Diabetes Dialogue: FDA Clearance of Tidepool Loop
As advancing technology continues to push patient care into the future, a new emphasis has been placed on creating technologies with the ability to be customized and precise to each patient. There may be no fields where this is more evident than in diabetes technologies, where breakthroughs seem to occur on a regular basis and, earlier this month, a historic, first-of-its-kind clearance from the US Food and Drug Administration furthered this ability to customize and adapt care in an individualized manner most for each person with diabetes.
Named Tidepool Loop, the prescription-only mobile app, which was created by Tidepool, received clearance from the FDA for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons 6 years of age and older. A 501(c)3 organization founded in 2013, Tidepool Loop represents the latest addition to a suite of software tools from Tidepool that already includes Tidepool Web, Tidepool Mobile, and Tidepool Uploader. A patient-led project, the Tidepool Loop was created with the intent of allowing people with diabetes to use the app with compatible integrated continuous glucose monitors (iCGM) and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. The app, which is only available for the iPhone at the time of writing and is also the first app to enable insulin delivery from a compatible Apple Watch, is also designed to recommend and deliver correction boluses when glucose values are predicted to exceed predefined thresholds.
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