Disease Modification Outcomes in Diabetes: a Delphi Study

N/ANot Yet RecruitingNCT07201532

University of Leicester300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Type 2 Diabetes

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants will fall into one of two groups: 1. Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care. 2. People with type 2 diabetes. All participants will be ≥18 years of age. Exclusion Criteria: 1. Potential participants who are not willing to provide informed consent or participate in the Delphi study. 2. Those who are unable to understand English. 3. Those without the capability to respond to the online survey.

Outcomes

Primary Outcomes

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

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