Milpitas, Calif.-based Bigfoot’s program is now available in California, Texas, Florida, Pennsylvania, Ohio, New York, New Jersey, Massachusetts and other New England states. The program is offered as a bundle of devices, supplies and services and delivered as a 30-day subscription to eliminate upfront costs. Bigfoot Unity is eligible for insurance coverage and generally should be covered by insurance, although copays vary.
According to a news release, the availability of the Bigfoot Unity program, which received FDA clearance last month, will expand to other markets throughout 2021 and 2022.
Bigfoot Unity, a first-of-its-kind system, features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy. The smart pen caps offer on-demand insulin dose decision support in an effort to minimize guesswork and help patients to follow their doctors’ instructions.
The company touts the Unity system as the first and only solution for those 12 years old and up with type 1 and type 2 diabetes who are on MDI therapy that directly uses integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system to provide an insulin dose recommendation.
“As an industry, we need to fix the broken therapy cycle for treating diabetes so both patients and clinicians can be successful in realizing better outcomes,” Bigfoot Biomedical CEO Jeffrey Brewer said in the release. “With these innovative, connected technologies, we can address many of the challenges faced by clinicians. Our Bigfoot Unity program is designed to act as a real-time partner in diabetes management so clinicians focus on what really matters.”
The Bigfoot Unity program centers around the Bigfoot Clinic Hub. The secure, cloud-based platform takes passively captured and uploaded data from the Bigfoot Unity and FreeStyle Libre 2 to allow for providers to make informed, timely therapy adjustments while addressing potential issues between visits before they become critical, Bigfoot said.
For clinicians, the innovative approach of the Bigfoot Unity Program is centered around the Bigfoot Clinic Hub™, a secure, cloud-based platform. Data from their patients using the Bigfoot Unity System and a FreeStyle Libre 2 sensor is passively captured and uploaded to the Clinic Hub from the System’s smart pen caps whenever WiFi or cellular signal is present providing on-demand access.
“Advances in technology are moving at a rapid pace, necessitating a radical change in diabetes care,” Brewer added. “It’s long overdue, especially for those who rely on multiple daily injections of insulin and their clinicians.”
