Connected Tech Making Diabetes Management Easier

Abbott-Bigfoot collaboration integrates FreeStyle Libre 2 with first-of-its-kind smart insulin pen cap.

Connected Tech Making Diabetes Management Easier
Strategy and Strength | May 10, 2021

It's getting easier to manage diabetes for the approximately 2.6 million people1 in the U.S. who need multiple daily insulin injections as Abbott's much-anticipated partnership with medical device startup Bigfoot Biomedical comes to life.

Bigfoot has received clearance from the U.S. Food and Drug Administration for the Bigfoot Unity Diabetes Management system. This first-of-its-kind system2 features smart pen caps for disposable insulin pens — injection devices, about the size of a marker, that people with diabetes use to inject insulin — which integrate with Abbott's world-leading3 FreeStyle Libre 2 technology.

Here's how it works: The Bigfoot Unity smart pen cap for rapid-acting insulin uses glucose data captured every minute by the FreeStyle Libre 2 sensor, worn on the back of the upper arm, to provide on-demand insulin dosing recommendations for people ages 12 and older with diabetes who need multiple insulin injections a day. The dosing recommendations appear on the pen cap's digital screen and are based on instructions from the user's health care provider.

These recommendations help provide a real-time answer to the question: "How much insulin should I take right now?"

And it's an example of how the Abbott-Bigfoot partnership is leading the way for connected technology, the future of diabetes care, and making management of diabetes easier for people who need to inject insulin multiple times a day.

"People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it's important to develop connected technologies that simplify the experience," said Jared Watkin, senior vice president of Abbott's Diabetes Care business.

"Through Abbott's collaboration with Bigfoot Biomedical, we're providing automated information that personalizes diabetes management."

Abbott and Bigfoot partnership

Abbott's strength in the high-tech diabetes market — which is vast and growing with 463 million adults globally living with diabetes — is reflected by its full year 2020 FreeStyle Libre worldwide sales, which exceeded $2.5 billion, up more than 40% on an organic basis versus the prior year.4

Demand for FreeStyle Libre branded products is projected to continue rising in the coming years due, in part, to additional partnerships coming to fruition, increasing reimbursement coverage, and future generations of the FreeStyle Libre portfolio.

"We remain enthusiastic about Abbott's pipeline. The [FreeStyle] Libre platform continues to exceed our expectations," wrote BTIG analyst Marie Thibault in a January 28 note.5

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Other key features of the Bigfoot Unity system include:

  • The first to automatically capture integrated continuous glucose monitoring data, time of dose and upload that information to the cloud.6 This enables the user's health care provider to access this integrated information remotely, without the need for an in-person visit.
  • The first to be compatible with all major brands of rapid- and long-acting disposable insulin pens in the U.S., so people can continue using the Bigfoot Unity system and FreeStyle Libre 2 technology if they change their insulin pen brand.

Abbott continues to expand its FreeStyle portfolio and innovate the technologies by creating smarter, easier-to-use systems that make the requirements of diabetes care as seamless as possible.

Learn more about some of Abbott's latest diabetes care innovations: FreeStyle Libre 2 (received FDA clearance in June 2020).

References
1Data on file. Bigfoot Biomedical.
2Based on available products for multiple daily injection therapy of insulin as of April 2021.
3Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.
42020 Annual Report, Abbott.
5Marie Thibault, BTIG, Abbott Laboratories, January 28, 2021.
6Transfer of data depends on availability of Wi-Fi or cellular data signal.

Important Safety Information

Bigfoot Unity Diabetes Management System
FREESTYLE LIBRE 2

INDICATIONS AND IMPORTANT SAFETY INFORMATION
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*

WARNINGS/LIMITATIONS*:

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.
*Please refer to www.freestylelibre.us for the indications and important safety information.

Bigfoot Unity Diabetes Management System

Indications and Important Safety Information

The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in people ages 12 years and older. The Bigfoot Unity System provides glucose monitoring data via Abbott’s FreeStyle Libre 2 integrated continuous glucose monitoring system. The system incorporates real-time alarm capabilities and is designed to replace blood-glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist people with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription. The Bigfoot Unity System is also intended to communicate autonomously with digitally connected medical devices where the patient manually controls therapy sessions.

A health care professional must provide appropriate settings for the device based on user specific criteria. It is not intended to be used by individuals who dose insulin in ½ unit increments, take multiple daily doses of long-acting insulin or take high doses of vitamin C (more than 500 mg per day).