FDA Clears Insulet’s Omnipod Automated Insulin Delivery System for Type 2 Diabetes

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The FDA has cleared Insulet Corporation’s Omnipod 5 Automated Insulin Delivery System for use by adults with type 2 diabetes, marking the first such system approved for both type 1 and type 2 diabetes management. According to the company, the device automatically adjusts insulin delivery every five minutes through its advanced SmartAdjust technology. FDA clearance was based on results from the SECURE-T2D clinical study, which demonstrated that Omnipod 5 significantly reduced HbA1c levels.¹

“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, President, CEO, Insulet Corporation, in a press release. “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.”

The SECURE-T2D pivotal trial included 305 diverse patients across 21 sites in the United States between the ages of 18 and 75 years, all living with type 2 diabetes and were on an insulin regimen for at least three months. Additionally, patients were required to have a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin. Secondary endpoints included demonstrating improvements in time in range, time in hyperglycemia, and demonstrating non-inferiority for hypoglycemia.²

Results demonstrated a 2.1% drop for those with severe hyperglycemia, improved time in range by nearly five hours per day, and reduced diabetes distress.1 Additionally, mean HbA1c was lowered from 8.2% to 7.4% with Omnipod 5. Time in range was also significantly improved with Omnipod 5, jumping from 45% to 66%, driven by reductions in hyperglycemia levels, including time above 180, 250, and 300 mg/dL. Further, insulin use was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during automated insulin delivery.²

According to Insulet, there were no instances of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome. There were 13 serious adverse events reported, with one case of severe hypoglycemia during the treatment phase that was determined to be unrelated to trial device malfunction.²

Insulet added that there are currently over 30 million people living with type 2 diabetes in the United States, including six million who require treatment with insulin and 2.5 million relying on multiple daily injections. Further, it is estimated that only one-quarter of patients 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%. It is not uncommon for insulin therapy to be delayed or not properly intensified, regardless of guideline recommendations for advanced insulin treatment.¹

“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” said. Anne L. Peters, MD, director, University of Southern California Westside Center for Diabetes, in the press release. “Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life. I believe this innovative technology has the potential to transform the lives of insulin-requiring people with type 2 diabetes.”

References

1. Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes. Insulet. August 26, 2024. Accessed August 27, 2024. https://investors.insulet.com/news/news-details/2024/Omnipod-5-Automated-Insulin-Delivery-System-is-now-FDA-cleared-for-People-with-Type-2-Diabetes/default.aspx

2. Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes. Insulet. June 21, 2024. Accessed August 27, 2024. https://investors.insulet.com/news/news-details/2024/Insulets-SECURE-T2D-Pivotal-Trial-Results-Demonstrate-Omnipod-5-Improves-Clinical-Outcomes-and-Quality-of-Life-in-Type-2-Diabetes/default.aspx