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

The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy.

Included in the Bigfoot Unity System are two smartpen caps for both rapid- and long-acting insulin, a connected mobile app, an integrated FreeStyle Libre 2 Sensor from Abbott and a blood glucose meter.

What sets Bigfoot’s system apart is the smartpen caps that take data from the FreeStyle Libre 2 continuous glucose monitor to give users insulin dose recommendations based on a physician’s instructions. To use the smartpen cap for rapid-acting insulin, users scan the FreeStyle Libre 2 sensor and the pen cap displays their current glucose value as well as any recommended correction doses.

The Unity System also provides reminders for long-acting insulin doses and notifications for when a person’s glucose level is too low. All of the data is stored and shared with the Bigfoot app for users and their healthcare providers to view their health history.

Additionally, Bigfoot’s smartpen caps are compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens, including those produced by Eli Lilly, Novo Nordisk and Sanofi.

WHY THIS MATTERS

For the more than 34 million people in the U.S. with diabetes, multiple-dose injection therapy is one way to manage their condition. It involves one injection of long-acting insulin as a background dose and then rapid-acting doses at mealtimes.

While this therapy offers flexibility around mealtimes because of the rapid-acting insulin, it can be tricky for some people to adjust their insulin dosages, according to Diabetes.co.uk.

“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 a statement.

“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 LARGER TREND

Prior to today’s news, Bigfoot closed a series of well-funded financing rounds worth $55 million apiece.

The company has been working with Abbott for a number of years to integrate Abbott's FreeStyle Libre sensors with Bigfoot’s insulin delivery solutions.

Others focusing on smartpens are Medtronic, which has the InPen that can connect with the Guardian Connect connected glucose monitoring; Novo Nordisk, which recently integrated its smartpens with Roche's diabetes management app mySugr's Logbook; and Eli Lilly, which just inked a series of integration deals for its forthcoming Tempo Pen and Tempo Smart Button products.

ON THE RECORD

“There are more than 7 million people in the U.S. on insulin therapy, and many use insulin injections multiple times a day, yet there have been few advancements for this hugely underserved market,” Brewer said. “Bigfoot Unity is specifically designed to be simple and accessible – no matter the person’s level of technical expertise – removing a key barrier to health equity. We know people with diabetes want to be successful with their insulin therapy, and it’s often complex and expensive technology that gets in the way.”