Omnipod 5 Pūnaehana Hoʻouna Insulin Automated
HOAKAKA:
NO KA POE ME INSULIN e koi ana i ka ma'i ma'i ma'i TYPE 1 I 2 MAKAHIKI A OI.
Hoʻomalu Insulin Automated
ka hoʻomalu ʻana i ka insulin no ka poʻe me ka maʻi diabetes type 1
ʻO Omnipod 5* me ka ʻenehana SmartAdjust™ e hoʻokele pono ana i ka hāʻawi ʻana i ka insulin i kēlā me kēia 5 mau minuke me ka hoʻohana ʻana i kahi pahu glucose maʻamau e kōkua i ka hōʻemi ʻana i ka manawa o ka hyperglycaemia a me ka hypoglycaemia.b,c,d1
- Ke koho ʻana i nā pahuhopu glucose i ka manawa o ka lā, i ka lā a pau; hiki ke hoʻololi ʻia mai ka 110–150 mg/dL (6.1–8.3 mmol/L)e
- ʻO ka Pūnaehana AID wale nō me ka helu helu SmartBolus, i ʻike ʻia me ka waiwai a me ke ʻano o Dexcom G6 CGM
OMNIPOD 5 KA HOʻOPIʻI I KA MANA GLYCEMIC NO KA POE MAKUA, NA ʻOPIʻOPIʻI, A me nā kamaliʻi me T1D ma nā haʻawina PIVOTAL C, D, F1, 2
- ʻO 76% ka manawa i ka laulā ma kahi pahuhopu o 110mg/dl (6.1mmol/L) i nā pākeke a me nā ʻōpio (14-70 mau makahiki) a me 68% TIR holoʻokoʻa i nā keiki (2-13.9 mau makahiki)
- Ua hoʻemi nui ʻia ka HbA1c i nā keiki liʻiliʻi loa (2.0-5.9 mau makahiki), nā keiki (6-13.9 mau makahiki), a me nā pākeke a me nā ʻōpio (14-70 mau makahiki) e 0.5%, 0.7% a me 0.4% pākahi.
- 33% ho'ēmi manawa i ka hyperglycaemia i nā keiki, 24% i nā mākua a me nā ʻōpio 1
- He 60% ka emi ʻana o ka hypoglycaemia i ka pō a me 46% ka nui o nā pākeke a me nā ʻōpio.
Hoʻololi i ka hele c,b1
ʻAʻohe hoʻopaʻa ʻana i kēlā me kēia lā, paipu, a i ʻole manamana lima
- Tubeless, wai, i Pod me ka ʻenehana SmartAdjust™ i kūkulu ʻia
- Hoʻohui ʻia me ka Dexcom G6 CGM System j
I KA OMNIPOD 5 PIVOTAL HAAWINA
Ua hōʻike ka poʻe mākua i ka haʻahaʻa haʻahaʻa i ka wā e ʻai ai i ka hoʻohālikelike ʻana i ka lāʻau lapaʻau mua c,g
Ua hōʻike nā mākua o nā keiki i ka maikaʻi o ka hiamoe ma mua o ka hoʻomaʻamaʻa mua c,g
Ua hilinaʻi nā mea hoʻohana makua a me nā mākua o nā keiki i ka noho palekana ʻana mai ka pilikia o ka hypoglycaemia i hoʻohālikelike ʻia i ka lāʻau mua c,g
Generation AID, CE-marked a hiki koke mai
ʻO Omnipod 5*–He kōkua kōkua, hōʻailona CE a hiki koke mai
- Hoʻomaikaʻi ʻia ka mana glycemic ma waena o nā pūʻulu makahiki āpau mai ka makahiki 2 i loko o ʻelua mau haʻawina pivotal, ʻoiai ʻo ka manawa ma ka hypoglycaemia e mau ana ka haʻahaʻa b,c,d,f 1,2
- ʻAʻohe hoʻopaʻa ʻana i kēlā me kēia lā, paipu, a i ʻole nā manamana lima h1
- Tubeless, wai, i Pod me ka ʻenehana SmartAdjust™ i kūkulu ʻia
E 'Ōlelo REP ME KOU
E ʻimi i nā pono o OMNIPOD 5
ʻOi aku ka maikaʻi i ka CSII, a i ʻole e pono ai i kahi ʻōnaehana hāʻawi insulin tubeless maʻalahi i ka holo ʻana i Omnipod 5… Hiki ke lilo ʻo Omnipod DASH® i mea hoʻonā maikaʻi i kēia lā.
