Abbott has struck a deal to combine its FreeStyle Libre glucose sensing technology with Bigfoot Biomedical’s experimental insulin delivery device. The agreement sets Bigfoot up to start a pivotal trial of a version of its delivery system that incorporates the Abbott technology next year.
FreeStyle Libre consists of a wearable sensor and handheld reader. Scanning the sensor delivers a glucose reading. Bigfoot’s smartphone app will take the glucose data and turn them into insulin dosing recommendations or use them to trigger automatic deliveries from its pump device.
Bigfoot devices trialed to date have incorporated the Dexcom G5 continuous glucose monitoring system. Dexcom and Bigfoot teamed up to combine their technologies in 2015. But with Abbott’s device freeing users from the need to calibrate the sensor with finger pricks, Bigfoot has struck a deal to use the FreeStyle Libre technology in all the insulin delivery systems it sells in the U.S.
A pivotal trial stands between Bigfoot and those sales. Bigfoot plans to start trialing a version of its system incorporating the Abbott technology next year, setting it up to bring the product to market by 2020, according to the Chicago Tribune. Bigfoot had previously said it planned to file for FDA approval early in 2018.
Abbott is also yet to win FDA approval for FreeStyle Libre; a decision is pending. But as the FDA will assess Bigfoot’s insulin delivery system as a whole, the startup could in theory bring its device to market before Abbott gets a green light.
Bigfoot has spent the past two years preparing for the anticipated introduction of its device by raising $35.5 million in a series A round, running a clinical trial and acquiring the developers of insulin pumps and pens. The Abbott agreement builds on these earlier deals.
“A no-calibration glucose sensor is the final piece of the puzzle needed to enable consumer-friendly and accessible integrated insulin delivery systems,” Bigfoot CEO Jeffrey Brewer said in a statement.