Insulet has received U.S. Food and Drug Administration (FDA) clearance that extends the Omnipod 5 automated insulin delivery (AID) system to adults with type 2 diabetes. This makes it the only AID system FDA-cleared for both type 1 and type 2 diabetes management, the company said.
 
Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified.
 
Insulet’s SECURE T2D clinical study showed that compared to previous 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 9.0% 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 showed a clinically meaningful improvement in diabetes distress.
 
Omnipod 5 eliminates the need for multiple daily injections and automatically adjusts insulin delivery every five minutes using SmartAdjust technology. It’s also the first tubeless AID system that communicates with a continuous glucose monitor (CGM) to proactively correct for highs and protect against lows.
 
“[This] 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.”