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.