FDA clears novel smart cap for insulin pens
The FDA granted 510(k) clearance for a first-of-its-kind connected smart cap for insulin pens, recommending insulin doses for people with diabetes prescribed multiple daily injection therapy, according to an industry press release.
The Bigfoot Unity diabetes management system (Bigfoot Biomedical), which features smart caps that are integrated with Abbott’s FreeStyle Libre 2 system, translates continuously monitored glucose data into on-demand insulin dose recommendations displayed on the pen-cap screen for ease of use, according to the company. The system also includes real-time hypoglycemia alerts and is compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens.
“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 the release. “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 has three primary components — proprietary smart pen caps for both rapid- and long-acting insulin, a mobile app and integrated FreeStyle Libre 2 integrated continuous glucose monitor (iCGM) sensor — that fit into the person’s dose decision process when they need it throughout the day, according to the release.
The smart pen cap for rapid-acting insulin allows the user to scan the FreeStyle Libre 2 sensor, displaying the user’s current glucose value, trend arrow and any recommended correction dose. The smart pen cap also directly displays the health care provider’s suggested meal insulin doses with the correction dose, according to the release.
According to the company, the Bigfoot Unity system is the only FDA-cleared connected solution to display physician-recommended dose at point-of-therapy using current iCGM data on the pen cap, and to upload iCGM and dose-time data without manual intervention from the patient or the health care provider to enable 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,” Jared Watkin, senior vice president for diabetes care at Abbott, said in the 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.”
In a statement supporting the FDA decision, JDRF calls the Bigfoot Unity system “a win for both the type 1 and type 2 diabetes communities as it broadens the options of treatment to alleviate daily burdens.”
“Together with the JDRF T1D Fund, we congratulate the Bigfoot Biomedical team on its relentless and continued work to help better the lives of individuals with diabetes,” the organization stated in a press release.