Medical Device Network

Insulet plans label expansion for Omnipod in type 2 diabetes

The positive data from the pivotal trial showed glycaemic improvements with Omnipod use for type 2 diabetics requiring daily insulin treatment.

Insulet is looking to expand the use of its tubeless insulin pump, Omnipod 5 automated insulin delivery system (Omnipod 5), in people with type 2 diabetes who require insulin.

The company shared the results from the open-label SECURE-T2D clinical trial (NCT05815342) that evaluated the safety and efficacy of Omnipod 5.

Insulet has also submitted the data to the US Food and Drug Administration (FDA) to expand Omnipod 5’s indication for use in the type 2 diabetes population. If approved, the company plans to launch the Omnipod 5 for type 2 diabetes use in the US early next year.

The diabetes care market is expected to grow to be worth $33.5bn in 2030, as per the GlobalData market model. This growth will be mostly driven by insulin delivery devices, with these devices market is forecasted to generate $25.6bn in 2030.

Omnipod 5 is cleared by the US FDA and has a European CE mark for use in patients aged two years and older with type 1 diabetes. The device can pair with a continuous glucose monitor (CGM), including the DexCom G6 CGM system and Abbott FreeStyle Libre 2 Plus, to automatically adjust insulin delivery.

The SECURE-T2D study enrolled 305 adult participants with type 2 diabetes. The participants were observed for 14 days where they managed their diabetes per their usual routine, of either insulin injections or pump therapy. Following this, the participants used Omnipod 5 along with Dexcom G6 CGM for 13 weeks.

The participants observed significant reductions in HbA1c of 0.8%, with participants with higher baseline HbA1c of over 9% seeing a decrease of 2.1%. The time in hyperglycaemia was reduced, with time in the normal glucose range increasing by 4.8 hours/day. However, the risk of hypoglycaemia was not increased with the use of Omnipod 5.

The participants observed a reduction in the total daily insulin dose from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day with Omnipod 5. The study participants also reported a significant and clinically meaningful improvement in diabetes distress, reported through the validated type 2 diabetes distress assessment system (T2-DDAS) surveys.

There was only one reported case of severe hypoglycaemia, which was found to be unrelated to device malfunction. There were no instances of diabetic ketoacidosis or hyperosmolar hyperglycaemic syndrome. Furthermore, 13 additional serious adverse events were observed during the study, but none were glycaemia-related nor related to the trial device. The data from the trial was presented at the American Diabetes Association (ADA) 84th Scientific Sessions taking place in Florida from 21-24 June.