The Time in Range Coalition (TIRC) is committed to educating global regulators—including the FDA and EMA—on the importance of TIR for diabetes care and the need for TIR to be integrated into the development and approval of therapies to further the awareness and access of CGM metrics.
This includes reducing barriers to diabetes technology access for all people with diabetes, engaging with key stakeholders to increase clinical and patient-reported evidence supporting TIR as a clinically meaningful endpoint, and collaborating with already established initiatives. We aim to ensure that the perspectives of people with diabetes are at the forefront of regulatory decision-making, and have cemented ourselves as uniquely-positioned thought leaders working towards aligning regulatory and clinical efforts so that people with diabetes have the best access, guidance, and outcomes possible.
The following documents are part of our work to directly impact regulatory bodies, and have been submitted to multiple agencies throughout the years. Many have led to direct engagement with these regulatory bodies, pushing forward our goal of education, access, and adoption.
TIRC Comments for CMS – November 2022
TIRC Comments on FDA Draft Guidance – August 2023
TIRC Comments for FDA Digital Health Technologies Framework – May 2023
TIRC MEDCAC Meeting Comments – April 2024
TIRC – Letter to Commissioner Martin Makary – April 2025
TIRC Written Comments – Senate FDA FY2026 Funding – May 2025
TIRC Written Comments – House FDA FY2026 Funding – May 2025
TIRC Response to HHS Deregulatory RFI – July 2025