Insulet宣布FDA 510(k)批准Omnipod® 5算法增强功能，重新定义胰岛素输送并简化Pod体验-动脉网

Insulet Announces FDA 510(k) Clearance of Omnipod® 5 Algorithm Enhancements that Redefine Insulin Delivery and Simplify the Pod Experience

AHHM 等信源发布 2025-12-05 17:08

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Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System. These updates to the Omnipod 5 algorithm set a new benchmark in tubeless diabetes technology by offering a lower 100 mg/dL Target Glucose option and a more seamless automated experience..

Insulet公司是其Omnipod®品牌产品在无管路胰岛素泵技术领域的全球领导者，今天宣布其已获得FDA 510(k)许可，对Omnipod 5自动化胰岛素输送系统进行了重大改进。这些针对Omnipod 5算法的更新通过提供更低的100 mg/dL目标血糖选项以及更无缝的自动化体验，在无管路糖尿病技术领域树立了新的标杆。

“This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022,” said Eric Benjamin, Insulet Executive Vice President and Chief Operating Officer. “These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them.

“这是自2022年Omnipod 5系统推出以来，我们在算法方面取得的最重要的进步，”Insulet执行副总裁兼首席运营官埃里克·本杰明表示。“这些新功能满足了用户最迫切需要的两项改进，并体现了我们致力于为糖尿病患者及支持他们的医疗保健提供者带来有意义创新的不懈承诺。”

Every improvement we make is designed to strengthen clinical outcomes while making the Pod experience simpler, more personalized, and so seamless it disappears into everyday life.”.

“我们所做的每一项改进都旨在加强临床效果，同时让 Pod 的体验更简单、更个性化，无缝到融入日常生活。”

More Flexibility with a Lower Target Glucose Setting

更低的目标血糖设定带来更大的灵活性

The new 100 mg/dL Target Glucose expands Omnipod 5’s customization range to six settings between 100-150 mg/dL in 10 mg/dL increments. This flexibility allows healthcare providers to tailor insulin delivery more precisely, supporting individuals seeking tighter glucose management or those striving to meet specific glucose goals.

新的 100 mg/dL 目标葡萄糖值将 Omnipod 5 的自定义范围扩展为在 100-150 mg/dL 之间以 10 mg/dL 为增量的六个设置。这种灵活性使医疗保健提供者能够更精确地调整胰岛素输送，帮助那些寻求更严格葡萄糖管理或努力实现特定葡萄糖目标的人群。

It also directly impacts automated insulin delivery and improves the algorithm’s responsiveness. Real world evidence has shown that lowering the glucose target is associated with increased time in range, with no clinically meaningful change in Time Below Range1 (TBR)..

它还直接影响自动胰岛素输送并提高算法的响应性。真实世界证据表明，降低葡萄糖目标值与范围内时间增加相关，且范围内时间低于范围1（TBR）无临床意义上的变化。

Designed with Patients and HCPs in Mind

专为患者和医疗保健专业人员设计

In addition, the upgraded Omnipod 5 algorithm helps users stay in Automated Mode with fewer interruptions, even during prolonged high glucose events. These advancements are designed to deliver strong clinical results with increased flexibility and greater ease of use, with fewer interruptions to daily life..

此外，升级的Omnipod 5算法帮助用户在自动模式下保持更少的中断，即使在长时间的高血糖事件中也是如此。这些进步旨在提供强大的临床结果，同时增加使用的灵活性和便利性，并减少对日常生活的影响。

“These enhancements to the Omnipod 5 algorithm are a meaningful step forward. As a clinician, it’s exciting to offer patients a system that not only supports strong clinical outcomes but also builds their confidence in managing diabetes daily. More target glucose options and fewer interruptions mean a better experience for people with diabetes and their families,” said Dr.

“这些对Omnipod 5算法的增强是一个有意义的进步。作为一名临床医生，能够为患者提供一个不仅支持良好的临床结果，还帮助他们建立每日管理糖尿病信心的系统，这非常令人兴奋。更多的目标血糖选项和更少的干扰意味着糖尿病患者及其家人将获得更好的体验，”博士表示。

Anita Swamy, MD, Pediatric Endocrinologist and Medical Director of the Chicago Children’s Diabetes Center..

