An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

Summary

INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu).

The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium.

The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.

One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

Conditions

• Type 1 Diabetes Mellitus

Sponsors & Collaborators

• Innovative Medicines Initiative

  collaborator OTHER

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

• David B Dunger · University of Cambridge

• Mikael Knip · University of Helsinki

• Chantal Mathieu · Katholieke Universteit Leuven

Eligibility

Min Age

1 Year

Max Age

44 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-14

Primary Completion

2022-10-31

Completion

2022-10-31

Countries

• Austria
• Belgium
• Denmark
• Finland
• France
• Germany
• Italy
• Luxembourg
• Norway
• Poland
• Slovenia
• Sweden
• United Kingdom

Study Locations