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.