ʻIke palekana koʻikoʻi
Hōʻike ʻia ka Omnipod 5 Automated Insulin Delivery System no ka hoʻohana ʻana e nā poʻe me ka maʻi diabetes type 1 i nā poʻe 2 makahiki a ʻoi aku. Hoʻohana ʻia ka Omnipod 5 System no ka mea maʻi hoʻokahi, hoʻohana i ka home a koi i ka nānā ʻana o ka mea mālama ola kino. Ua kūpono ka ʻōnaehana Omnipod 5 me nā insulins U-100: NovoLog®, Humalog®, a me Admelog®. E nānā i ka Omnipod® 5 Automated Insulin Delivery System Guide Guide a me www.omnipod.com/safety no ka ʻike palekana piha me nā hōʻailona, contraindications, nā ʻōlelo aʻoaʻo, nā ʻōlelo aʻo.
Ke hoʻohana ʻia i ke ʻano maʻalahi me Dexcom G6 CGM, hana ka Omnipod 5 System i nā hoʻololi i ka hāʻawi ʻana i ka insulin i kēlā me kēia 5 mau minuke e pili ana i ka waiwai CGM o ka mea hoʻohana i kēia manawa, nā helu glucose i wānana ʻia he 60 mau minuke i ka wā e hiki mai ana, ke ʻano glucose, a me ka hāʻawi ʻana o ka insulin i hala e lawe mai i ka glucose i he pahu hopu hoʻohana. b Pono i kahi Dexcom G6 CGM. c Ka ho'āʻo pivotal prospective ma 240 poʻe me ka T1D makahiki 6-70 makahiki (128 'ōpio / makua makahiki makahiki 14-70 makahiki a me 112 keiki makahiki 6¬-13.9 makahiki). Ua komo ka haʻawina i kahi māhele ST 14 lā a ukali ʻia e 3 mau mahina Omnipod 5 HCL. ʻO ka nui o ka nui o ka hypoglycemia koʻikoʻi a me ka ketoacidosis diabetic i ka wā o ka AID he 4.8 a me 1.2 mau hanana i kēlā me kēia 100 kanaka-makahiki. CGM i nā mākua / ʻōpio a me nā keiki ST vs 1-mahina Omnipod 70: 180% vs 3.9%, P<10.0; 3% vs 5%, P<64.7, kēlā me kēia. Mean HbA73.9c: baseline vs Omnipod 0.0001 hoʻohana i nā pākeke / ʻōpio a me nā keiki, kēlā me kēia (52.5% vs 68.0%, P<0.0001; 1% vs 5%, P<7.16).
ʻO ka manawa ma luna o ka laulā (> 180 mg / dL [10.0 mmol / L]) e like me ke ana ʻana e CGM i nā pākeke / ʻōpio a me nā keiki ST vs 3-malama Omnipod 5: 32.4% vs 24.7%; 45.3% vs. 30.2%, P<0.0001. ʻO ka manawa Median ma lalo o ka palena (<70 mg / dL [3.9 mmol / L]) e like me ke anaʻana e CGM i nā mākua /'ōpio a me nā keiki ST vs 3-mahina Omnipod 5: 2.0% vs 1.1%, P<0.0001; 1.4% vs 1.5%, P=0.8153. ʻO ka manawa Median ma lalo o ka pae (<70 mg/dL [3.9 mmol/L]; 12 AM - <6 AM) e like me ke ana ʻana e CGM i nā pākeke / ʻōpio a me nā keiki ST vs 3-mahina Omnipod 5: 2.07% vs 0.82%, p< 0.0001; 0.78% vs 0.78%, P=0.0456. ʻO nā hoʻohālikelike he mau loli pili. f Ka hoʻāʻo ʻana ma 1 mau mea komo me T8D makahiki 80-1 makahiki. Ua komo ka haʻawina i kahi māhele ST 2 lā a ukali ʻia e 5.9 mau mahina Omnipod 14 HCL.
I kēia manawa ma ka laulā (70–180 mg/dL [3.9–10.0 mmol/L]) i nā keiki liʻiliʻi loa e like me ke ana ʻana e CGM: ST = 57.2%, 3-mahina Omnipod 5 = 68.1%, P<0.05. Mean HbA1c: ST vs Omnipod 5 hoʻohana i nā keiki ʻōpio loa 7.4% vs 6.9%, P<0.05. ʻO ka manawa Median ma lalo o ka palena (<70 mg/dL [3.9 mmol/L]) e like me ke ana ʻana e CGM: ST vs Omnipod 5 hoʻohana i nā keiki liʻiliʻi loa (2.2% vs 1.9%, P<0.05) .2 g ʻO ka lāʻau mua i nā pākeke a nā keiki, kēlā me kēia: 15.6% MDI, 84.4% CSII; 9.6%MDI, 90.4% CSII. I ka wā o ka Omnipod 5 pivotal hoʻokolokolo, ʻike ka poʻe makua 18-70 makahiki (N=111) i ka hoʻomaikaʻi ʻana i ka ʻai ʻana i ka helu ʻai pilikia ma hope o 3 mau mahina o ka hoʻohana ʻana iā Omnipod 5 i hoʻohālikelike ʻia me ST: mean T1-DDS Eating Distress Subscale: 1.74 vs. 1.97, pakahi.
