雅培两款新型非处方连续血糖监测系统获FDA批准

Abbott(NYSE:ABT)todayannouncedU.S.FoodandDrugAdministration(FDA)clearancefortwonewover-the-countercontinuousglucosemonitoring(CGM)systems–LingoandLibreRio,whicharebasedonAbbott'sworld-leadingFreeStyleLibrecontinuousglucosemonitoringtechnology1,nowusedbyabout6millionpeopleglobally2.Thenewlyclearedsystemshavebeenintentionallydesignedtomeetdifferentneeds–Lingoforconsumerswhowanttobetterunderstandandimprovetheirhealthandwellness,andLibreRioforadultswithType2diabeteswhodonotuseinsulinandtypicallymanagetheirdiabetesthroughlifestylemodifications..

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LibreRio,它们基于雅培世界领先的FreeStyleLibre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。。

'Thereisnoone-size-fitsallapproachforglucosemonitoring,whichiswhywe'vedesigneddifferentproductsfordifferentpeople–allbasedonthesameworld-leadingbiowearabletechnology1,'saidLisaEarnhardt,executivevicepresidentandgrouppresidentofAbbott'smedicaldevicesbusiness.'Peoplelivingwithdiabetesneedcertainfeaturesliketrackingmedicationsorsharingdatawithahealthcareprovider.

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。

Peoplewithoutdiabetesneeddifferentfeaturestomanagetheirmetabolichealth,includingpersonalizedcoachingtopromoteactionablelifestylechanges.'.

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'sconsumerbiowearable,Lingo,isdesignedforconsumers18yearsandolderwhoarelookingtoimprovetheiroverallhealthandwellness.Lingowilltrackglucoseandprovidepersonalizedinsightsandcustomizedcoachingtohelppeoplecreatehealthyhabits,retraintheirmetabolismandimprovetheiroverallwell-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。

AccordingtoaUniversityofNorthCarolinastudy,only12percentofAmericansaremetabolicallyhealthy3basedonfivekeyindicatorsofmetabolichealth,includingglucoselevels,indicatingthatmostoftheU.S.populationhasroomtoimprovetheirmetabolism.Inaddition,inarecentonlineconsumersurveyconductedbyTheHarrisPollonbehalfofAbbott,82percentofAmericanssaytheywouldchangetheirhabitsifabiowearableprovidedactionable,personalizedcoachingtohelpthemmanagetheirhealth.4.

根据北卡罗莱纳大学(UniversityofNorthCarolina)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。

TheLingosystemcombinesabiosensorthatiswornontheupperarmfor14days5andcontinuouslystreamsglucosedatatoacoachingapplicationonasmartphone–translatingthebody'slanguageandgivinginsightsontheperson'sreactiontofood,exerciseandlife'sdailystressors.

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。

'ContinuousglucosemonitorsareatoolIrecommendtomypatientstoraisetheiroverallawarenessoffactorsthataffecttheirglucoseandareaninvaluableholisticwellnesssolution,'saidFredSt.Goar,M.D.,cardiologistandmedicaldirectorofElCaminoHealthHeartandVascularInstitute.'Researchhasshownthatoveralllowerglucoseexposureinthegeneralpopulationisassociatedwithreducedlong-termrisktodevelopingcardiovasculardisease,diabetes,Alzheimer'sandcertaincancers.

ElCamino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。

Makingcontinuousglucosemonitorswidelyavailablewillundoubtedlyhaveadramaticeffectontheoverallhealthandwell-beingofthebroaderpopulation.'.

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。”。

Visitwww.hellolingo.comandsignuptobenotifiedassoonasLingoisavailableintheU.S.LingoisalsoavailableintheUK.

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。

LibreRioLibreRiowillbeAbbott'sfirstover-the-counterCGMsystemforpeoplewithdiabetesintheU.S.Itisdesignedforpeopleages18andolderwithType2diabeteswhodonotuseinsulinandtypicallymanagetheirdiabetesthroughlifestylemodifications.LibreRioisthefirstover-the-counterCGMsystemwithameasurementrangeof40-400mg/dL,allowingformeasurementofextremelyloworhighglucoseevents..

LibreRioLibreRio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。LibreRio是第一个非处方CGM系统,测量范围为40-400mg/dL,可以测量极低或极高的葡萄糖事件。。

DiabetesisamongthetoppublichealthchallengesintheU.S.,withapproximately38.4millionpeoplelivingwiththecondition6.FreeStyleLibresystemshavebeenavailableover-the-counterinmorethan50countriesoverthelastdecade;however,intheU.S.,theyhaveonlybeenavailablethroughprescription..

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。。

LibreRiowilljoinAbbott'soverallLibreportfolioofCGMsystems,nowusedbyabout6millionpeopleacrossmorethan60countries2.TheLibreportfoliointheU.S.consistsoftheFreeStyleLibre2andFreeStyleLibre3systemsforpeoplewithalltypesofdiabetes–Type1,Type2andgestational.

LibreRio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FreeStyleLibre2和FreeStyleLibre3系统,适用于所有类型的糖尿病患者-1型,2型和妊娠期。

FreeStyleLibresystemsrequireaprescriptionandhavewidereimbursementbymostmajorinsurersintheU.S.2LibreRiomaymakeiteasierforAmericanswithdiabetestotryaCGMandbegintoseeprogresstowardtheirhealthgoals,empoweringthemwithinformationtodiscusswiththeirhealthcareproviderattheirnextvisit..

FreeStyleLibre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。2LibreRio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。。

Clinicalandreal-worlddatafromthemillionsofpeoplethatuseFreeStyleLibresystemsshowthatthetechnologyhelpspeopleimprovetheirglucosecontrol,lowertheirHbA1c,decreasediabetes-relatedhospitaladmissions,andimprovetheirqualityoflife7,8.Libresystemsconsistofabiosensorplacedonthebackofthearmforupto15days,andareaderoracompatiblesmartphoneapp9,whichdisplaysglucosemeasurements..

Abbottcontinuestoinvestinitsworld-leadinginnovationforpeoplewithdiabetes,includingexpandingmanufacturingcapacityanddevelopingafirst-of-its-kindsensorthatisdesignedtomeasurebothglucoseandketoneinthesamesensor.

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。

AboutAbbott:Abbottisaglobalhealthcareleaderthathelpspeoplelivemorefullyatallstagesoflife.Ourportfoliooflife-changingtechnologiesspansthespectrumofhealthcare,withleadingbusinessesandproductsindiagnostics,medicaldevices,nutritionalsandbrandedgenericmedicines.Our114,000colleaguesservepeopleinmorethan160countries.

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。

AboutLingo:TheLingoGlucoseSystemisintendedforusers18yearsandoldernotoninsulin.Itisnotintendedfordiagnosisofdiseases,includingdiabetes.TheLingoprogramdoesnotguaranteethateveryonewillachievethesameresultsasindividualresponsesmayvary.Consultyourhealthcareprofessionalbeforemakingchangestoyourdietorexerciseregimenorifyouhaveaneatingdisorderorahistoryofeatingdisorders..

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。。

AboutLibreRio:LibreRioisanover-the-counterintegratedcontinuousglucosemonitoring(iCGM)deviceindicatedfornon-insulinusingpersonsages18andolder.FailuretouseLibreRioasinstructedinlabelingmayresultinmissingasevereloworhighglucoseevent.Ifreadingsdonotmatchsymptomsorexpectations,useafingerstickvaluefromabloodglucosemeterfortreatmentdecisions..

关于LibreRio:LibreRio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LibreRio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。。

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