Prof D Dunger
Prof M Peakman
INNODIA is a consortium involving 33 academic from countries across Europe, industries and charitable organisations. The overarching aims of INNODIA are to advance our ability to predict, stage and evaluate the progression of Type 1 Diabetes (T1D). Like many EU projects, these goals of INNODIA will be achieved through a collaborative approach across a series of work streams called ‘work-packages’.
Three INNODIA work-packages – the Clinical Observational Study (Prof. David Dunger/Cambridge University); the Search for Biomarkers (Prof. Mark Peakman/Kings College, London) and the Design of Interventional Studies (Dr Adrian Mander/Cardiff University), are being led or co-led by researchers in the UK who are experts in their respective field. Additionally, Professor David Dunger has a central role in the overall delivery of the project which he co-coordinates with Professor Chantal Mathieu from the University of Leuven (Belgium).
Clinical Observational Study
The Clinical Observational Study’s main objective is to investigate the relationship between changes in β-cell function, immune profiles, genetic and environmental factors in newly diagnosed T1D patients and T1D family members at increased risk for the development of T1D. The Department of Paediatrics, University of Cambridge is coordinating this work package and both Cambridge University Hospitals NHS Foundation Trust and University of Cambridge sponsor the study.
The recruitment of participants involves 15 INNODIA partners from 10 different countries and is managed by Dr Sylvaine Bruggraber at the University of Cambridge.
Dr S Bruggraber
Clinical observational studies EU coordinator University of Cambridge
Who can participate?
INNODIA aims to study children and adults throughout Europe aged between 1 and 45 years who are either
An Unaffected family member
- first-degree healthy relative (siblings, half-sibling, children and parents) of someone who has been diagnosed recently or the past with type 1 diabetes before the age of 45
A Newly Diagnosed
- type 1 diabetes patients who have been diagnosed over the last 6 weeks
Where can I take part?
In the East of England, the Cambridge team, led by Prof David Dunger and coordinated by Di Picton, has open satellites recruitment sites to facilitate participant involvement.
Prof. David Dunger
Cambridge site Principal investigator
D Picton
Clinical observational studies UK coordinator University of Cambridge
Screening: autoantibody positive participants will be referred to other sites for follow-up
Participant identification: eligible participants will be referred to other sites for visits
What is involved?
For Unaffected Family Members (first degree healthy relative)
- First-degree healthy relatives are tested for diabetes related autoantibodies in the blood (screening visit lasting under 1h). The presence of these autoantibodies indicate that the autoimmune process is activated and that there may be an increased risk of developing T1D. In the majority of participants, the result of the autoantibody testing will be negative. If no autoantibodies are detected, participants will be asked to complete a short health questionnaire each year over a four years period, and may be recalled on occasion for further blood sampling. Antibody positive participants, will be invited to attend a total of seven assessments over a period of four years in which their risk of developing T1D will be assessed. Between appointments, these participants will also be asked to perform finger-prick blood samples every month at home.
*ideally within 3 months of receiving the autoantibody results
For Newly Diagnosed
Newly-diagnosed T1D patients will be asked to attend 5 study visits over a period of 2 years. Between appointments, newly diagnosed Type 1 diabetes patients will be asked to take a finger-prick blood sample every month at home.
- First-degree healthy relatives are tested for diabetes related autoantibodies in the blood (screening visit lasting under 1h). The presence of these autoantibodies indicate that the autoimmune process is activated and that there may be an increased risk of developing T1D. In the majority of participants, the result of the autoantibody testing will be negative. If no autoantibodies are detected, participants will be asked to complete a short health questionnaire each year over a four years period, and may be recalled on occasion for further blood sampling. Antibody positive participants, will be invited to attend a total of seven assessments over a period of four years in which their risk of developing T1D will be assessed. Between appointments, these participants will also be asked to perform finger-prick blood samples every month at home.
For more information please email INNODIA-recruit@paed.cam.ac.uk
The project received funding under the grant agreement n° 115797 (INNODIA) under the Joint Initiative Innovative Medicines Initiative 2 (www.imi.europa.eu). It was approved in November 2015 and launched in January 2016. The joint initiative is supported by the European Union’s Horizon 2020 research and innovation program, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Juvenile Diabetes Research Foundation (JDRF) and the Leona M. and Harry B. Helmsley Charitable Trust.
The clinical observational study has been reviewed by an independent research Ethics committee and is sponsored by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Links to other sites for information about the study and videos
