The Bigfoot Unity™ Diabetes Management Program is a real-time partner to health care providers (HCPs) to help you support a broad population of your insulin-requiring patients who use multiple daily injections (MDI).
Enables Individual Patient Success: The Bigfoot Unity™ Diabetes Management System provides tools to your MDI patients to support them in following your recommended therapy and insulin dosing instructions.
Equips your Clinic with Tools to Scale Population Health Management: The Program provides secure, on-demand technologies and services for your practice, enabling you to provide individualized, proactive care at a distance, while easily managing a large population of your MDI patients under the Bigfoot Unity Program.
Automatically Collects Data to Support Remote Physiologic Monitoring: The Bigfoot Unity System passively collects glucose and insulin dose time data without intervention from your patient.
The Bigfoot Unity System, which is the centerpiece of our larger Bigfoot Unity Program, is the first and only FDA cleared solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly integrates continuous glucose monitoring (iCGM) data to provide an insulin dose recommendation.1 The dose, which is based upon instructions from the person's health care provider, is displayed directly on proprietary, connected smart caps of 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?”
Bigfoot bundles together hardware and software components needed for technology to support MDI therapy. Your patient 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.
The kit isn’t the whole program. The overall Bigfoot Unity Diabetes Management Program also provides them with the Bigfoot Unity Mobile App for iPhone and connects them to you to facilitate ongoing, continual care. Bigfoot provides your patients with training and onboarding to their new tools, supporting them every step of the way.
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.
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 Transfer of data depends on availability of Wi-Fi or cellular data signal.
8 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.
9 CPT™ is a registered trademark of the American Medical Association.
10Each report or any claim adjudication support provided under the Bigfoot Unity diabetes management program is for reference only, and is not a guarantee of coverage, a guarantee of reimbursement for any item or service reimbursed under any governmental or third-party payer, or advice that referenced CPT codes are applicable.
* Information provided by Bigfoot is presented for illustrative purposes only as a courtesy and does not constitute coding, reimbursement, or legal advice. Each HCP is responsible for any decision regarding which code(s) to report, if any, considering the items and services furnished, the patient’s clinical facts and circumstances, and applicable coding rules, including the requirement to code to the highest level of specificity possible.
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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