ArticleTrials2022
INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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Who cites it
26 citing papers in PubMed, 37 citations in OpenAlex.
- Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial.Nature medicine · 2023Trial
- Transcriptomics of type 1 diabetes progression: a validation study in newly diagnosed patients.EBioMedicine · 2026Article
- Reducing Diabetic Ketoacidosis in Pediatric Type 1 Diabetes: The Impact of Screening Programs and Early Disease-Modifying Treatment.Journal of clinical medicine · 2026Review
- From Screening to Delivery of Disease-Modifying Therapy: Real World Follow-Up of Children With Early-Stage Type 1 Diabetes.Diabetes, obesity & metabolism · 2026Article
- The Risk of Disease Progression of Type 1 Diabetes in First-Degree Relatives of People With Type 1 Diabetes: Design and Rationale of a Prospective, Longitudinal Study in China.Diabetes, obesity & metabolism · 2026Article
- The Role of Adaptive and Innovative Trial Designs in Diabetes Research: A Scoping Review.Diabetes care · 2026Article
- Optimizing Type 1 Diabetes Screening in People With Family History: A German Perspective.Journal of diabetes science and technology · 2025Review
- Transformative collaborations in a time of change: Europe's unique model for public-private-philanthropic partnerships.The Lancet regional health. Europe · 2025Article
- Connecting the Spots: Serial Home C-peptide Measurements Paint an Accurate Picture of Change in β-Cell Function.Diabetes care · 2025Article
- Targeted serum proteomics of longitudinal samples from newly diagnosed youth with type 1 diabetes affirms markers of disease.Diabetologia · 2025Article
- Leveraging artificial intelligence and machine learning to accelerate discovery of disease-modifying therapies in type 1 diabetes.Diabetologia · 2025Review
- Advancing European paediatric research - the contribution of the Innovative Health Initiative.Frontiers in medicine · 2025Article
- Observational
- Article
- Presentation and characteristics of children with screen-detected type 1 diabetes: learnings from the ELSA general population pediatric screening study.BMJ open diabetes research & care · 2024Article
- Gut microbiome shifts in people with type 1 diabetes are associated with glycaemic control: an INNODIA study.Diabetologia · 2024Article
- Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes.Diabetologia · 2024Article
- Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes.Diabetes care · 2024Article
- A set of circulating microRNAs belonging to the 14q32 chromosome locus identifies two subgroups of individuals with recent-onset type 1 diabetes.Cell reports. Medicine · 2024Article
- The INNODIA Type 1 Diabetes Natural History Study: a European cohort of newly diagnosed children, adolescents and adults.Diabetologia · 2024Article
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Authors and funding
10 authors at 6 institutions in 5 countries.
Funding
Abstract
backgroundThe INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials.
methodsIn this context, we have developed a Master Protocol, based on the "backbone" of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. DISCUSSION: The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.
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