Omnipod 5 Automated Insulin Delivery System
INDICATION:
KUVANHU VANE INSULIN INODA TYPE 1 DIABETES AGERE 2 YEARS ZVIKURU.
Automated Insulin Control
automated insulin control kune vanhu vane Type 1 chirwere cheshuga1
Omnipod 5* ine SmartAdjust™ tekinoroji inogonesa kuunza insulin maminetsi ega ega mashanu uchishandisa yakasarudzika glucose tarisiro kubatsira kuderedza nguva mu hyperglycemia uye hypoglycaemia.b,c,d5
- Kusarudzwa kwezvinangwa zveglucose nenguva yezuva, zuva rose; inogona kuchinjika kubva pa110–150 mg/dL (6.1–8.3 mmol/L)
- Iyo chete AID System ine SmartBolus karukureta, inoziviswa neDexcom G6 CGM kukosha uye maitiro
OMNIPOD 5 YAKASIMBIDZWA KUDZORA GLYCEMIC KUVAKURU, VECHIDUKU, UYE VANA VANE T1D MUZVIDZIDZO ZVINOKOSHA C, D, F1, 2
- 76% nguva iri pakati pe110mg/dl (6.1mmol/L) muvakuru nevachiri kuyaruka (14-70 years) uye 68% yakazara TIR muvana (2-13.9 years)
- HbA1c yakaderedzwa zvakanyanya muvana vadiki kwazvo (2.0-5.9 makore), vana (6-13.9 makore), uye vakuru nevachiri kuyaruka (14-70 makore) ne0.5%, 0.7% uye 0.4% zvakateerana1,2
- 33% yakaderedzwa nguva mu hyperglycemia muvana, 24% muvakuru nevechiri kuyaruka 1
- 60% kuderedza mu hypoglycemia usiku hwose uye 46% zvachose muvakuru nevechiri kuyaruka 1
Kugadziriswa pakufamba c,b1
Hapasisina akawanda majekiseni ezuva nezuva, tubing, kana fingersticksh1
- Tubeless, isina mvura, iPod ine yakavakirwa-mukati SmartAdjust™ tekinoroji
- Yakabatanidzwa neiyo Dexcom G6 CGM System j
MU OMNIPOD 5 PIVOTAL DZIDZO
Vakuru vakarondedzera kuderera kwekunetseka pakudya vachienzanisa nekutanga kurapwa c, g
Vabereki vevana vakashuma kunaka kwekurara kuri nani zvichienzaniswa nekutanga kurapwa c, g
Vashandisi vakuru uye vabereki vevana vainzwa vaine chivimbo mukugara vakachengeteka kubva panjodzi yehypoglycemia kana ichienzaniswa nekutanga kurapwa c, g.
Generation AID, CE-yakamaka uye inouya munguva pfupi
Omnipod 5*–inotevera chizvarwa AID, CE-yakaiswa chiratidzo uye iri kuuya munguva pfupi
- Kuvandudza glycemic control kumapoka ose emakore kubva pazera re2 mune zvidzidzo zviviri zvinokosha, nepo nguva mu hypoglycaemia yakaramba yakaderera b, c, d, f 1,2.
- Hapasisina akawanda majekiseni ezuva nezuva, tubing, kana zvigunwe h1
- Tubeless, isina mvura, iPod ine yakavakirwa-mukati SmartAdjust™ tekinoroji
TAURA REP NEWAKO
ONGORORA ZVINOBATSIRA ZEOMNIPOD 5
Kunyangwe inokodzera zvirinani kuCSII, kana kuti ichida yakapusa tubeless insulin yekuendesa sisitimu mukumhanya-kusvika kuOmnipod 5… Omnipod DASH® inogona kuve mhinduro yakanaka nhasi.
Ruzivo Rwakakosha Chekuchengetedza
Iyo Omnipod 5 Automated Insulin Delivery System inoratidzwa kuti ishandiswe nevanhu vane Type 1 chirwere cheshuga mellitus muvanhu vane makore maviri zvichikwira. Iyo Omnipod 2 System inoitirwa murwere mumwe chete, kushandiswa pamba uye inoda kutariswa kwemushandisi wehutano hwehutano. Iyo Omnipod 5 System inoenderana neinotevera U-5 insulins: NovoLog®, Humalog®, uye Admelog®. Tarisa kuOmnipod® 100 Automated Insulin Delivery System User Guide uye www.omnipod.com/safety kuti uwane ruzivo rwakakwana rwekuchengetedza kusanganisira zviratidzo, contraindications, yambiro, yambiro, uye mirayiridzo.
