FDA Clears Bigfoot BioMedical’s Smart Insulin Pen Caps


The FDA cleared Bigfoot BioMedical's Diabetes Management System.

The FDA has granted 510(k) clearance to Bigfoot Biomedical’s Bigfoot Unity Diabetes Management System, the first of its kind to translate continuously monitored glucose data into on-demand insulin dose recommendations displayed on the pen cap screen. The smart pen cap is integrated with Abbott’s FreeStyle Libre 2 system and is used to treat type 1 and type 2 diabetes.

The dose decision support system for people using multiple daily injection therapy is also the first and only FDA-cleared device with real-time hypoglycemia alerts. It is compatible with all major US brands of rapid- and long-acting insulin pens, including Eli Lilly, Novo Nordisk, and Sanofi, and is approved for those aged 12 and over.

“Diabetes management is incredibly hard because insulin has no fixed dose or timing, leaving individuals to constantly determine their doses and configure devices as they make multiple critical decisions every day about how much insulin to take,” said Jeffrey Brewer, CEO of Bigfoot Biomedical, in a company statement.

Specifically, Bigfoot Unity uses integrated continuous glucose monitoring (iCGM) system data from FreeStyle Libre 2 to provide an insulin dose recommendation based on physicians’ suggestions. Using the system, patients will no longer need to manually input glucose data on a separate device.

The system consists of 3 components: smart pen caps, a mobile app, and an integrated FreeStyle Libre iCGM sensor. The smart pen cap lets patients scan the sensor, displaying the current glucose value, trend arrow, and a recommended correction dose, while also showing the provider’s suggested meal insulin doses with the correction dose.

Because patients with diabetes can be overwhelmed by data from multiple devices, developing technologies to simplify their experience is crucial, explained Jared Watkin, senior vice president of Diabetes Care at Abbott.

If a patient misses their usual long-acting dose or their glucose value falls below 55 mg/dL, the system will notify the user with alerts. When WiFi or cell signals are present, data from the iCGM and time-of-dose data from pen caps are automatically captured and uploaded to the cloud. Health care providers can view this data through the Bigfoot Clinic Hub.

The Bigfoot Unity program focuses on helping providers deliver individualized and proactive care to patients.

“The program’s holistic approach focuses upon the key aspects of insulin management for patients struggling with glycemic control, insulin dosing, or those experiencing hypoglycemic unawareness,” according to the company statement.

Overall, the program aims to replace guesswork with connectivity and simplicity and acts as a real-time partner for patients and providers. It will be available via select diabetes clinics beginning in the spring of 2021.

“Bigfoot Unity is specifically designed to be simple and accessible—no matter the person’s level of technical expertise—removing a key barrier to health equity,” said Brewer. “We know people with diabetes want to be successful with their insulin therapy, and it’s often complex and expensive technology that gets in the way.”

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