Sangano reSpanish Agency for Medicines and Health Products (AEMPS) rakatanga chirongwa chekubatsira Ziviso yekuchengetedza maererano neDexcom One+ app ye iOSApp iyi, inoshandiswa nevanhu vazhinji vane chirwere cheshuga kuti vaongorore huwandu hweshuga yavo vachishandisa nharembozha, yakaziviswa nemugadziri, Dexcom, Inc. (United States), kuBazi reHutano, iro riri kutarisira sangano rine basa rekutarisa huwandu hweshuga. Sangano iri rakaziviswa nezvechikanganiso chingangoitika musoftware muapp iyi nemugadziri wacho pachake.
Dambudziko iri rinonyanya kukanganisa shanduro dzekushandisa dziri pakati pe1.5 ne1.6izvo zvingasaita sezvaitarisirwa. Kukundikana uku kunogona kukonzera kuti glucose values ​​yekare uye miseve yekare iratidzwe pachiratidziro kwechinguva chidiki, zvichikonzera njodzi yekunonoka nyevero dzeglucose yakakwira kana yakaderera.
Dambudziko resoftware rinogona kukanganisa kuratidzwa kweglucose
Zvichienderana neruzivo rwakapihwa kuAEMPS, chikanganiso chinoitika kana Dexcom One+ iOS app inotama kubva kumashure kuenda kumberi pa iPhone kana chimwe chishandiso chinoenderana nacho mushure mekunge chasiyiwa chisina kushandiswa kwenguva yakati. Panguva iyoyo, skrini inogona kupenya uye kuratidza zvakatevedzana estimated glucose values ​​​​(EGV) yekare uye trend arrows.
Mukati memasekonzi iwayo, mushandisi aigona kuona kuverenga kwekare sekunge kwaive kwemazuva ano data rakarurama risati raonekwa. Izvi zvinogona kukonzera kuvhiringidzika, kunyanya kune avo vanovimba nealerts dzinongoerekana dzaitika kuti vasarudze nekukurumidza nezvekurapa kwavo, sezvo sisitimu yacho yakagadzirirwa kupa yambiro nekukurumidza yekuchinja kukuru kwemazinga eglucose.
AEMPS inosimbisa kuti mamiriro ezvinhu aya anogona kutungamira ku hypoglycemia kana hyperglycemia hazvigone kuonekwa panguva yakakodzeraKana kuverenga kuri kuratidzwa pachiratidziro kusingaratidze mamiriro chaiwo eglucose panguva iyoyo, mhinduro yemurwere inogona kunonoka kana kusakwana, zvichikonzera migumisiro yakakosha yekiriniki.
Maitiro aya akafanana neakambotsanangurwa mune mamwe maapplication kubva kukambani imwe chete, akadai se Dexcom G7 iOS uye Dexcom G7 Watch shanduro dze iOS 2.9.0 kusvika 2.11.2, umo maitiro akafanana ekukundikana akaonekwa pakuchinja app kuenda kumberi.
Chii chinonzi Dexcom One+ uye ndiani anoshandisa iyi app kuSpain?
Dexcom One+ app ye iOS chikamu che Sisitimu yeDexcom One+ inochengetedza glucose (CGM)Sisitimu iyi inobvumira kuyera nguva dzose huwandu hweglucose mu interstitial fluid uchishandisa sensor inotumira data kunharembozha, pachinzvimbo chekushandisa zvigunwe zvechinyakare chete.
Zvinoratidzwa kuti vanhu vane makore anopfuura maviri, kusanganisira vakadzi vane pamuviriIzvi zvinoreva kuti mazano aya anosanganisira vana, vakuru, uye varwere vane pamuviri vanoshandisa tekinoroji iyi sechikamu chekurapa kwavo chirwere cheshuga zuva nezuva. Sisitimu iyi yakagadzirirwa kutsiva zvakanyanya kuyerwa kweshuga muropa re capillary pakuita sarudzo dzekurapa.
AEMPS inotiyeuchidza kuti kududzirwa kwakarurama kwemhedzisiro kubva muhurongwa hweDexcom One+ CGM kunofanirwa kubva pane mafambiro uye kuverenga kwakatevedzana izvo sensor inopa nekufamba kwenguva, kwete muchiyero chimwe chete. Nekuda kwechikonzero ichi, kuratidza data rekare kwenguva pfupi kunogona kukanganisa mafambiro chaiwo ari kuita glucose.
MuSpain, Dexcom One+ app ye iOS inogoverwa kuburikidza ne Apple App Store Inoshandiswa pamwe chete nesensa inoenderana nayo nevanhu vane chirwere cheshuga vanoda kunyatsoongororwa kwehuwandu hweshuga yavo. Yambiro yeAEMPS yakanangana kune avo vanoshandisa application zvakananga uye kune vanochengeta varwere nenyanzvi dzehutano dzinovarapa.
