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Not yet recruiting NCT07201532

Disease Modification Outcomes in Diabetes: a Delphi Study

Observational Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eDelphi method.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

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

Primary outcome measures

  • Delphi Round 1 [Time frame: Three to four weeks]
  • Delphi Round 2 [Time frame: Three to four weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07201532 · 4602UE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