ARTICLE SUMMARY:
Insulet and Tandem Diabetes Care now have FDA clearance to market their automated insulin delivery systems on-label in the US for type 2 diabetes, and more—including Medtronic, Beta Bionics, and Sequel Med Tech—are likely to follow, ushering in a new era of growth and innovation in the insulin pump industry.
With two automated insulin delivery (AID) systems—from Insulet and Tandem Diabetes Care—now FDA cleared for use on-label by people with type 2 diabetes (T2D), and more expected to follow, the US insulin pump market appears to be headed for a decisive growth spurt in the months and years ahead. The full impact is difficult to predict at this early juncture, but analysts believe the stage is set for a “multiyear tailwind” as this “new era” in insulin pump therapy takes hold.
Insulet was the first mover here, gaining a T2D label for its Omnipod 5 (O5) patch-pump AID system in August 2024, a full quarter sooner than expected and well ahead of its competitors. Tandem followed in February 2025 with FDA clearance for its new Control IQ+ AID algorithm, which is cleared for use by type 2s aged 18 years and older as well as type 1s aged 2 years and older. Control IQ+ is available in the US on Tandem’s t:slim and Mobi durable AID systems (Mobi is Tandem’s smaller, wearable pump form factor).
Medtronic is next in line: the company expects to file a type 2 FDA submission for the MiniMed 780G AID system sometime in the first half of 2025, which would put it on track for clearance late this year or early next year. With its large sales force and service capabilities, Medtronic could have an advantage in the type 2 market among primary care physicians who aren’t as familiar with pump technology as endocrinologists, but the company will face strong competitive headwinds from Insulet and Tandem. And while Medtronic’s recent deal to integrate Abbott’s popular Libre continuous glucose monitor (CGM) technology into its 780G AID could help, the timing of that integration is still unclear. (See “Medtronic Takes a Turn, Inks Deal With Abbott for CGM,” MedTech Strategist, September 13, 2024.)
AID newcomers Beta Bionics and Sequel Med Tech, while currently focused on type 1 diabetes, have also expressed interest in the type 2 opportunity and could prove to be formidable competitors, given their systems’ user-friendly attributes and their early moves into the pharmacy channel.
