Studies - IfDT - Institut für Diabetes-Technologie

Warning! JavaScript is deactivated.

If you want to use all functions of this website, please enable JavaScript in your browser.

Our Institute performs clinical studies and cooperates with external study sites.

Primary aims are studies about Diabetes mellitus

Clinical examination of medical products
- Continuous tissue glucose measurement
  - Test studies of CM devices
  - Studies on physiology of tissue glucose
- Automatic pancreas (AP)
  - Studies on development of algorithms
- We also examine and test lancet devices, test strips, insulin pumps, etc.
Efficiency evaluations of in vitro diagnostics
- Efficiency evaluations of blood glucose measurement devices as per ISO 15197 (DAkkS-accredited according to DIN EN ISO/IEC 17025)*
Diabetes Studies & AMG Studies
- Nutrition of diabetics
- Participation in Phase 1-4 Studies
Recruitment of people with type 1 and type 2 diabetes

We accompany studies during all phases

Concept
Paperwork (e.g. ethical committee applications, responsible Authorities, BfArM)
Recruitment
Performance
Coordination of study sites
Data management
Monitoring
Evaluations, Congresses, Publications

* As an independent testing laboratory recognised by the ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten), we do not offer any consulting services for manufacturers and distributors in the field of blood-glucose monitoring systems for self-testing beyond the scope of the study.

Our Clinical Studies are performed in accordance with the provisions of Regulations (EU) 2017/745 of the European Parliament and of the Council concerning medical devices (MDR) and in vitro diagnostic medical devices (IVDR), the provisions of the Medical Devices Implementation Act (MPDG), the Medical Devices Act (MPG) and the Medicinal Products Act (AMG). We work in accordance with the guidelines of ICH-GCP (International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human use – Guideline for Good Clinical Practice of January 17, 1997), as well as national, European and international legal regulations like International Organization Standards (ISO), guidelines of the European Union (EU), guidelines of the Food and Drug Administration (FDA), guidelines of Good Clinical Practice of clinical studies of drugs in human beings (GCP) of April 9, 2004 as well as according to the recommendations of World Medical Association (WMA) in the Declaration of Helsinki.