FDA approves the first smart insulin pen cap to help with dosing

Bigfoot Unity works with Abbott's FreeStyle Libre 2 glucose monitoring system.

Bigfoot Biomedical

The Food and Drug Administration has rubber-stamped a smart cap system for insulin pens. Bigfoot Unity works with an integrated continuous glucose monitoring system (iCGM) to provide recommendations for insulin doses. According to Bigfoot Biomedical, it's the "only FDA-cleared dose decision support system with real-time hypoglycemia alerts" and it can help patients minimize the guesswork for how much insulin they need.

For now, Bigfoot Unity only supports Abbott's FreeStyle Libre 2, one of the two major iCGMs alongside Dexcom. It's designed for people with Type 1 or Type 2 diabetes who are using multiple daily injection (MDI) therapy. The connected smart cap displays the recommended dose, along with the patient's glucose value and trend arrow, without them having to manually enter their blood sugar data on a separate device.

The FDA has given the system 510(k) clearance, approving it for use by patients aged 12 and older. Bigfoot says the cap is compatible with all major rapid- and long-acting disposable insulin pens in the US, including ones from Eli Lilly and Company, Novo Nordisk and Sanofi. Bigfoot Unity can also remind patients when they have missed their usual dose and provide alerts when the glucose value drops below 55 mg/dL.

Time-of-dose data and details from the iCGM are uploaded to the cloud when the system, which includes a mobile app, has a WIFi or mobile data connection. That could help patients avoid having to log the data manually. Health care providers will have access to the data through a secure web portal.

Bigfoot Unity could make insulin management much more straightforward for many people with diabetes. The system will be available through some clinics starting this spring.