New Smart Insulin Pen Cap System for Diabetes Just Got FDA Approval

The first-of-its-kind smart pen cap could help treat Type 1 and Type 2 diabetes.
Fabienne Lang
Smart insulin pen capBigfoot Biomedical

A little over one in 10 people in the U.S., that's 34.2 million residents, were living with diagnosed and undiagnosed diabetes in 2018, as a U.S. Centers for Disease Control and Prevention's (CDC) 2020 report stated. Between 90 and 95 percent of these people have Type 2 diabetes, and the rest have Type 1. 

That's a decent amount of people in the U.S. alone who live with diabetes. So it's surprising to find out that monitoring and administering insulin — which is the key "ingredient" diabetics either lack entirely (Type 1), or don't respond to or make enough of (Type 2) — is still not an easy task for diabetics, as Healthline points out.

But that may be about to change. On Monday, May 10, the U.S. Food and Drug Administration (FDA) approved biomedical company Bigfoot Biomedical's "Bigfoot Unity Diabetes Management System." The system features smart insulin pen caps that recommend insulin doses for diabetics who require multiple daily injection (MDI) therapy.

How Bigfoot Biomedical's system works

"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," said Jeffrey Brewer, CEO of Bigfoot Biomedical. 

To minimize this time consuming, old-fashioned system, Bigfoot Biomedical's smart pen caps give on-demand, insulin dose decision support so that patients don't have to guess the amount, and makes it easier for them to follow their doctor's instructions. 

The system is made up of three main components: the proprietary smart pen caps for both rapid- and long-acting insulin, a mobile app, and an integrated FreeStyle Libre 2 iCGM sensor.

New Smart Insulin Pen Cap System for Diabetes Just Got FDA Approval
Bigfoot Unity Diabetes Management System. Source: Bigfoot Biomedical

This is the first system that works for people with Type 1 and Type 2 diabetes on MDI therapy that uses an integrated continuous glucose monitoring system from Abbott’s FreeStyle Libre 2 system, which then gives an accurate insulin dose recommendation.

The system displays all the required information on a connected smart cap for the patient's disposable insulin pens, and there's no need to manually input glucose data in a separate system, as has been the case up until now. 

Other measures are being looked into to help support people living with diabetes. For instance, a weekly insulin dose system has been undergoing clinical trials since 2020, and scientists have been working on bioprinting properties that can bioprint a pancreas that could end diabetes. 

Having to inject yourself multiple times a day to boost your body's insulin levels is no easy or fun task, so it's good to see new systems and technologies coming into place to help support people living with diabetes.

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