Njodzi dzinogona kuitika kuhutano hwemurwere
Njodzi huru yakaonekwa neAEMPS ndeyekuti mushandisi anogona Kukundikana kuona kudonha kukuru kana kuwedzera kweglucose panguva Izvi zvinokonzerwa nekuratidzwa kwekuverenga kwekare kana kunonoka kwezviziviso zvekushandisa. Izvi zvinogona kukanganisa zvakananga kuchengetedzeka kwemurwere.
Ngatifungei, semuenzaniso, kuti app inoratidza kukosha kwakasimba kana museve wekuti glucose iri kuderera nekukurumidza. Muchiitiko ichocho, zvinogoneka kuti Yambiro yeHypoglycemia: Usasvetuka-svetuka panguva yaunofaniraIzvi zvinogona kukonzera dambudziko guru kana rikasagadziriswa nekukurumidza. Saizvozvowo, kunonoka kutaura nezvekukwira kweshuga muropa kunogona kuwedzera huwandu hweshuga muropa pasina munhu kutora matanho anodiwa ekugadzirisa.
Uyezve, kusarudza data rekare kunogona kukonzera kusagadzirisa kwakakwana kwemuyero we insulin kana mamwe marapirwo, zvichiwedzera njodzi yekusawirirana kweshuga muropa. Sangano iri rinosimbirira kuti izvi hazvisi nyaya yekurerutsira kana kugadzira maapplication chete, asi dambudziko rinogona kukanganisa hutano zvakananga.
Saka, AEMPS inosimbisa kukosha kwevanhu vakakanganiswa nehutachiona hwe ... Ndokumbirawo kuti rigadzirise nekukurumidza sezvinobvira.Haisi zano rehunyanzvi chete, asi chiyero chekuchengetedza.
Mavhezheni akanganiswa uye kuvandudzwa kweDexcom One+ iOS
Yambiro yeAEMPS inotarisa zvakanyanya pane shanduro 1.5 kusvika 1.6 yeDexcom One+ app ye iOS, ine chekuita nereferensi yechigadzirwa SW14244. Sekureva kwemugadziri, mavhezheni aya anogona kusashanda sezvaitarisirwa uye anogona kuratidza kutadza kwatsanangurwa kana app ikaunzwa pamberi.
Sangano iri rinoshuma kuti Kugadzirisa shanduro idzi kuenda kune yazvino uno vhezheni inotodiwaDexcom yakazivisa kuti, kubva musi wa30 Kubvumbi, 2026, vashandisi havachakwanisi kushandisa shanduro 1.5 ne1.6, sezvo dzicharega kushanda. Nemamwe mashoko, pamusoro pekusachengeteka, vachabviswa pabasa.
Saka, chero ani zvake anoshandisa mavhezheni aya anokurudzirwa kugadzirisa application nekukurumidza sezvinobvira, pasina kumirira nguva yakatarwa. Chinangwa ndechekuderedza mukana wekuti mumwe munhu arambe achishandisa software iyo, kunyangwe ichiita seinovhura uye kugamuchira data, Inogona kuratidza ruzivo rwekare rweglucose.
Sangano reSpanish Agency for Medicines and Health Products (AEMPS) raziva nezvedambudziko iri kuburikidza neDexcom, Inc., kambani ine basa rehurongwa uhwu, iri muSan Diego (USA), uye rakasarudza kuparadzira yambiro iyi kuvashandisi, vanochengeta varwere nenyanzvi dzehutano kuitira kuti ruzivo urwu rusvike kuSpain zvakanyanya uye nekukurumidza.
Matanho anokurudzirwa kune varwere nevanovachengeta
Muchiziviso chayo chepamutemo, sangano reSpanish Agency for Medicines and Health Products (AEMPS) rinosanganisira mazano akawanda kune varwere nevanotarisira varwere vachishandisa Dexcom One+ app pamidziyo ye iOS. Kutanga, rinokumbira vashandisi kuti vaone kana vaine yakagamuchira chiziviso mukati meapp pachayo neruzivo rwakapihwa nekambani. Ruzivo urwu runotsanangura dambudziko uye runotsanangura matanho ekutora.
