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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Emile
Hendriks
aejh6@medschl.cam.ac.uk
Dr
Emile
Hendriks
aejh6@medschl.cam.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Diabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Type 1 diabetes (T1D) is a chronic disease affecting around 17 million people worldwide. The disease may present at any age, but most typically develops in early life with a peak around puberty. The scientific insights to the triggering events, disease susceptibility, and subsequent pathophysiological events leading to a failing beta-cell function and beta cell loss (beta cells are found in the pancreas produce insulin)in human T1D are quite limited and disease modifying therapeutic approaches to address T1D are not available today.
The INNODIA consortium comprises of 33 partners including 26 academic institutes and clinics, 4 European national pharmaceutical industry associations (EFPIA), 2 patient organizations and one medium sized enterprise (SME) and was launched in response to the first call of the Innovative Medicines Initiative (IMI2)on 19 January 2016.
INNODIA aims to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of T1D. This will be achieved by developing a European infrastructure for the recruitment, detailed clinical phenotyping and biosampling (including blood, stool and urine sampling)of a large cohort of newly diagnosed (ND) patients with T1D and unaffected family members (UFM)generating an unrivalled bioresource for T1D discovery science. Workpackage 1 is one of 6 workpackages and is responsible for the recruitment of participants with T1D and their UFM (first degree relatives).
UFMs will be tested for diabetes autoantibodies at their screening visit and those that are positive will be followed up for 4 years(7 visits). UFMs that are negative to autoantibodies will be sent a health questionnaire every year until the end of the study (4 years)and maybe recalled for further sampling.
ND participants will be invited to join the study within 6 weeks of diagnosis and then attend study visits at 3, 6, 12 and 24 months from diagnosis.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Newly diagnosed participants 1. Non-type 1 diabetes (type 2, monogenic diabetes and secondary diabetes) 2. Concurrent use of immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results* 3. Expected non-compliance with the protocol 4. Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because problems in interpreting data or safety concern 5. Participating in interventional or other drug research studies which could affect the primary objectives of the study *Please refer to the study manual for listed medications Unaffected family members 1. Relative has type 2 diabetes, monogenic diabetes or diabetes secondary to another medical condition 2. Concurrent use of immunosuppressive agents including oral steroids or medication likely to confound the interpretation of study results* 3. Any medical history or clinical relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the participant ineligible for inclusion because of problems in interpretation of data or safety concerns 4. Participating in an interventional or other drug research which could affect the primary objectives of the study *Please refer to the study manual for listed medications
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Emile
Hendriks
aejh6@medschl.cam.ac.uk
Dr
Emile
Hendriks
aejh6@medschl.cam.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST and funded by European Commission .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 31472
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