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Say Hello to a Real-Time Partner

The Bigfoot Unity Diabetes Management System is a real-time partner to health care professionals (HCPs) to help support a broad population of insulin-requiring patients who use multiple daily injections (MDI). The Bigfoot Unity™ Diabetes Management System provides tools to your MDI patients to support them in following your recommended therapy and insulin dosing instructions.

 

BIGFOOT UNITY

bf hand pen

Dose Decision Support System

The Bigfoot Unity System, is the first FDA cleared solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly integrates continuous glucose monitoring (CGM) data to provide an insulin dose recommendation.1 The dose, which is based upon instructions from the person's health care professional, is displayed directly on proprietary, connected smart caps that replace the current disposable insulin pen cap the person's disposable insulin pens. Cleared for use by individuals aged 12 and up, the system is designed to clearly, and in real time, help answer the question, “How much insulin would my doctor recommend I take right now?”

Important Safety Information for the Bigfoot Unity Diabetes Management System
The Bigfoot Unity System is indicated for the management of diabetes in persons 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The system must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems.

The Bigfoot Unity System requires a prescription. A health care provider must supply appropriate settings for the device based on user specific criteria. It is not intended to be used by individuals who dose insulin in ½ unit increments, take multiple daily doses of long-acting insulin or take high doses of vitamin C (more than 500 mg per day). 

The system provides dose recommendations; however, the final decision on when and how to dose is up to the individual user. Failure to use the system according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury.

For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the Bigfoot Unity User Guide.

1 510(k) K202145

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission.

WEB-400006 Rev G, AUG 2023