Topic
Date published
29/09/2026
Researchers from the University of Leicester and the NIHR ARC East Midlands are part of a team which has developed the first framework for outcomes relevant to disease modification in type 2 diabetes.
Disease modification is a new concept that refers to interventions that may change the progression of disease and prevent complications.
Traditionally, the management of type 2 diabetes has focused on glycaemic control and cardiovascular risk factors, rather than focussing on altering long‑term disease trajectory.
Increasing evidence indicates that progression and complications in type 2 diabetes may be modifiable, but the absence of a core outcome set (COS) for disease modification limits trial design and intervention comparison. A core outcome set helps researchers to measure a consistent set of outcomes in studies of a health condition.
To address this gap, researchers developed a core outcome set using Delphi methodology, a research method used to gain consensus among experts on complex issues.
The result was the identification of 35 outcomes across 11 domains, including, diabetic foot ulcer, gangrene, and/or amputation, diabetes distress, retinopathy, and cerebrovascular events.
Published in The Lancet Diabetes & Endocrinology, the framework has been described by its authors as a “first step” towards a more standardised approach which will strengthen the evaluation of interventions aiming to modify the trajectory of type 2 diabetes.
The framework, which has been funded by the American Diabetes Association® (ADA), was presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Milan on September 29.
Professor Kamlesh Khunti, Co-Director of the NIHR ARC East Midlands, Co-Theme Lead at the NIHR Biomedical Research Centre Leicester, Professor of Primary Care Diabetes and Vascular Medicine at the University of Leicester, and Chair of the Consensus Panel, said: “This framework aims to support outcome selection, consistency across trials, comparison of interventions, and evaluation of disease‑modifying strategies in type 2 diabetes. These are core outcomes identified collectively by patients, healthcare professionals and researchers.
“The 35 outcomes offer a framework for consistent outcome selection for trial development while maintaining the flexibility required for diverse interventions.
“As new therapies emerge, particularly those targeting obesity, cardiovascular and kidney disease, and hepatic steatosis, these outcomes should be refined and tested further.”
“This framework highlights the strengths of ADA’s Evidence Synthesis team in using the Delphi process to reach consensus to bring together both the clinical and patient perspective. Having both perspectives is important as we move towards standardised approach to disease modification in type 2 diabetes and for new therapies that emerge,” said Sharon Saydah, PhD, MHS, ADA’s Vice President of Clinical Evidence and Quantitative Methods.
To read the full paper, click here.