Testing the 4T Program in the T1D Exchange

About This Grant

Project Summary: Despite decades of evidence supporting the benefits of intensive diabetes management, outcomes for youth with type 1 diabetes (T1D) in the U.S. remain suboptimal. The modest improvements seen nationally contrast with international data. To address this gap, we developed and tested the Teamwork, Targets, and Technology for Tight Glycemia (4T) Program. The 4T team-based model initiates early continuous glucose monitoring (CGM), education on automated insulin delivery (AID), and remote patient monitoring (RPM) using the Timely Interventions for Diabetes Excellence (TIDE) platform to achieve tight glucose control. TIDE applies algorithms to CGM data to triage patients into actionable categories, enabling just-in-time, personalized care delivery by the diabetes care team. The evidence-based 4T program, recently published in Nature Medicine, reduced HbA1c by 1.1 unit (%) and increased those with HbA1c <7% by 2.3 times (28% to 64%) at 1-year post-T1D diagnosis compared to historic controls. In this U34 proposal (PAR-25-090), ‘Testing the 4T Program in the T1D Exchange,’ we will evaluate the implementation and effectiveness of the 4T Program in an established and receptive US network of pediatric diabetes centers in the T1D Exchange Quality Improvement Collaborative (T1DX-QI). The project will be guided by the Implementation Research Logic Model to identify contextual determinants (barriers and facilitators), select and tailor implementation strategies, and organize implementation and effectiveness outcomes using the RE-AIM framework. The U34 phase includes four specific aims at different healthcare system levels: (1) care team, refining workflows to facilitate engagement with RPM and TIDE; (2) organizational, tailoring TIDE and associated systems to local sites; (3) leadership, sharing best practices and developing financial sustainability strategies, including processes for RPM reimbursement; and (4) systems, building study infrastructure to collect and analyze data from CGM, electronic health records, and patient- reported outcomes (PROs), with a focus on reducing care variability. The U34 phase will prepare for a U01 type 2 hybrid trial using a randomized stepped wedge design. Testing the 4T Program in the T1D Exchange will help maximize the benefits of diabetes technology by improving glycemia, enhancing PROs, supporting consistent access to care, and developing sustainable, scalable strategies for the 4T model in pediatric diabetes care. This research builds on strong prior collaborations between Stanford and the T1DX-QI. Participating centers have already engaged in key preparation activities, including attending a 4T–T1DX workshop in January 2025, confirming data sharing as evidenced by co- authoring three ADA abstracts as part of this U34 proposal. The overarching goal of this U34 proposal is to implement sustainable clinical care that integrates technology, precision medicine, and thereby improve outcomes for newly diagnosed youth with T1D across the U.S.