FDA Clears Omnipod 5 Automated Insulin Delivery System for Use in Adults With Type 2 Diabetes

The FDA has expanded the indication for the Omnipod 5 Automated Insulin Delivery system (Insulet Corporation) to include patients with type 2 diabetes aged 18 years and older. Previously, it was indicated for the management of type 1 diabetes in patients 2 years and older, but it now can be used in both type 1 and type 2 diabetes.^1,2

Image credit: Insulet

The interoperable automated glycemic controller is a SmartAdjust software that automatically adjusts insulin delivery to a patient with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. Previously, insulin therapy options for those with type 2 diabetes were limited to methods such as injections via syringe, an insulin pen, or an insulin pump, all of which require patients to self-administer 1 or more times per day and check their blood glucose. Omnipod 5 helps simplify diabetes management, automatically adjusting insulin delivery every 5 minutes.^1,2

“The FDA has long worked with the diabetes community to ensure access to additional options and flexibilities for diabetes management,” said Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, in a news release. “Automated insulin dosing technology has previously been available only for people with type 1 diabetes.”¹

The FDA reviewed data from a recent clinical trial, SECURE-T2D (NCT05815342), which demonstrated glycemic improvements in adult patients with type 2 diabetes who used Omnipod 5. The included patients were using a current insulin regimen for at least 3 months prior to enrollment. According to the investigators, other criteria included a baseline HbA1c between 7% and 12% (for those only using basal insulin) and 12% or less (for those using basal and bolus or pre-mixed insulin). All participants underwent an initial 14 days of standard therapy, then used the Omnipod 5 system for a 13-week period.^2,3

More than half (55%) of the total 305 enrolled participants were on a stable dose of glucagon-like peptide-1 receptor agonists, and 73% used multiple daily injections of insulin. Additionally, approximately 21% of patients used basal-only insulin at baseline, and 5.6% used an insulin pump.³

The trial’s primary objective was to evaluate the change in HbA1c with Omnipod 5 in adults aged 18 to 75 years with type 2 diabetes. Secondary objectives included improvements in time in range, time in hyperglycemia, and non-inferiority for hypoglycemia. An additional secondary objective was diabetes distress, which is a patient-reported outcome.^2-4

According to the findings, there were significant reductions in mean HbA1c (8.2% to 7.4%) regardless of the patients’ prior therapy at the start of the trial, time in hyperglycemia, and total daily insulin dose, as well as a large improvement in time in range (increased from 45% to 66%, or 4.8 hours/day) without increasing time in hypoglycemia. In addition, there was a clinically meaningful improvement in diabetes distress. Further, time below 54 mg/dL and time below 70 mg/dL were observed to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improved glycemic control with Omnipod 5 did not increase the risk of hypoglycemia.³

“Today’s action helps expand access to this important diabetes management tool to millions of adults living in the US with type 2 diabetes,” said Tarver in the news release. “The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes.”¹

In addition, reports by patients through individual surveys showed there was a significant and clinically meaningful improvement in diabetes distress, with the percentage of patients with high diabetes distress being reduced significantly. Further, there were no instances of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.³

According to the investigators, there was 1 incidence of severe hypoglycemia during the treatment phase; however, this was considered to be unrelated to the trial device’s malfunction. A total of 13 additional serious adverse events were reported by patients, but not were related to the trial device or glycemia.³

“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, Insulet President and CEO, in a news release. “…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.”²

REFERENCES

1. FDA. FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes. News release. August 26, 2024. Accessed August 27, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes

2. Insulet. Omnipod® 5 Automated Insulin Delivery System is now FDA-cleared for People with Type 2 Diabetes. News release. 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

3. Insulet. Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes. June 21, 2024. News release. 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

4. OP5-005 Using Omnipod 5 in Adults With Type 2 (SECURE-T2D). ClinicalTrials.gov identifier: NCT05815342. Updated May 31, 2024. Accessed August 27, 2024. https://clinicaltrials.gov/study/NCT05815342