FDA greenlights Bigfoot Biomedical’s insulin recommending diabetes administration system


This morning Bigfoot Biomedical announced that it has received FDA 510 (k) clearance for its Bigfoot Unity Diabetes Management System.

The system has been approved for people 12 years of age and older with type 1 or type 2 diabetes who are using multiple-dose injection therapy.

The Bigfoot Unity System includes two fast and long-acting insulin smartpen caps, a connected mobile app, an integrated Abbott FreeStyle Libre 2 sensor, and a blood glucose meter.

What sets the Bigfoot System apart is the smartpen caps that take data from the FreeStyle Libre 2 continuous glucose monitor to provide insulin dose recommendations to users based on a doctor’s instructions. To use the fast-acting insulin smartpen cap, users scan the FreeStyle Libre 2 sensor and the pen cap displays their current glucose level and any recommended correction doses.

The Unity system also reminds you of long-acting doses of insulin and notifies you when a person’s glucose levels are too low. All data is stored and shared with the Bigfoot app so users and their healthcare providers can view their medical history.

In addition, Bigfoot smartpen caps are compatible with all major US brands of fast and long-acting disposable insulin pens, including those manufactured by Eli Lilly, Novo Nordisk and Sanofi.


For the more than 34 million people in the US with diabetes, multiple-dose injection therapy is one way to manage their condition. It is an injection of long-acting insulin as a background dose and then fast-acting doses with meals.

While this therapy offers flexibility in terms of meals due to the fast-acting insulin, some people can find it difficult to adjust their insulin dosages, according to Diabetes.co.uk.

“Diabetes management is incredibly difficult because insulin does not have a fixed dose or timing. As a result, individuals must constantly determine their doses and configure devices as they make several critical decisions each day about how much insulin to take,” he said Jeffrey Brewer, CEO of Bigfoot Biomedical. said in a statement.

“At Bigfoot, we want to relieve the burden of diabetes on people who take insulin by taking the fearful guesswork out of insulin dosing in a convenient and easy way.”


Prior to today’s news, Bigfoot completed a series of well-funded funding rounds valued at $ 55 million apiece.

The company has worked with Abbott for several years to integrate Abbott’s FreeStyle Libre sensors with Bigfoot’s insulin delivery solutions.

Others who focus on smartpens are Medtronic with the InPen, which can interface with the glucose monitoring connected to Guardian Connect. Novo Nordisk, which recently integrated its smartpens into Roche’s diabetes management app mySugr’s Logbook; and Eli Lilly, who has just signed a number of integration agreements for their upcoming Tempo Pen and Tempo Smart Button products.


“There are more than 7 million people in the US on insulin therapy, and many use insulin injections several times a day. However, little progress has been made in this extremely underserved market,” Brewer said. “Bigfoot Unity was specifically designed to be simple and accessible – regardless of the person’s technical expertise – and to remove a major barrier to health equality. We know that people with diabetes want their insulin therapy to be successful, and it is often a complex and expensive technology that gets in the way. “