Loop and Learn with Tidepool Loop, 1.30.2023

Howard Look, CEO and Brandon Arbiter, VP share lots of news and information about the newly FDA-approved Tidepool Loop.

Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in persons six years of age and greater.

Tidepool Loop, a patient-led project, is the first application of its kind to receive clearance from the FDA, and is also the first to enable insulin delivery from a compatible Apple Watch. The algorithm technology in Tidepool Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed predefined thresholds.

“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” said Howard Look, CEO and co-founder of Tidepool. “I’d also like to personally acknowledge and celebrate the contributions of the DIY community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research who made this milestone possible.”