Insulet laid out plans for new diabetes devices at an investor event last week, including a fully automated insulin delivery system for people with Type 2 diabetes.
The company is working on updates to its current Omnipod 5 device, plans to debut its Omnipod 6 device in 2027 and expects to launch a separate, fully-closed loop system for people with Type 2 diabetes in 2028, CEO Ashley McEvoy said.
Insulet, which leads the market for insulin patch-pumps, is also working on bringing its devices to more people with Type 2 diabetes, after receiving an expanded label from the Food and Drug Administration last year.
“We’re just … one year into Type 2,” McEvoy said. “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’s plans to build a fully closed-loop system for people with Type 2 diabetes was perhaps the most noteworthy announcement. Unlike other automated insulin delivery systems on the market, the new system would not require users to input meals or count carbohydrates to calculate bolus insulin doses.
The system is intended to be more accessible and easier to manage and prescribe because it will not require manual input, Chief Operating Officer Eric Benjamin said. Insulet has completed enrollment in a safety and feasibility study, called Evolution 2, and aims to start a pivotal trial in 2026. The company will first focus on people with Type 2 diabetes who take basal and mealtime insulin, Benjamin said, but Insulet also sees an opportunity for those who only take basal insulin.
The COO fielded questions about why Insulet chose to target Type 2 diabetes for its first fully closed-loop system.
“In general, people who live with Type 1 expect quite tight glycemic control and the risk of [hypoglycemia] is severe,” Benjamin said. “And so, balancing those two things, we see that being iterative.”
Over time, as Insulet’s algorithms and personalization improve, more people with Type 1 diabetes might choose to interact with Insulet’s system without manually bolusing, Benjamin said.
The opportunity with Type 2 is “profoundly different,” giving the company the ability to skip any need to have a bolus option and allowing it to offer a technology in primary care offices that is as simple as a CGM, according to Benjamin. He added that Insulet sees a chance to bring this Type 2 technology to market in 2028 as it works on a fully closed-loop option for Type 1.
Next flagship pump in 2027
Insulet is also working on developing the next version of its flagship patch-pump, the Omnipod 6, as well as updates to its current Omnipod 5 system.
The company plans to debut its Omnipod 6 device in 2027. Like the current system, it will be a hybrid closed-loop, requiring some user input. Omnipod 6 will also feature a new algorithm that learns from each user’s insulin requirements, leading to better outcomes, especially for people who bolus less, Benjamin said.
Insulet’s Strive study for the device is fully enrolled, with data and a 510(k) filing expected next year, J.P. Morgan analyst Robbie Marcus wrote in a research note.
For Omnipod 5, Insulet will add a lower target range next year and connect the system with all major continuous glucose monitors on the market, including Abbott’s Libre 3 Plus. Insulet is also going to launch a new data platform next year for users and healthcare providers.
“We have a lot of runway ahead on Omnipod 5,” McEvoy said, adding that many countries still don’t have the device, and Insulet expects more growth from the current flagship system.
Questions about future growth
Insulet’s shares initially fell on Thursday after the event but then recovered, closing at $331.17 on Friday.
“Our sense is that some investors may have been hoping for more meaningful form factor changes for [Omnipod 6] vs. the updates which are seemingly more software-driven and connectivity-focused, especially since at least two competitor patch pumps are expected to be fully launched by 2027,” Leerink Partners analyst Mike Kratky wrote in a research note.
Kratky expects Insulet to maintain its leadership position in Type 1 and Type 2 diabetes in the near term.
Insulet estimates the global market for automated insulin delivery at $5.7 billion, with Insulet expecting its 2025 sales to account for roughly $2.7 billion of the total. The company expects the market to expand to approximately $9 billion by 2028.
