Assessment of Response Rates and Yields for Two Tools for... | NCT00950313

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

NCT00950313

Sponsor

University of Leicester

Status

Completed

Last Update Posted

Jan 30, 2020Actual

Enrollment

432Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Self Assessment
Electronic risk score

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jul 30, 2009

First Submission Date that Met QC Criteria

Jul 30, 2009

First Posted Date

Jul 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2020

Last Update Posted Date

Jan 30, 2020Actual

Name	Class
University Hospitals, Leicester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

432Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Other: Electronic risk score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self Assessment	Other	Self assessment used to determine current risk of diabetes and likelihood of requiring further testing	Self Assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in response rates to invitation to 2nd stage blood test		12 months

Secondary Outcomes

Measure	Description	Time Frame
Increase in yield of OGTT positive results through filtering of high risk participants that pass 1st and 2nd stage screens		12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kamlesh Khunti, MD	University of Leicester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leicester City PCT		Leicester	Leicestershire		United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059026	Diagnostic Self Evaluation

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided