Our sister site, Drug Delivery Business News, reports that the FDA cleared the Omnipod 5 system for the type 2 diabetes population.
The Acton, Massachusetts-based company said in June that it submitted study results to the FDA for an expansion of Omnipod 5’s indications for use. Those results demonstrated glycemic improvements with the use of Omnipod 5 compared to prior treatment of insulin injections or pump therapy in adults with type 2 diabetes.
Outcomes included significant reductions in HbA1c, time in hyperglycemia and total daily insulin dose. Insulet also reported a large improvement in time in range without increasing time in hypoglycemia. The company also said the study demonstrated a clinically meaningful improvement in diabetes distress.
Insulet says more than 30 million people live with type 2 diabetes in the U.S. and about 6 million require insulin. Of those, Insulet says 2.5 million use multiple daily injections (MDI). The company hopes to bring its patch pump technology to that population with the new FDA indication.
Read the full story at our sister site, Drug Delivery Business News.