Kana ichishandiswa mune otomatiki modhi neDexcom G6 CGM, iyo Omnipod 5 System inogadzirisa kuburitsa insulin maminetsi mashanu ega ega zvichibva pane yazvino CGM kukosha kwemushandisi, kukosha kweglucose kufanotaura maminetsi makumi matanhatu mune ramangwana, maitiro eglucose, uye yapfuura insulin kuendesa kuunza glucose chinangwa chinotsanangurwa nemushandisi. b Inoda Dexcom G5 CGM. c Inotarisirwa kuyedzwa kwakakosha muvatori vechikamu 60 vane T6D vane makore 240-1 (6 vechidiki/vakuru vane makore 70–128 makore uye 14 vana vane makore 70¬–112). Chidzidzo chacho chaisanganisira 6-day ST phase inoteverwa ne13.9-mwedzi Omnipod 14 HCL chikamu. Kuwanda kwehuwandu hwehuwandu hwehutachiona hweHyglycemia uye chirwere cheshuga ketoacidosis panguva yeAID chikamu chaive 3 uye 5 zviitiko pa4.8 munhu-makore, zvichiteerana.1.2 d Panguva imwecheteyo (100-1 mg / dL [70-180 mmol / L]) sezvakayerwa ne CGM muvakuru / vechidiki uye vana ST vs 3.9-mwedzi Omnipod 10.0: 3% vs 5%, P <64.7; 73.9% vs 0.0001%, P <52.5, zvichiteerana. Zvinoreva HbA68.0c: yekutanga vs Omnipod 0.0001 kushandiswa muvakuru / vechidiki nevana, maererano (1% vs 5%, P <7.16; 6.78% vs 0.0001%, P <7.67).
Panguva ino pamusoro pehuwandu (> 180 mg / dL [10.0 mmol / L]) sezvakayerwa neCGM muvakuru / vechidiki uye vana ST vs 3-mwedzi Omnipod 5: 32.4% vs 24.7%; 45.3% vs. 30.2%, P <0.0001, maererano. Nguva yepakati pasi pehuwandu (<70 mg / dL [3.9 mmol / L]) sezvakayerwa neCGM muvakuru / vechidiki uye vana ST vs 3-mwedzi Omnipod 5: 2.0% vs 1.1%, P <0.0001; 1.4% vs 1.5%, P = 0.8153, zvichiteerana. Nguva yeMedhia iri pasi pehuwandu (<70 mg/dL [3.9 mmol/L]; 12 AM - <6 AM) sekuyerwa neCGM muvakuru/vachiri kuyaruka nevana ST vs 3-mwedzi Omnipod 5: 2.07% vs 0.82%, p< 0.0001; 0.78% vs 0.78%, P=0.0456, zvichiteerana. Kuenzanisa kune kuchinja kwakasiyana.1 e Glucose zvinangwa zvinogona kugadziriswa kusvika ku8 zvikamu pazuva. f Inotarisirwa kuyedzwa muvatori vechikamu makumi masere vane T80D vane makore 1–2. Chidzidzo chacho chaisanganisira 5.9-day ST phase inoteverwa ne14-mwedzi Omnipod 3 HCL chikamu.
Panguva ino muhuwandu (70-180 mg/dL [3.9-10.0 mmol/L]) muvana vaduku zvikuru sekuyerwa neCGM: ST = 57.2%, 3-mwedzi Omnipod 5 = 68.1%, P<0.05. Zvinoreva HbA1c: ST vs Omnipod 5 kushandiswa muvana vaduku zvikuru 7.4% vs 6.9%, P<0.05. Nguva yepakati iri pasi pehuwandu (<70 mg/dL [3.9 mmol/L]) sekuyerwa neCGM: ST vs Omnipod 5 inoshandiswa muvana vadiki zvikuru (2.2% vs 1.9%, P<0.05) 2 g Kusati kwatanga kurapwa muvakuru uye vana, maererano: 15.6% MDI, 84.4% CSII; 9.6% MDI, 90.4% CSII. Munguva yeOmnipod 5 pivotal trial, vanhu vakuru vane makore 18-70 makore (N = 111) vakawana kuvandudzwa kwekudya kwekutsvaga kwekutsvaga mushure memwedzi ye3 yeOmnipod 5 kushandiswa kuenzaniswa ne ST: zvinoreva T1-DDS Eating Distress Subscale: 1.74 vs. 1.97, zvichiteerana.
