The US Food and Drug Administration (FDA) has cleared the Bigfoot Unity Diabetes Management System, a cap device that connects to insulin pens and translates continuous glucose data into dosing recommendations, for use in individuals aged 12 and older.
The Bigfoot Unity System has three primary components — proprietary smart pen caps for both rapid- and long-acting insulin, a mobile app, and an integrated FreeStyle Libre 2 (Abbott) integrated continuous glucose monitor (iCGM) sensor, which was FDA-cleared in June 2020 — that fit into the person's dose-decision process when they need it throughout the day.
It allows the user to scan the FreeStyle Libre 2 sensor, displaying the user's current glucose value, trend arrow, and recommended correction dose. The smart pen cap also directly displays the health care provider's suggested meal insulin doses with the correction dose so the system gives the person with diabetes information to make real-time treatment decisions.
It also includes hypoglycemia alerts and is compatible with all major US brands of rapid- and long-acting disposable insulin pens.
Health care providers can monitor the patient's data through a secure web portal called the Bigfoot Clinic Hub.
"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, in a press statement.
"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."
JDRF said in a statement it "applauds the US FDA on its decision to provide clearance for the Bigfoot Unity Diabetes Management by Bigfoot Biomedical."
The new system "fills a critical gap and brings benefits of automation and device interconnectedness to people with diabetes who rely on multiple daily injections to manage their blood sugar levels." It is a "win for both the type 1 and type 2 diabetes communities as it broadens the options of treatment to alleviate daily burdens."
Growing Market for Smart Insulin Pens
The device is the latest advance in the "smart pen" field of semiautomated insulin delivery in which pen and compatible devices, software, and platforms are teamed up in various combinations to provide easier insulin dosing for patients with diabetes who require multiple daily injections but don't wear insulin pumps.
On May 6, 2021, Eli Lilly announced it had signed "strategic international agreements" with Dexcom, Glooko, MyDiabby Healthcare, and Roche to provide platforms or devices compatible with Lilly's prefilled Tempo Pen, which is already available in several global markets, and the Tempo Smart Button, currently in late-stage development and pending CE mark.
And in November 2020, Medtronic launched a new version of its smart insulin pen with integrated CGM called the InPen. The reusable insulin injector pen uses a smartphone app to calculate dosing of short-acting insulin based on CGM readings and allows users to view glucose readings and insulin dose information. It was originally launched in 2017 by Companion Medical, and the company was acquired by Medtronic in September 2020.
Novo Nordisk and Sanofi are also developing products in the smart pen space.
More information about the Bigfoot Unity Program is available here.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.
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Cite this: FDA Clears Cap Device for 'Smart' Insulin Pens for Diabetes - Medscape - May 11, 2021.