Tidepool Gains FDA Clearance for Its Crowdsourced Insulin Dosing App

Diabetes nonprofit organization Tidepool has received FDA clearance for its crowd-sourced Tidepool Loop, the first automated insulin dosing app that works from an Apple Watch.

The app, developed as a patient-led and supported project, helps manage type 1 diabetes in patients six years and older.

The app works with multiple integrated continuous glucose monitors (iCGMs) and alternate controller enabled pumps to automatically increase, decrease or suspend delivery of basal, or slow-acting “background,” insulin based on iCGM readings and predicted glucose values.

The app also can recommend and deliver a correction when glucose rises above set thresholds.