Clinical Research Unit

The Clinical Research Unit was established in April 2007 in order to strengthen and expand the clinical research already taking place at Steno Diabetes Center.

The Clinical Research Unit is an independent unit specialized in carrying out clinical trials of a high professional level in cooperation with other research teams at Steno Diabetes Center and the pharmaceutical industry.

By combining expertise and resources in a clinical research unit, the overall running of clinical studies is improved and becomes more effective, giving the possibility of expanding activities.

Aim
The overall aim is to develop and improve the treatment of diabetes and through this to improve the prognosis and life quality for people with diabetes.

The long-term aim is to educate and train health professionals to enable them to conduct good clinical research.

The Clinical Research Units offers

• Planning, preparation and implementation of new studies
• Coordinated execution of studies and patient examinations
• Contributions to data collection and treatment
• Communication and reporting of results

The clinical studies are conducted in accordance with the Helsinki Declaration, EU regulations and Danish law and the principles of 'Good Clinical Practice'. All studies are registered with the relevant authories, for instance, Comittee for Research Ethics, the Danish Medicines Agency and the Data Protection Agency.

The unit has the following facilities at its disposal:

• Six beds with the option of an overnight stay
• Two consultation rooms for outpatient check-ups
• A laboratory
• Equipment for clinical examinations, e.g. electrocardiograms, tests for autonomic and peripheral neuropathy, pulse wave velocity etc.
• Continuous glucose monitoring (CGMS)
• DXA- scanning (bone and body composition)
• Ultrasound examination of the carotic arteries
• Offices, storage of study material and trial medication, rooms for trial participants and a kitchen