I-Omnipod ye-5 ye-Automated Insulin Delivery System
ISALATHISO:
KUBANTU ABANE-INSULIN ABAFUNA UHLOBO LWESEKEKO ESI-1 ABADALA IMINYAKA emi-2 nangaphezulu.
Ulawulo lwe-Insulin oluzenzekelayo
Ukulawulwa kwe-insulin ngokuzenzekelayo kubantu abanesifo sikashukela sohlobo loku-1
I-Omnipod 5* ene-SmartAdjust™ itekhnoloji ilawula ngokuqhubekayo ukuhanjiswa kwe-insulin rhoqo ngemizuzu emi-5 isebenzisa i-glucose ekujoliswe kuyo ukunceda ukunciphisa ixesha kwi-hyperglycaemia kunye ne-hypoglycaemia.b,c,d1
- Ukukhetha iithagethi zeglucose ngexesha lemini, yonke imini; ukulungiswa ukusuka ku-110-150 mg/dL (6.1–8.3 mmol/L) e
- Ekuphela kweNkqubo ye-AID ene-SmartBolus calculator, enolwazi ngexabiso kunye ne-Dexcom G6 CGM
I-OMNIPOD 5 ULAWULO LWEGLYCEMIC OLUPHUCILEYO KUBANTU ABADALA, ABAFIKISAYO, NABANTWANA ABANE-T1D KWIZIFUNDO EZINGUNDOQO C, D, F1, 2
- I-76% yexesha kuluhlu kwithagethi ye-110mg / dl (6.1mmol / L) kubantu abadala kunye nolutsha (iminyaka eyi-14-70) kunye ne-68% iyonke i-TIR kubantwana (i-2-13.9 iminyaka)
- I-HbA1c yancitshiswa kakhulu kubantwana abancinci kakhulu (iminyaka eyi-2.0-5.9), abantwana (iminyaka eyi-6-13.9), kunye nabantu abadala kunye nolutsha (iminyaka eyi-14-70) ngo-0.5%, 0.7% kunye ne-0.4% ngokulandelanayo1,2
- I-33% inciphisa ixesha kwi-hyperglycemia ebantwaneni, i-24% kubantu abadala kunye nolutsha olufikisayo.
- 60
Uhlengahlengiso ekuhambeni c,b1
Azisekho iinaliti ezininzi zemihla ngemihla, iityhubhu, okanye ifingersticksh1
- I-tubeless, ingenamanzi, i-iPod enobuchwepheshe obakhelwe ngaphakathi be-SmartAdjust™
- Idityaniswe neNkqubo echanekileyo ye-Dexcom G6 CGM j
KWI-OMNIPOD 5 IZIFUNDO EZINGUNDOQO
Abantu abadala babika uxinzelelo oluphantsi xa besitya xa kuthelekiswa nonyango lwangaphambili c, g
Abazali babantwana bachaza umgangatho ongcono wokulala xa kuthelekiswa nonyango lwangaphambili c, g
Abasebenzisi abadala kunye nabazali babantwana baziva bezithembile ngokuhlala bekhuselekile kumngcipheko we-hypoglycaemia xa kuthelekiswa nonyango lwangaphambili c, g.
I-Generation AID, i-CE-marked kwaye iyeza kungekudala
I-Omnipod 5*–isizukulwana esilandelayo i-AID, i-CE-imakishwe kwaye iyeza kungekudala
- Ukuphuculwa kolawulo lwe-glycemic kuwo onke amaqela eminyaka yobudala ukusuka kwi-2 kwizifundo ezimbini ezibalulekileyo, ngelixa ixesha le-hypoglycaemia lahlala liphantsi b, c, d, f 1,2
- Azisekho iinaliti zemihla ngemihla, iityhubhu, okanye iintonga zeminwe h1
- I-tubeless, ingenamanzi, i-iPod eneteknoloji eyakhelweyo ye-SmartAdjust™
THETHA REP NAKHO
HLOLA IINZUZO ZE-OMNIPOD 5
Ingaba ifaneleka ngakumbi kwi-CSII, okanye idinga inkqubo yonikezelo lwe-insulin ye-tubeless kwi-Omnipod 5… I-Omnipod DASH® ingaba sisisombululo esihle namhlanje.
Ulwazi loKhuseleko oluBalulekileyo
I-Omnipod 5 Automated Insulin Delivery System iboniswa ukuba isetyenziswe ngabantu abane-Type 1 yesifo sikashukela kubantu abaneminyaka eyi-2 ubudala nangaphezulu. I-Omnipod 5 System yenzelwe isigulana esinye, ukusetyenziswa ekhaya kwaye ifuna ukubeka iliso kumboneleli wezempilo womsebenzisi. I-Omnipod 5 System iyahambelana ne-insulin ye-U-100 elandelayo: i-NovoLog®, i-Humalog®, kunye ne-Admelog®. Jonga kwi-Omnipod® 5 Automated Insulin Delivery System Isikhokelo somsebenzisi kunye www.omnipod.com/safety ngolwazi olupheleleyo lokhuseleko kuquka imiqondiso, contraindications, izilumkiso, izilumkiso, kunye nemiyalelo.
