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Table 1 Inclusion and exclusion criteria of the INNODIA natural history study

From: INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Inclusion criteria

To be included in the study, participants with newly diagnosed type 1 diabetes must:

1. Have given written informed consent to participate

2. Be aged between 1 and < 45 years

3. Be less than 6 weeks from the diagnosis of type 1 diabetes and requiring insulin treatment

Exclusion criteria

1. Non-type 1 diabetes (type 2 diabetes, monogenic diabetes and secondary diabetes)

2. Concurrent use of long-term 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 clinically relevant abnormality that is deemed by the principal investigator and/or co-investigator to make the patient ineligible for inclusion because of problems in interpreting data or safety concerns

5. Participating in interventional or other drug research studies which could affect the primary objectives of the study