New EMA Guidance for the Development of Diabetes drugs have been published: Implication for inclusion of Continuous Glucose Monitoring (CGM) in clinical trials phase I-IV
“The use of devices allowing continuous blood glucose monitoring is encouraged and regarded as useful in adults and children to describe overnight glucose profiles and postprandial hyperglycaemia.”
The EMA published new guidance on June 29 covering the development of all diabetes drugs. These guidelines went into effect in November making it very relevant and top of mind for all people involved in diabetes drug development. These guidelines will have vast implications on all clinical trials for diabetes related drugs. “The use of devices allowing continuous blood glucose monitoring is encouraged and regarded as useful in adults and children to describe overnight glucose profiles and postprandial hyperglycaemia.” There are 5 separate mentions of Continuous Glucose Monitoring (CGM) within the guidelines covering orals, insulins and other injectable.
Join us to hear clinical researchers and regulatory experts discuss the specific implications of the guidance, its possible interpretation, and data analytic techniques to get the most value from the data captured with this technology. Different product options and tradeoffs will also be addressed as well as practical tips and tricks for successfully integrating CGM into clinical trial protocols.
Moderator: Barbara Ameer, PharmD, MBA, BCPS, FCP, Robert Wood Johnson Medical School
Poul Strange, MD, PhD., Medical Director and President, Integrated Medical Development
Steve Stagliano, Program Manager, Institutional CGM, Medtronic Diabetes
Up-to-date, detailed information can be found at the BioPharma Research Council website at: