Type 2 diabetes is a chronic condition affecting approximately 8.5% of the world’s population.
There is currently no published core outcome set for use in trials of treatment for type 2 diabetes. Consequently the outcomes measured may vary from trial to trial limiting the ability to combine and utilise data efficiently.
This core outcome set will focus on outcomes of importance when treating (not preventing) type 2 diabetes in an adult population.
Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2805-2
Dr Nicola Harman
Research Associate, University of Liverpool
Professor Paula Williamson
Professor of Biostatistics, University of Liverpool
Jacques Demotes-Mainard
European Clinical Research Infrastructure Network
Caroline Terwee
VU University Medical Center, Amsterdam
Michal Raess
INFRAFRONTIER GmbH
Silvio Garattini
Istituto Mario Negri
Serena Battaglia
European Clinical Research Infrastructure Network
Patricia da Silva-Buttkus
Helmholtz Zentrum München
Valerie Gailus-Durner
Helmholtz Zentrum München
Sanna Prinsen
VU University Medical Center, Amsterdam
Disease Category: Endocrine & metabolic
Disease Name: Diabetes mellitus , Type 2 Diabetes
Age Range: 16 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Researchers
- Service users
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
Systematic review to identify reported outcome measures in clinical trials in type 2 diabetes
Systematic review of patient reported outcome measures
Delphi exercise with key stakeholders
Consensus meeting to discuss and agree final core outcome set
***Next steps will include seeking consensus on how these outcomes should be measured and to provide this guidance to researchers***