Type 2 DiabetesNCT07201532
Disease Modification Outcomes in Diabetes: a Delphi Study
An observational study of Type 2 Diabetes, run by University of Leicester.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- eDelphi method
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care and people with type 2 diabetes.
Who may be able to join
- 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.
Who cannot join
- 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.
About this 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.
- Conditions
- Type 2 Diabetes
- Being tested
- eDelphi method
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDelphi methodOther
A Delphi consensus study will be undertaken to establish a core outcome set for disease modification in type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare practitioners and researchers | Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care Receives: Other: eDelphi method | |
| People with type 2 diabetes | Not described Receives: Other: eDelphi method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Three to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startSep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201532
- Sponsor's protocol ID
- 4602UE
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Modification Outcomes in Diabetes: a Delphi Study
- ClinicalTrials.gov ID
- NCT07201532
- Acronym / sponsor ID
- 4602UE
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare practitioners and researchers | – | Other: eDelphi methodHealthcare practitioners and researchers working in the field of diabetes research and/or clinical care |
| People with type 2 diabetes | – | Other: eDelphi method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthcare practitioners and researchers working in the field of diabetes research and/or clinical care and people with type 2 diabetes.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eDelphi methodA Delphi consensus study will be undertaken to establish a core outcome set for disease modification in type 2 diabetes. | Other | Healthcare practitioners and researchers, People with type 2 diabetes |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by University of Leicester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delphi Round 1 (time frame: Three to four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.