/ -- Medtronic plc (NYSE: MDT), a global leader in medical technology, today announced CE (Conformité Européenne) Mark in

/ -- 全球医疗技术领导者美敦力公司（纽约证券交易所代码：MDT）今天宣布获得CE（欧洲合格认证）标志

to expand indications of the MiniMed™ 780G system for use by individuals aged 2 years and older, during pregnancy, as well as type 2 insulin-requiring diabetes. To gain CE Mark for this expansion of indications, published clinical data in 2–6-year-olds, pregnant women, and people living with type 2 diabetes was reviewed.

为了扩大MiniMed™ 780G系统在2岁及以上人群、孕妇以及需要胰岛素治疗的2型糖尿病患者中的使用适应症。为了获得此项适应症扩展的CE认证，审查了已发表的关于2-6岁儿童、孕妇以及2型糖尿病患者的临床数据。

This expanded indication underscores the commitment Medtronic has to advancing access to automated insulin delivery (AID) technology for broader and more diverse populations, helping to improve outcomes and quality of life for people at every stage of life living with diabetes..

这一扩展适应症强调了美敦力致力于推动更广泛和多样化人群获取自动胰岛素输送（AID）技术的决心，有助于改善各个生活阶段糖尿病患者的生活质量和健康结果。

Expanded age indication extends benefits of AID systems for young children with type 1 diabetes

扩大的年龄指征使1型糖尿病幼儿受益于AID系统的好处得以延伸。

Data from the LENNY trial, recently published in

LENNY 试验的数据，最近发表在

The Lancet Diabetes & Endocrinology

《柳叶刀糖尿病与内分泌学》

demonstrated the safety and efficacy

证明了安全性和有效性

of the MiniMed™ 780G system in children aged 2-6 years old with type 1 diabetes (T1D). Participants in the multi-center, randomized controlled, crossover trial achieved a 0.6% lower HbA1C and 9.9% higher time in range (TIR) when the system was used in auto mode, compared to those using it in manual mode. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode..

MiniMed™ 780G 系统在2-6岁患有1型糖尿病（T1D）的儿童中的应用。在这项多中心、随机对照、交叉试验中，参与者在自动模式下使用该系统时，HbA1C降低了0.6%，范围内时间（TIR）提高了9.9%，相比之下手动模式下则未达到相同效果。父母和护理人员还报告称，在自动模式下使用该系统时，睡眠质量得到改善，并且对低血糖的恐惧有所减少。

'As a parent, nothing is more important than giving my child the freedom to just be a kid — but managing type 1 diabetes made that feel nearly impossible,' said

“作为父母，没有什么比给予孩子自由、让他单纯地做自己更重要的事情了——但管理1型糖尿病让我觉得这几乎不可能，”

Paul Schulz

保罗·舒尔茨

, based in

，总部位于

Barcelona, Spain

西班牙巴塞罗那

, whose son Marc lives with type 1 diabetes. 'Ever since Marc was diagnosed with diabetes at age 4, we have been lucky to count on support from Medtronic. This doesn't mean it has always been easy, but since starting the MiniMed™ 780G system, so much has changed. It's like we've gained a teammate — one that works around the clock to help manage his diabetes.

，她的儿子马克患有1型糖尿病。“自从马克在4岁时被诊断出糖尿病以来，我们很幸运能得到美敦力的支持。这并不是说一直以来都很轻松，但自从开始使用MiniMed™ 780G系统后，一切都发生了很大的变化。就像我们多了一个队友——一个全天候帮助管理他糖尿病的队友。

It's very freeing.'.

它非常自由。

Automated insulin delivery (AID) systems are rapidly becoming the standard of care for children with type 1 diabetes across

自动胰岛素输送（AID）系统正迅速成为1型糖尿病儿童护理的标准方法。

NICE guidelines (TA943)

NICE指南（TA943）

recommend hybrid closed-loop systems for all children and adolescents with T1D. Recognizing the importance of AID therapy, NHS England has a 5-year plan to roll out AID systems to most people with T1D, with children up to the age of 18 years old being prioritized because of their high need to optimize care.