Xa isetyenziswe kwimodi ezenzekelayo kunye ne-Dexcom G6 CGM, i-Omnipod 5 System yenza uhlengahlengiso ekuhanjisweni kwe-insulin rhoqo ngemizuzu ye-5 ngokusekelwe kwixabiso le-CGM yomsebenzisi, ixabiso le-glucose liqikelelwe kwimizuzu engama-60 kwixesha elizayo, ukuhamba kwe-glucose, kunye nokuhanjiswa kwe-insulin edlulileyo ukuzisa i-glucose. ekujoliswe kuko okuchazwe ngumsebenzisi. b Ifuna i-Dexcom G6 CGM. c Ulingo olulindelekileyo olulindelekileyo kubathathi-nxaxheba abangama-240 abane-T1D abaneminyaka eyi-6-70 (abafikisayo abali-128/abadala abaphakathi kweminyaka eli-14 ukuya kuma-70 kunye nabantwana abali-112 abaneminyaka eyi-6¬–13.9). Uphononongo lubandakanya isigaba se-ST seentsuku ze-14 esilandelwa yinyanga ye-3 ye-Omnipod 5 isigaba se-HCL. Izinga leziganeko ze-hypoglycemia enzima kunye ne-ketoacidosis yesifo sikashukela ngexesha le-AID yi-4.8 kunye neziganeko ze-1.2 kwi-100 yomntu-iminyaka, ngokulandelanayo.1 d Ngelo xesha kuluhlu (70-180 mg / dL [3.9-10.0 mmol / L]) njengoko kulinganiswe ngo. I-CGM kubantu abadala / abaselula kunye nabantwana ST vs 3-inyanga ye-Omnipod 5: 64.7% vs 73.9%, P <0.0001; 52.5% vs 68.0%, P<0.0001, ngokulandelanayo. Ithetha i-HbA1c: isiseko esisisiseko vs i-Omnipod 5 ukusetyenziswa kubantu abadala / abaselula kunye nabantwana, ngokulandelanayo (7.16% vs 6.78%, P<0.0001; 7.67% vs 6.99%, P <0.0001).
Okwangoku ngaphezu koluhlu (> 180 mg / dL [10.0 mmol / L]) njengoko kulinganiswa neCGM kubantu abadala / abaselula kunye nabantwana ST vs 3-inyanga ye-Omnipod 5: 32.4% vs 24.7%; 45.3% vs. 30.2%, P <0.0001, ngokulandelanayo. Ixesha eliphakathi ngaphantsi koluhlu (<70 mg / dL [3.9 mmol / L]) njengoko kulinganiswe yiCGM kubantu abadala / abaselula kunye nabantwana ST vs 3-inyanga ye-Omnipod 5: 2.0% vs 1.1%, P <0.0001; 1.4% vs 1.5%, P = 0.8153, ngokulandelanayo. Ixesha eliphakathi ngaphantsi koluhlu (<70 mg / dL [3.9 mmol / L]; 12 AM - <6 AM) njengoko ilinganiswe yiCGM kubantu abadala / abaselula kunye nabantwana ST vs 3-inyanga ye-Omnipod 5: 2.07% vs 0.82%, p< 0.0001; 0.78% vs 0.78%, P = 0.0456, ngokulandelanayo. Uthelekiso lutshintsho oluhambelanayo.1 Iithagethi zeGlucose zinokuhlengahlengiswa ukuya kuthi ga kwi-8 yamacandelo ngosuku. f Ulingo olulindelekileyo kubathathi-nxaxheba abangama-80 abane-T1D abaneminyaka eyi-2–5.9 ubudala. Uphononongo lubandakanya isigaba se-ST seentsuku ezili-14 esilandelwa yinyanga ye-3 ye-Omnipod 5 isigaba se-HCL.
Okwangoku kuluhlu (70-180 mg / dL [3.9-10.0 mmol / L]) kubantwana abancinci kakhulu njengoko kulinganiswe yiCGM: ST = 57.2%, inyanga ye-3 ye-Omnipod 5 = 68.1%, P<0.05. Kuthetha i-HbA1c: I-ST vs i-Omnipod 5 isetyenziswe kubantwana abancinci kakhulu 7.4% vs 6.9%, P<0.05. Ixesha eliphakathi elingaphantsi koluhlu (<70 mg / dL [3.9 mmol / L]) njengoko kulinganiswe yiCGM: ST vs Omnipod 5 ukusetyenziswa kubantwana abancinci kakhulu (2.2% vs 1.9%, P <0.05) .2 g Unyango lwangaphambili kubantu abadala kunye abantwana, ngokulandelanayo: 15.6% MDI, 84.4% CSII; 9.6%MDI, 90.4% CSII. Ngethuba lovavanyo olubalulekileyo lwe-Omnipod 5, abantu abadala abaneminyaka eyi-18-70 iminyaka (N = 111) bafumana ukuphuculwa kokutya kovavanyo lovavanyo emva kweenyanga ze-3 zokusetyenziswa kwe-Omnipod 5 xa kuthelekiswa ne-ST: ithetha i-T1-DDS Eating Distress Subscale: 1.74 vs. 1.97, ngokulandelelanayo.