Ua ʻike nā mākua o nā keiki 6-11.9 makahiki (N=82) a me nā mākua 18-70 makahiki (N=111) i ka hoʻomaikaʻi ʻana i ka helu hōʻoia hilinaʻi hypoglycaemia ma hope o 3 mau mahina o ka hoʻohana ʻana iā Omnipod 5 i hoʻohālikelike ʻia me ST: mean score HCS = 3.59 vs. 3.34; a me 3.65 vs 3.52. Ua ʻike nā mākua o nā keiki 6-11.9 makahiki (N=82) i ka hoʻomaikaʻi ʻana i ka helu noiʻi maikaʻi o ka hiamoe ma hope o 3 mau mahina o ka hoʻohana ʻana iā Omnipod 5 i hoʻohālikelike ʻia me ST: mean PSQI Overall Sleep Quality Subscore = 0.70 vs 1.13, each.1 h Inā ʻike ka glucose a ʻAʻole kūlike nā heluhelu mai Dexcom G6 i nā hōʻailona a i ʻole nā manaʻo, pono e hoʻohana ʻia kahi mita glucose koko e hoʻoholo ai i ka mālama ʻana i ka maʻi diabetes. i He helu IP28 ka Pod a hiki i 25 kapuai no 60 mau minuke. ʻAʻole wai wai ka mea hoʻoponopono. ʻO ka mea ʻike Dexcom G6 a me ka mea hoʻolele ke kūpaʻa i ka wai a hiki ke hoʻopaʻa ʻia ma lalo o ʻewalu kapuaʻi o ka wai a hiki i 24 mau hola me ka ʻole o ka hemahema ke hoʻokomo pono ʻia. j Dexcom G6 CGM System kuai kaawale. Pono e hoʻohana ʻia ka Pūnaehana Omnipod 5 me ka polokalamu Dexcom G6 a ʻaʻole kūpono me ka mea hoʻokipa Dexcom G6.
AID, hāʻawi i ka insulin automated; CGM, ka nānā ʻana i ka glucose mau; CSII, hoʻomau i ka hoʻokomo ʻana o ka insulin subcutaneous; DKA, ketoacidosis diabetic; HbA1c, hemoglobin glycated; HCL, huila pani pani; MDI, he nui o na injections i kela la i keia la, ST, ma'i ma'amau; T1D, maʻi maʻi type 1.
Nā kuhikuhi
- Brown S et al. ʻO ka hoʻāʻo multicenter o kahi ʻōnaehana hāʻawi insulin automated ma ke kino me nā pahuhopu glycemic maʻamau i nā keiki keiki a me nā poʻe mākua me ka maʻi diabetes type 1. Ka mālama ʻana i ka maʻi diabetes. 2021;44(7):1630-1640.
- Sherr JL et al. Nā hopena palekana a me ka glycemic me kahi ʻōnaehana hāʻawi insulin automated tubeless i nā keiki liʻiliʻi loa me ka maʻi diabetes type 1: kahi hoʻāʻo hoʻokolohua hoʻokahi lima, multicenter. Ka mālama ʻana i ka maʻi diabetes. 2022; doi: 10.2337/dc21-2359 [Ma mua o ka paʻi pūnaewele].
© 2022 Insulet Corporation. ʻO Omnipod, SmartAdjust, a me ka Omnipod 5 hōʻailona hōʻailona a i ʻole hōʻailona inoa inoa o Insulet Corporation ma ʻAmelika Hui Pū ʻIa a me nā ʻāina ʻē aʻe. Ua mālama ʻia nā kuleana āpau. ʻO Dexcom a me Dexcom G6 nā inoa inoa inoa o Dexcom, Inc. a hoʻohana ʻia me ka ʻae. ʻO nā hōʻailona ʻē aʻe a pau ka waiwai o ko lākou mau mea nona. ʻO ka hoʻohana ʻana i nā hōʻailona ʻaoʻao ʻekolu ʻaʻole ia he hōʻoia a i ʻole ka manaʻo i kahi pilina a i ʻole pili ʻē aʻe. 1 King St, Hammersmith London W6 9HR INS-OHS-07-2022-00001 v.1
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