美敦力MiniMed 780G，有新进展

器械之家2025-07-24

器械之家医疗器械媒体报道先锋分享专业医疗器械知识关注来源：Medtech Dive 医潜医疗科技巨头美敦力（NYSE:MDT）近期宣布，其最新一代自动胰岛素输送（AID）系统MiniMed 780G已获得CE标志认证，适应症范围扩展至2型糖尿病患者、2岁及以上1型糖尿病儿童及妊娠期糖尿病患者。此次认证标志着该设备在欧洲市场的应用人群显著扩大，同时为公司计划拆分成立的独立糖尿病业务公司MiniMed...

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780G成为欧洲首个获批用于2型糖尿病的AID系统。支持的临床数据包括：2型糖尿病患者临床试验：95例2型糖尿病患者数据显示，系统使用后糖化血红蛋白（HbA1c）平均降低0.7%，血糖范围时间（70-180 mg/dL）提升至80%，低血糖（<54 mg/dL）时间低于0.5%。真实世界证据：26,427例2型患者分析显示，平均范围时间超70%（国际共识目标），严重低血糖发生率低于1%。目前该系统在美国仍处于2型糖尿病适应症审批阶段，美敦力正与FDA密切沟通提交资料。低龄儿童应用获数据支持通过LENNY试验（2-6岁1型糖尿病儿童），自动模式相较手动模式实现：HbA1c降低0.6%范围时间延长9.9%英国NHS及德国糖尿病协会已将AID系统纳入儿童护理标准推荐。英国儿科内分泌学家Fiona Campbell博士评价：\"该技术减轻家庭监测负担，支持儿童健康发育，是生活质量的关键变革。\"妊娠期血糖管理创新针对妊娠期1型糖尿病患者，系统可设定更低血糖目标（≤100 mg/dL），欧洲研究显示：严格范围时间达66.5%（传统治疗显著改善）夜间低血糖减少，治疗满意度提升该结果符合国际指南对妊娠期AID使用的推荐。此前，Insulet的Omnipod 5（2024年8月）和Tandem Diabetes Care（2025年2月）相继获FDA批准用于2型糖尿病。美敦力通过欧洲认证抢占国际市场先机，其全闭环算法与Simplera CGM的整合优势或成差异化竞争力。MiniMed 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