DiabetesATTENDNCT00950313
Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
A study testing Self Assessment and Electronic risk score in people with Diabetes, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Self Assessment and Electronic risk score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-75 years old (30 -75 years old if South Asian origin)
Who cannot join
- Current diagnosis of diabetes
- Terminal illness or mental incapacity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme.
Read the detailed description
The University Hospitals of Leicester and The University of Leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. This study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the NHS Health Check programme.
- Conditions
- Diabetes
- Being tested
- Self Assessment, Electronic risk score
- Keywords
- Diabetes, Screening, Risk, Self assessment
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self AssessmentOther
Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
Electronic risk scoreOther
Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.
| Study group | Role | What they receive |
|---|---|---|
| Self Assessment | Active comparator | Patients are approached and asked to complete a risk score that will determine their current risk of diabetes and the likelihood of requiring further testing. Receives: Other: Self Assessment |
| Electronic risk score | Active comparator | Patients diabetes riks is determined based on their data held on practice systems. Patients are then invited for further testing based on this score. Receives: Other: Electronic risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in response rates to invitation to 2nd stage blood test
Measured: 12 months
Secondary outcomes (1)
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Kamlesh Khunti, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950313
- Sponsor's protocol ID
- 0132
- Acronym
- ATTEND
- Status last verified
- Jul 2009
- First submitted
- 30 Jul 2009
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes
- ClinicalTrials.gov ID
- NCT00950313
- Acronym / sponsor ID
- ATTEND / 0132
- Conditions
- Diabetes
- Keywords
- Diabetes, Screening, Risk, Self assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 31 Jul 2009 (estimated)
- 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.
The purpose of this study is to establish the most effective method of increasing attendance to screening of type 2 Diabetes within a primary care setting within the backdrop of the NHS Health Check programme.
Detailed description
The University Hospitals of Leicester and The University of Leicester have developed a self-assessment risk score and a practice data risk score that can be used in a variety of setting to detect undiagnosed diabetes and impaired glucose regulation. This is done to establish a simple and effective 1st stage screen to identify those people at risk of diabetes and engage the public to increase the number of high risk individuals attending screening invitations but reducing the overall number of oral glucose tolerance tests. This study aims to test in a pragmatic way the use of such tools in a primary care setting administered by primary care staff as part of the NHS Health Check programme.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Assessment | Active comparator | Other: Self AssessmentPatients are approached and asked to complete a risk score that will determine their current risk of diabetes and the likelihood of requiring further testing. |
| Electronic risk score | Active comparator | Other: Electronic risk scorePatients diabetes riks is determined based on their data held on practice systems. Patients are then invited for further testing based on this score. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40-75 years old (30 -75 years old if South Asian origin)
Key exclusion criteria (2 listed)
- Current diagnosis of diabetes
- Terminal illness or mental incapacity
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 |
|---|---|---|
| Self AssessmentSelf assessment used to determine current risk of diabetes and likelihood of requiring further testing | Other | Self Assessment |
| Electronic risk scorePatients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing. | Other | Electronic risk score |
Primary outcome
Increase in response rates to invitation to 2nd stage blood test
Time frame: 12 months
1 secondary outcome
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens
Time frame: 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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. This study is not recruiting at the moment.
Kamlesh Khunti, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Assessment and Electronic risk score in people with Diabetes, run by University of Leicester at 1 site in United Kingdom.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in response rates to invitation to 2nd stage blood test (time frame: 12 months). 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 30 Jan 2020.