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The Bigfoot Unity® Diabetes Management System is indicated for the management of diabetes in persons age 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 device is intended for single patient use only and requires a prescription. Bigfoot Unity® is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.

Bigfoot Unity Diabetes Management System ("Bigfoot Unity System") integrates The continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc. FreeStyle Libre 2 Flash Glucose Monitoring system ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth. The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses. The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.

The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 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 device is intended for single patient use only and requires a prescription. Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.

The Bigfoot Unity Diabetes Management System ('Bigfoot Unity System') integrates continuous glucose monitoring with insulin dose recommendations to support people with diabetes mellitus who use disposable insulin pens for self-injection of insulin. The system consists of the Abbott Diabetes Care, Inc.'s FreeStyle Libre 2 Flash Glucose Monitoring System ("FreeStyle Libre 2") integrated continuous glucose monitor (iCGM) sensor, two reusable insulin pen caps (one each for rapid-acting and long-acting insulin pens) and a mobile application. The components communicate via near field communication (NFC) and Bluetooth. The device generates glucose data using the FreeStyle Libre 2 sensor and displays the data (value and trend) on the rapid-acting insulin pen cap. The rapid-acting pen cap also displays correction and meal insulin doses based upon settings prescribed by the user's healthcare provider and the available glucose data. The long-acting pen cap displays the long-acting insulin dose prescribed by the user's healthcare provider. From the dose recommendations on the pen caps as well as other contextually relevant information such as glucose trend arrows and current exercise status, users determine the doses to take. Users manually select an insulin dose and administer it using the pens according to the insulin manufacturers' instructions. In addition to dose information, both pen caps track the time of insulin doses. The mobile app provides fixed and configurable system alerts based upon data generated by the FreeStyle Libre 2 sensor. It also enables entry of the healthcare provider prescribed insulin dosing regimen as well as provides system alerts and historical information. In addition, the mobile app manages the secure wireless communication between the system components and enables the transfer of the system data to the cloud.