Bigfoot Unity™ Diabetes Management System

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Say Hello to Your Real-Time Diabetes Partner

Introducing Bigfoot Unity, your real-time partner to manage insulin-requiring diabetes with multiple daily injection (MDI) therapy.

No more anxious guesswork. No more endless fingersticks+. The Bigfoot Unity Diabetes Management System is part of an entirely new, simple program designed to help you manage insulin-requiring diabetes holistically.


It’s your real-time, always-there partner, so you don’t need to do it all alone. Because together, we’ve got this.

 

Diabetes Management Tools that Enable and Empower

The Bigfoot Unity Program includes the Bigfoot Unity System, the first-of-its-kind smart pen caps that incorporate integrated continuous glucose monitor (iCGM) data and health care provider instructions to provide insulin dose recommendations for people with diabetes who use multiple daily injections (MDI) of insulin.1 The system is designed to fit naturally into your workflow by displaying dosing recommendations based upon your health care provider’s instructions and glucose readings from the iCGM sensor right on connected smart caps for your disposable insulin pens.

Seamless

Integrates with the accurate,2 more affordable,3 and easy-to-use4 FreeStyle Libre 2 sensor that provides the Bigfoot Unity System with hypoglycemia5 alerts in real time.6

Compatible

Provides flexibility as the only FDA cleared system to support all major brands of both long-acting (basal) and rapid-acting (bolus) disposable insulin pens.1

Comprehensive

Delivered as a conveniently bundled subscription, with no upfront costs for patients.7

Smart and Well Connected

The Bigfoot Unity Program provides tools to help you manage insulin-requiring diabetes, but the real magic is in how the components securely connect and work together, in the background, to keep you supported.

 

 

The Bigfoot Unity Welcome Kit. Connected and Comprehensive.

Bigfoot bundles together hardware and software components needed for technology to support MDI therapy. You will receive a comprehensive welcome kit containing Bigfoot’s smart pen caps for long-acting and rapid-acting insulins, two FreeStyle Libre 2 sensors, pen needles, a backup blood glucose meter and supplies.

 

All the Components. All Working Together.

Each of these 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 for you.

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White Cap for Rapid-Acting Insulin

The White Cap is the heart of the system. It displays your health care provider’s therapy recommendations for rapid-acting insulin. Its large, easy-to-read screen displays information to help you to make the right dosing decisions. The White Cap allows you to scan the FreeStyle Libre 2 sensor to view your current glucose and a trend arrow. It fits within your existing workflow and it automatically captures and uploads glucose and dosing time data to you and your health care provider to help you manage your diabetes.8

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Black Cap for Long-Acting Insulin

The Black Cap is where you can view your health care provider’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. The Black Cap works with the Bigfoot Unity Mobile App to help you take your long-acting insulin dose consistently by sending you potential missed dose alerts. The system automatically captures and sends your dosing time data for you and your health care provider to help you manage your diabetes.7

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FreeStyle Libre 2 Sensor

The FreeStyle Libre brand is the #1 CGM worldwide.9 The sensor automatically monitors glucose day and night++ and provides the Bigfoot Unity System with hypoglycemia5 alerts in real time.6 Instead of painful fingersticks+, you simply tap the White Cap on the Sensor to capture current glucose data. Through the Bigfoot Unity Mobile App, the sensor also connects to your iPhone, displaying your current glucose range and providing a detailed glucose history.

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Mobile App

The Bigfoot Unity Mobile App is where you input and can review your provider’s therapy recommendations. The app provides a glanceable display of your current glucose range and important real-time alerts. It automatically collects data from the rest of the components and generates graphs of your glucose and insulin dose time history to give you a cohesive view.

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Blood Glucose Meter

If you’d prefer to use fingerstick tests, if your symptoms don’t match the CGM reading, or when indicated by the system, the Meter can be used as an input to the dose recommendations. Unlike traditional meters, the data is automatically captured and shared with the rest of the Bigfoot Unity System. Your blood glucose value is displayed on your White Pen Cap, and stored with all your glucose readings in the app.

Insulin Compatibility

We’ve designed Bigfoot Unity Caps for every major brand of BOTH long-acting (basal) and rapid-acting (bolus) disposable insulin pens that are offered in the U.S. We know first-hand that people with diabetes need to switch out their insulins due to clinical reasons or insurance coverage. The program includes replacement pen caps should your provider change your prescribed insulin. Now switching insulins doesn’t mean that you need to switch your insulin management solution too.

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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.

Ongoing Supplies

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The Bigfoot Unity Program includes ongoing resupply, providing you with blood glucose meter test strips, pen needles and alcohol swabs. The supplies are delivered to your door on a regular basis, so you shouldn't have to worry about running out when you need them most.

Searching for Bigfoot?

The Bigfoot Unity System is currently available by prescription from health care providers in limited markets. Ask your clinician if they are familiar with Bigfoot Unity and if it is an option for you. 

Health care providers who would like additional information can contact us here:

HCP CONTACT FORM

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.

Important Safety Information for the Bigfoot Unity Diabetes Management Program
The Bigfoot Unity Diabetes Management Program incorporates components intended to support health care providers in remote physiologic monitoring of their enrolled patients, facilitating on-going diabetes therapy adjustments. The Program does not incorporate real-time monitoring (by either Bigfoot or any other entity, including the health care provider) and does not replace the enrolled patient’s responsibility to proactively monitor their own glucose values and make appropriate treatment decisions.

*Bigfoot Unity System does not automatically alert your health care provider to potentially serious glycemic conditions or other health conditions, and you should ask your health care providers about their intended data review plan. Bigfoot Unity does not relieve the patient (or their caregivers) of their responsibility to proactively monitor their glucose data and to contact their health care provider or emergency services (e.g., call 911) if there is a suspected emergency health condition, such as, but not limited to, a severe hypoglycemia or a severe hyperglycemia. Bigfoot does not automatically review, monitor, evaluate, or analyze any information generated or collected by the Bigfoot Unity System.

1 Based on available products for multiple daily injection therapy of insulin as of May 2021.
2 Bigfoot Unity System User Guide.
3 Data on file, Abbott Diabetes Care Inc. Based on a comparison of list prices of the FreeStyle Libre 2 system versus competitors’ CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
4 Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore, the study data is applicable to both products.
Haak, T. Diabetes Therapy (2017): https://doi.org/10.1007/s13300-016-0223-6. 2. Campbell, F. Pediatr Diabetes (2018): https://doi.org/10.1111/pedi.12735.
5 Table 6.4 - Classification of hypoglycemia. American Diabetes Association. Glycemic targets:Standards of Medical Care in Diabetes–2021. Diabetes Care 2021;44(Suppl. 1):S73–S84. https://doi.org/10.2337/dc21-S006
6 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.
7 HCPs with patients enrolled in the Bigfoot Unity diabetes management program will receive monthly invoices for applicable subscription fees. There is no upfront cost to the HCP or patients from Bigfoot for enrolling new patients. Any and all amounts billed to the patient or their insurance by the HCP are solely determined by the HCP.
8 Transfer of data depends on availability of Wi-Fi or cellular data signal.
9 Data based on the number of users worldwide for FreeStyle Libre family of personal CGMs compared to the number of users for other leading personal CGM brands and based on CGM sales dollars compared to other leading personal CGM brands.

+ Fingersticks are required to use your Bigfoot Meter for diabetes treatment decisions when (1) Sensor data is not available, (2) when you see the words "Use Meter" on the White Cap, or (3) if your Sensor glucose reading does not match how you feel.
++ 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.

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