Insulet's Omnipod 5 Wins FDA Approval for Type 2 Diabetes

Insulet Corp.'s PODD groundbreaking Omnipod 5 Automated Insulin Delivery ("AID") system (Omnipod 5) received the FDA's approval for use by type 2 diabetes patients (ages 18 years and above). The news comes after the company submitted 510(k) for an expanded indication of Omnipod 5 to the FDA, in June 2024, based on the favorable clinical outcomes of the SECURE-T2D pivotal trial.

With this development, Omnipod 5 is the first and only AID system indicated for both type 1 and type 2 diabetes.

Insulet's Robust Opportunity in the Type 2 Space

Diabetes is a chronic and life-threatening disease for which there is no known cure. The more common variant, type 2 diabetes, is characterized by the body's inability to either properly utilize or produce enough insulin. More than 30 million people are living with type 2 diabetes in the United States, with approximately 6 million people requiring insulin. Of these, roughly 2.5 million are using multiple daily injections ("MDI") — a form of insulin therapy that involves injecting fast-acting insulin before meals (bolus) to lower blood glucose levels to a healthy range.

Although medical therapies have advanced in the past 20 years, the percentage of adults with type 2 diabetes achieving recommended HbA1c (a common measure of blood glucose levels) targets has not seen any significant change. Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7% or less and half of this population has an HbA1c greater than 8%. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified.

The SECURE-T2D Trial Boosts Approval of PODD's Omnipod 5

This is the largest study ever completed for the use of AID in type 2 diabetes, featuring highly diverse study participants who are representative of the general population in the United States. Insulet recently presented data showing that Omnipod 5 significantly improves health outcomes while making life easier for people with type 2 diabetes.

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The trial demonstrated that compared with prior insulin therapy methods in adults with type 2 diabetes, using Omnipod 5 resulted in considerable reductions in HbA1c — 0.8% overall and 2.1% in those with prior HbA1c 9% or higher. Time in hyperglycemia and total daily insulin dose were also reduced. In addition, there was a 20% improvement in time in range, increasing 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.

Insulet's Omnipod 5 Simplifies Type 2 Diabetes Management

The latest announcement from the company represents a significant milestone for the treatment of type 2 diabetes, providing an easy-to-use, patient-centric technology. The tubeless pod therapy, Omnipod 5, has set a new standard in diabetes management, allowing individuals to achieve better health outcomes while giving them greater confidence and freedom in their daily lives. Insulet's president and CEO expressed excitement about the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community.

The Omnipod 5 System leads to improved results by eliminating the need for MDI and automatically adjusting insulin delivery every 5 minutes, using its advanced SmartAdjust technology. As the top-rated and most prescribed pump in the United States, Omnipod 5 is waterproof, discreet and wearable. This is the first tubeless AID system that communicates with a continuous glucose monitor, proactively correcting for highs and protecting against lows, day and night. The system is easy to prescribe through the pharmacy and widely covered by many insurance plans, including Medicare Part D.

Insulet's Prospects in the Type 2 Diabetes Industry

Per a Precedence Research report, the global market for type 2 diabetes was valued at $32 billion in 2022 and expected to witness a CAGR of 8.2% by 2032.

The introduction of new, more effective and safer therapeutic compounds is paving the way for the development of new treatments. Additionally, the rising obesity epidemic in many regions of the world is boosting the industry's profitability.  

Recent Developments of Insulet

Insulet unveiled its new state-of-the-art manufacturing facility in Malaysia this month, which strategically positions the company to cater to the huge demand for Omnipod. The 400,000-square-foot facility strengthens the company's global operational capabilities and supply chain resiliency and currently runs with a local workforce that has been upskilled and trained.

PODD's Price Performance

In the past year, Insulet shares have lost 0.3% against the industry's rise of 14%.

Zacks Rank and Key MedTech Stocks

Insulet currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Exact Sciences EXAS, Boston Scientific BSX, and SiBone SIBN. Each of these carries a Zacks Rank #2 (Buy) at present.

Exact Sciences' shares have fallen 25.3% in the past year. Estimates for the company's loss per share have improved from $1.09 to 95 cents in 2024 and from 26 cents to 6 cents in 2025 in the past 30 days. EXAS' earnings beat estimates in three of the trailing four quarters and matched in one, delivering an average surprise of 56.2%. In the last reported quarter, it posted an earnings surprise of 75.7%.

Estimates for Boston Scientific's 2024 earnings per share have moved to $2.40 from $2.36 in the past 30 days. Shares of the company have gained 47.8% in the past year compared with the industry's growth of 13.7%. BSX's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.

Estimates for SiBone's 2024 loss per share have narrowed to 89 cents from 95 cents in the past 30 days. Shares of the company have lost 20.6% in the past year against the industry's 12.3% growth. SIBN's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.4%. In the last reported quarter, it delivered an earnings surprise of 15.4%.

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