Omnipod 5 Sistemụ nnyefe insulin na-akpaghị aka

Ngosipụta:
Maka ndị nwere insulin chọrọ ụdị ọrịa shuga 1 dị afọ abụọ na karịa.

Njikwa insulin na-akpaghị aka

njikwa insulin akpaghị aka maka ndị nwere ụdị ọrịa shuga 1
Omnipod 5* na teknụzụ SmartAdjust™ na-arụsi ọrụ ike na-achịkwa nnyefe insulin kwa nkeji ise ọ bụla site na iji ebumnuche glucose ahaziri iji nyere aka belata oge hyperglycemia na hypoglycaemia.b,c,d5.

• Nhọrọ nke ebumnuche glucose n'oge ụbọchị, ụbọchị niile; mgbanwe site na 110-150 mg/dL (6.1-8.3 mmol/l)e
• Naanị Sistemụ AID nwere mgbako SmartBolus, mara uru na omume Dexcom G6 CGM

OMNIPOD 5 MARA GLYCEMIC njikwa maka ndị okenye, ndị ntorobịa, na ụmụaka nwere T1D n'ọmụmụ ihe PIVOTAL C, D, F1, 2

• 76% oge n'ogo na ebumnuche nke 110mg/dl (6.1mmol/L) na ndị okenye na ndị nọ n'afọ iri na ụma (14-70 afọ) na 68% n'ozuzu TIR na ụmụaka (2-13.9 afọ)
• HbA1c belatara nke ukwuu n'ime ụmụaka dị obere (afọ 2.0-5.9), ụmụaka (afọ 6-13.9), na ndị okenye na ndị nọ n'afọ iri na ụma (afọ 14-70) site na 0.5%, 0.7% na 0.4% n'otu n'otu1,2.
• 33% belatara oge hyperglycemia n'ime ụmụaka, 24% na ndị okenye na ndị nọ n'afọ iri na ụma 1
• Mbelata 60% nke hypoglycemia n'abali yana 46% n'ozuzu ya na ndị okenye na ndị nọ n'afọ iri na ụma 1

Ndozi na aga c,b1

Agakwaghị ọtụtụ injections kwa ụbọchị, tubing, ma ọ bụ mkpịsị aka1

• Tubeless, waterproof,i Pod nke arụnyere na teknụzụ SmartAdjust™
• Ejikọtara ya na Dexcom G6 CGM System j

N'ime OMNIPOD 5 PIVOTAL NDỤMỤ

• Ndị okenye kwuru na nrụgide dị ala mgbe ha na-eri nri ma e jiri ya tụnyere ọgwụgwọ mbụ c, g
• Ndị nne na nna ụmụaka kwuru na ihi ụra ka mma ma e jiri ya tụnyere ọgwụgwọ mbụ c,g
• Ndị okenye na ndị nne na nna nke ụmụaka nwere obi ike na ha ga-echebe onwe ha pụọ ​​​​na ihe ize ndụ nke hypoglycemia ma e jiri ya tụnyere ọgwụgwọ mbụ c,g

Generation AID, akara CE ma na-abịa ngwa ngwa

Omnipod 5*-AID ọgbọ na-abịa, akara CE ma na-abịa n'oge adịghị anya

• Ọganihu glycemia n'ime afọ niile site na afọ 2 n'ime ọmụmụ ihe abụọ dị mkpa, ebe oge hypoglycemia dị obere b,c,d,f 1,2.
• Agakwaghị ọtụtụ injections kwa ụbọchị, tubing, ma ọ bụ mkpịsị aka h1
• Tubeless, waterproof, i Pod nwere teknụzụ SmartAdjust™ arụnyere n'ime ya

Kpọọ onye nke gị okwu
Chọpụta Uru OMNIPOD 5

Ma ọ dabara nke ọma na CSII, ma ọ bụ na ọ dị mkpa maka usoro nnyefe insulin tube na-enweghị tube na-erute Omnipod 5… Omnipod DASH® nwere ike ịbụ ezigbo ngwọta taa.

Ozi nchekwa dị mkpa

Edepụtara sistemu nnyefe insulin akpaghị aka nke Omnipod 5 maka ndị nwere ụdị ọrịa shuga mellitus nke 1 n'ime ndị gbara afọ 2 na karịa. Ezubere Sistemu Omnipod 5 maka onye otu onye ọrịa, iji ụlọ ma chọọ nlekọta nke onye na-ahụ maka ahụike onye ọrụ. Sistemụ Omnipod 5 dakọtara na insulins U-100 ndị a: NovoLog®, Humalog® na Admelog®. Rụtụ aka na ntuziaka onye ọrụ Omnipod® 5 akpaghị aka na nnyefe insulin www.omnipod.com/safety maka ozi nchekwa zuru oke gụnyere ihe ngosi, contraindications, ịdọ aka ná ntị, ịdọ aka ná ntị, na ntụziaka.

