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The FDA approves the first sensible cup of insulin-assisted insulin


The program of Food and Drugs has a rubber seal for a smart insulin cap. Bigfoot Unity works on a continuous glucose link (iCGM) to provide insulin levels. According to Bigfoot Biomedical, it is “the only method that can be eliminated by the FDA with specific information on hypoglycemia” and can help patients reduce the estimated amount of insulin they may need.

Currently, Bigfoot Unity only supports Abbott’s FreeStyle Libre 2, one of the two largest ICGMs near Dexcom. Designed for people with Type 1 or Type 2 diabetes who use multiple MDI injections. A smart integrated screen shows the right level, along with the patient’s amount of sugar and a moving arrow, without them having to inject their own blood sugar into another device.

The FDA has it was granted order 510 (k) permit, allowing it to be used by patients 12 years of age or older. Bigfoot says the cap is in line with all major insulin loss registers in the US, including those of Eli Lilly and Company, Novo Nordisk and Sanofi. The Bigfoot Alliance could also remind patients of missing their normal dose and also warn them if blood sugar levels fall below 55 mg / dL.

More data and time from iCGM is uploaded to the cloud while the app, which includes a mobile app, has WIFi or mobile connectivity. This can help patients avoid acting write notices manually. Health care workers should be able to access the information through a secure page.

The Bigfoot partnership could make it easier for insulin management for many people with diabetes. The method is available through other hospitals starting this year.

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