Vabereki vevana vane makore 6-11.9 makore (N = 82) uye vakuru vane makore 18-70 (N=111) vakawana kuvandudzwa kweiyo hypoglycaemia kuvimba kweongororo yezvibodzwa mushure memwedzi mitatu yeOmnipod 3 kushandiswa zvichienzaniswa neST: zvinoreva HCS mamakisi = 5 vs. 3.59; uye 3.34 vs 3.65, zvichiteerana. Vabereki vevana 3.52-6 makore (N = 11.9) vakawana kuvandudzwa kwehutano hwekurara ongororo chibodzwa mushure memwedzi mitatu yeOmnipod 82 kushandiswa zvichienzaniswa neST: zvinoreva PSQI Yakazara Kurara Hunhu Subscore = 3 vs 5, zvichiteerana.0.70 h Kana glucose yambiro uye kuverenga kubva kuDexcom G1.13 hakuenderane nezviratidzo kana zvinotarisirwa, mita yeglucose yeropa inofanira kushandiswa kuita sarudzo dzekurapa chirwere cheshuga. i Iyo Podhi ine IP1 chiyero chekusvika 6 tsoka kwemaminetsi makumi matanhatu. Mudzori haapindi mvura. Iyo Dexcom G28 sensor uye transmitter inodzivirira mvura uye inogona kunyudzwa pasi pemamita masere emvura kwemaawa anosvika makumi maviri nemana pasina kukundikana kana yaiswa zvakanaka. j Dexcom G25 CGM System inotengeswa zvakasiyana. Iyo Omnipod 60 System inofanirwa kushandiswa neDexcom G6 app uye haienderane neDexcom G24 inogamuchira.
AID, automated insulin delivery; CGM, inoenderera glucose monitor; CSII, inopfuurira subcutaneous insulin infusion; DKA, chirwere cheshuga ketoacidosis; HbA1c, glycated hemoglobin; HCL, hybrid yakavharwa loop; MDI, majekiseni akawanda ezuva nezuva, ST, kurapa kwakajairika; T1D, Type 1 chirwere cheshuga.
References
- Brown S et al. Multicenter kuyedza ye tubeless, pa-muviri automated insulin yekuendesa system ine customizable glycemic zvinangwa muvana uye vakuru vatori vechikamu vane Type 1 chirwere cheshuga. Chirwere cheshuga. 2021;44(7):1630-1640.
- Sherr JL nevamwe. Chengetedzo uye glycemic mhedzisiro ine tubeless otomatiki insulin yekuendesa sisitimu muvana vadiki kwazvo vane Type 1 chirwere cheshuga: imwe-ruoko, multicenter kiriniki yekuyedza. Chirwere cheshuga. 2022; doi: 10.2337/dc21-2359 [Pamhepo pamberi pekudhindwa].
© 2022 Insulet Corporation. Omnipod, SmartAdjust, uye Omnipod 5 logo zviratidzo zvekutengesa kana zviratidzo zvakanyoreswa zveInsulet Corporation muUnited States of America nedzimwe nzvimbo dzakasiyana. Kodzero dzese dzakachengetwa. Dexcom neDexcom G6 zvikwangwani zvakanyoreswa zveDexcom, Inc. uye zvinoshandiswa nemvumo. Zvimwe zviratidzo zvese zvinhu zvevaridzi vazvo. Kushandiswa kwevechitatu-bato zviratidzo hakuunze tsigiro kana kureva hukama kana humwe hukama. 1 King St, Hammersmith London W6 9HR INS-OHS-07-2022-00001 v.1
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omnipod Omnipod 5 Automated Insulin Delivery System [pdf] User Manual Omnipod 5 Automated Insulin Delivery System, Omnipod 5, Automated Insulin Delivery System, Insulin Delivery System, Delivery System |