The Bigfoot Unity™ Diabetes Management system decision support system has FDA clearance to help patients with type 1 or type 2 diabetes that are on multiple daily injections therapy (MDI).
Bigfoot Unity is a connected system composed of a proprietary smart insulin pen cap, CGM sensor (Abbott’s FreeStyle Libre), and a mobile app. The app displays an insulin dose recommendation right on the pen cap screen at the time of the injection. The dose is calculated using current CGM data and is based on the prescriber’s instructions for mealtime doses, correction doses, and basal insulin doses. Bigfoot Unity captures CGM readings and time-of-dose data automatically in the connected system, so the user doesn’t have to enter data manually.
A patient’s injected insulin dose requirements constantly change, and it is a complex calculation for even the most experienced to determine how much insulin they need at any given time.
In the future, Bigfoot Unity will incorporate an AI-based insulin dosing algorithm that will make those calculations quickly, providing highly personalized insulin dosing recommendations through the pen cap. The Bigfoot app also has dosing reminders and hypoglycemia alerts.