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Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance for two new over-the-counter continuous glucose monitoring (CGM) systems – Lingo™ and Libre Rio™, which are based on Abbott's world-leading FreeStyle Libre® continuous glucose monitoring technology1, now used by about 6 million people globally2. The newly cleared systems have been intentionally designed to meet different needs – Lingo for consumers who want to better understand and improve their health and wellness, and Libre Rio for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications..
雅培(纽约证券交易所:ABT)今天宣布美国食品和药物管理局(FDA)批准了两种新的非处方连续血糖监测(CGM)系统-Lingo™和Libre Rio™,它们基于雅培世界领先的FreeStyle Libre®连续血糖监测技术1,目前全球约有600万人使用2。新批准的系统是为了满足不同的需求而专门设计的-对于想要更好地了解和改善健康状况的消费者来说是行话,对于不使用胰岛素并且通常通过改变生活方式来管理糖尿病的2型糖尿病成年人来说是自由的。。
'There is no one-size-fits all approach for glucose monitoring, which is why we've designed different products for different people – all based on the same world-leading biowearable technology1,' said Lisa Earnhardt, executive vice president and group president of Abbott's medical devices business. 'People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider.
雅培医疗器械业务执行副总裁兼集团总裁丽莎·恩哈特(LisaEarnhardt)说,血糖监测没有一刀切的方法,这就是为什么我们为不同的人设计了不同的产品——所有产品都基于同一种世界领先的生物穿戴技术1糖尿病患者需要某些功能,如跟踪药物或与医疗保健提供者共享数据。
People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes.'.
没有糖尿病的人需要不同的功能来管理他们的代谢健康,包括个性化指导以促进可行的生活方式改变。”。
LingoAbbott's consumer biowearable, Lingo, is designed for consumers 18 years and older who are looking to improve their overall health and wellness. Lingo will track glucose and provide personalized insights and customized coaching to help people create healthy habits, retrain their metabolism and improve their overall well-being.
LingoAbbott的消费者生物可穿戴设备Lingo是为18岁及以上的消费者设计的,他们希望改善整体健康状况。Lingo将跟踪血糖,并提供个性化的见解和定制的指导,以帮助人们养成健康的习惯,重新训练他们的新陈代谢并改善他们的整体幸福感。
According to a University of North Carolina study, only 12 percent of Americans are metabolically healthy3 based on five key indicators of metabolic health, including glucose levels, indicating that most of the U.S. population has room to improve their metabolism. In addition, in a recent online consumer survey conducted by The Harris Poll on behalf of Abbott, 82 percent of Americans say they would change their habits if a biowearable provided actionable, personalized coaching to help them manage their health.4.
根据北卡罗莱纳大学(University of North Carolina)的一项研究,基于代谢健康的五个关键指标,包括血糖水平,只有12%的美国人代谢健康3,这表明大多数美国人有改善新陈代谢的空间。此外,哈里斯民意调查(HarrisPoll)最近代表雅培(Abbott)进行的一项在线消费者调查显示,82%的美国人表示,如果生物穿戴设备提供可行的个性化指导,帮助他们管理健康,他们会改变习惯。
The Lingo system combines a biosensor that is worn on the upper arm for 14 days5 and continuously streams glucose data to a coaching application on a smart phone – translating the body's language and giving insights on the person's reaction to food, exercise and life's daily stressors.
Lingo系统结合了一个戴在上臂上14天的生物传感器5,并将葡萄糖数据连续传输到智能手机上的教练应用程序中-翻译身体的语言,并提供有关人对食物,运动和日常生活压力的反应的见解。
'Continuous glucose monitors are a tool I recommend to my patients to raise their overall awareness of factors that affect their glucose and are an invaluable holistic wellness solution,' said Fred St. Goar, M.D., cardiologist and medical director of El Camino Health Heart and Vascular Institute. 'Research has shown that overall lower glucose exposure in the general population is associated with reduced long-term risk to developing cardiovascular disease, diabetes, Alzheimer's and certain cancers.
El Camino健康心脏与血管研究所心脏病专家兼医学主任弗雷德·圣戈尔(FredSt.Goar)医学博士说:“连续血糖监测仪是我推荐给患者的一种工具,可以提高他们对影响血糖因素的整体认识,是一种无价的整体健康解决方案。”研究表明,一般人群中总体较低的葡萄糖暴露与降低患心血管疾病、糖尿病、阿尔茨海默病和某些癌症的长期风险有关。
Making continuous glucose monitors widely available will undoubtedly have a dramatic effect on the overall health and well-being of the broader population.' .
毫无疑问,广泛使用连续血糖监测仪将对广大人群的整体健康和福祉产生巨大影响。”。
Visit www.hellolingo.com and sign up to be notified as soon as Lingo is available in the U.S. Lingo is also available in the UK.
