Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000652572
Ethics application status
Approved
Date submitted
12/04/2024
Date registered
21/05/2024
Date last updated
21/05/2024
Date data sharing statement initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing NursE recording Accuracy and Time taken for blood glucose checks with different glucose meters (NEAT) - Pilot Study
Scientific title
Prospective audit: nursing time and blood glucose accuracy comparison between standard and Wi-Fi connectivity Statstrip glucometers - pilot study
Secondary ID [1] 311854 0
None
Universal Trial Number (UTN)
U1111-1306-5962
Trial acronym
NEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 333382 0
Hyperglycaemia 333383 0
Hypoglycaemia 333384 0
Blood glucose monitoring 333385 0
Condition category
Condition code
Metabolic and Endocrine 330075 330075 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this pilot study is to assess the accuracy and time to transcription of the traditional, standard care glucose meter compared to the Point of Care (POC) testing glucose meter with wi-fi connectivity. The results of this study will inform the power calculation of the second part of this study, as detailed in a separate ANZCTR application. 10 patient participants will be recruited for the pilot study. The blood glucose of these individuals will be measured via a traditional glucometer and a POC Testing glucometer with connectivity to Wi-Fi. The Point of Care Testing glucose meter works similarly to the traditional glucose meter, except it automatically uploads the blood glucose reading to the patient participant’s electronic medical record (EMR). The nursing staff will need to be registered and provided with an individualised barcode swipe prior to testing the patient participant’s blood glucose. The nurse participant will also check blood glucose with the traditional glucose meter and transcribe the reading onto the relevant EMR, and part of the study is to assess the time taken for this transcription process to occur. As standard care, transcription of the BGL into EMR should immediately occur after the reading is taken. A single nurse participant will perform both measurements in a single patient. Nurse participants will be given training to operate the Wi-Fi connectivity glucose meter. The training will be provided by credentialed diabetes educator and POC testing NSW Health Pathology staff, and it will take approximately 10 minutes. Training will occur within 4 weeks prior to enrolment of the first patient participant. There will be a period of the nurses practicing using the connectivity glucose meters prior to enrolment of the first patient participant. Two assessor timekeepers will independently assess the time taken for the procedure in each of the 10 patients.
Intervention code [1] 328312 0
Treatment: Devices
Intervention code [2] 328527 0
Diagnosis / Prognosis
Comparator / control treatment
The control arm is the traditional glucose meter BGL transcription time and accuracy.
Control group
Active

Outcomes
Primary outcome [1] 337833 0
Composite nursing time taken to measure blood glucose and time taken to transcribe the reading into the EMR (Cerner Powerchart) using standard glucose meter, in comparison with time taken for a glucose level to appear on the screen of the connectivity glucose meter to wi-fi.
Timepoint [1] 337833 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] 433426 0
Transcription errors
Timepoint [1] 433426 0
After completion of transcription per patient
Secondary outcome [2] 434734 0
Transposition errors. i.e. entry into incorrect patient file
Timepoint [2] 434734 0
Patient participant files will be reviewed for this secondary outcome when data collection for the 10 individuals have been completed
Secondary outcome [3] 434735 0
Reason for delay to recording of BGL in the EMR
Timepoint [3] 434735 0
Performed by assessor at time of observation
Secondary outcome [4] 434992 0
Other error which has not been described but monitored for and detected during the implementation phase
Timepoint [4] 434992 0
Performed by assessor at time of observation or time of audit, at which ever time point this is detected

Eligibility
Key inclusion criteria
1. For patient participants: patients who are admitted on the surgical wards at Nepean Hospital with pre-existing diabetes treated with diet alone, oral tablets or injectable therapy (e.g. insulin, GLP-1 agonists), who require regular blood glucose testing as part of the standard clinical care, including those already on continuous glucose monitoring.

2. 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 research 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
27/05/2024
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] 26345 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 42318 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 316197 0
Hospital
Name [1] 316197 0
In kind support from the medical and nursing staff at Nepean Hospital
Country [1] 316197 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Country
Australia
Secondary sponsor category [1] 318380 0
None
Name [1] 318380 0
Address [1] 318380 0
Country [1] 318380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315013 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 315013 0
https://www.nbmlhd.health.nsw.gov.au/researchoffice
Ethics committee country [1] 315013 0
Australia
Date submitted for ethics approval [1] 315013 0
18/11/2022
Approval date [1] 315013 0
19/12/2022
Ethics approval number [1] 315013 0
2022/ETH02266

Summary
Brief summary
Audit comparing amount of nursing time taken and accuracy of blood glucose levels recorded in the electronic medical record for the standard Nova Biomedical glucose meter currently used for clinical care compared with the AMSL wi-fi connectivity Statstrip glucose meter. Nova Biomedical manufactures a wi-fi connectivity glucose meter which can upload its glucose data directly to the patient electronic medical record (eMR). We anticipate that using the wi-fi connectivity glucose meters will substantially save nursing time and also contribute to an increase in the accuracy of glucose recording in the eMR. We plan to compare the time taken to check and record in the eMR a finger prick glucose level using each glucose meter type and to determine the proportion of glucose levels recorded accurately in the eMR by each technique (correct patient, correct time, correct glucose level and delay to glucose being documented in the eMR).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133430 0
A/Prof Emily Hibbert
Address 133430 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 133430 0
Australia
Phone 133430 0
+61 0419606608
Fax 133430 0
Email 133430 0
emily.hibbert@sydney.edu.au
Contact person for public queries
Name 133431 0
Laura Conway
Address 133431 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 133431 0
Australia
Phone 133431 0
+61 47344754
Fax 133431 0
Email 133431 0
laura.conway@health.nsw.gov.au
Contact person for scientific queries
Name 133432 0
Emily Hibbert
Address 133432 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 133432 0
Australia
Phone 133432 0
+61 0419606608
Fax 133432 0
Email 133432 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?




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.