Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes

Diabetes Clinical Trial

— ATTEND  

Official title:

Assessment of Response Rates and Yields for Two Tools for Early Detection of Non-diabetic Hyperglycaemia and Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950313
• Other study ID #: 0132
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2009
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 40-75 years old (30 -75 years old if South Asian origin)

Exclusion Criteria:

• Current diagnosis of diabetes

• Terminal illness or mental incapacity

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hyperglycemia

Intervention

Other:
• Self Assessment
Self assessment used to determine current risk of diabetes and likelihood of requiring further testing
• Electronic risk score
Patients current risk of diabetes is determined by a electronic risk algorithm. They are then invited to attend fof further testing.

Locations

Country	Name	City	State
United Kingdom	Leicester City PCT	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in response rates to invitation to 2nd stage blood test		12 months
Secondary	Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens		12