FDA Grants Clearance to Smart Insulin Pen Caps for Diabetes


The smart pen cap system is associated with real-time hypoglycemia alerts and insulin dose recommendations.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to smart pen caps for insulin pens used to treat type 1 diabetes (T1D) and type 2 diabetes (T2D).

The clearance was granted to Big Foot Biomedical for their Bigfoot Unity Diabetes Management System, which uses smart pen caps to provide on-demand insulin doses for patients using multiple daily injection (MDI) therapy.

It is the first FDA granted dose decision support system that has minute-by-minute hypoglycemia alerts through integrated continuous glucose monitoring system (iCGM) data to provide dose recommendations.

The system will display a physician recommended dose using iCGM data on the pen cap, while also integrating with the Abbot FreeStyleLibre 2 system for glucose monitoring.

Patients can scan the FreeStyle Libre 2 sensor which will display the current glucose value, trend arrow, and a recommended correction dose. The system will also show patients the suggested meal insulin dose from their provider.

This treatment notified patients if they have missed their usual long-acting insulin dose. A low glucose alert will appear when a patient’s glucose level has fallen below 55 mg/dL, as well as an option alert when the glucose levels fall below 70 mg/dL.

Data from the iCGM and time-of-dose data from the system are uploaded to the cloud when it is possible, where health care providers can access the data through a secure web portal.

The FDA clearance system focuses on assisting clinicians deliver individualized care to patients with insulin-requiring diabetes.

Jim Malone, MD, chief medical officer for Bigfoot Biomedical said the clearance for the program “could be a game changer”.

“By replacing guesswork and complexity with connectivity and simplicity, the Bigfoot Unity program is truly serving as that real-time partner for both patients and providers when it comes to dose decision support and overall diabetes management,” said Malone in a statement.

Clinicians and health care providers can deliver care remotely, while also providing an accessible system for new patients and support to make insulin-dosing decisions.

In a statement accompanying the approval, Jeffrey Brewer, CEO of Bigfoot Biomedical expressed his pride in the company’s “advancements for this hugely underserved market.”

“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,” Brewer said.

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