Insulet Corporation announced positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin. The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes.

The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress. Even though over 30 million people live with type 2 diabetes in the United States,1 there are no AID systems currently FDA-cleared for this population.

Insulet recently submitted these study results to the FDA for an expansion of Omnipod 5?s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S. in early 2025. Omnipod 5 is currently FDA-cleared in the U.S. and C.E. marked for use in those with type 1 diabetes aged two years and older. Key Data Highlights · Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from 8.2% to 7.4%, or a reduction of 0.8%.

Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was 2.1% for those with a baseline HbA1c =9.0%. Significant improvements for HbA1c were observed regardless of prior therapy at the start of the trial, including: Multiple daily injections and in those transitioning from basal-only insulin therapy. GLP-1 users and non-GLP-1 users, suggesting that adults with type 2 diabetes who require insulin therapy can greatly benefit from AID regardless of whether they are already using other glucose-lowering medication.

Current users or non-users of continuous glucose monitoring (CGM), suggesting an added benefit of AID in type 2 diabetes beyond the glycemic benefit observed with CGM use. Time in range significantly improved with Omnipod 5, increasing by 20%, or 4.8 hours/day, from 45% to 66%. This finding was driven by reductions in hyperglycemia levels including time above 180, 250 and 300 mg/dL.

Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improving glycemic control with Omnipod 5 did not increase hypoglycemia risk. Additional outcomes analysis showed that the amount of insulin used was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day.

As reported by patients through individual surveys (T2-DDAS), there was a significant and clinically meaningful improvement in diabetes distress: the percentage of participants with high diabetes distress (T2-DDAS total score =2.0) was significantly reduced. There were no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). There was one occurrence of severe hypoglycemia during the treatment phase, deemed unrelated to trial device malfunction.

There were 13 additional serious adverse events, but none were glycemia-related nor related to the trial device.