FAQs

1. What questionnaires will be requested to be filled out?

The six questionnaires used in this study have been validated and translated into Danish. Here is the list and what they provide information about

  • CSI (celiac symptom index): Examines symptoms of gluten intolerance. 
  • PAGI-SYM (patient assessment of gastrointestinal symptoms): Examines symptoms from the gastrointestinal tract, including delayed emptying of the stomach.
  • MNSI (Michigan neuropathy screening instrument): Examines symptoms of nerve damage in the hands and feet.
  • GSRS (gastrointestinal symptom rating scale): Examines upper and lower gastrointestinal symptoms.
  • VFQ-25 (Visual function questionnaire): Examines symptoms of visual disturbances
  • PEIQ (the pancreatic exocrine insufficiency questionnaire): Examines symptoms from the pancreas.

2. What are the next steps after filling out the questionnaires?

After participating in the questionnaire survey the first time, you will be invited by mail to fill in identical questionnaires after 3 months. You will then be contacted every six months. The email will contain a link to the database that will lead you directly to the questionnaires.

When you have completed the questionnaires twice with 3 month intervals, you can see a report with your results on the last page. You can print this report and possibly share it with your diabetes doctor or nurse so that together you can discuss any changes or treatment options that suit you.

3. What are the benefits of taking part in this study?

By joining this study you will be able to easily monitor key aspects that matter to you in a comprehensive way and have full autonomy to evaluate and determine what works best for you .

4. Is my data secure and handled privately?

The questionnaires are completed through a secure digital electronic research database. Your personal data is handled in accordance with the Data Protection Regulation and the Data Protection Act. All data that can identify you as a person or at group level will be pseudonymised and is only visible to the senior researcher Aalborg University Hospital/Mech-Sense. For more information, go to the FAQ section - How is your data managed

1. Is this a clinical trial of a new drug?

No, this is only an epidemiological study. You will be able to obtain information about the results of your participation, which you can use at encounters with your diabetes doctor or diabetes nurse.

2. What are the risks of participating in the DICODI clinical research?

There are no risks associated with participating in the DICODI clinical research. Your feedback is voluntary and will be used to improve the diagnoses of diabetes complications and therefore enable adjustments to your treatment.

3. Who can participate in the DICODI clinical research?

The DICODI clinical research study is generally open for participants who are 18 years or older, have been diagnosed with diabetes, and are suffering from digestive complications.

4. For how long should I participate in this research project?

This is an open-ended study, and you will receive a more accurate diagnosis after the first round of completing the questionnaires- 24 months. Participants can contribute for as long as they want to benefit from better continuous diagnostics and monitoring. Each participation helps the research team to accumulate a greater basis for research, which will contribute to increased knowledge of the late complications of diabetes and symptoms from the gastrointestinal tract.

5. Can I discontinue my participation at any time?

Yes. You may cancel your participation at any time by clicking on the 'Delete Account' button in your profile. Any previously submitted questionnaires will remain in the research database as pseudonymized data.

1. Who can see or use my personal data?

All data is processed pseudonymously and is only visible to the principal investigator at the respective university of your country.

2. Can I retrieve my own data from the questionnaires?

Yes. Your own data can be retrieved and used for further information to your diabetes doctor or diabetes nurse. The results are visible on the last page after all questionnaires are filled out and can be downloaded and printed from there.

3. How safe is my data?

The database is a secure research platform. Your personal information is handled in accordance to country specific regulations. All data that can identify you or your study group will be pseudonymized.

4. For how long will the obtained results from the questionnaires be retained?

10 years after the study is finalized (in some countries it could be longer if required by the law).

5. Will there be quality control and monitoring of the accumulated data?

Yes. Research studies should always be subject to quality control and continuous monitoring for the correctness of compiled data.

1. Can I omit some questions or questionnaires that don't seem to apply to me?

We would like to ask you to fill out all questionnaires. You are generally able to select the answer that is most applicable to you.

2. What equipment do I need to participate?

You may log in and fill out the questionnaires through a computer, tablet, or smartphone. You will need an Internet connection to access the website (https://www.dicodi.net).

3. How often do I need to fill out the questionnaires?

All questionnaires, which are validated as a diagnostic tool, should be filled out every 90 days.

4. What happens if I forget to fill out the questionnaires?

It is recommended to fill out the questionnaires every 90 days, in order to get the most benefit from the clinical research incl. periodic information. However, if you forget to fill them out, just do so again when you remember.

5. Can I change my answers in the questionnaire after I completed it?

Once you press the 'submit' button, the answers cannot be changed. However, you will have the opportunity to submit a new, updated response every 90 days.

1. Can the results serve as a medical diagnosis?

No. The results of the test represent only your approximate diagnosis. An accurate diagnosis can only be determined by a healthcare professional.

2. What medical responsibility does the study, or study team, take for my diabetes?

None. Please consult your regular diabetes doctor if questions arise.

3. Do I need to meet the research doctor or team?

There is no requirement to meet the research doctor/team in person. Completion of the questionnaires and delivery of the results all take place digitally online. There is a portal and an email contact address to reach out to the research doctor for any questions or clarification.

4. Can I share the results with my regular diabetes doctor and diabetes nurse?

Yes, you can share the results with your diabetic doctor/nurse to help them design more suitable treatments for you. However, you should keep in mind that the obtained test results serve only as a supporting tool and require additional tests for an accurate diagnosis.

5. Do I have to update the changes in my used medications, if they occur?

You will be asked to update possible changes in your treatment e.g., new medicine, higher doses etc. every three months before filling in a new set of questionnaires.