Mgbe ejiri ya na ọnọdụ akpaka na Dexcom G6 CGM, Omnipod 5 Sistemụ na-eme mgbanwe na nnyefe insulin kwa nkeji 5 dabere na uru CGM nke onye ọrụ ugbu a, ụkpụrụ glucose buru amụma nkeji 60 n'ọdịniihu, usoro glucose na nnyefe insulin gara aga iji weta glucose. ebumnuche akọwapụtara onye ọrụ. b chọrọ Dexcom G6 CGM. c Ọnwụnwa dị mkpa na-atụ anya na ndị sonyere 240 nwere T1D dị afọ 6-70 (ndị ntorobịa 128 / ndị okenye dị afọ 14-70 na ụmụaka 112 dị afọ 6¬-13.9). Ọmụmụ ihe ahụ gụnyere usoro 14 ụbọchị ST na-esote usoro Omnipod 3 HCL nke ọnwa 5. Ọnụ ọgụgụ nke hypoglycemia siri ike na ketoacidosis na-arịa ọrịa mamịrị n'oge usoro AID bụ 4.8 na 1.2 omume kwa afọ 100 mmadụ, otu n'otu n'otu. CGM na ndị okenye / ndị nọ n'afọ iri na ụma na ụmụaka ST vs 1-ọnwa Omnipod 70: 180% vs 3.9%, P<10.0; 3% vs 5%, P <64.7, n'otu n'otu. Pụtara HbA73.9c: baseline vs Omnipod 0.0001 na-eji ndị okenye / ndị nọ n'afọ iri na ụma na ụmụaka, n'otu n'otu (52.5% vs 68.0%, P<0.0001; 1% vs 5%, P<7.16).

Oge dị n'elu oke (> 180 mg / dL [10.0 mmol / L]) dị ka a tụrụ site na CGM na ndị okenye / ndị ntorobịa na ụmụaka ST vs 3-ọnwa Omnipod 5: 32.4% vs 24.7%; 45.3% vs. 30.2%, P<0.0001, n'otu n'otu. Oge etiti oge n'okpuru oke (<70 mg / dL [3.9 mmol/L]) dị ka a tụrụ site na CGM na ndị okenye / ndị ntorobịa na ụmụaka ST vs 3-ọnwa Omnipod 5: 2.0% vs 1.1%, P<0.0001; 1.4% vs 1.5%, P=0.8153, n'otu n'otu. Oge etiti oge n'okpuru oke (<70 mg/dL [3.9 mmol/L]; 12 AM - <6 AM) dị ka atụpụtara site na CGM na ndị okenye / ndị nọ n'afọ iri na ụma na ụmụaka ST vs 3-ọnwa Omnipod 5: 2.07% vs 0.82%, p< 0.0001; 0.78% vs 0.78%, P=0.0456, n'otu n'otu. Ntụnyere bụ mgbanwe mgbanwe.1 e Glucose lekwasịrị anya nwere ike imezi ihe ruru 8 nkeji kwa ụbọchị. Ọnwụnwa na-atụ anya na ndị sonyere 80 nwere T1D gbara afọ 2–5.9. Ọmụmụ ihe ahụ gụnyere usoro 14 ụbọchị ST na-esote usoro Omnipod 3 HCL nke ọnwa 5.

N'oge dị na nso (70-180 mg/dL [3.9-10.0 mmol/L]) n'ime ụmụaka dị obere ka a tụrụ ya na CGM: ST = 57.2%, 3-ọnwa Omnipod 5 = 68.1%, P<0.05. Pụtara HbA1c: ST vs Omnipod 5 na-eji na obere ụmụaka 7.4% vs 6.9%, P<0.05. Oge etiti oge dị n'okpuru oke (<70 mg/dL [3.9 mmol/L]) dị ka atụpụtara site na CGM: ST vs Omnipod 5 na-eji na obere ụmụaka (2.2% vs 1.9%, P <0.05) .2 g tupu ọgwụgwọ na ndị okenye na ụmụaka, n'otu n'otu: 15.6% MDI, 84.4% CSII; 9.6% MDI, 90.4% CSII. N'oge ule dị mkpa nke Omnipod 5, ndị okenye dị afọ 18-70 (N = 111) nwere ọganihu na-eri nri nyocha nyocha mgbe ọnwa 3 nke Omnipod 5 jiri tụnyere ST: pụtara T1-DDS Ịri Ahụhụ Subscale: 1.74 vs. 1.97, n'otu n'otu.

