Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001007921
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
20/09/2011
Date last updated
17/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Diabetes Case Detection through Emergency Department Admissions
Scientific title
A cluster randomised trial of diabetes detection through routine blood glucose testing among people admitted to hospital through Emergency Departments
Secondary ID [1] 262980 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 270702 0
Condition category
Condition code
Metabolic and Endocrine 271003 271003 0 0
Diabetes
Public Health 271008 271008 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine testing of blood glucose for all patients admitted to hospital through Emergency Departments, who have blood taken.
Measurement of HbA1c if blood glucose >=14 mmol/L.
Notification of Diabetes Services if blood glucose >=14 mmol/L so that patient can receive early assessment by the diabetes team during the period of their inpatient admission.
Intervention code [1] 269323 0
Early detection / Screening
Comparator / control treatment
Routine testing of blood glucose for all patients admitted to hospital through Emergency Departments, who have blood taken.
Control group
Active

Outcomes
Primary outcome [1] 279558 0
To determine if the intervention leads to improved detection and diagnosis of diabetes amongst hyperglycaemic people admitted through Emergency, who had not previously been diagnosed with diabetes

Criteria for primary outcome:
Admission BGL elevated (greater than or equal to 14 mmol/L)
And documentation in notes of the likely diagnosis and there is plan for follow-up (eg; with GP, diabetes educator or Endocrinologist)
And one or more of the following:
i) HbA1c greater than or equal to 6.5% (where the normal range is 4-6%)
ii) Another fasting BGL greater than or equal to 7.0 during admission
iii) Another random BGL greater than or equal to 11.1 during admission
iv) Meeting WHO criteria for diagnosis of diabetes upon follow-up testing post-discharge
v) Requiring regular anti-diabetic medication at discharge
Timepoint [1] 279558 0
During hospital admission
Secondary outcome [1] 287900 0
To determine if the intervention leads to lower mean length of stay for hyperglycaemic patients who had not previously been diagnosed with diabetes as recorded in the NSW Admitted Patients Data Collection
Timepoint [1] 287900 0
During hospital admission
Secondary outcome [2] 294165 0
To determine if the intervention leads to fewer care complications (eg infection occurring in hospital, acute renal failure occurring in hospital, acute coronary syndrome occurring in hospital) for hyperglycaemic patients who had not previously been diagnosed with diabetes as recorded in the NSW Admitted Patients Data Collection
Timepoint [2] 294165 0
During hospital admission
Secondary outcome [3] 294166 0
To determine if the intervention leads to a lower hospital readmission rate within one year (for any condition) for hyperglycaemic patients who had not previously been diagnosed with diabetes as recorded in the NSW Admitted Patients Data Collection
Timepoint [3] 294166 0
Within one year of discharge

Eligibility
Key inclusion criteria
All patients admitted to hospital through Emergency Departments who have blood taken.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomised trial
Based on hospital randomisation

A random list of randomisation codes were generated off site by a statistician. This was paired against the participating hospitals listed in random order which was independently computer generated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subject allocation was based on hospital randomisation

A random list of randomisation codes were generated off site by a statistician. This was paired against the participating hospitals listed in random order which was independently computer generated, with stratification into district and tertiary hospitals. Thus hospitals were allocated to intervention or control.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
cluster randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2011
Actual
31/05/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
900
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269788 0
Government body
Name [1] 269788 0
NHMRC
Country [1] 269788 0
Australia
Funding source category [2] 269900 0
Government body
Name [2] 269900 0
NSW Agency for Clinical Innovation
Country [2] 269900 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Hawkesbury Rd
Westmead Hospital
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 268826 0
Government body
Name [1] 268826 0
NSW Agency for Clinical Innovation
Address [1] 268826 0
PO Box 699
Chatswood NSW 2057
Country [1] 268826 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271746 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 271746 0
Hawkesbury Rd
Westmead Hospital
Westmead NSW 2145
Ethics committee country [1] 271746 0
Australia
Date submitted for ethics approval [1] 271746 0
Approval date [1] 271746 0
08/03/2010
Ethics approval number [1] 271746 0
HREC2010/2/4.4(3100)
Ethics committee name [2] 290859 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [2] 290859 0
Ethics committee country [2] 290859 0
Australia
Date submitted for ethics approval [2] 290859 0
Approval date [2] 290859 0
26/03/2014
Ethics approval number [2] 290859 0
HREC/CIPHS/4

Summary
Brief summary
This health services research study aims to evaluate, using a single blind, cluster randomised control design the novel system of routine blood glucose testing amongst all patients admitted to hospital via Emergency, followed by automatic notification of the relevant hospital’s Diabetes Services for those who are hyperglycaemic, to assess related improvement in diabetes case detection and subsequent implementation of diabetes care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33108 0
Prof N Wah Cheung
Address 33108 0
Dept of Diabetes & Endocrinology, Westmead Hospital,
Hawkesbury Rd,
Westmead NSW 2145
Country 33108 0
Australia
Phone 33108 0
6102 98456796
Fax 33108 0
Email 33108 0
[email protected]
Contact person for public queries
Name 16355 0
Prof N Wah Cheung
Address 16355 0
Westmead Hospital
Hawkesbury Rd
Westmead
NSW 2145
Country 16355 0
Australia
Phone 16355 0
610298455555
Fax 16355 0
610296355691
Email 16355 0
[email protected]
Contact person for scientific queries
Name 7283 0
Prof N Wah Cheung
Address 7283 0
Westmead Hospital
Hawkesbury Rd
Westmead
NSW 2145
Country 7283 0
Australia
Phone 7283 0
610298455555
Fax 7283 0
610296355691
Email 7283 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRoutine glucose assessment in the emergency department for detecting unrecognised diabetes: a cluster randomised trial.2019https://dx.doi.org/10.5694/mja2.50394
N.B. These documents automatically identified may not have been verified by the study sponsor.