SCORE-IT - Selecting a Core Outcome Set for Randomised Effectiveness trials In Type 2 Diabetes

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.



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

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

Further Study Information

Current Stage: Ongoing
Date: January 2017 - July 2018
Funding source(s): CORBEL EU Horizon 2020

Health Area

Disease Category: Endocrine & metabolic

Disease Name: Diabetes mellitus , Type 2 Diabetes

Target Population

Age Range: 16 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Researchers
- Service users

Study Type

- 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***