Insulet Releases Omnipod 5 Automated Insulin Delivery System in Germany

Insulet Corporation has launched its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D) in its third market, Germany. Omnipod 5 is also available in the United States and United Kingdom.
 
“We know people in Germany living with type 1 diabetes want the most advanced technology options for making diabetes management easier,” said Dr. Trang Ly, Ph.D., Insulet’s senior vice president and medical director. “With our data showing improved clinical outcomes from users in the United States over the past year, we are confident in our ability to make a difference in Germany and additional markets in the near future.”
 
Omnipod 5 is the first CE marked tubeless automated insulin delivery (also known as hybrid closed loop) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. The system¹ includes the tubeless Pod enhanced with SmartAdjust technology and a handheld Controller integrated with the SmartBolus Calculator. The system is interoperable with Dexcom G6 for automated insulin delivery to help protect against high and low glucose levels.²
 
Laura Mysliwietz, a 29-year-old medical technologist, is excited the Omnipod 5 is now available in her country. “Before I transitioned to Omnipod last year, I was using a traditional insulin pump, but the tubing was always in my way. Now, I sometimes forget that I have an insulin pump on my body,” she said. “Being tubeless makes my life so much easier, and the addition of an automated insulin delivery system will give me even more freedom to manage my type 1 diabetes. I can’t wait to use Omnipod 5!”
 
Insulet has presented real-world data from 36,634 adults³ and 18,516 children and adolescents⁴ with type 1 diabetes in the United States showing the highly favorable glycemic outcomes first reported in Omnipod 5 pivotal trials are achievable among Omnipod 5 users of all ages in the real world.
 
Omnipod 5 is now available in Germany and has received its medical aid numbers from the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), making it reimbursable by health insurers.
 
The company intends to make Omnipod 5 available for most European customers by the end of 2024.
 
Insulet Corporation, headquartered in Massachusetts, is a medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides an alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. The Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible smartphone or Omnipod 5 Controller. Insulet also leverages the design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. 

References 
¹ Integration with the Dexcom G6 CGM system is required for automated insulin delivery.
² Study in 240 people with T1D aged 6 to 70 years involving two weeks standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode. Average time with high blood glucose in adults/adolescents and children, standard therapy vs. three-month Omnipod 5: 32.4% vs. 24.7%; 45.3% vs. 30.2%. Median time with low blood glucose in adults/adolescents and children, standard therapy vs. three-month Omnipod 5: 2.0% vs. 1.1%; 1.4% vs. 1.5%. Brown et. al. Diabetes Care (2021). Study in 80 children with T1D aged 2 to 5.9 years involving two weeks of standard diabetes therapy followed by three months Omnipod 5 use in Automated Mode. Average overnight time (12AM-6AM) with high blood glucose in children for standard therapy vs. Omnipod 5 was 38.4% vs. 16.9%. Average day time (6AM-12AM) with high blood glucose in children for standard therapy vs. Omnipod 5 was 39.4% vs. 29.5%. Median overnight time (12AM-6AM) with low blood glucose in children for standard therapy vs. Omnipod 5 was 3.41% vs. 2.13%. Median day time (6AM-12AM) with low blood glucose in children for standard therapy vs. Omnipod 5 was 3.43% vs. 2.46%. Sherr J, et. al. Diabetes Care (2022).
³ Lal R., et al, 57-OR Presented at the American Diabetes Association Scientific Sessions 2023.
⁴ Sherr J.L., et al, P-898 Presented at the American Diabetes Association Scientific Sessions 2023.