Device for smart insulin management receives FDA clearance

Published On 2021-05-13 05:30 GMT   |   Update On 2021-05-13 09:13 GMT

USA: A system that can help in improve insulin dosing in patients with either type 1 or type 2 diabetes has received US FDA's 510(k) clearance.

The system named Bigfoot Unity Diabetes Management System features connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy. 

"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," Jeffrey Brewer, CEO of Bigfoot Biomedical said in a statement. "At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way."


The Bigfoot Unity System is the first and only solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly uses integrated continuous glucose monitoring system (iCGM) data from Abbott's FreeStyle Libre 2 system to provide an insulin dose recommendation, which is based on a physician's instructions. The dose is displayed directly on a proprietary, connected smart cap for the person's disposable insulin pens without the need to manually input glucose data on a separate device. 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?" 


The Bigfoot Unity System is the only FDA-cleared connected solution to:

  • Display physician recommended dose at point-of-therapy using current iCGM data right on the pen cap
  • Seamlessly integrate with Abbott's FreeStyleLibre 2 system, the leading sensor-based glucose monitoring system in the U.S. and worldwide
  • Compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens—including those produced by Eli Lilly and Company, Novo Nordisk and Sanofi
  • Upload iCGM and dose-time data without manual intervention from the patient or the health care provider to enable ongoing, proactive patient care through remote physiologic monitoring

"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, Diabetes Care, Abbott. "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."

Article Source : US FDA

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