FDA Approves Smart Insulin Pen Cap that Offers Personalized Insulin Dosing Advice

Diabetes can be a difficult disease to live with for some of us. From remembering to check blood sugar levels to calculating how much insulin to give oneself to traveling with diabetes supplies, there’s always something important for a person with diabetes to be thinking about. Luckily, however, new technologies, such as continuous glucose monitors and insulin pumps, are being invented and perfected all the time to improve the lives of people with diabetes.

One of the latest inventions to grace the market is a smart insulin pen cap that is capable of giving personalized advice on insulin dosing to each patient based on their blood glucose data. According to a press release, the system is for people who have been prescribed multiple daily insulin injection therapy.

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“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,” says Jeffrey Brewer, CEO of Bigfoot Biomedical, the company behind this new device. “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.”

Bigfoot Biomedical now has FDA 510(k) clearance for the pen cap as part of its Bigfoot Unity diabetes management system. The system also includes a mobile app and integrated FreeStyle Libre 2 integrated continuous glucose monitor sensor.

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The Bigfoot Unity diabetes management system works by connecting to Abbott’s FreeStyle Libre 2 system. It uses the data from a continuous glucose monitor to calculate on-demand insulin dose recommendation, which it displays on the pen-cap screen. The system also includes real-time alerts for hypoglycemic episodes and is compatible with all major U.S. brands of disposable insulin pens, both rapid-acting and long-acting.

When a person uses the smart pen cap to scan the FreeStyle Libre 2 sensor, it will display the user’s current glucose value, an arrow to denote which direction that number is trending, and any recommended insulin dose to correct the person’s blood sugar. The pen cap also has the ability to display the user’s suggested meal insulin dose as provided by their healthcare provider.

In a statement supporting the FDA decision, JDRF says the Bigfoot Unity system is “a win for both the type 1 and type 2 diabetes communities, as it broadens the options of treatment to alleviate daily burdens.”

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Bigfoot Biomedical says this is the only FDA-cleared connected solution that displays physician-recommended insulin doses at point-of-therapy using current CGM data. It is also the first device to upload CGM data and dose-time data for remote monitoring without manual intervention from the patient or healthcare provider.

“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,” says Jared Watkin, senior vice president for diabetes care at 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.”

We’re excited to see this new advancement Bigfoot Biomedical has made in improving the lives, health, and safety of people with diabetes. Would you try this new invention?

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