Kana mushandisi asati aona chero meseji yakadaro, zvinokurudzirwa kuti abate Dexcom zvakananga kuti uwane ruzivo rwepamutemo. Kambani iyi inopa akasiyana-siyana Nzira dzekubatsira vatengi uye dzekutsigira tekinoroji muSpain, inowanikwa kuburikidza newebhusaiti yekutaurirana (https://www.dexcom.com/es-ES#contacto), sevhisi yekutsigira tekinoroji (+34 900 423 292) uye sevhisi yevatengi (es.info@dexcom.com, +34 900 423 292).
Danho rinotevera nderekutarisa kuti ndeipi shanduro yeapplication yakaiswa pa iOS device. AEMPS inokurudzira kutarisa kana app iri pakati pe Mavhezheni akabatwa: 1.5 kana 1.6Kana zvakadaro, kuvandudzwa hakuonekwi sechinhu chekusarudza, asi sechinodiwa kuti urambe uchishandisa sisitimu yacho zvakavimbika.
Kuti mugadzirise, mushandisi anofanira kushandisa Dexcom One+ app pa iPhone yake, odzvanya sarudzo ye "Update App", obva aisa vhezheni yazvino inowanikwa paApple App Store. Kana kudhawunirodha nekuiisa kwapera, zvinokurudzirwa kuti muvhurezve app yacho uye tarisa kuti zvese zviri kushanda zvakanakakuona kuti kuverenga kweglucose uye zviziviso zvinogamuchirwa nemazvo.
AEMPS inotiyeuchidza kuti, kana musi wa30 Kubvumbi, 2026 wasvika, shanduro dzekare hadzichashandi, saka Avo chete vakagadzirisa zvinhu ndivo vanokwanisa kuramba vachishandisa Dexcom One+ iOS. pamidziyo yavo. Kufungidzira zuva iroro kunobatsira kudzivirira kukanganiswa kwekutarisa kwezuva nezuva.
Mirayiridzo chaiyo yevashandi vezvehutano
Dare rinoona nezvemitemo harisi kungotaura nezvevarwere nemhuri dzavo chete, asi riri kukumbira pachena kuti vashandi vezvehutano vanoshanda nevanhu vane chirwere cheshugaVanachiremba vekutanga, vanachiremba ve endocrinologists, vanamukoti, vadzidzisi vechirwere cheshuga, nevamwe vashandi vane basa guru mukuparadzira yambiro dzakadai.
Sangano reSpanish Agency for Medicines and Health Products (AEMPS) rinokumbira kuti nyanzvi idzi dzizivise varwere vanoshandisa Dexcom One+ CGM system nezvechikanganiso chakaonekwa mu iOS application. Kana zvichidikanwa, vanokumbirwawo kupa chiziviso chakagadzirwa nekambani, kunyanya kana mushandisi asina kugamuchira kana kuverenga chiziviso panharembozha yavo.
Uyezve, vanokurudzirwa kuti vasimbise kuti ndinoda kugadzirisa shanduro 1.5 ne1.6 kubva kuDexcom One+ iOS app, vachitsanangura kuti kukundikana kuita izvi hakungoisi vashandisi panjodzi yekuchengetedzeka chete, asi zvinorevawo kuti havazokwanisi kushandisa app iyi mushure menguva yakatarwa. Rutsigiro urwu rwakakosha kuve nechokwadi chekuti hapana anosara nekuda kwekushaya ruzivo kana mibvunzo yehunyanzvi.
Munzvimbo dzine sarudzo dzine chekuita neshuga yeropa dzinoitwa kakawanda pazuva—kugadzirisa insulin, kudya makabhohaidhiretsi, kuchinja kwekurovedza muviri—kubatana pakati pevarwere nenyanzvi dzehutano kwakakosha. Yambiro yeAEMPS inoratidza kuti Chengetedza mapurogiramu ehutano achivandudzwa Icho chikamu chebasa iroro revanhu vose.
Kunyangwe chikanganiso chataurwa ichi chichibva padambudziko resoftware, mhedzisiro yacho inogona kunge iri yekiriniki. Nokudaro, sangano iri rinoyeuchidza nyanzvi dzehutano kuti dzinofanira kungwarira mhando idzi dzezviziviso zvemutemo uye kubatsira varwere vavo kududzira nekushandisa mazano acho.
Yambiro iyi yese ine chekuita neDexcom One+ iOS inosimbisa pfungwa yekuti, muzvishandiso zvehutano zvemazuva ese, Chikanganiso chidiki chehunyanzvi chinogona kutungamira kusarudzo dzisina kururama dzekurapa. Kana ikasagadziriswa nenguva, kugadzirisa app, kutarisa vhezheni yakaiswa, uye kuramba uchitaurirana nerutsigiro rweDexcom nechikwata chehutano zvinova matanho akakosha ekuderedza njodzi uye kuramba uchishandisa sisitimu zvakachengeteka sezvinobvira.