Ndị nne na nna nke ụmụaka dị afọ 6-11.9 (N=82) na ndị okenye dị afọ 18-70 (N = 111) nwetara mmụba na akara nyocha ntụkwasị obi hypoglycaemia mgbe ọnwa 3 nke Omnipod 5 jiri tụnyere ST: pụtara HCS akara = 3.59 vs. 3.34; na 3.65 vs 3.52, n'otu n'otu. Ndị nne na nna nke ụmụaka 6-11.9 afọ (N = 82) nwetara mmụba na akara nyocha nyocha ụra mgbe ọnwa 3 nke Omnipod 5 jiri tụnyere ST: pụtara PSQI N'ozuzu Ụra Ogo Subscore = 0.70 vs 1.13, n'otu n'otu.1 h Ọ bụrụ na ọkwa glucose na ọkwa. Ọgụgụ sitere na Dexcom G6 adabaghị na mgbaàmà ma ọ bụ atụmanya, ekwesịrị iji mita glucose ọbara mee mkpebi ọgwụgwọ ọrịa shuga. i The Pod nwere ọkwa IP28 maka ihe ruru 25 ụkwụ maka nkeji 60. Onye njikwa anaghị egbochi mmiri. Ihe mmetụta Dexcom G6 na onye na-ebufe bụ mmiri na-egbochi mmiri yana enwere ike imikpu ya n'okpuru ụkwụ asatọ nke mmiri ruo awa 24 na-enweghị ọdịda mgbe etinyere ya nke ọma. j Dexcom G6 CGM Sistemụ rere iche. Ekwesịrị iji Sistemu Omnipod 5 jiri ngwa Dexcom G6 ma adabakọghị na nnata Dexcom G6.

AID, nnyefe insulin na-akpaghị aka; CGM, nyocha glucose na-aga n'ihu; CSII, infusion insulin subcutaneous na-aga n'ihu; DKA, ọrịa shuga ketoacidosis; HbA1c, glycated haemoglobin; HCL, ngwakọ mechiri emechi; MDI, ọtụtụ injections kwa ụbọchị, ST, ọgwụgwọ ọkọlọtọ; T1D, ụdị ọrịa shuga 1.

Ntụaka

1. Brown S et al. Nnwale dị iche iche nke usoro nnyefe insulin na-akpaghị aka na ahụ nke nwere ebumnuche glycemic nwere ike ịhazi ya na ụmụaka na ndị okenye sonyere nwere ụdị ọrịa shuga 1. Nlekọta Ọrịa shuga. 2021;44 (7): 1630-1640 .
2. Sherr JL et al. Nsonaazụ nchekwa na glycemic site na sistemụ nnyefe insulin akpaaka na-enweghị tube na ụmụaka nwere ụdị ọrịa shuga 1: otu ogwe aka, nnwale ụlọ ọgwụ ọtụtụ. Nlekọta Ọrịa shuga. 2022; doi: 10.2337/dc21-2359 [Online tupu ebipụta].

© 2022 Insulet Corporation. Omnipod, SmartAdjust na akara Omnipod 5 bụ ụghalaahịa ma ọ bụ ụghalaahịa edenyere n'akwụkwọ ikikere nke Insulet Corporation na United States of America na ikike ndị ọzọ dị iche iche. Ikike niile echekwabara. Dexcom na Dexcom G6 bụ ụghalaahịa edenyere n'akwụkwọ ikikere nke Dexcom, Inc. ma ejiri ikike mee ya. Ighalaahịa ndị ọzọ niile bụ ihe onwunwe nke ndị nwe ha. Ojiji ụghalaahia nke ndị ọzọ anaghị abụ nkwado ma ọ bụ gosi mmekọrịta ma ọ bụ mmekọ ọzọ. 1 King St, Hammersmith London W6 9HR INS-OHS-07-2022-00001 v.1

Akwụkwọ / akụrụngwa

omnipod Omnipod 5 Sistemụ nnyefe insulin na-akpaghị aka [pdf] Akwụkwọ ntuziaka onye ọrụ Omnipod 5 Sistemụ Nnyefe Insulin akpaghị aka, Omnipod 5, Sistemụ Nnyefe Insulin akpaghị aka, Sistemụ Nnyefe Insulin, Sistemụ Nnyefe.

Ntụaka

• Akwụkwọ ntuziaka onye ọrụ