Bigfoot Unity™ Diabetes Management System

Bigfoot Unity System | Bigfoot Unity System Components | Compatiblity 

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Say Hello to a Real-Time Diabetes Partner

Introducing the Bigfoot Unity Diabetes Management System, a real-time partner to manage insulin-requiring diabetes with multiple daily injection (MDI) therapy.

 

Diabetes Management Tools that Enable and Empower

The Bigfoot Unity System includes smart pen caps that incorporate integrated continuous glucose monitor (iCGM) data and health care professionals (HCPs) instructions to provide insulin dose recommendations for people with diabetes who use multiple daily injections (MDI) of insulin.1 

Seamless

Integrates with the FreeStyle Libre 2 sensor that provides the Bigfoot Unity System with hypoglycemia2 alerts in real time.3

Compatible

Provides flexibility as the only FDA cleared system to support major brands of both long-acting (basal) and rapid-acting (bolus) disposable insulin pens.4

Comprehensive

Delivered as a conveniently bundled subscription.

All the Components. All Working Together.

Each of the Bigfoot Unity Systems' simple-to-use components has its own vital job. Together, they act as an always-there support team — providing dose recommendations, low glucose alerts, and collecting crucial data automatically and securely to help make diabetes management simple.

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White Cap for Rapid-Acting Insulin

  • Displays HCP’s therapy recommendations for rapid-acting insulin.
  • Large, easy-to-read screen displays information to help make the right dosing decisions.
  • Scans the FreeStyle Libre 2 sensor to view current glucose, trend arrow, and correction doses right on the pen cap.
  • Automatically captures and uploads glucose and dosing time data to the system.5
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Black Cap for Long-Acting Insulin

  • Displays HCP’s therapy recommendations for long-acting insulin.
  • With a click of a button, its large, easy-to-read screen displays the time since your last recorded dose.
  • With another click, it displays the recommended long-acting dose amount.
  • Works with the Bigfoot Unity Mobile App to help patients consistently take the long-acting insulin dose by sending you potential missed dose alerts from the App.
  • The system automatically captures and uploads dosing time data.5
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FreeStyle Libre 2 Sensor

The sensor automatically monitors glucose day and night++ and provides the Bigfoot Unity System with hypoglycemia2 alerts in real time.3 Instead of painful fingersticks+, simply tap the White Cap on the Sensor to capture current glucose data. Through the Bigfoot Unity Mobile App, the sensor also connects to the mobile device, displaying the current glucose range and providing a detailed glucose history.

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Mobile App

  • The Bigfoot Unity Mobile App is the all-in-one area to manage the system.
  • Settings from the HCP are input through the App.
  • The App shows the current glucose range and important real-time alerts.
  • It automatically collects data from the components.5
  • Displays graphs of the glucose and insulin dose time history.
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Blood Glucose Meter

The connected Bigfoot Blood Glucose meter can be used for input for a dose recommendations when fingerstick test are necessary or preferred.

  • Data is automatically captured and shared with the rest of the Bigfoot Unity System.5 
  • The blood glucose value is displayed on your White Pen Cap, and stored with all your glucose readings in the app.

Compatible Insulins and Components

We’ve designed Bigfoot Unity Caps for major brands of BOTH long-acting (basal) and rapid-acting (bolus) disposable insulin pens that are offered in the U.S.4 The perscription includes replacement pen caps should the HCP change the prescribed insulin.

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Remote Care

Part of the Bigfoot Unity Program includes ongoing, remote care from your health care provider. The Bigfoot Unity System makes this simple for you by passively collecting data in the background, without any work on your part. The data is then automatically available to your clinician through a secure, online portal.8 That means your data is stored and accessible in one simple place, supporting your health care provider to deliver remote care to you, conveniently, between office visits.

Bear in mind, however, that YOU always remain wholly in control of day-to-day management of your diabetes. The remote care, that the system enables, never automatically administers insulin or alerts your provider to take proactive action. Bigfoot is your partner to help you control diabetes rather than letting diabetes control you.

Important Safety Information for the Bigfoot Unity Diabetes Management System
The Bigfoot Unity System is indicated for 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
2 Table 6.4 - Classification of hypoglycemia. American Diabetes Association. Glycemic targets:Standards of Medical Care in Diabetes–2023. Diabetes Care 2023;46(Suppl. 1):S97–S110. https://doi.org/10.2337/dc23-S006
3 In order to receive alerts, notifications and Critical Alerts must be turned on and the sensor must be within 20 feet of the phone with the Bigfoot Unity Mobile App active. Alerts only available on the phone. For compatible phones, please visit www.bigfootbiomedical.com/compatible.
4 Based on available products for multiple daily injection therapy of insulin as of June 2023.
5 Transfer of data depends on availability of Wi-Fi or cellular data signal

+ Fingersticks are required to use the Bigfoot Meter for diabetes treatment decisions when (1) Sensor data is not available, (2) when the words "Use Meter" on the White Cap, or (3) if the Sensor glucose reading does not match how the user feels.
++ Scanning is required every 8 hours for 14 days to get a complete glycemic picture.


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

WEB-400004 Rev H, AUG 2023