Insulet Unveils Ambitious Plans for Next-Generation Diabetes Devices

Insulet, a leading manufacturer of insulin patch-pumps, has announced its strategic roadmap for the coming years, including plans for new devices aimed at revolutionizing diabetes management. The company's ambitious agenda includes updates to its current Omnipod 5 system, the development of a next-generation Omnipod 6 device, and a groundbreaking fully closed-loop system for Type 2 diabetes patients.

Omnipod 6 and Near-Term Enhancements

Insulet's flagship product, the Omnipod 5, is set to receive significant updates in the near future. The company plans to expand its compatibility with major continuous glucose monitors (CGMs) on the market, including Abbott's Libre 3 Plus. Additionally, a new data platform for users and healthcare providers is slated for launch next year, along with the introduction of a lower target range option.

Looking further ahead, Insulet aims to debut its Omnipod 6 device in 2027. This next-generation patch-pump will feature a hybrid closed-loop system, similar to its predecessor, but with notable improvements. Chief Operating Officer Eric Benjamin highlighted a new algorithm that learns from each user's insulin requirements, potentially leading to better outcomes, especially for those who bolus less frequently.

The company's Strive study for Omnipod 6 has completed enrollment, with data and a 510(k) filing expected next year, according to J.P. Morgan analyst Robbie Marcus.

Pioneering Fully Closed-Loop System for Type 2 Diabetes

Perhaps the most significant announcement from Insulet is its plan to launch a fully closed-loop insulin delivery system for people with Type 2 diabetes in 2028. This innovative system aims to eliminate the need for manual input of meals or carbohydrate counting to calculate bolus insulin doses, making it potentially more accessible and easier to manage for both patients and healthcare providers.

CEO Ashley McEvoy emphasized the company's focus on Type 2 diabetes, stating, "We're just ... one year into Type 2. Everything we're doing — from customer experience, to how we're selling it, to how we're really taking away any barriers to access and affordability — we're going to go deep there."

Insulet has already completed enrollment in a safety and feasibility study called Evolution 2 and plans to initiate a pivotal trial in 2026. The initial target population will be Type 2 diabetes patients who require both basal and mealtime insulin, with potential future expansion to those only on basal insulin.

Market Outlook and Industry Position

Insulet estimates the global market for automated insulin delivery to reach $5.7 billion, with the company expecting its 2025 sales to account for approximately $2.7 billion of that total. By 2028, Insulet projects the market to expand to around $9 billion.

Despite the ambitious plans, some investors have expressed concerns about the nature of the updates, particularly for Omnipod 6. Leerink Partners analyst Mike Kratky noted that some may have hoped for more significant form factor changes rather than the primarily software-driven and connectivity-focused improvements announced.

Nevertheless, Kratky expects Insulet to maintain its leadership position in both Type 1 and Type 2 diabetes markets in the near term, highlighting the company's strong market presence and innovative pipeline.