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Novel “Smart” Pen Cap for Insulin Dosing Receives FDA Clearance in Patients with Diabetes


The novel Bigfoot Unity Diabetes Management System could help improve insulin dosing in patients with type 1 or type 2 diabetes.



The US Food and Drug Administration (FDA) recently granted 510(k) clearance to the novel Bigfoot UnityDiabetes Management System that could help improve insulin dosing in patients aged ≥12 years with type 1 or type 2 diabetes.

The Diabetes Management System device uses a smart cap connected to a patient’s insulin pen that provides on-demand, physician-recommended insulin doses for patients with type 1 diabetes or type 2 diabetes using multiple daily injection therapy.

“For health care providers the Bigfoot Unity diabetes management program could be a gamechanger by connecting them to data that can provide better insight into what their patients are actually doing,” said diabetologist Jim Malone, MD, chief medical officer, Bigfoot Biomedical, in a company press release. “By replacing guesswork and complexity with connectivity and simplicity, the Bigfoot Unity program is truly serving as that real-time partner for both patients and providers when it comes to dose decision support and overall diabetes management.”

The Diabetes Management System is the only FDA-cleared connected solution that directly uses integrated continuous glucose monitoring (iCGM) system data from Abbott’s FreeStyle Libre 2 system. The proper dose is displayed directly on the connected smart cap to give patient’s real-time answers to questions related to insulin dosing. There is no need to manually input glucose data on a separate device.

Insulin has no fixed dosing or timing which makes managing diabetes “incredibly hard,” observed Jeffrey Brewer, Bigfoot Biomedical CEO, in the press release. That leaves patients to determine doses, configure devices, and make multiple critical decisions about how much insulin to take every day, commented Brewer. He says the company hopes that it can minimize “the anxious guesswork involved with insulin dosing.”

The device also issues alerts to the user if they have missed their usual long-acting insulin dose and/or if their glucose levels fall below 55 mg/dL, according to the press release. There is also an optional low glucose alert if levels fall below 70 mg/dL.

Data from the iCGM and time-of-dose data from the pen caps are automatically captured and uploaded to the cloud when WiFi or cellular signal is present. Health care providers can view patient data through a secure web portal, the Bigfoot Clinic Hub.

"People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it's important to develop connected technologies that simplify the experience," said Jared Watkin, senior vice president of Diabetes Care, Abbott, in the same press release. "Through Abbott's collaboration with Bigfoot Biomedical, we're integrating our revolutionary, easy-to-use FreeStyle Libre 2 technology with the Bigfoot Unity System to provide automated information for personalized diabetes management."

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