Image: Bigfoot Biomedical
The Food and Drug Administration has granted approval for an innovative smart pen cap system to help those with both Type 1 and Type 2 diabetes better manage their insulin dosage. This is huge news, as the system could help diabetics eliminate the guesswork when it comes to figuring out how much insulin to take, using real-time data.
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The Bigfoot Unity smart pen caps are made by Bigfoot Biomedical and are meant to be used by patients undergoing multiple daily injection therapy. The smart pen caps received 510 (k) clearance from the FDA, and according to the company, it’s the first system of its kind. It works in tandem with the Abbott FreeStyle Libre 2 integrated continuous glucose monitoring system (iCGM) to provide real-time blood glucose data. The user scans the sensor, and the cap then displays a patient’s blood sugar, a trend arrow, and a suggested dosage based on those values and what’s been recommended by their physician. Bigfoot Unity caps can be used by anyone ages 12 and up, and also work with all major insulin pens—both rapid and long-acting—from Eli Lilly and Company, Novo Nordisk, and Sanofi. (You can watch a video explainer of how the caps work here.)