The Food and Drug Administration (FDA) has granted 510(k) clearance to the Bigfoot Unity™ Diabetes Management System, which includes smart pen caps that recommend insulin doses for patients 12 years of age and older with diabetes on multiple daily injection (MDI) therapy.
The Bigfoot Unity System uses integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system and consists of smart pen caps for rapid- (white cap) and long-acting (black cap) insulin, as well as a mobile app. Clinician recommended doses are displayed on the pen cap digital screen based on glucose data captured by the FreeStyle Libre 2 iCGM sensor.
Data from the iCGM and time-of-dose data from the pen caps are automatically uploaded to the cloud enabling health care providers to access the information remotely. The Bigfoot Unity mobile app also notifies patients of missed doses and provides a low glucose alert.
“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,” said Jeffrey Brewer, CEO of Bigfoot Biomedical. “At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way.”
The Bigfoot Unity caps are compatible with all major US brands of rapid- and long-acting disposable insulin pens.
- Bigfoot Biomedical® receives FDA clearance for Bigfoot Unity™ Diabetes Management System, featuring first-of-its-kind smart pen caps for insulin pens used to treat type 1 and type 2 diabetes. [press release]. Milpitas, CA: Bigfoot Biomedical; May 10, 2021.
- Abbott-Bigfoot collaboration integrates FreeStyle Libre 2 with first-of-its-kind smart insulin pen cap. [press release]. Abbott; May 10, 2021.