Insulet Keeps Diabetes Tech Thriving with New ClearanceInsulet Keeps Diabetes Tech Thriving with New Clearance

Insulet’s announcement of FDA clearance of the Omnipod 5, an automated insulin delivery system, continued the momentum the diabetes tech market experienced this week.

The Acton, MA-based company said the Omnipod 5 is now indicated for use by people with type 2 diabetes (ages 18 years and older) making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management.

“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.”

Marie Thibault, an analyst with BTIG wrote in a research note, “The approval comes earlier than expected as Insulet had guided to an expected clearance by the end of the year.

The clearance was bolstered by data from the  SECURE-T2D clinical study. Results demonstrated that compared to prior insulin therapy methods in adults with type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher. Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.

“We note that reimbursement for Omnipod 5 is already well-established via pharmacy benefit for type 1 diabetes and type 2 diabetes,” Thibault wrote. “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 O5 label and targeted investments will help increase adoption in the type 2 market where pump penetration remains in the single digits.”

The announcement comes around the same time Dexcom reported it was launching Stelo, the first ever over-the-counter continuous glucose monitor.  However, this isn’t the only singnificant news that happened in diabetes tech in August.

Earlier, Medtronic and Abbott announced an unlikely collaboration. Under the partnership, Abbott would design a CGM that would be marketed by Medtronic.