClinicalTrials portal.