NCT04653545

Brief Summary

People with type 2 diabetes are two-and-a-half times more likely to experience heart failure and twice more likely to have a heart attack compared to people without diabetes. People coming to hospital often have unknown hyperglycaemia. It is thought that three quarters of people admitted to the Coronary care unit with a myocardial infarction have hyperglycaemia and over a third of whom are undiagnosed with diabetes and over 40% with impaired glucose tolerance (IGT). All of these patients are at greater risk of poor outcomes in the presence of uncontrolled hyperglycaemia. Patients presenting to A\&E have routine bloods taken for condition which are they are being investigated and treated for. Therefore the aim of the study is to identify the prevalence of undiagnosed diabetes (HbA1c \>48mmol/mol) or impaired glucose tolerance/pre-diabetes (HbA1c \>39mmol/mol) in patients attending the accident and emergency department or acute medical unit and to see if this is a good screening measure for diagnosis of diabetes. This project will help identify those undiagnosed with glucose intolerance (T2D and IGT) and instigate appropriate treatment and improve outcomes for this group of patients. This will in the long term reduce the burden to the NHS. This project will help in the development of guidance for diagnosis of T2D in an acute setting and treatment for hospital admission and continued care. This project will include 10,000 consecutive patients over the age of 30 years attending the A\&E or AMU departments of Tameside and Glossop Integrated Care NHS FT. All patients will be screened for glucose intolerance with a blood test in which patients' blood would be taken anyway for clinical reasons and the laboratory will perform an HbA1c investigation on the sample collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,050

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3.2 years

First QC Date

November 25, 2020

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • What is the prevalence of glucose intolerance (diabetes and IGT) in patients presenting to an acute medical emergency department?

    How many patients not known to have diabetes, are diagnosed with the condition

    52 weeks

Secondary Outcomes (3)

  • Diabetes complications, if any, are present

    52 weeks

  • Cardiovascular complications

    52 weeks

  • Diabetes control in those with known diabetes

    52 weeks

Interventions

HbA1cDIAGNOSTIC_TEST

Blood will be taken as per requirement for patients being admitted to hospital. A small sample will be sent to the biochemistry department for measurement of HbA1 (by HPLC method). All patients who are diagnosed with diabetes (or known to have diabetes) will have a foot examination and retinal and renal screening and cardiovascular assessment for diabetes complications.

Also known as: Foot examination and other screening for diabetes complications, Lipds and renal function

Eligibility Criteria

Age30 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the accident and emergency department and acute medical wards of a district general hospital

You may qualify if:

  • Aged ≥30 years.
  • Males and female sex

You may not qualify if:

  • Aged \<30 years.
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tameside Hospital NHS Foundation Trust

Ashton-under-Lyne, Greater Manchester, OL6 9RW, United Kingdom

Location

Related Publications (1)

  • Jude EB, Saluja S, Heald A, Widiatmoko D, Schaper N, Anderson SG. Improving Diabetes and Pre-Diabetes Detection in the UK: Insights From HbA1c Screening in an Acute Hospital's Emergency Department. Diabetes Ther. 2025 Oct;16(10):1917-1932. doi: 10.1007/s13300-025-01777-w. Epub 2025 Aug 6.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Kidney Function Tests

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Edward Jude

    Tameside and Glossop Integrated Care NHS FT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 4, 2020

Study Start

February 1, 2022

Primary Completion

April 24, 2025

Study Completion

April 24, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

All data will kept on trust computer that is password protected. None will be shared with those outside the research team

Locations