FDA clears tubeless automated insulin delivery system for adults with type 2 diabetes
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Key takeaways:
- The FDA has cleared the Omnipod 5 for adults aged 18 years and older with type 2 diabetes.
- The automated insulin delivery system cut HbA1c by 0.8 percentage points at 13 weeks in the SECURE-T2D trial.
The FDA has cleared an automated insulin delivery system for adults aged 18 years and older with type 2 diabetes, Insulet Corp. announced.
As Healio previously reported, the Omnipod 5 (Insulet) was the first tubeless automated insulin delivery system available for people with type 1 diabetes in the U.S. The FDA originally cleared the system for people aged 6 years and older with type 1 diabetes in January 2022. The FDA expanded its clearance to young children aged 2 to 5 years with type 2 diabetes in August 2022. The FDA has again expanded the Omnipod 5’s clearance to include adults aged 18 year and older with type 2 diabetes. According to a press release from the company, the new indication makes the Omnipod 5 the first automated insulin delivery system available for both type 1 and type 2 diabetes in the U.S.
The clearance follows the presentation of data from the SECURE-T2D trial at the American Diabetes Association Scientific Sessions in June. As Healio previously reported, adults with type 2 diabetes using the Omnipod 5 had a decrease in HbA1c from 8.2% at baseline to 7.4% at 13 weeks. HbA1c dropped from 8.6% at baseline to 7.5% at 13 weeks for adults who previously only used basal insulin. According to the release, adults with an HbA1c of 9% or higher before initiating Omnipod 5 in the trial had an HbA1c reduction of 2.1 percentage points from baseline to 13 weeks.
Time in range during SECURE-T2D improved from 45% at baseline to 66% at 13 weeks, while time in hyperglycemia with a glucose level of more than 180 mg/dL dropped from 54% at baseline to 34% at 13 weeks.
“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” Anne L. Peters, MD, a Healio | Endocrine Today Editorial Board member, professor of clinical medicine at the University of Southern California Keck School of Medicine and director of the University of Southern California Westside Center for Diabetes, said in the 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.”
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