Type 1 Diabetes (T1D) is an autoimmune disease where the body’s own immune system mistakenly attacks insulin-producing beta cells in the pancreas. It’s an irreversible process, meaning that people living with T1D must rely on lifelong insulin therapy to survive.

Anyone can be diagnosed with T1D at any age. In contrast, Type 2 diabetes is primarily linked to insulin resistance, where the body still produces insulin but is unable to use it effectively. While type 2 diabetes can sometimes be managed or even reversed with lifestyle changes and medications, T1D has no cure, making continuous insulin administration the only option. The mental, emotional, and physical burden on individuals with the disease is relentless with studies estimating that individuals with T1D make around 180 health-related decisions each and every day and the risk of complications is ever present.

The INNODIA consortium, part of the Innovative Medicines Initiative, is working to address this. INNODIA is a public private partnership that brings together industry, academia, foundations including BT1D and patient organisations[1] creating a pan-European research and clinical trial infrastructure.

The INNODIA consortium has made significant strides in T1D research through a robust, pan-European network of validated clinical centers. This infrastructure has enabled the collection of comprehensive clinical data and biosamples from individuals newly diagnosed with T1D. It has helped advance the understanding of beta cell function decline and identify novel biomarkers. These biomarkers are crucial for future patient stratification in clinical trials, which could enhance targeted treatments and prevention strategies.

INNODIA’s contribution goes beyond infrastructure to include the development of a Master Protocol for Phase 2 Clinical Trials. This standard framework leverages its natural history study to support multiple phase 2 trials with investigational medicinal products (IMPs). Key features of the protocol include:

• Standardized assessment of drug efficacy and safety,
• Consistent collection of mechanistic data,
• Use of adaptive designs with shared control groups for combination therapies,
• Improved trial design with robust sample size calculations, optimizing biomarker use for patient stratification.

The protocol is pivotal for phase 2 T1D research, addressing existing limitations in dose evaluation and response variability.

INNODIA and its successor, INNODIA HARVEST, have partnered with several pharmaceutical companies to explore treatments aimed at halting T1D progression. For example:

• Repurposing drugs traditionally used for blood pressure control, has shown promise in protecting beta cells in T1D patients.
• Drugs being studied for  immune-regulating effects to maintain insulin secretion.
• Studying medicines to evaluate immune protection in newly diagnosed patients.

The studies target children, adolescents, and adults recently diagnosed with the disease, focusing on preserving beta cell function during the critical "honeymoon" period, a temporary phase shortly after diagnosis when the body still produces some insulin.

At the heart of INNODIA’s success is its Patient Advisory Committee (PAC), the first of its kind in an Innovative Medicines Initiative (IMI) project. The PAC ensures that individuals with T1D and their families are central to decision-making, guiding research priorities, recruitment, and study design to meet real patient needs. This pioneering inclusion of patient voices has set a new standard for patient-centered research in Europe.

And the consortium is looking to the future; in anticipation of the IMI funding phase ending, INNODIA has founded INNODIA iVZW, a non-profit organization that will continue its legacy. Based in Leuven, Belgium INNODIA iVZW includes founding members from prominent European research institutions. Their goals include:

• Expanding clinical infrastructure, particularly in underrepresented European regions,
• Enhancing access to data and biosamples for biomarker research,
• Supporting expertise sharing within the European T1D research community,
• Empowering individuals with T1D in clinical trials through continued PAC engagement.

With four ongoing clinical trials, the INNODIA consortium continues to advance type 1 diabetes research and treatment options. As patients living with type 1 diabetes continue to address the demands of their disease day after day, through the creation of INNODIA iVZW, the INNODIA consortium will continue to provide invaluable resources, data, and insights, advancing the fight against type 1 diabetes well into the future.

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.  

[1] A full list of INNODIA partners can be found at www.innodia.eu