Scientific Program

Preliminary program subject to change

Monday, 3 December 2018



Session 1: Publication and presentation of studies


Editorial decision making: fair or fanciful?
Sally Marshall, UK


An Editor’s Perspective: The Do’s and Don’ts in Clinical Trial Manuscripts
Richard DonnellyUK

  • An Editor’s perspective on  clinical trial manuscript submissions
  • A discussion of the (imperfect) processes of peer review and editorial decision-making
  • Trends & changes in publication practice; the ‘impact Factor’ game

How to write an unattractive clinical trials abstract

Coffee Break and visit the Exhibition

Session 2: Observational and real-life studies: insecure?


Are most pharmacoepidemiological studies data junk? Can confounding be overcome?
Philip Home


Meta-analysis: mostly a confidence trick?
Edoardo Mannucci

  • Meta-analysis of endpoints different from the primary endpoints of the trials included: strengths and weaknesses
  • The impact of methodological choices in designing a meta-analysis: how selection criteria and statistical approaches can affect final results
  • Selective publication and selective disclosure: how systematic reviews and meta-analyses can help.

CVD-REAL: real-value or misleading?
David Fitchett,

Lunch Break and visit the Exhibition

Session 3: Statistical issues for RCTs


Propensity Scores: uses and abuses
Nick Freemantle, UK

  • How do propensity scores work to enable comparisons between different treatments?
  • What are the strengths and limitations of the propensity score approach?
  • Under what circumstances can I trust propensity score analyses?


Hierachical testing: uses and limitations

Network analysis of clinical trials data: merits and problems
Patricia Guyot, France

  • Principles of NMA and basic steps: research question, systematic literature review, feasibility assessment, analyses
  • Possible issues in the context of diabetes: scarce versus large evidence, potential effects modifiers and outcomes of interest
  • Potential remedies: population-adjustment method, meta-regression and sensitivity analyses

Coffee Break and visit the Exhibition

Session 4: Safety and tolerability data – insensitive and overwhelming?


Uncommon things commonly occur:  how best to handle 1000's of SAEs
Nigel Jones, UK

Which PROM? satisfaction, quality of life, and many others
Matthew Reaney, UK

Poster session with presenters and moderators

Tuesday, 4 December 2018



Session 5: Use of CGM in glucose-outcome studies; ensuring validity


What is needed to make it acceptable to regulators?


CGM detected hypoglycaemia: definitions, limitations and added value
Ulrik Pedersen-Bjergaard, Denmark

  • An international consensus on reporting of CGM-detected hypoglycaemia in clinical research has been reached
  • CGM may provide a complete recording of hypoglycaemic exposure including events which are not recognized by the patients
  • CGM is less accurate in the hypoglycaemic range and CGM-detected hypoglycaemia should be assessed together with SMBG-based data


CGM: the problem of hyper-repeated measurement and valid statistical analysis

Panel discussion

Coffee Break and visit the Exhibition

Session 6: RCTs in the medication development programme


What would be the manufacturer wish list?
David Ørsted, Denmark


A new perspective on endpoints for CVOTs in diabetes


Have CVOTs gone off the rails – should the paradigm change?
Francesco Giorgino,

Panel discussion

Lunch Break and visit the Exhibition

Session 7: Data issues from big to long to clinical practice


Can we successfully use data from large populations and diverse datasets (big data)?
Avraham Karasik, Israel


Synthesizing multiple clinical trial inputs into guidelines and practice
Baruch Itzhak, Israel

Understanding legacy effects: epidemiology or metabolic

Antonio Ceriello, Italy

Coffee Break and visit the Exhibition

Session 8: Outcomes: class or individual medication effects?


SGT-2 blockers
Eberhard Standl,


DPP-4 inhibitors


Tina Vilsbøll, Denmark

Panel discussion

Congress closing