Abazali babantwana abaneminyaka eyi-6-11.9 iminyaka (N = 82) kunye nabantu abadala abaneminyaka eyi-18-70 iminyaka (N = 111) bafumana uphuculo kwi-hypoglycaemia yovavanyo lokuzithemba emva kweenyanga ezi-3 zokusetyenziswa kwe-Omnipod 5 xa kuthelekiswa ne-ST: ithetha ukuba amanqaku e-HCS = 3.59 vs. 3.34; kunye ne-3.65 vs 3.52, ngokulandelanayo. Abazali babantwana be-6-11.9 iminyaka (N = 82) bafumana ukuphuculwa kwinqanaba le-survey yekhwalithi yokulala emva kweenyanga ze-3 ze-Omnipod 5 yokusetyenziswa xa kuthelekiswa ne-ST: ithetha i-PSQI i-Sleep Quality Subscore jikelele = 0.70 vs 1.13, ngokulandelanayo.1 h Ukuba izilumkiso ze-glucose kunye ukufundwa kwe-Dexcom G6 akufani neempawu okanye ukulindela, imitha ye-glucose yegazi kufuneka isetyenziswe ukwenza izigqibo zonyango lwesifo sikashukela. i I-Pod inomlinganiselo we-IP28 ukuya kuthi ga kwi-25 yeenyawo kwimizuzu engama-60. Umlawuli akanamanzi. I-sensor ye-Dexcom G6 kunye ne-transmitter ayinamanzi kwaye inokuthi ifakwe phantsi kweenyawo ezisibhozo zamanzi ukuya kwiiyure ze-24 ngaphandle kokusilela xa ifakwe ngokufanelekileyo. j Dexcom G6 CGM System ithengiswa ngokwahlukeneyo. I-Omnipod 5 System kufuneka isetyenziswe kunye ne-Dexcom G6 app kwaye ayihambelani ne-Dexcom G6 receiver.
I-AID, ukuhanjiswa kwe-insulin ngokuzenzekelayo; I-CGM, i-monitor ye-glucose eqhubekayo; I-CSII, i-insulin eqhubekayo ye-subcutaneous infusion; DKA, isifo seswekile ketoacidosis; I-HbA1c, i-hemoglobin ye-glycated; I-HCL, i-hybrid ivaliwe iluphu; I-MDI, ii-injection ezininzi zemihla ngemihla, i-ST, unyango oluqhelekileyo; T1D, uhlobo 1 seswekile.
Iimbekiselo
- UBrown S et al. Ulingo lwe-Multicenter ye-tubeless, kumzimba wenkqubo yokuhanjiswa kwe-insulin ezenzekelayo kunye neethagethi ze-glycemic ezizenzekelayo kubantwana kunye nabathathi-nxaxheba abadala abanesifo seswekile se-1. Ukhathalelo lwesifo seswekile. 2021;44(7):1630-1640.
- USherr JL et al. Ukhuseleko kunye neziphumo ze-glycemic kunye ne-tubeless automated insulin delivery system kubantwana abancinci kakhulu abanesifo sikashukela sohlobo lwe-1: ingalo enye, ilingo leklinikhi eninzi. Ukhathalelo lwesifo seswekile. 2022; doi: 10.2337/dc21-2359 [kwi-intanethi phambi koshicilelo].
© 2022 Insulet Corporation. I-Omnipod, i-SmartAdjust, kunye ne-Omnipod 5 logo ziimpawu zorhwebo okanye ziimpawu zorhwebo ezibhalisiweyo ze-Insulet Corporation e-United States of America kunye nezinye iindawo ezahlukeneyo zolawulo. Onke Amalungelo Agciniwe. I-Dexcom kunye ne-Dexcom G6 ziimpawu zorhwebo ezibhalisiweyo ze-Dexcom, Inc. kwaye zisetyenziswa ngemvume. Zonke ezinye iimpawu zorhwebo ziyipropati yabanini bazo. Ukusetyenziswa kweempawu zokurhweba zomntu wesithathu akuthethi ukuvuma okanye kuthetha ubudlelwane okanye enye indibaniselwano. 1 King St, Hammersmith London W6 9HR INS-OHS-07-2022-00001 v.1
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