The Food and Drug Administration has granted approval to Tandem Diabetes Care for its advanced Control-IQ+ algorithm, designed specifically for individuals with Type 2 diabetes. This innovative automated insulin delivery (AID) system integrates seamlessly with glucose monitors and Tandem’s insulin pumps, offering a precise and personalized approach to managing insulin levels.

Empowering Patients with Unmatched Precision and Accessibility

A New Era of Personalized Treatment

The Control-IQ+ algorithm represents a significant leap forward in the management of Type 2 diabetes. By leveraging real-time data from continuous glucose monitors, this technology automatically adjusts basal insulin dosages, ensuring patients receive the optimal amount of insulin at the right time. CEO John Sheridan highlighted during an earnings call that this expanded indication now covers all Type 2 diabetes patients using insulin, effectively doubling Tandem’s potential market in the United States.Tandem has meticulously refined the Control-IQ algorithm, broadening its applicability by adjusting weight ranges and total daily insulin requirements. Chief Commercial Officer Mark Novara announced plans for a pilot launch of the updated software set to begin in March. The company will also present findings from a comprehensive 300-person randomized controlled trial at the International Conference on Advanced Technologies & Treatments for Diabetes, underscoring the robust clinical evidence supporting this breakthrough.

Competing in a Growing Market

With Insulet’s Omnipod 5 having received FDA clearance for Type 2 diabetes last summer, competition in this space is intensifying. Insulet CEO Jim Hollingshead expressed confidence in his company’s position, emphasizing their clear path to success. According to CFO Ana Maria Chadwick, Type 2 diabetes patients are expected to contribute significantly to Insulet’s revenue growth, with these users representing over 30% of new customers in the fourth quarter. Insulet estimates that approximately 2.5 million Americans with Type 2 diabetes take multiple daily doses of insulin, while another 3 million rely solely on basal insulin.

Driving Awareness and Expanding Coverage

Both companies face the challenge of increasing awareness about the benefits of AID systems among Type 2 diabetes patients. Historically, insulin pump therapy has been more commonly associated with Type 1 diabetes. To address this, Tandem plans to expand its pharmacy sales channels and secure broader Medicare coverage. CFO Leigh Vosseller noted that while many commercial insurance plans already cover insulin pumps for Type 2 diabetes similarly to Type 1, there are still stringent Medicare requirements. The company is actively working with peers to push for a national coverage determination review.

Economic Impact and Future Prospects

Tandem reported a strong financial performance in 2024, with revenues reaching $940.2 million, marking a 26% year-over-year increase. For 2025, the company projects sales between $997 million and $1 billion. Meanwhile, Insulet experienced a 22% revenue growth to $2.1 billion in 2024, forecasting a further increase of 16% to 20% in 2025. These figures underscore the growing importance of AID systems in diabetes management and highlight the promising future of this technology.