建议所有患有1型糖尿病的儿童和青少年使用混合闭环系统。认识到AID治疗的重要性，英格兰国家医疗服务体系（NHS）制定了一项为期5年的计划，将AID系统推广至大多数1型糖尿病患者，其中优先考虑18岁以下的儿童，因为他们对优化护理的需求较高。

from the German Diabetes Association advise offering AID to all pediatric patients, provided they or their caregivers can use the technology safely. In addition, the 2024 ISPAD guidelines

来自德国糖尿病协会的建议是，向所有儿科患者提供AID，前提是他们或其护理人员能够安全使用该技术。此外，2024年ISPAD指南

strongly recommend AID systems to improve time in range, reduce hypo- and hyperglycemia, enhance quality of life, and ease the burden of care — especially overnight.

强烈推荐使用AID系统来增加血糖在目标范围内的时间，减少低血糖和高血糖的发生，提高生活质量，并减轻护理负担，尤其是在夜间。

'Advancements in Automated Insulin Delivery (AID) systems are revolutionizing how we care for children with type 1 diabetes,' said Dr.

“自动胰岛素输送（AID）系统的进步正在革新我们照顾1型糖尿病儿童的方式，”博士说道。

Fiona Campbell

菲奥娜·坎贝尔

, a leading pediatric endocrinologist in the UK. 'For families, these systems lift the relentless burden of constant monitoring and insulin adjustments. Better glucose control in children can support healthier growth and brain development, better sleep, and the freedom to simply enjoy being a child.

英国领先的儿科内分泌学家表示：“对于家庭来说，这些系统减轻了持续监测和胰岛素调整的沉重负担。更好的血糖控制可以帮助儿童更健康的成长和大脑发育、更好的睡眠，并且能够自由地享受童年。”

It's a transformative shift in both outcomes and quality of life.'.

这是一个在结果和生活质量方面的变革性转变。

Navigating pregnancy with type 1 diabetes: A smarter, safer path forward

用1型糖尿病导航怀孕：一条更智能、更安全的前进路径

Pregnancy presents unique challenges for women with type 1 diabetes. Hormonal shifts and physiological changes can make glucose management more complex, while the developing baby is especially vulnerable to both high and fluctuating blood sugar levels. To protect both mother and child, clinical guidelines recommend a much tighter glucose target during pregnancy—known as Pregnancy Time in Range (TIRp)—set between 63 and 140 mg/dL (3.5-7.8 mmol/L)..

妊娠为患有 1 型糖尿病的女性带来了独特的挑战。激素变化和生理改变会使血糖管理更加复杂，而发育中的胎儿对高血糖和血糖波动尤其敏感。为了保护母婴健康，临床指南建议在妊娠期间设定更严格的血糖目标，称为妊娠期血糖范围内时间（TIRp），范围为 63 至 140 mg/dL（3.5-7.8 mmol/L）。

This is where advanced technology like the MiniMed™ 780G system can make a meaningful difference. The system's ability to target glucose levels as low as 100 mg/dL (5.5 mmol/L) offers a powerful tool for achieving tighter control. In a European study

这就是像 MiniMed™ 780G 系统这样的先进技术可以产生有意义的差异之处。该系统能够将血糖水平控制低至 100 mg/dL（5.5 mmol/L），为实现更严格的控制提供了强有力的工具。在一项欧洲研究中

evaluating its use during pregnancy, women using the MiniMed™ 780G system achieved an average TIRp of 66.5%—a significant improvement over traditional insulin therapy. The system also delivered better overnight glucose control, reduced overall and nighttime hypoglycemia, and higher treatment satisfaction among expectant mothers.

在评估其在怀孕期间的使用时，使用MiniMed™ 780G系统的女性达到了平均66.5%的TIRp（目标范围内时间百分比），相比传统胰岛素治疗有了显著改善。该系统还提供了更好的夜间血糖控制，减少了总体和夜间低血糖的发生，并提高了孕妇的治疗满意度。

These outcomes align with a growing body of evidence and a recent Clinical Practice Guideline jointly published by the European Society of Endocrinology and the U.S. Endocrine Society.

这些结果与越来越多的证据以及欧洲内分泌学会和美国内分泌学会最近联合发布的临床实践指南一致。

supporting the use of AID systems with the goal of improving maternal and fetal health outcomes during pregnancy.

支持使用AID系统，以改善孕期母婴健康状况为目标。

MiniMed™ 780G system now indicated for type 2 diabetes

MiniMed™ 780G系统现在适用于2型糖尿病

The MiniMed™ 780G system is now also approved for use in

MiniMed™ 780G 系统现已获批用于

Europe

欧洲

for people with type 2 diabetes. In a recently published

对于患有 2 型糖尿病的人。在最近发表的

multi-center, pivotal trial in 95 people with type 2 diabetes, the use of the MiniMed™ 780G system resulted in a 0.7% reduction in HbA1c (from a baseline of 7.9%) and an increase in TIR to 80% (from a baseline of 72%) with a time below range (70 mg/dL; 3.9 mmol/L) under 0.5%. Additionally, real-world data.

