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ACTON, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced its groundbreaking Omnipod 5 Automated Insulin Delivery System (Omnipod 5) is now indicated for use by people with type 2 diabetes (ages 18 years and older) in the U.S., making it the first and only AID system FDA-cleared for both type 1 and type 2 diabetes management..
马萨诸塞州阿克顿市(商业新闻短讯)--全球无管胰岛素泵技术领导者、拥有Omnipod®品牌产品的Insulet Corporation(NASDAQ:PODD)(Insulet或该公司)今天宣布,其开创性的Omnipod 5自动胰岛素输送系统(Omnipod 5)目前适用于美国2型糖尿病患者(18岁及以上),是FDA批准用于1型和2型糖尿病管理的第一个也是唯一的急救系统。。
“Today’s announcement represents a significant milestone in providing easy-to-use, patient-centric technology for the treatment of type 2 diabetes,” said Jim Hollingshead, Insulet President and Chief Executive Officer. “Insulet is paving the way for these individuals to achieve better health outcomes while living with greater confidence and freedom through the game-changing benefits of tubeless Pod therapy.
Insulat总裁兼首席执行官吉姆·霍林斯海德(JimHollingshead)表示:“今天的宣布标志着为治疗2型糖尿病提供易于使用、以患者为中心的技术的一个重要里程碑。”。“通过无内胎豆荚疗法改变游戏规则的好处,Islet正在为这些人铺平道路,使他们能够获得更好的健康结果,同时拥有更大的信心和自由。
Omnipod 5 is setting a new standard in diabetes management, and we are thrilled with the opportunity to make a lasting impact on the insulin-requiring type 2 diabetes community.”.
Omnipod 5正在制定糖尿病管理的新标准,我们很高兴有机会对需要胰岛素的2型糖尿病社区产生持久影响。”。
There are over 30 million people living with type 2 diabetes in the U.S.1, with approximately 6 million people who require insulin, of which 2.5 million are using multiple daily injections (MDI)2. Despite advances in medical therapy over the past 20 years, there has been no significant change in the percentage of adults with type 2 diabetes achieving recommended HbA1c targets3.
。尽管过去20年来药物治疗取得了进展,但2型糖尿病成年人达到推荐HbA1c目标的百分比没有显着变化3。
Only a quarter of individuals with type 2 diabetes on insulin are achieving an HbA1c of 7.0% or less, and half of this population has an HbA1c greater than 8.0%4. Despite guideline recommendations for insulin treatment in advanced disease, insulin therapy is often delayed or not appropriately intensified5..
只有四分之一的胰岛素治疗2型糖尿病患者的HbA1c达到7.0%或更低,其中一半人群的HbA1c高于8.0%4。尽管有针对晚期疾病胰岛素治疗的指南建议,但胰岛素治疗通常会延迟或未适当强化5。。
Insulet recently presented data showing that Omnipod 5 significantly improves health outcomes while making life easier for people with type 2 diabetes. The SECURE-T2D clinical study demonstrated that compared to prior insulin therapy methods in adults with type 2 diabetes, Omnipod 5 use resulted in considerable reductions in HbA1c: 0.8% overall and 2.1% in those with prior HbA1c 9.0% or higher6.
Islet最近提供的数据显示,Omnipod 5显着改善了健康状况,同时使2型糖尿病患者的生活更加轻松。SECURE-T2D临床研究表明,与先前的2型糖尿病成人胰岛素治疗方法相比,Omnipod 5的使用导致HbA1c显着降低:总体降低0.8%,先前HbA1c 9.0%或更高的患者降低2.1%6。
Time in hyperglycemia and total daily insulin dose were also reduced, and there was a 20% improvement in time in range, increasing by 4.8 hours per day, without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress..
高血糖时间和每日总胰岛素剂量也减少了,时间范围内改善了20%,每天增加了4.8小时,而低血糖时间没有增加。该研究还证明了糖尿病困扰的临床意义改善。。
The Omnipod 5 System simplifies diabetes management and leads to improved results by eliminating the need for MDI and automatically adjusting insulin delivery every 5 minutes using its advanced SmartAdjust™ technology. As the #1 prescribed and #1 favorite pump7 in the U.S., the waterproof8, discreet, and wearable Omnipod 5 is the first tubeless AID system that communicates with a continuous glucose monitor, proactively correcting for highs and protecting against lows, day and night 9,10.
Omnipod 5系统通过使用其先进的SmartAdjust™技术,无需MDI并每5分钟自动调整胰岛素输送量,简化了糖尿病管理并改善了结果。作为美国规定的和最受欢迎的泵7,防水,谨慎和可穿戴的Omnipod 5是第一个与连续血糖监测仪通信的无管急救系统,可以主动纠正高血糖并防止低血糖,昼夜9,10。
The system is easy to prescribe through the pharmacy and widely covered by many insurance plans, including Medicare Part D..
该系统很容易通过药房开出处方,并被许多保险计划广泛覆盖,包括医疗保险D部分。。
“I’ve seen first-hand how difficult it is for patients to reach their targets with injections,” said Dr. Anne L. Peters, Director of the University of Southern California Westside Center for Diabetes. “Omnipod 5 makes it easier for people with type 2 diabetes to take their insulin and stay in range, leading to remarkable improvements in clinical outcomes and overall quality of life.
南加州大学西区糖尿病中心主任安妮·彼得斯(AnneL.Peters)博士说:“我亲眼目睹了患者通过注射达到目标的难度。”。“Omnipod 5使2型糖尿病患者更容易服用胰岛素并保持在范围内,从而显着改善临床结果和整体生活质量。
I believe this innovative technology has the potential to transform the lives of insulin-requiring people with type 2 diabetes.”.
我相信这项创新技术有可能改变需要胰岛素的2型糖尿病患者的生活。”。
About Insulet Corporation:
关于Islet Corporation:
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.
总部位于马萨诸塞州的Insulet Corporation(NASDAQ:PODD)是一家创新型医疗器械公司,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胰岛素管理系统为传统的胰岛素输送方法提供了独特的替代方案。
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.
无管一次性Pod设计简单,可穿戴,无需查看或操作针头,可提供长达三天的不间断胰岛素输送。Insulat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集成,无需每天多次注射即可管理血糖,无需手指,并且可以通过美国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, please visit insulet.com and omnipod.com..
Insulat还利用其Pod的独特设计,定制其Omnipod技术平台,用于在其他治疗领域输送非胰岛素皮下药物。有关更多信息,请访问insulet.com和omnipod.com。。