I-US Food and Drug Administration ivume "inkqubo edibeneyo yokujonga iswekile yegazi" yokuqala e-China ngomhla wama-27 ukujonga amanqanaba eswekile yegazi kwizigulana ezinesifo seswekile ngaphezulu kweminyaka emi-2 ubudala, kwaye ingasetyenziswa kunye ne-insulin auto-injection. Nezinye izixhobo ezisetyenziswa kunye.
Eli sweni libizwa ngokuba “yi-Dkang G6” sisijongi seswekile yegazi esithe ukuba nkulu kancinane kune-dime kwaye sibekwe elukhumbeni lwesisu ukuze abanesifo seswekile balinganise iswekile yegazi ngaphandle kokufuna umnwe. Imonitha ingasetyenziswa rhoqo iiyure ezili-10. Guqula kube kanye ngosuku. Isixhobo sidlulisela idatha kwisoftware yezonyango yefowuni rhoqo ngemizuzu emi-5, kwaye ilumkisa xa i-glucose yegazi iphezulu kakhulu okanye iphantsi kakhulu.
Isixhobo sinokusetyenziswa kunye nezinye izixhobo zokulawula i-insulin ezifana ne-insulin autoinjectors, iipompo ze-insulin, kunye nemitha yeglucose ekhawulezayo. Ukuba isetyenziswe kunye ne-insulin auto-injector, ukukhutshwa kwe-insulin kubangelwa xa i-glucose yegazi iphakama.
Umntu ofanelekileyo ophethe i-US Drug Administration wathi: "Inokusebenza ngezixhobo ezahlukeneyo ezihambelanayo ukuvumela abaguli ukuba bazenzele izixhobo zokulawula isifo seswekile."
Ndiyabulela ukuhlanganiswa kwayo okungenamthungo kunye nezinye izixhobo, i-US Pharmacopoeia iye yahlula i-Dekang G6 njenge "yesibini" (icandelo lolawulo olukhethekileyo) kwizixhobo zonyango, ukubonelela ngokulula ukuphuhliswa kwe-monitor edibeneyo edibeneyo ye-glucose yegazi.
I-US Pharmacopoeia ivavanye izifundo ezimbini zeklinikhi. Isampuli yayiquka abantwana be-324 abangaphezu kweminyaka eyi-2 kunye nabantu abadala abanesifo sikashukela. Akukho zithintelo ezibi ezifunyenweyo ngexesha leentsuku ezili-10 zokubeka iliso.
Ixesha lokuposa: Jul-02-2018
