Omnipod 5 FDA Cleared for Use in Adults With Type 2 Diabetes
The device was previously cleared for use in children and adults with type 1 diabetes.
Following FDA clearance, the Omnipod 5 Automated Insulin Delivery System is now indicated for use in adults with type 2 diabetes and is the first and only automated insulin delivery system that is FDA cleared for use in the management of both type 1 and type 2 diabetes.1
The Omnipod 5 first received FDA clearance in 2022: In January 2022, the device was cleared for use in individuals aged 6 years and older with type 1 diabetes.2 In August 2022, the device received additional clearance for use in children aged 2 years and older with type 1 diabetes.3 The device is integrated with the Dexcom G6 and Dexcom G7 continuous glucose monitors (CGMs) and is controlled via an app on a compatible smartphone.
The Omnipod 5 is now cleared for use in adults with type 2 diabetes. | Image credit: lukszczepanski - stock.adobe.com
Earlier this year, results of SECURE-T2D (NCT05815342) were presented at the American Diabetes Association 84th Scientific Sessions, held June 21 to June 24, 2024, in Orlando, Florida.4 The primary goal of SECURE-T2D was change in HbA1c in adults with type 2 diabetes with a current insulin regimen for at least 3 months. Secondary objectives included demonstrated improvements in time in range, time in hyperglycemia, noninferiority for hypoglycemia, and diabetes distress.
Crucially, SECURE-T2D was “one of the most racially diverse studies in diabetes technology,” with data from 305 participants across 21 US sites and a study population that included 24% Black and 22% Hispanic individuals.
READ MORE: Dexcom’s OTC Continuous Glucose Monitor Now Available in US
Trial results showed a significant reduction of 0.8% in HbA1c (8.2% to 7.4%), with a greater decrease of 2.1% in HbA1c for participants with a higher HbA1c at baseline (≥9.0%). Time in range also significantly improved, with an increase of 20% or 4.8 hours per day (45% to 66%), driven by hyperglycemia level reduction, while time below 54 mg/dL and 70 mg/dL were noninferior, indicating that using the Omnipod 5 to improve glycemic control did not increase hypoglycemia risk.
Additionally, patient reported diabetes distress outcomes via the Type 2 Diabetes Distress Assessment System (T2-DDAS) were improved in a significant and clinically meaningful way.
“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” said Anne L. Peters, MD, director of the University of Southern California Westside Center for Diabetes. “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,” Peters added.
Over 30 million individuals in the US are living with type 2 diabetes, 6 million of whom require insulin and 2.5 million of whom are using multiple daily injections to manage their disease. Although there have been significant advances in medical therapy for diabetes over the past 2 decades, “there has been no significant change in the percentage of adults with type 2 diabetes achieving recommended HbA1c targets,” the press release noted.1 Currently, only one-quarter of those with type 2 diabetes using insulin are achieving an HbA1c of 7.0% or less; half of that population has an HbA1c of 8.0% or greater, and—despite guideline recommendations—insulin therapy may be delayed or not intensified appropriately.
The Omnipod 5 automatically adjusts insulin delivery every 5 minutes, eliminating the need for multiple daily injections. It is the first tubeless automated insulin delivery system that communicates with a continuous glucose monitor to avoid instances of both high and low insulin. According to Insulet, the system is both easy to prescribe and covered widely by a variety of insurance plans, including Medicare Part D.
READ MORE: Diabetes Resource Center
References
Omnipod 5 Automated Insulin Delivery System is now FDA-cleared for people with type 2 diabetes. News release. Insulet. August 26, 2024. Accessed August 26, 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
Insulet announces FDA clearance of its Omnipod 5 automated insulin delivery system, first tubeless system with smartphone control. News release. Insulet. January 28, 2022. Accessed August 26, 2024. https://investors.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-its-Omnipod-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control/default.aspx
Insulet announces FDA clearance of Omnipod 5 for children aged two years and older with type 1 diabetes. News release. Insulet. August 22, 2022. Accessed August 26, 2024. https://investors.insulet.com/news/news-details/2022/Insulet-Announces-FDA-Clearance-of-Omnipod-5-for-Children-Aged-Two-Years-and-Older-with-Type-1-Diabetes/default.aspx
Insulet’s SECURE-T2D pivotal trial results demonstrate Omnipod 5 improves clinical outcomes and quality of life in type 2 diabetes. News release. Insulet. June 21, 2024. Accessed August 26, 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
