First FDA Approved Smart Insulin Pen Caps Advise Patients On Dosing

A 2020 Centers for Disease Control and Prevention report stated that 34.2 million Americans were living with diagnosed and undiagnosed diabetes in 2018. Despite the prevalence of diabetes and its treatment options, it is often still a struggle for patients to determine what doses of insulin are necessary.

Bigfoot Biomedical has recently received clearance from the Food and Drug Administration on its Bigfoot Unity smart insulin pen caps. These caps are suitable for people with Type I or Type 2 diabetes who require multiple daily injection therapy. They are compatible with Abbott's FreeStyle Libre 2 and can display recommended dose, glucose value, and trend arrows.

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The Bigfoot Unity diabetes management system also provides real-time hypoglycemia alerts, correction doses, and suggested meal insulin doses from the health care provider. The system can also alert the patient when the glucose value drops below 55 mg/dl.

The three main components of the Unity system include the smart pen caps, a mobile app, and the FreeStyle Libre 2 iCGM sensor. The system is compatible with all major United States brands of rapid and long-acting disposable insulin pens.

The Food and Drug Administration has granted Bigfoot Biomedical's Unity diabetes management system the 510(K) clearance for patients 12 years and older. Bigfoot Biomedical announced that it is the “only FDA cleared dose decision support system with real time hypoglycemia alerts.”

With one in ten Americans living with diabetes, there is a high volume of patients who require multiple daily injections, many of whom struggle to make important decisions about their health every day. Bigfoot Biomedical is working to decrease the guesswork of insulin doses for patients.

The system can also help patients save time logging data manually as the dose data from the iCGM is uploaded to the cloud when the system is able to establish a Wi-Fi or mobile data connection. Health care providers also have access to the data through a secure web portal, allowing patients to work with their providers on long-term goals and treatment options.