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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will fall into one of two groups:

Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care.
People with type 2 diabetes. All participants will be ≥18 years of age.

Exclusion criteria

Potential participants who are not willing to provide informed consent or participate in the Delphi study.
Those who are unable to understand English.
Those without the capability to respond to the online survey.

Treatment and study plan

eDelphi method

Other

A Delphi consensus study will be undertaken to establish a core outcome set for disease modification in type 2 diabetes.

Primary outcomes

Delphi Round 1

Time frame: Three to four weeks

The Delphi methodology is an interactive multi-stage process, with each stage building on the data of the previous results in order to gain consensus from the participants. This is achieved through a series of surveys interspersed with controlled feedback containing the aggregated results from all participants in the study cohort.

In Delphi Round 1, participants will be asked to rate the importance of outcomes for inclusion or exclusion using a 9-point Likert scale.
Delphi Round 2

Time frame: Three to four weeks

In Round 2, participants will be asked to rate the importance of remaining outcomes that did not reach consensus for inclusion or exclusion in Round 1 using a 9-point Likert scale. Consensus is defined as a minimum of 70% of participants who rated an outcome as 1-3 "Not important" and should be excluded or 7-9 and indicates an outcome is "Critical" and should be included.

If necessary, a third round of the survey will be administered to attempt to reach consensus on the remaining outcomes/instruments that did not do so in the previous rounds. Results will inform the development of the final COS.

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

American Diabetes Association

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 1, 2025
Registry last updated: Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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