Tidepool, a non-profit leader advancing innovation in diabetes technology, today announced it has been awarded research funding from Breakthrough T1D, the leading global type 1 diabetes (T1D) research and advocacy organization, to support clinical evaluation of an investigational “unannounced meal” feature for Tidepool Loop. First cleared by the Food and Drug Administration (FDA) in 2023, Tidepool Loop is an automated insulin dosing (AID) smartphone application intended for the management of T1D in persons six years of age and older. Funding from Breakthrough T1D will support a randomized crossover trial of Tidepool Loop’s unannounced meal feature, which is designed to automatically adjust insulin delivery around meals without manual carbohydrate announcements. Results will inform a future submission for FDA clearance.

People living with T1D make an estimated 180+ additional health decisions every day, and meals are among the most demanding parts of the mental load, with mealtime boluses (insulin delivered to cover the food being eaten) often being late or missed altogether. Tidepool Loop 3.0, the intended product of the research, aims to reduce the requirements for manual meal announcements by dynamically assessing and adapting to the user’s current insulin needs to correct and handle unexpected glucose excursions.

“Breakthrough T1D helped make Tidepool Loop possible, and this grant lets us take on one of the heaviest burdens that remain for AID users: mealtime,” said Brandon Arbiter, CEO and Co-founder of Tidepool. “By enabling Tidepool Loop to safely manage meals without manual announcements, we can reduce the daily burden of diabetes and give people back a meaningful share of their day.”

“Breakthrough T1D is committed to reducing the daily burden of managing type 1 diabetes and improving health outcomes. Despite significant advances in AID, mealtime insulin management remains a challenge for many people living with T1D. Advancing technologies that remove the need for user intervention at meals is an important part of our mission,” said Amin GhavamiNejad, PhD, Senior Research Scientist at Breakthrough T1D.

Streamlining Diabetes Management Through Algorithm Enhancements

Building upon its foundational FDA clearance, Tidepool submitted Tidepool Loop 2.0 for FDA review in July 2026. Tidepool Loop 2.0 is designed to respond more quickly to rising glucose levels with automated bolus dosing and to make adjusting insulin delivery simpler with customizable presets, plus dedicated exercise presets and in-app exercise education.

Tidepool Loop 3.0 represents the next evolutionary step. By integrating unannounced meal support, version 3.0 aims to reduce or eliminate the need for carbohydrate counting. The enhanced algorithm adopts a balanced approach to reducing manual inputs while maintaining tight glycemic targets and safe, strong clinical outcomes.

Honoring Open-Source Roots

Tidepool Loop represents the vision and contributions of a large open-source community whose pioneering spirit, lived experience, and relentless innovation proved that fully automated dosing systems could transform lives. Tidepool remains deeply committed to carrying this community-led mission forward and to making accessible, regulated, and impactful technology that improves care and quality of life for everyone living with diabetes.

About Tidepool

Tidepool is a recognized innovator in diabetes software on a mission to make diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. Founded in 2013, Tidepool hosts a suite of software tools for people with diabetes and the clinics that serve them, including Tidepool+, Tidepool Mobile, Tidepool Uploader, and the FDA-cleared Tidepool Loop. Through strategic industry partnerships, Tidepool Loop is commercially available via partner-developed adaptations, such as the twiist™ AID System powered by Tidepool, now available in the iOS App Store. Built with enterprise-grade security, the Tidepool platform is HIPAA-compliant and SOC 2 Type II-compliant. Tidepool is a registered 501(c)3 nonprofit organization. Learn more at tidepool.org. Follow us on LinkedIn.

About Breakthrough T1D, Formerly JDRF

As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.

Forward Looking Statements

This press release contains forward-looking statements regarding Tidepool’s organizational objectives, anticipated software releases, and current and planned submissions to the U.S. Food and Drug Administration (FDA). These statements reflect our current views based on information currently available to us and are not guarantees of future performance.

Tidepool Loop 2.0 is the subject of a pending 510(k) submission. It has not been cleared by the FDA and is not available for sale in the United States. Tidepool Loop 3.0 is under development, has not been submitted to or cleared by the FDA, and is not available for sale in the United States.

Actual results, product features, or timelines may differ materially from those described in this release due to risks and uncertainties. These include but are not limited to delays in software development, the outcome and timing of FDA’s review including the possibility that features described in this release are modified, limited or not included in a cleared product, the possibility that the FDA does not clear a submission, the timing and results of clinical studies supporting future submissions, and technical challenges in integrating with third-party devices. We assume no obligation to publicly update or revise any forward-looking statement contained in this press release, whether as a result of new information, future events or otherwise.

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