Disease Modification Outcomes in Diabetes: a Delphi Study

Type 2 diabetes is a condition when the pancreas does not produce enough of the hormone, insulin, or the insulin that is formed does not function effectively. This results in high blood sugar levels. Type 2 diabetes is associated with other health conditions, and people with the condition have a higher chance of dying earlier and having other complications. People with type 2 diabetes take a lot of different types of medications. The current treatments that exist aim to manage blood sugar levels, rather than affect the progression of the disease. The research involving treatments that impact the long-term progression of type 2 diabetes is sometimes hard to understand. This is because research studies measure a lot of different outcomes (outcomes are items we measure to show that the study has worked and/or it is safe). One way of improving research is to make sure that we are measuring the same outcomes, but also that these outcomes are important to people living with type 2 diabetes and healthcare professionals. This can be done by using a core outcome set (COS). A COS is a short list of outcomes that are important to researchers, healthcare professionals and people living with type 2 diabetes. The aim of this study is to design a COS for research studies for disease modification in type 2 diabetes via an e-Delphi study. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provider their opinions in an iterative approach for answering questions over several rounds. This will also take place using surveys online.

NCT Number	NCT07201532
Lead Sponsor	University of Leicester Collaborators: American Diabetes Association
Conditions	Type 2 Diabetes
Enrollment	300 participants
Start Date	2025-09
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-10-01