在一项涉及95名2型糖尿病患者的多中心关键试验中，使用MiniMed™ 780G系统后，糖化血红蛋白（HbA1c）降低了0.7%（从基线的7.9%降至7.2%），目标范围内时间（TIR）提升至80%（从基线的72%增加），且低于目标范围（70 mg/dL；3.9 mmol/L）的时间控制在0.5%以下。此外，真实世界数据也显示了类似结果。

of 26,427 MiniMed™ 780G system users who were identified as having type 2 diabetes (based on self-reported diagnosis and/or total daily insulin dose), demonstrated good glycemic control, on average exceeding the international consensus of 70% time in range (70-180 mg/dL) and maintaining time below range of less than 1%.

在26,427名被认定为患有2型糖尿病（基于自我报告的诊断和/或每日总胰岛素剂量）的MiniMed™ 780G系统用户中，平均血糖控制良好，超过国际共识的70%时间处于目标范围（70-180 mg/dL），并且保持低于目标范围的时间少于1%。

In the U.S., Medtronic is actively working with regulatory authorities to bring the benefits of advanced diabetes technology to a broader population. A submission to expand the use of the MiniMed™ 780G system for individuals with type 2 diabetes is currently under review by the U.S. Food and Drug Administration (FDA).

在美国，美敦力公司正积极与监管机构合作，将先进糖尿病技术的优势带给更广泛的人群。目前，美国食品和药物管理局 (FDA) 正在审查一份申请，以扩大MiniMed™ 780G系统在2型糖尿病患者中的使用范围。

Additionally, U.S. clinical trials are underway to examine the use of the MiniMed™ 780G system in 2–6-year-olds..

此外，美国正在进行临床试验，以研究MiniMed™ 780G系统在2至6岁儿童中的应用。

About the MiniMed™ 780G system

关于MiniMed™ 780G系统

The MiniMed™ 780G system is the most advanced insulin pump system from Medtronic. The MiniMed™ 780G system's SmartGuard algorithm (also referred to as the advanced hybrid closed-loop algorithm) automates the delivery of insulin every five minutes — personalizing these doses to auto-correct

MiniMed™ 780G系统是美敦力最先进的胰岛素泵系统。MiniMed™ 780G系统的SmartGuard算法（也称为高级混合闭环算法）每五分钟自动输送胰岛素——个性化这些剂量以实现自动校正。

highs every five minutes based on CGM readings.

每五分钟根据CGM读数得出的高点。

The system is designed to be used at a target glucose of 100 mg/dl (5.5 mmol/L) that can be adjusted and personalized on an individual basis.

该系统设计用于目标葡萄糖水平为 100 mg/dl（5.5 mmol/L），可以根据个体情况进行调整和个性化设置。

† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off.

† 指自动校正，提供团注辅助功能。可以无需用户干预自动输送所有自动校正剂量，该功能可以打开和关闭。

§ Refers to SmartGuard™ feature. Individual results may vary.

§ 指 SmartGuard™ 功能。个人结果可能有所不同。

About the Diabetes Business at Medtronic

关于美敦力的糖尿病业务

Medtronic Diabetes is on a mission to make diabetes more predictable, so everyone can embrace life to the fullest with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront..

美敦力糖尿病事业部致力于让糖尿病变得更可预测，让每个人都能在最需要的时候，通过最先进的糖尿病技术和始终如一的支持，充分享受生活。四十多年来，我们开创了多项首创的创新技术，并坚定致力于通过下一代传感器（CGM）、智能给药系统以及数据科学和人工智能的力量，设计糖尿病管理的未来，同时始终将用户体验置于首位。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in

大胆思考。更大胆的行动。我们是美敦力。美敦力公司，

, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

是全球领先的医疗技术公司，大胆攻克人类面临的最棘手健康问题，寻找并提供解决方案。我们的使命——减轻痛苦、恢复健康、延长生命——团结了来自150多个国家的95,000多名充满热情的员工。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们广泛的知识、永无止境的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit .

我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为我们的世界带来更好的结果，请对我们有更多期待。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力（纽约证券交易所代码：MDT）的更多信息，请访问。