阿妮塔·斯瓦米，医学博士，儿科内分泌学家，芝加哥儿童糖尿病中心医疗主任。

The updates to the Omnipod 5 algorithm are anticipated to launch in the United States in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes.

预计对Omnipod 5算法的更新将于2026年上半年在美国推出，该产品适用于2岁及以上1型糖尿病患者以及18岁及以上的2型糖尿病患者。

1 Forlenza G, et al. Presented at: ATTD; March 19-22, 2025; Amsterdam, NL. Real-world data from 403 people with type 1 diabetes aged 2+ using the Omnipod 5 System who transitioned from the (150 mg/dL or 8.3 mmol/L) to (110 mg/dL or 6.1 mmol/L) Target Glucose. Each Target Glucose was used for a consecutive period of 14-90 days.

Forlenza G 等。发表于：ATTD；2025年3月19-22日；荷兰阿姆斯特丹。来自403名2岁以上使用Omnipod 5系统的1型糖尿病患者的真实世界数据，这些患者从（150 mg/dL 或 8.3 mmol/L）目标血糖过渡到（110 mg/dL 或 6.1 mmol/L）目标血糖。每个目标血糖值连续使用了14至90天。

Median time in Range (70-180 mg/dL) (3.8-10 mmol/l) improved 11.8% (p<0.05). Median time (<70 mg/dL or <3.8 mmol/l) +0.23% (p<0.05). Real-world data from 58 people with type 2 diabetes (T2D) aged 18+ using the Omnipod 5 System who transitioned from 150 mg/dL to 110 mg/dL Target Glucose. Each Target Glucose was used for a consecutive period of 14-90 days.

范围内（70-180 mg/dL）（3.8-10 mmol/l）的中位时间提高了11.8%（p<0.05）。中位时间（<70 mg/dL 或 <3.8 mmol/l）增加了0.23%（p<0.05）。来自58名18岁以上使用Omnipod 5系统的2型糖尿病（T2D）患者的真实世界数据，这些患者的目标血糖从150 mg/dL调整为110 mg/dL。每个目标血糖值连续使用了14至90天。

Median time in Range (70-180 mg/dL) improved 10.4% (p<0.05). Median time < 70 mg/dL +0.04% (non-significant). Omnipod 5 results based on users with ≥75% of days with ≥220 readings available. Data on File. RF-042025-00013.

范围内（70-180 mg/dL）的中位时间提高了10.4%（p<0.05）。中位时间<70 mg/dL增加了0.04%（无显著性差异）。Omnipod 5结果基于≥75%的天数具有≥220次读数的用户。数据存档。RF-042025-00013。

About Insulet Corporation:

关于Insulet公司：

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative 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 a unique alternative to traditional insulin delivery methods.

Insulet Corporation（纳斯达克股票代码：PODD），总部位于马萨诸塞州，是一家创新的医疗设备公司，致力于通过其Omnipod产品平台简化糖尿病患者及其他疾病患者的生活。Omnipod胰岛素管理系统为传统的胰岛素输送方法提供了一种独特的替代方案。

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’s flagship innovation, 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 personal smartphone in the U.S.

凭借其简单、可穿戴的设计，无管路的一次性Pod可提供长达三天的持续胰岛素输送，且无需看到或处理针头。Insulet的旗舰创新产品——Omnipod 5自动胰岛素输送系统，与连续血糖监测仪相集成，能够实现无需多次每日注射、零指尖采血的血糖管理，并且在美国可以通过兼容的个人智能手机进行控制。

or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, visit Insulet.com or omnipod.com..

或通过Omnipod 5控制器。Insulet还利用其Pod的独特设计，将其Omnipod技术平台定制用于其他治疗领域中非胰岛素皮下药物的递送。欲了解更多信息，请访问Insulet.com或omnipod.com。

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