Individuals who use multiple daily injection (MDI) therapy to manage diabetes don’t take a standardized insulin dose in every shot. Instead, they must calculate the proper dosage based on blood glucose levels, carbohydrate intake, the size of the previous dose, and other factors. Bigfoot Biomedical has received FDA clearance for a connected smart pen cap system that provides personalized dosage calculation to reduce the anxiety associated with multiple daily injection (MDI) therapy.
The FDA cleared the Bigfoot Unity Diabetes Management System for users age 12 and above with Type 1 and Type 2 diabetes. The system includes a smart insulin pen cap that integrates with the FreeStyle Libre 2 glucose monitoring system and a mobile app. Programmed with recommendations from the patient’s physician, the caps obtain data directly from the Libre 2, eliminating the need for manual calculations.
After scanning the glucose monitor, the cap displays the current blood glucose value, a trend arrow, and any recommended correction dose. It fits on standard rapid- and long-acting disposable insulin pens. In addition to on-demand dose recommendations, the Bigfoot Unity system sends reminders for regular, timed insulin doses and low glucose value alerts.
Users can also skip the hassle and concerns about errors resulting from logging every dose manually throughout the day. Bigfoot Unity automatically uploads its data to the cloud whenever a WiFi or cellular connection is available. The Bigfoot Clinic Hub, a web portal, allows the patient’s healthcare team to monitor the patient remotely, reducing the need for in-person visits.
Having received 510(K) clearance from the FDA, Bigfoot Biomedical can legally sell the Bigfoot Unity system in the United States. The 510(k) clearance ensures that a new device has demonstrated substantial equivalence compared to similar devices already approved and available — such as Medtronic’s InPen — and is therefore deemed to be safe and effective.