Objective
The REDDIE Patient Advisory Council (PAC) aims to ensure that the patient voice is central to how real-world data is collected, managed, shared, and used within REDDIE. A key focus is helping show why patient access to data matters and how real-world data can better reflect what is most important to people living with diabetes.
Specifically, the PAC will:
*Highlight why it is important for patients to have access to registry data
*Identify barriers to data transparency and meaningful patient involvement, and help find ways to address them
*Support the development of patient-friendly standards for real-world data and clear, accessible communication tools
*Act as a link between people with diabetes and the scientific and regulatory work within REDDIE
Background Rationale
REDDIE (Real-World Evidence for Decisions in Diabetes) is a European consortium working to improve how health data from everyday care is used to guide decisions about diabetes treatment and care. In addition to traditional clinical trials, which often involve limited and highly selected groups of patients, REDDIE focuses on real-world data—information collected through routine healthcare, such as national diabetes registries. This kind of data can show how treatments and technologies perform for people with diabetes in real-life settings.
Using data from large national registries across Europe, REDDIE aims to develop shared standards, practical guidance, and advanced analytical methods to support decision-making by regulators and health authorities. The goal is to help ensure that new and innovative diabetes solutions—including medicines, medical devices, diagnostic tools, and digital health technologies—are safe, effective, and affordable for the broad and diverse population of people living with diabetes.
While REDDIE is strongly focused on improving data-driven decision-making, people with diabetes often face challenges when it comes to accessing or benefiting from registry-based data. Many patients are not informed about how their data is used, have limited access to results, or lack opportunities to shape how registries are designed and governed. A recent review identified nine diabetes registries across Europe and found wide differences in transparency, patient involvement, and long-term goals. One clear conclusion was the need for registries that are more centered on people with diabetes—registries that build trust, encourage meaningful patient engagement, and support long-term self-management.
To help address this gap, a Patient Advisory Committee (PAC) will be created. The PAC will bring the patient perspective directly into REDDIE’s work by contributing to project design, governance, and communication. By involving patients consistently, the PAC will help ensure that real-world data is used in ways that are understandable, transparent, and aligned with what matters most to people living with diabetes.
Description of Project
This project supports the creation of a Patient Advisory Committee (PAC) within the REDDIE European diabetes initiative to ensure that the perspectives of people living with diabetes are reflected in how health data is used.
REDDIE relies on real-world data from large diabetes registries to inform decisions about treatments and technologies. However, patients often have limited visibility into how their data is used and little opportunity to influence which outcomes are prioritized. The PAC is designed to help address this gap by bringing lived experience into the project’s work.
Through the PAC, people with diabetes will help highlight outcomes that matter most to patients—such as time spent in a healthy glucose range, the impact of low blood sugar events, and quality of life—and identify barriers to data transparency and patient engagement. The PAC will also support the development of patient-friendly communication tools to make real-world data more accessible and understandable.
By strengthening the patient voice in the use of real-world data, this project aims to improve trust, relevance, and patient benefit, helping ensure that diabetes research better reflects real-life needs and experiences.
Anticipated Outcome
This project aims to strengthen the inclusion of the patient perspective in how real-world data is collected, accessed, and used within the REDDIE initiative. Through the establishment of a Patient Advisory Committee (PAC), the project will help highlight why patient access to data matters and how real-world data can better reflect patient priorities.
The PAC will provide structured input on patient-relevant outcomes commonly used in diabetes research and will help identify challenges related to data transparency and patient engagement across existing diabetes registries. This input is expected to inform ongoing discussions within REDDIE on data harmonization and communication practices.
Overall, the project is intended to support greater awareness of patient needs in the use of registry-based real-world data, contributing to more patient-aligned, transparent, and meaningful use of evidence within REDDIE, without altering the project’s scientific or regulatory objectives.
Relevance to T1D
This project is expected to directly benefit people living with Type 1 diabetes by ensuring that their experiences and priorities are reflected in how health data is collected and used. Through the REDDIE collaboration, the project will generate real-world evidence that is both meaningful to patients and suitable for use by regulators and health authorities.