Questions and Answers

Questions About our Studies

You have questions regarding our projects, procedures and general conditions? Here you will find some answers to frequently asked questions. If you still have open questions, you are very welcome to get in touch with us and we will do our best to answer all your questions. 

  • How to become a study participant?

    If you are interested in becoming a study participant, feel free to contact us by phone: +49 731/509 90-0 or by email diabetes@idt-ulm.de. We will send you our information package and a questionnaire. As soon as you have filled in the original form, signed it and sent it back to us, we can consider you as a possible participant for upcoming studies. We will come back to you and contact you by phone by the time we plan a study which could be of interest for you. At that time we will inform you without any obligations about the planned procedure and aim of the study. You will have all the time you need to consider whether you want to participate in that study or not. You will not enter into any commitment.   

  • What kind of studies are performed at the IfDT?

    We perform outpatient, inpatient as well as partially inpatient clinical studies. Outpatient studies usually last a few hours, clinical studies typically last a few days sometimes including an inpatient stay overnight at our institute.

  • What devices/systems are being tested as part of the projects?

    For each project, there is a defined question that also defines the device(s) or system(s). Within the projects, we test e.g. blood glucose meters, continuous glucose monitoring (CGM) systems, insulin pumps, non-invasive meters and the like.

  • Who can take part in clinical studies?

    Depending on the project there are defined prerequisites for participation which are described in the study protocol. Our task is it to find people that meet those criteria. Typical criteria in our studies are

    • Persons older than 18 years
    • People with diabetes mellitus type 1 or type 2
    • People with high blood pressure or hypercholesterolemia
    • People without diabetes mellitus
  • Can I take part in a study despite concomitant diseases?

    Yes, every study participant will be checked for his current health status before the start of the study. You can participate in a study if your pre-existing conditions do not exclude you based on the participation requirements.

  • How big is the time requirement for a clinical study?

    The duration of stay at the institute can vary – depending on the study – from a few hours up to a number of days.

  • Do I have to be on-site for taking part in a study or can I do it from home as well?

    The preliminary examinations for the studies take place at the institute. Depending on the study requirements it is also possible to test the products at home under everyday conditions.   

  • In case I spent the night during an inpatient study at your institute, what are the rooms like?

    During the study you will have a single bedroom. Additionally to standard features the modern rooms for test persons are equipped with:

    • Internet access
    • Desk
    • Wash basin (Toilets and showers are located on the corridor)
    • Lockable cupboard for your personal belongings
  • How often can I take part in the studies?

    In order to protect your own physical health, we recommend taking breaks up to three months in between two studies (depending on the study requirements).

  • Can I discontinue the study?

    Your participation is always voluntary, you can discontinue the study any time without giving reasons for it and you will not suffer any disadvantage as a result.

  • Will there be coverage for my travel costs?

    In many studies you will receive a compensation for expenses and/or your travel costs will be re-inbursed.

  • What do I need to bring for a study stay?
    • Personal belongings, if you stay overnight of course everything you need for that.
    • The study investigator should be informed about all observed abnormalities and changes, for example new diagnosis or medications.
    • Everything you need for your diabetes therapy and all other medications that you are taking on a regular basis.
  • What are the risks for me in participating in a study? How safe are the studies for myself?

    In studies there are, like in any other treatment, associated risks and potential side-effects. The sponsor of the study is obligated to perform a risk-benefit-evaluation. This evaluation will be checked by the corresponding authority (e.g. ethics committee, Bundesinstitut für Arzneimittel und Medizinprodukte) before approval of the study. Before study participation the study investigator will explain all potential risks to you. In case there are unexpected and severe side-effects or other severe complications happening, we will stop the study immediately for your own safety. There is insurance coverage for all study participants. For us the well-being and the safety of our study participants is our number one priority.

  • Do I need to change or interrupt my usual therapy for a study?

    If it is necessary for a study to interrupt your usual therapy, we will always discuss this with you in close consultation with our study physicians during the study. After the end of the study you are of course free to return to your usual therapy.  

  • Are there defined meals or am I free to eat whatever I want?

    This is depending on the study requirements and will always be discussed with the study physician and you before participating in a study.

  • I have food allergies/ intolerances or I am a vegetarian/vegan. Will you consider this during the meals of a study?

    Of course we will take your food allergies/intolerances into account and consider if you are a vegetarian/vegan.

  • What are my benefits in study participation?
    • You will be medically supervised in every study.
    • If you wish you or your physician will receive a copy of your examination results.
    • You can receive information about new therapeutic possibilities.

To improve the reader-friendliness of our website, we use the generic masculine. In the context of equal treatment, we would like to point out that the content of our website is aimed at all genders and does not contain any valuation.