Tidepool, a Palo Alto, California-based nonprofit developing diabetes management software, has received research funding from Breakthrough T1D to advance an automated insulin delivery algorithm designed to reduce the need for manual carbohydrate counting and mealtime insulin adjustments.
The grant will support clinical evaluation of an investigational “unannounced meal” feature for Tidepool Loop, a smartphone-based automated insulin dosing application intended for people living with type 1 diabetes.
The technology aims to automatically adjust insulin delivery in response to changes in glucose levels associated with eating, potentially reducing the daily management responsibilities faced by people using automated insulin delivery systems.
Tidepool Loop initially received clearance from the U.S. Food and Drug Administration in 2023 for managing type 1 diabetes in individuals ages six and older.
The latest research initiative will support a randomized crossover clinical trial evaluating the safety and performance of the proposed meal management functionality. Results from the study are intended to inform a future FDA clearance submission.
Current automated insulin delivery systems typically rely on users to enter carbohydrate information or announce meals so that insulin can be delivered in anticipation of food consumption.
However, meal announcements can be delayed, inaccurate, or missed, making it hard to keep glucose levels within a desired range.
Tidepool cited estimates suggesting that people living with type 1 diabetes make more than 180 additional health-related decisions daily, with mealtime management representing a substantial portion of that workload.
The company’s proposed algorithm is designed to recognize changing insulin requirements and adjust dosing in response to glucose fluctuations, reducing dependence on manual meal entries.
The investigational functionality is being developed as part of Tidepool Loop 3.0, the company’s next-generation software platform.
Tidepool Loop 3.0 builds on the company’s ongoing development of Tidepool Loop 2.0, which was submitted for FDA review in July 2026.
Version 2.0 is designed to respond more quickly to rising glucose levels through automated bolus dosing while simplifying insulin adjustments through customizable presets.
It also includes dedicated exercise presets and educational resources intended to help users manage insulin requirements around physical activity.
Version 3.0 is expected to further expand automated capabilities by introducing support for meals that have not been manually announced.
The objective is to simplify diabetes management while maintaining appropriate glucose targets and clinical safety standards.
Tidepool emphasizes that its technology development builds on contributions from the open-source diabetes technology community, which helped establish early approaches to automated insulin delivery.
Founded in 2013, the organization develops software intended to make diabetes information more accessible and useful for patients, clinicians, and researchers.
Its products include Tidepool+, Tidepool Mobile, Tidepool Uploader, and Tidepool Loop.
The company’s technology is also commercially available through partner-developed adaptations, including the twiist automated insulin delivery system.
Breakthrough T1D, formerly known as JDRF, supports research and advocacy initiatives intended to improve diabetes management and advance treatments for type 1 diabetes.
The newly funded research reflects continued efforts to reduce the practical demands of insulin therapy through more advanced automation.
Tidepool Loop 2.0 remains under FDA review, while Tidepool Loop 3.0 is still in development and has not been submitted for regulatory clearance. Neither version is currently cleared for commercial sale in the United States.
KEY QUOTES:
“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. 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.”
Brandon Arbiter, CEO And Co-Founder Of Tidepool
“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.”
Amin GhavamiNejad, PhD, Senior Research Scientist At Breakthrough T1D
