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.

To celebrate the historic clearance and provide real-world perspective on what it means for people with type 1 diabetes, Diana Isaacs, PharmD, an endocrine clinical pharmacist and coordinator of the CGM Program at the Cleveland Clinic, and Natalie Bellini, DNP, an endocrine nurse practitioner with R&B Medical Group, tackle the clearance of the Tidepool Loop in this special edition episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives. In the episode, hosts discuss the clearance, what is unique about the app’s customizability, and other top points for people with diabetes and members of the diabetes care team to consider with the technology moving into the future.

All episodes of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives are available in an audio-only format on Spotify and Apple Podcasts.