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FDA Clears Tidepool Loop: First iPhone-Controlled Automated Insulin Dosing App for Type 1 Diabetes

• Tidepool Loop, developed by non-profit Tidepool, receives FDA clearance as the first iPhone-controlled automated insulin dosing app for type 1 diabetes management in patients aged six and above.

• The innovative app works with compatible continuous glucose monitors and insulin pumps to automatically adjust basal insulin delivery and recommend correction boluses based on glucose predictions.

• The breakthrough approval establishes a regulatory pathway for future Automated Insulin Dosing systems and enables first-ever insulin delivery control via Apple Watch.

The US Food and Drug Administration has cleared Tidepool Loop, marking a significant advancement in diabetes management technology. This groundbreaking automated insulin dosing app, developed by the non-profit organization Tidepool, represents the first iPhone-controlled interoperable automated glycemic controller approved for type 1 diabetes management in patients six years and older.

Revolutionary Features and Functionality

The app's sophisticated algorithm interfaces with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to provide automated insulin management. The system can automatically adjust basal insulin delivery - increasing, decreasing, or suspending doses based on real-time glucose readings and predicted values. Additionally, it can calculate and deliver correction boluses when glucose levels are anticipated to exceed predetermined thresholds.
In a notable technological breakthrough, Tidepool Loop becomes the first application to enable insulin delivery control through a compatible Apple Watch, offering unprecedented convenience for users.

Community-Driven Development

Howard Look, CEO and co-founder of Tidepool, emphasized the collaborative nature of the achievement: "We knew this day would come, but we couldn't have achieved it without the support of the entire diabetes community, including the FDA." The project received crucial backing from several organizations, including JDRF, The Helmsley Charitable Trust, and the Tullman Foundation.
The development process notably incorporated insights from the DIY community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research, demonstrating the power of community-led innovation in medical technology.

Impact on Diabetes Care

"Tidepool Loop's ground-breaking FDA clearance represents a pivotal step towards a world where people with T1D can choose the pump, CGM, and algorithm that are best for them – and have all three work together," stated Aaron Kowalski, CEO of JDRF.
The clearance establishes Tidepool Loop as a predicate device for future interoperable Automated Insulin Dosing (AID) submissions, potentially streamlining the regulatory process for similar innovations. This development could accelerate the advancement of diabetes management technologies and improve patient care options.

Implementation and Future Plans

Tidepool is currently finalizing partnerships with device manufacturers to ensure seamless integration for both healthcare providers and patients. While initial launch partners haven't been announced, the company has confirmed a development partnership with Dexcom and is in discussions with other medical device companies for future platform integration.
The app will join Tidepool's existing suite of diabetes management tools, which includes Tidepool Web, Tidepool Mobile, and Tidepool Uploader, creating a comprehensive ecosystem for diabetes care management.
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Reference News

[1]
Automated insulin dosing app Tidepool Loop FDA-cleared
pharmaphorum.com · Jan 24, 2023
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