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.

Insulet公司已在其德国第三个市场为两岁及以上患有1型糖尿病（T1D）的个人推出Omnipod 5自动胰岛素输送系统（Omnipod 5）。Omnipod 5在美国和英国也有售。

“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.” .

Insulet的高级副总裁兼医疗总监Trang Ly博士说：“我们知道德国1型糖尿病患者希望获得最先进的技术选择，使糖尿病管理更容易。”。“我们的数据显示，过去一年美国用户的临床结果有所改善，我们对在不久的将来在德国和其他市场发挥作用的能力充满信心。”。.

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.

Omnipod 5是第一个与Dexcom G6连续血糖监测（CGM）系统集成的CE标记的无管自动胰岛素输送（也称为混合闭环）系统。该系统1包括采用SmartAdjust技术增强的无管吊舱和与SmartBolus计算器集成的手持控制器。

The system is interoperable with Dexcom G6 for automated insulin delivery to help protect against high and low glucose levels.2 .

该系统可与Dexcom G6互操作，用于自动胰岛素输送，以帮助预防高血糖和低血糖水平。.

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.

29岁的医疗技术专家Laura Mysliwietz很高兴Omnipod 5现在在她的国家上市。她说：“在去年过渡到Omnipod之前，我一直在使用传统的胰岛素泵，但管子一直在进行中，现在，我有时忘记自己身上有胰岛素泵。”。

“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!” .

“无内胎使我的生活变得更加容易，增加自动化的胰岛素输送系统将使我有更多的自由来管理我的1型糖尿病。我迫不及待地使用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.

Insulet提供了来自36634名成年人3和18516名美国1型糖尿病儿童和青少年4的真实世界数据，显示Omnipod 5中首次报道的高度有利的血糖结果。关键试验可以在现实世界中所有年龄段的Omnipod 5用户中实现。

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.

Omnipod 5现已在德国上市，并已从德国国家法定健康保险基金协会（GKV Spitzenverband）获得医疗援助号码，使其可由健康保险公司报销。

The company intends to make Omnipod 5 available for most European customers by the end of 2024.

该公司打算在2024年底为大多数欧洲客户提供Omnipod 5。

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.

Insulet公司总部设在马萨诸塞州，是一家医疗器械公司，致力于通过其Omnipod产品平台简化糖尿病和其他疾病患者的生活。Omnipod胰岛素管理系统提供了传统胰岛素输送方法的替代方案。凭借其简单，可穿戴的设计，无管一次性吊舱可提供长达三天的不间断胰岛素输送，而无需查看或处理针头。

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. .

Omnipod 5自动胰岛素输送系统与连续血糖监测仪集成，可管理血糖，无需多次每日注射，零指尖，可通过兼容的智能手机或Omnipod 5控制器进行控制。Insulet还通过定制Omnipod技术平台来利用其Pod的设计，以便在其他治疗领域提供非胰岛素皮下药物。 .

References

工具书类

1 Integration with the Dexcom G6 CGM system is required for automated insulin delivery.

1与Dexcom G6 CGM系统集成是自动胰岛素输送所必需的。

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%.

2 240例6〜70岁T1D患者的研究，包括两周标准糖尿病治疗，随后三个月Omnipod 5以自动化模式使用。成人/青少年和儿童高血糖的平均时间，标准治疗与三个月Omnipod 5:32.4%比24.7%；45.3%对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.

成人/青少年和儿童低血糖中位时间，标准治疗与三个月Omnipod 5:2.0%比1.1%；1.4%对1.5%.Brown等人，糖尿病护理（2021）。对80名2〜5.9岁T1D患儿进行了为期两周的标准糖尿病治疗，随后三个月Omnipod 5以自动化模式使用。

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.

标准治疗儿童与Omnipod 5相比，高血糖的平均过夜时间（上午12点至上午6点）分别为38.4%和16.9%。标准治疗儿童与Omnipod 5相比，高血糖的平均白天时间（上午6点至上午12点）分别为39.4%和29.5%。标准治疗儿童低血糖的中位过夜时间（上午12点至上午6点）与。

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)..

Omnipod 5分别为3.41%和2.13%。标准治疗组与Omnipod 5组儿童低血糖的中位时间（上午6点至12点）分别为3.43%和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.

3 Lal R.等人，57-OR在美国糖尿病协会科学会议2023上发表。

4 Sherr J.L., et al, P-898 Presented at the American Diabetes Association Scientific Sessions 2023.

4 Sherr J.L.等人，P-898在美国糖尿病协会科学会议2023上发表。