访问www.hellolingo.com并注册,以便在美国使用Lingo后尽快收到通知。Lingo在英国也可以使用。
Libre RioLibre Rio will be Abbott's first over-the-counter CGM system for people with diabetes in the U.S. It is designed for people ages 18 and older with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications. Libre Rio is the first over-the-counter CGM system with a measurement range of 40-400 mg/dL, allowing for measurement of extremely low or high glucose events..
Libre RioLibre Rio将是雅培在美国为糖尿病患者设计的首个非处方CGM系统。该系统专为18岁及以上不使用胰岛素且通常通过改变生活方式来管理糖尿病的2型糖尿病患者而设计。Libre Rio是第一个非处方CGM系统,测量范围为40-400 mg/dL,可以测量极低或极高的葡萄糖事件。。
Diabetes is among the top public health challenges in the U.S., with approximately 38.4 million people living with the condition6. FreeStyle Libre systems have been available over-the-counter in more than 50 countries over the last decade; however, in the U.S., they have only been available through prescription..
糖尿病是美国最大的公共卫生挑战之一,约有3840万人患有糖尿病6。在过去的十年中,自由式自由泳系统已经在50多个国家的柜台上提供;然而,在美国,它们只能通过处方获得。。
Libre Rio will join Abbott's overall Libre portfolio of CGM systems, now used by about 6 million people across more than 60 countries2. The Libre portfolio in the U.S. consists of the FreeStyle Libre 2 and FreeStyle Libre 3 systems for people with all types of diabetes – Type 1, Type 2 and gestational.
Libre Rio将加入雅培的CGM系统整体Libre投资组合,目前已有60多个国家的约600万人使用2。美国的Libre投资组合包括FreeStyle Libre 2和FreeStyle Libre 3系统,适用于所有类型的糖尿病患者-1型,2型和妊娠期。
FreeStyle Libre systems require a prescription and have wide reimbursement by most major insurers in the U.S.2 Libre Rio may make it easier for Americans with diabetes to try a CGM and begin to see progress toward their health goals, empowering them with information to discuss with their healthcare provider at their next visit..
FreeStyle Libre系统需要处方,并且美国大多数主要保险公司都有广泛的报销。2 Libre Rio可能会使患有糖尿病的美国人更容易尝试CGM,并开始看到朝着健康目标取得的进展,从而为他们提供信息,以便在下次访问时与医疗保健提供者进行讨论。。
Clinical and real-world data from the millions of people that use FreeStyle Libre systems show that the technology helps people improve their glucose control, lower their HbA1c, decrease diabetes-related hospital admissions, and improve their quality of life7,8. Libre systems consist of a biosensor placed on the back of the arm for up to 15 days, and a reader or a compatible smartphone app9, which displays glucose measurements..
来自数百万使用FreeStyle Libre系统的人的临床和现实数据显示,该技术有助于人们改善血糖控制,降低HbA1c,减少与糖尿病相关的住院率,并提高生活质量7,8。Libre系统包括一个放置在手臂后部长达15天的生物传感器,以及一个阅读器或兼容的智能手机app9,它可以显示血糖测量值。。
Abbott continues to invest in its world-leading innovation for people with diabetes, including expanding manufacturing capacity and developing a first-of-its-kind sensor that is designed to measure both glucose and ketone in the same sensor.
雅培继续投资于其全球领先的糖尿病患者创新技术,包括扩大制造能力和开发首创用于测量同一传感器中葡萄糖和酮的传感器。
About Abbott: Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
关于雅培:雅培是一家全球医疗保健领导者,帮助人们在生命的各个阶段生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域,在诊断、医疗器械、营养品和品牌仿制药领域拥有领先的业务和产品。我们的114000名同事为160多个国家的人民服务。
About Lingo: The Lingo Glucose System is intended for users 18 years and older not on insulin. It is not intended for diagnosis of diseases, including diabetes.The Lingo program does not guarantee that everyone will achieve the same results as individual responses may vary. Consult your healthcare professional before making changes to your diet or exercise regimen or if you have an eating disorder or a history of eating disorders..
关于Lingo:Lingo葡萄糖系统适用于18岁及以上不服用胰岛素的用户。它不用于诊断疾病,包括糖尿病。行话计划并不能保证每个人都能取得相同的结果,因为个人的回答可能会有所不同。在改变饮食或锻炼方案之前,或者如果你有进食障碍或进食障碍史,请咨询你的医疗保健专业人员。。
About Libre Rio:Libre Rio is an over-the-counter integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons ages 18 and older. Failure to use Libre Rio as instructed in labeling may result in missing a severe low or high glucose event. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions..
关于Libre Rio:Libre Rio是一种非处方集成连续血糖监测(iCGM)设备,适用于18岁及以上使用非胰岛素的人群。未能按照标签中的说明使用Libre Rio可能会导致错过严重的低血糖或高糖事件。如果读数与症状或预期不符,请使用血糖仪的指尖值进行治疗决策。。