Course of a Study

Studies at the IfDT

In our projects we test safety, usability, performance and accuracy of medical devices in the context of clinical studies. We investigate different medical devices among others in the area of diabetes technology, such as blood glucose meters, systems for continuous glucose monitoring (CGM) or insulin pumps. The studies are conducted with devices which are already on the market as well as with devices which are still in the development stages and are not approved yet. 

Outpatient Studies

Outpatient studies take place during the day, i. e. without an overnight stay at our institute. The study duration depends on the respective project and can last from a few hours up to a whole day. Sometimes it is required to attend several appointments on different days, for example if you receive a device to be tested at home.

The aim:

In our outpatient studies we mostly investigate medical devices which are, e. g., used in the treatment of the disease diabetes mellitus. An important focus is the quality control of blood glucose meters as well as the testing of corresponding new developments. Among others, we also perform accuracy studies or development studies with blood pressure monitors or devices to measure HbA1c or cholesterol levels. Studies in which you are supposed to take the devices home for testing also request ambulant appointments in our institute. Those studies can include e. g. systems for continuous glucose monitoring (CGM), non-invasive glucose meters, insulin pumps or similar devices.      

The Process of Outpatient Studies

If you have any questions about our projects, please feel free to contact us and we will answer all your questions about study participation.

  • Step 1: Selection of subjects
    • For every study the study protocol defines eligibility criteria, such as age, previous illnesses or laboratory results. From all subjects that have in principle agreed to participate in studies we select suitable participants for each study. Most of the times we are looking for subjects with diabetes mellitus type 1 or 2 but sometimes we also have studies in which subjects without diabetes can take part.   
    • The first contact is usually by phone, sometimes also by e-mail with a short explanation of the study content, the estimated duration of stay and the financial compensation. We are happy to send you written information material in which you can read all important details regarding the study. Afterwards you can decide if you want to participate or not. In case you want to take part in the study we are happy to make all the required appointments with you at our institute.
  • Step 2: Information, consent and preliminary examination
    • Before the start of the study a study physician will inform you about the study details and potential risks and side-effects. All your questions regarding the study will be answered.  .
    • If you decide to participate in the study you have to sign the informed consent form.
    • Afterwards there will be a preliminary examination, the so called screening, in which you will be tested for eligibility for the study. This can, e. g., include blood or urine analyses.
    • As soon as we have analyzed all results from the screening and there are no reasons against, you will be included in the study. 
  • Step 3: Study procedure
    • The study procedures are determined by the respective study protocol.
    • During the study procedures you will use the medical device under investigation.
    • In many studies it is required to perform frequent fingersticks to measure blood glucose; venous blood collections are also possible. 
    • In some studies standardized test meals have to be eaten and/ or the insulin bolus (only for study participants with diabetes and insulin therapy) is modified after consultation with the study physician. Your blood glucose will be monitored very closely during your stay.
    • You will be medically supervised during your stay with us. Your safety and well-being is our major priority. We are happy to support you in all study procedures and will answer all your questions at any time.
  • Step 4: Discharge
    • By the time your study participation is finished you will receive your financial compensation. You are free to leave the study site as soon as the study physician agrees on it. We are happy to send the examination results to you or your study physician if you wish to. 

Inpatient or Partially Inpatient Studies

Inpatient or partially inpatient studies require at least one overnight stay at our institute. You will have a single-bedroom during your stay with us. The study will usually take part in little groups whose members you will usually meet and spend time with in our common room. In case you are interested, we offer workshops e. g. regarding diet or diabetes therapy during that time.

In partially inpatient studies you will spend part of the study at home and you will take the device to be tested home. At home you can usually follow your normal daily routines.      

 

The aim:

In all of our inpatient or partially inpatient studies we investigate medical devices which are used for example in the treatment of diabetes mellitus.

A major emphasis is the accuracy testing of systems for continuous glucose monitoring (CGM). We test both devices which are already on the market and devices which are newly developed. Here we also compare, depending on study requirements, different devices with each other. Aditionally, systems for non-invasive glucose measurement but also insulin pumps or systems for automated insulin dosing can be tested.    

The Process of Inpatient or Partially Inpatient Studies

If you have any questions about our projects, please feel free to contact us and we will answer all your questions about study participation.

  • Step 1: Selection of subjects
    • For every study there are eligibility criteria, such as age, previous illnesses or laboratory results defined in the study protocol. From all subjects that have offered their study participation in principle we select suitable participants for each study. Most of the times we are looking for subjects with diabetes mellitus type 1 or 2 but sometimes we also have studies in which non-diabetic, healthy subjects can take part.    
    • The first contact is usually by phone, sometimes also by e-mail with a short explanation of the study content, the estimated duration of stay and the financial compensation. We are happy to send you written information material in which you can read all important details regarding the study. Afterwards you can decide at home if you want to participate or not. In case you want to take part in the study we are happy to make all the required appointments with you at our institute.
  • Step 2: Information, consent and preliminary Examination
    • Before the start of the study there is a briefing with the medical investigator in which you will be informed about the study details and potential risks and side-effects. Here all your questions regarding the study will be answered.  
    • In case you decide to participate in the study you have to sign the informed consent.
    • Afterwards there will be a preliminary examination, the so called screening, in which it will be tested whether you are eligible for the study. This can for example include blood or urine analyses.
    • As soon as we have analyzed all results from the screening and there are no reasons against it you will be accepted for the study. 
  • Step 3: Study procedure
    • The study procedures are determined by the corresponding study plan.
    • During the study procedure you will use the medical device under investigation.
    • In many studies it is required to perform frequent fingersticks to measure blood glucose, venous blood collections are also possible. 
    • In some studies standardized test meals have to be eaten and/ or the insulin bolus (only for study participants with diabetes and insulin therapy) is changed after consultation with the study investigator. Your blood glucose will be monitored very closely during your stay.
    • You will be medically supervised during your stay with us. Your safety and well-being is our major priority. We are happy to support you in all study procedures and will answer all your questions at any time.
  • Step 4: Discharge
    • By the time your study participation is finished you are free to leave the study site as soon as the study investigator agrees on it. If you wish we are happy to send the examination results to you or your physician. 
    • The payment of the financial compensation depends on the study procedure and is managed individually depending on the study.

Please feel free to contact us

We are happy if you want to actively support us in our research for the benefit of people with diabetes type 1 or type 2.
In this way, you are making your own personal contribution to improving medical care.
We are looking forward to meet you!

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