The Medical University of Graz is the second largest Medical University of Austria with more than 2.200 employees conducting research, education and patient care for the benefit of health. The adjacent university hospital is a hub of innovative and high-end medicine and provides tertiary care services for the south-east of Austria. The Division of Endocrinology and Diabetology at the Department of Internal Medicine offers extensive outpatient services and a 21-bed inpatient ward for patients with diabetes, obesity and endocrine disease. Research interests of the Division focus on areas such as diabetes technology, hypoglycaemia and new pharmaceutical approaches for the treatment of diabetes mellitus. As tertiary center for patients with diabetes and endocrine diseases attending physicians play an important role in communication and negotiations with local, national and European agencies with regard to approval and preconditions for funding of novel drugs and medical devices.

The research group has a strong track record in diabetes technology with abundant expertise in the application and interpretation of continuous glucose monitoring signals, and is considered one of the leading centres in artificial pancreas research and decision support systems for the treatment of diabetes, both aiming to minimize the risk of hypoglycaemia. MUG will be the Work Package lead of WP8 with the main tasks to present novel definitions of hypoglycaemia and to facilitate the acceptance of continuous and flash glucose monitoring as novel methods to assess glycaemia during clinical studies for regulatory approval to notified bodies. Not only biochemical hypoglycaemia but also measures of psychosocial effects and economic burden of hypoglycaemia will be addressed. Within WP 5 MUG will conduct clinical trials as well as analyse existing clinical trial datasets in order to investigate the impact of continuous glucose monitoring-detected low values on biological, patient reported and health-economic outcomes and to provide guidance for its successful use in clinical trials.

Prof. Thomas Pieber

MD, Professor of Medicine, is Head of the Division of Endocrinology and Diabetology, Chief Scientific Officer, CBmed (Center for Biomarker Research) and Director of HEALTH at Joanneum Research. He has been Chairman of EASD in 2009 and is Scientific Board Member of EFSD. Prof. Pieber has a long-standing award-winning track record of innovation and research in the field of diabetes technology and pharmacodynamics/pharmacokinetics of novel antihyperglycaemic agents for over 30 years with over 300 peer reviewed papers. These publications cover novel technological approaches of diabetes management as well as mechanistic studies addressing hypoglycaemia and counter regulation. Prof. Pieber has been advisor to institutions and organisations such as EMA, Austrian Health Authorities or the JDRF.

Dr Julia Mader

MD, is Assistant Professor at MUG. She is consultant and lecturer in internal medicine. She is leading the diabetes technology unit at the Division. She is investigator in phase I – IV clinical studies testing medical devices for diabetes treatment and investigating pharmacokinetic and pharmacodynamic effects of long and short acting insulin analogues. Her research focuses on diabetes technology in particular on continuous glucose monitoring and artificial pancreas research. She is member of the insulin pump working group of the Austrian Diabetes Association and participates in the DPV (Diabetes-Patienten-Verlaufsdokumentation) initiative which aims to improve outcome in diabetes by facilitating standardized documentation and objective comparison of quality indicators of diabetes centres among Austria, Germany and Switzerland.

Dr Christina Gatschelhofer

PhD, is Senior Researcher at MUG. She is a biochemist with long-standing research experience in biomedical analytics in preclinical and clinical studies. Based on her professional background she focuses on medical writing since 8 years and has developed a keen interest in pharmaceutical drug development and regulatory affairs.