I-FDA igunyaze idivayisi yokuqala yokudoselwa kwe-insulin okuzenzakalelayo Thayipha i-2 sikashukela isimo.
Lokhu kulandela ukwanda kwezinkomba ze-Insulet SmartAdjust technology (i-interoperable glycemic controller) ekhonjiswe ukuphatha thayipha 1 sikashukela. Manje, lobu buchwepheshe bomthamo we-insulin obuzenzakalelayo buzokhonjiswa futhi butholakalele ukuphathwa Thayipha i-2 sikashukela kanjalo.
Lokhu kugunyazwa yi-FDA kusekelwe ekutholweni kwesivivinyo somtholampilo ngokusetshenziswa kobuchwepheshe be-Insulet SmartAdjust ngabantu abane Thayipha i-2 sikashukela ekwelashweni kwe-insulin. Ucwaningo luthole ukuthi ubuchwepheshe buphephile futhi kuthuthukisa ukulawula ushukela wegazi kubahlanganyeli.
Ubuchwepheshe be-Insulet SmartAdjust, isilawuli se-glycemic esisebenza ngokuzenzakalelayo isoftware elungisa ngokuzenzakalelayo ukulethwa kwe-insulin kumuntu onesifo sikashukela ngokuxhuma kwenye iphampu ye-insulin enikwe amandla isilawuli (ipompo ye-ACE) kanye ne-integrated continuous glucose monitor (iCGM).
Thayipha i-2 sikashukela isimo kubantu abaningi asiphenduli kahle ekuphathweni okungezona ezokwelashwa kanye nokwelashwa ngamaphilisi e-antidiabetes. Abantu abanjalo kudingeka bazinikeze i-insulini kanye noma ngaphezulu ngosuku besebenzisa umjovo noma ipeni le-insulin noma bampompa ukuze bagcine izinga likashukela egazini lingaphezu komkhawulo ophephile. Lokhu kudinga ukuhlolwa njalo mathupha kwamazinga kashukela egazini ukuze kube nomphumela ongcono kakhulu. I-Automated Insulin Dosing Device izoba inketho enengqondo yabantu abanjalo engathuthukisa izinga lempilo yabo.
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Imithombo:
- Ukukhishwa kwezindaba kwe-FDA - I-FDA Isula Idivaysi Yokuqala Ukuze Ivumele Ukudotshwa Kwe-insulin Okuzenzakalelayo Kubantu Abanesifo sikashukela sohlobo 2. Kuthunyelwe ngomhla ka-26 Agasti 2024. Itholakala e- https://www.fda.gov/news-events/press-announcements/fda-clears-first-device-enable-automated-insulin-dosing-individuals-type-2-diabetes
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