Clearance makes Omnipod 5, the company’s latest-generation AID system, the first and only such system cleared for type 1 and type 2 diabetes. Its indication covers those ages 18 and older in the type 2 population, while the system has been cleared for ages two and up in the type 1 bracket since 2022.
The Acton, Massachusetts-based company — one of the world’s largest diabetes technology companies — said in June that it submitted study results to the FDA for an expansion of Omnipod 5’s indications for use. Those results demonstrated glycemic improvements with the use of Omnipod 5 compared to prior treatment of insulin injections or pump therapy in adults with type 2 diabetes.
Outcomes included significant reductions in HbA1c, time in hyperglycemia and total daily insulin dose. Insulet also reported a large improvement in time in range without increasing time in hypoglycemia. The company also said the study demonstrated a clinically meaningful improvement in diabetes distress.
It has had studies underway for years evaluating the system for type 2. The company also has an FDA-cleared basal-only pod — Omnipod GO — for the type 2 population. Insulet said at the time of its submission that it aimed for a launch in the U.S. in early 2025.
“Today’s announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes,” said Jim Hollingshead, Insulet president and CEO. “Insulet is paving the way for these individuals to achieve better health outcomes while living with greater confidence and freedom through the game-changing benefits of tubeless Pod therapy. Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community.”
More about the Insulet Omnipod 5 and the type 2 diabetes opportunity
According to Insulet, more than 30 million people live with type 2 diabetes in the U.S. and about 6 million require insulin. Of those, Insulet says 2.5 million use multiple daily injections (MDI).
The company hopes to bring more of those people onto automated insulin delivery with its patch pump technology. The small, discreet, tubeless, wearable pod, features SmartAdjust technology that uses CGM readings to predict where glucose will be 60 minutes into the future. Omnipod 5 then increases, decreases, or pauses insulin delivery based on the user’s desired and customized glucose target.
Insulet has continued to develop the system since its initial launch. That includes the recent integrations of next-gen CGM, with both Abbott FreeStyle Libre 2 Plus and Dexcom G7 working with the pump. The company also initiated a limited release of the Omnipod 5 App for iPhone earlier this year.
Type 2 diabetes has become a big target for diabetes technology companies, with Insulet winning the automated insulin delivery race on that front. Tandem Diabetes Care completed enrollment for a study of its Control-IQ insulin delivery automation software for the type 2 population earlier this year. Embecta also has a closed-loop insulin delivery system for type 2 diabetes. That system, which has FDA breakthrough device designation, continues to move forward, according to the company.
Outside of insulin pumps, officials from both Abbott and Dexcom stressed the type 2 opportunity. They both have new over-the-counter CGMs for the type 2 population, with Dexcom’s launching today.
The analysts’ take
BTIG analysts Marie Thibault and Sam Eiber said the approval came earlier than expected as Insulet previously suggested clearance by the end of the year.
While Insulet declined to provide an update on commercial timelines, the company earlier this month said it has work underway on a targeted salesforce investment to focus on the type 2 population.
“We are confident we have a clear right to win in the type 2 space,” Hollingshead said on the company’s earnings call. “We expect to be the first to market in type 2 with an AID offering, and not just any AID offering, but with Omnipod 5, which is the product platform that quickly leapfrogged into market leadership once we launched it in type 1.”
The analysts said that type 2 patients made up around a quarter of Insulet’s new starts in the U.S. over the past few quarters. They view the new indication as a boost for the company, reiterating their “Buy” rating.
“While [type 2 diabetes] patients have been ~25% of [Insulet’s] new starts in the U.S. the last few quarters, we anticipate that a formal [Omnipod 5] label and targeted investments will help increase adoption in the [type 2 diabetes] market where pump penetration remains in the single digits,” the analysts wrote.
