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Trial registered on ANZCTR


Registration number
ACTRN12624000690550
Ethics application status
Approved
Date submitted
16/05/2024
Date registered
30/05/2024
Date last updated
30/05/2024
Date data sharing statement initially provided
30/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial comparing NursE recording Accuracy and Time taken for blood glucose checks with different glucose meters (NEAT)
Scientific title
Prospective audit: nursing time and blood glucose accuracy comparison between standard and Wi-Fi connectivity Statstrip glucometers - RCT
Secondary ID [1] 312089 0
None
Universal Trial Number (UTN)
U1111-1307-7496
Trial acronym
NEAT
Linked study record
This study is the randomised control trial to the pilot study ACTRN12624000652572

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 333715 0
Hyperglycaemia 333716 0
Hypoglycaemia 333717 0
Blood glucose monitoring 333718 0
Condition category
Condition code
Metabolic and Endocrine 330400 330400 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a direct follow up of the pilot NEAT study (ACTRN 12624000652572). The aim of this randomised control trial (RCT) is to compare the time taken and accuracy of blood glucose level (BGL) recording by nurses. For each routine BGL check on a patient, a nurse participants will be randomised to use either the standard care glucometer (control) or Point of Care Testing wi-fi enabled connectivity glucometer (intervention).

The number of glucose checks required for this study will be informed by a calculation using the results of the pilot study. Nurse participants will be randomised to either use the standard glucose meter or wi-fi enabled connectivity glucose meter. The Point of Care Testing glucose meter works similarly to the standard glucose meter, except it automatically uploads the blood glucose reading to the patient participant’s electronic medical record (EMR). If using the Point of Care Testing glucose meter, the nurse participant will need to be registered and provided with an individualised barcode swipe prior to testing the patient's blood glucose. Training of nurse participants will be provided during the pilot study phase. Training will be conducted by credentialed diabetes educator and POC testing NSW Health Pathology staff, and it will take approximately 10 minutes.

The patients are not participants in this study as their blood glucose will be check by the usual bedside fingerprick glucose meter method.
Intervention code [1] 328529 0
Treatment: Devices
Intervention code [2] 328530 0
Diagnosis / Prognosis
Comparator / control treatment
The control arm the use of standard fingerprick glucose meter, which requires a nurse to manually enter the BGL into the EMR. This is the current standard of clinical care.
Control group
Active

Outcomes
Primary outcome [1] 338156 0
Composite nursing time taken to measure blood glucose and time taken to transcribe the reading into the EMR using standard glucose meter. This will be compared with time taken for a glucose level to appear on the screen of the connectivity glucose meter via wi-fi.
Timepoint [1] 338156 0
Timing of intervention procedure - for both the standard of care glucose meter and connectivity glucose meter, after the nurse has all the necessary equipment, timing starts from when the nurse participant informs the patient participant that their BGL will be checked. Timing will finish when the glucose level appears onto the EMR screen of the patient participant file.
Secondary outcome [1] 434747 0
Transcription errors, when the incorrect value for blood glucose is entered into EMR, as compared to the actual value on the glucose meter
Timepoint [1] 434747 0
After completion of transcription per patient
Secondary outcome [2] 434748 0
Transposition errors. i.e. entry into incorrect patient file
Timepoint [2] 434748 0
Patient participant files will be reviewed for this secondary outcome when data collection has been completed
Secondary outcome [3] 434749 0
Reason for delay to recording of BGL in the EMR
Timepoint [3] 434749 0
Performed by assessor at time of observation
Secondary outcome [4] 435174 0
Other error which has not been described but monitored for and detected during the implementation phase
Timepoint [4] 435174 0
Performed by assessor at time of observation or time of audit, at which ever time point this is detected

Eligibility
Key inclusion criteria
For nurse participants: Nurses who are working on the surgical wards and involved in regular blood glucose measurements and who have been trained in the use of both the traditional glucose meter and wi-fi connectivity glucometers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Blood glucose measurements by nursing staff who are not trained to use the different types of glucometers (e.g. agency nurses, nursing students)
2. Patients without diabetes
3. Any nursing staff or patient who declines informed verbal consent to participate in the study

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)
Open-labelled intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via online randomisation tool
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26514 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 42553 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 316446 0
Hospital
Name [1] 316446 0
In kind support from the medical and nursing staff at Nepean Hospital
Country [1] 316446 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Country
Australia
Secondary sponsor category [1] 318615 0
None
Name [1] 318615 0
Address [1] 318615 0
Country [1] 318615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315237 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 315237 0
Ethics committee country [1] 315237 0
Australia
Date submitted for ethics approval [1] 315237 0
03/11/2022
Approval date [1] 315237 0
18/11/2022
Ethics approval number [1] 315237 0
2022/ETH02266

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134090 0
A/Prof Emily Hibbert
Address 134090 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134090 0
Australia
Phone 134090 0
+61 419606608
Fax 134090 0
Email 134090 0
emily.hibbert@sydney.edu.au
Contact person for public queries
Name 134091 0
Laura Conway
Address 134091 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134091 0
Australia
Phone 134091 0
+61 2 47344754
Fax 134091 0
Email 134091 0
laura.conway@health.nsw.gov.au
Contact person for scientific queries
Name 134092 0
Emily Hibbert
Address 134092 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134092 0
Australia
Phone 134092 0
+61 419606608
Fax 134092 0
Email 134092 0
emily.hibbert@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22334Study protocol    387758-(Uploaded-06-05-2024-15-19-23)-Study-related document.docx
22335Informed consent form    387758-(Uploaded-06-05-2024-15-19-49)-Study-related document.docx
22423Ethical approval    387758-(Uploaded-16-05-2024-15-12-10)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.