DIRECT - Innovative Medicines Initiative:
DIabetes REsearCh on patient straTification

People with Type 2 diabetes can have a very different experience. For example, some people’s blood sugar levels will get worse over time and some people’s blood sugar levels will remain the same. Some people experience side effects with common drugs used to treat Type 2 diabetes, while others don’t. Also some people will respond very well to certain treatments but other people respond badly.


The DIRECT project is intended to explore some of these differences, to work out why people don’t react in the same way. We will be able to see whether people with Type 2 diabetes are similar and if they have the same experience or not. This will help predict how other people might respond.


The studies hope to identify if there are signals, called ‘biomarkers’, which might flag whether particular patients belong to different sub-groups. These sub-groups are based on each patient’s experience of Type 2 diabetes. These biomarkers will be used to help diagnose people with Type 2 diabetes, and could be used to choose the best treatment pathways for them.


The first stage of the project is split into two areas:

  • Studying the way that Type 2 diabetes progresses in some patients.
  • Studying the way that different patients respond to different treatments.


The biomarkers found in these studies, will be tested further in the second stage of the project. In the second stage we want to see whether these biomarkers really are helpful in diagnosing people with Type 2 diabetes and in developing better treatments in the future.


The research is being funded by the European Union, with funding from some leading pharmaceutical companies. Together, this group of European researchers and scientists is called the DIRECT Consortium. DIRECT is interested in learning about the risk factors for diabetes and how people with diabetes begin their diabetes journey or respond to treatment.


UPDATE
This notice supplements the Participant Information Sheet that participants originally received when agreeing to take part in the study and provides further information in light of the new EU General Data Protection Regulation (‘GDPR’).

The Participant Information Sheets can accessed via the links at the top of this page. If you wish to contact the organisation holding your personal data (that is, your ‘study centre’) or their Data Protection Officer, their contact details can be found here.

The legal basis on which your information is used
Under the GDPR, data processing must be necessary for one of a number of specified purposes, that is, for a ‘legal basis.’ If you have questions about the legal basis on which your personal data are processed by your study centre, please contact them directly.

Requesting access to your personal data
The GDPR also gives you the right to access your personal data, although this can be subject to research exemptions which will vary between different countries.

To make a subject access request, please contact your study centre using the information provided above. You can also use these contact details to exercise your right to:

  • Erasure of your personal data;
  • Rectification of any inaccurate personal data concerning you. You may also have a right to have any incomplete data completed, depending on the purpose of the processing;
  • Restriction of the processing of your personal data for any of the reasons listed in the GDPR;
  • Data portability.
These GDPR rights may also be subject to national exemptions; please contact your study centre if you would like more information.

Complaints
You have the right to lodge a complaint with the data protection authority in your country, but if you have any concerns you can also raise them with the Data Protection Officer of your study centre in case the matter can be resolved.


For more information, and for updates on how the research is progressing please follow us on Twitter: @DIRECTdiabetes and visit our Facebook page: Direct Project.