Bigfoot Biomedical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Bigfoot Unity diabetes management system.
The Bigfoot Unity system consists of connected smart pen caps, which suggest insulin doses for people using multiple daily injection (MDI) therapy.
Bigfoot Unity smart pen caps offer on-demand and insulin dose decision support to avoid guesswork and allow patients to follow their doctor’s instructions in an easy way.
Bigfoot Unity system is claimed to be the first and only solution for people with Type 1 or Type 2 diabetes on MDI therapy, which directly uses integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system.
It will help deliver an insulin dose recommendation based on a physician’s instructions. The dose will be directly shown on a connected smart cap for the person’s disposable insulin pens, thereby helping to avoid manually input glucose data on a separate device.
The Bigfoot Unity system is said to be the only FDA-cleared connected solution to show physician recommended dose at point-of-therapy using current iCGM data right on the pen cap.
The company stated that the system can also be used with all major US brands of rapid and long-acting disposable insulin pens, including those provided by Eli Lilly, Novo Nordisk and Sanofi.
Bigfoot Biomedical CEO Jeffrey Brewer said: “Diabetes management is incredibly hard because insulin has no fixed-dose or timing, leaving individuals to constantly determine their doses and configure devices as they make multiple critical decisions every day about how much insulin to take.
“At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimising the anxious guesswork involved with insulin dosing in a convenient, simple way.”
