Disease Modification Outcomes in Diabetes: a Delphi Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care and people with type 2 diabetes.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • eDelphi method

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Healthcare practitioners and researchers1 intervention
Group B: People with type 2 diabetes1 intervention

Trial outcomes

Primary outcomes

1

Delphi Round 1

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.

Time frame
Three to four weeks
2

Delphi Round 2

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.

Time frame
Three to four weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leicester

Lead sponsor

American Diabetes Association

Collaborator

This trial is not recruiting at the moment. You can still explore other options: