The Food and Drug Administration just approved a revolutionary new smart cap system, named Bigfoot Unity, for all major rapid- and long-acting insulin pens in the U.S. With it, insulin management will become more straightforward for people with diabetes.
The cap, developed by Bigfoot Biomedical, is the “first and only FDA-cleared dose decision support system with real-time hypoglycemia alerts.” It will make it easier for patients to more easily gauge how much insulin they need at a time. The cap can also remind patients when the value goes below 55mg/dL.
The FDA gave the system 501(k) clearance, which means it’s approved for use in patients 12 and older. Unity is compatible with all major rapid- and long-acting disposable pens, including those from Novo Nordisk, Eli Lilly and Company, and Sanofi.
Currently, Bigfoot Unity only supports Abbott’s FreeStyle Libre 2, one of two prominent integrated continuous glucose monitoring systems (iCGM) that offer dosage recommendations. The convenient cap is designed for people with either Type 1 or Type 2 diabetes using multiple daily injection (MDI) therapy. It will also share the recommended dose alongside a patient’s glucose value and trend arrow, so no manual data entry is required on a secondary device.