Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000686404
Ethics application status
Approved
Date submitted
18/06/2025
Date registered
27/06/2025
Date last updated
27/06/2025
Date data sharing statement initially provided
27/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The Role of Continuous Glucose Monitoring in Hospitalised Patients with Insulin-Requiring Type 2 Diabetes Having an operation: OPERATION GLUCOSE
Query!
Scientific title
The Role of Continuous Glucose Monitoring on Glucose Management in Hospitalised Patients with Insulin-Requiring Type 2 Diabetes Having an operation
Query!
Secondary ID [1]
314581
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type-2 diabetes
337700
0
Query!
Glycaemic control in hospital
337701
0
Query!
Individuals with type-2 diabetes undergoing surgery
337702
0
Query!
Condition category
Condition code
Metabolic and Endocrine
334035
334035
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Continuous glucose monitor (CGM) group: The study team member will attach a Libre 2 Plus (Abbott) CGM device to the participant's arm during a pre-admission clinic appointment in hospital. The clinical team and patient will be able to monitor the glucose data either on a smartphone or within Libreview web-based platform. A low glucose alarm of 4.5 mmol/L will be set. Pre-operatively, the CGM group will still be encouraged to check finger-prick BGLs 4 times daily, as per standard of care, but will also have their CGM real-time data shared with the study team. Participants will be instructed to contact the study team if blood glucose levels (BGLs) are out of range (4-10 mmol/L). Participants will be advised on what to do if their phone alarms (immediate management of hypoglycaemia). In hospital, all clinical staff will perform usual standard of care. Staff can utilise real-time CGM data for making treatment decisions. The study team will use real-time CGM data to facilitate decision regarding insulin prescription. The participant will be instructed on how to safely remove the device after its 15 day wear.
Changes in management with standard testing compare with CGM will be assessed by reviewing treatment decisions and insulin dosage adjustment frequency, number of after-hour calls to medical officers for blood glucose reviews and number of times BGL triggers medical intervention.
Libreview software will facilitate download of all CGM glucose measurements.
Query!
Intervention code [1]
331213
0
Prevention
Query!
Intervention code [2]
331348
0
Treatment: Devices
Query!
Comparator / control treatment
Control group: The study team member will attach a Libre ProIQ CGM device to the participant's arm during a pre-admission clinic appointment in hospital. The CGM is blinded, such that the data will not be visible to the patient or the study team. Data will be stored on the device and available for download at the end of a 2 week period. The participant will be instructed on how to safely remove the device after its 2 week wear.
Preoperatively, both groups will be encouraged to check finger prick BGLs 4 times daily as per standard of care. In hospital, usual standard of care finger-prick testing will take place pre and post meals daily. Daily glucose management will be carried out as usual by the inpatient diabetes management team.
Libreview software will facilitate download of all CGM glucose measurements. Surgical and patient outcome measures will be obtained from review of the electronic medical record.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
341701
0
Glycaemic control
Query!
Assessment method [1]
341701
0
Percent time in target range (3.9-10.0 mmol/L) in the perioperative and post-operative period
Query!
Timepoint [1]
341701
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [1]
448398
0
Percent days with hypoglycaemia
Query!
Assessment method [1]
448398
0
No. of days with blood glucose levels < 4.0 mmol/L (extracted from sensor data) over the total no. of days of hospitalisation. (taken from electronic medical records)
Query!
Timepoint [1]
448398
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [2]
448399
0
Percent days with hyperglycaemia
Query!
Assessment method [2]
448399
0
No. of days with blood glucose levels > 10.0mmol/L (extracted from sensor data) over total no. of days of hospitalisation (extracted from electronic medical records)
Query!
Timepoint [2]
448399
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [3]
448400
0
Hypoglycaemic episodes
Query!
Assessment method [3]
448400
0
No. of episodes (defined as level 1 blood glucose < 4.0mmol/L and level 2 < 3.0mmol/L (extracted from sensor data))
Query!
Timepoint [3]
448400
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [4]
448401
0
Hyperglycaemic episodes
Query!
Assessment method [4]
448401
0
No. of episodes (defined as level 1 blood glucose level > 10.0mmol/L and level 2 > 13.9mmol/L and level 3 > 17.0mmol/L (extracted from sensor data))
Query!
Timepoint [4]
448401
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [5]
448402
0
Time in healthy blood glucose level range (4.0 - 10.0 mmol/L)
Query!
Assessment method [5]
448402
0
Time with blood glucose levels 4.0 - 10 mmol/L (extracted from sensor data)
Query!
Timepoint [5]
448402
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [6]
448409
0
Time with blood glucose levels below range
Query!
Assessment method [6]
448409
0
Time with blood glucose levels below range (level 1 < 4.0mmol/L, level 2 < 3.0mmol/L (extracted from sensor data))
Query!
Timepoint [6]
448409
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [7]
448411
0
Time with blood glucose levels above range
Query!
Assessment method [7]
448411
0
Time with blood glucose levels above range (level 1 > 10mmol/L, level 2 > 13.9mmol/L, level 3 > 17.9mmol/L (extracted from sensor data))
Query!
Timepoint [7]
448411
0
Real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [8]
448412
0
Mean glucose
Query!
Assessment method [8]
448412
0
Average glucose level over 15-day wear of sensor (mmol/L) extracted from sensor data
Query!
Timepoint [8]
448412
0
Average measured from real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [9]
448414
0
Glucose variability
Query!
Assessment method [9]
448414
0
Glucose variability over 15-day wear of sensor extracted from sensor data
Query!
Timepoint [9]
448414
0
Variability measured from real-time data over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [10]
448416
0
Number of timepoints for which blood glucose levels would trigger a change in management between CGM and POC
Query!
Assessment method [10]
448416
0
No. of timepoints per day (extracted from electronic medical records) for which BGL trigger a change in management with POC testing times compared with CGM (ie treatment decision changes, insulin dosage adjustments, after-hours calls to medical officers)
Query!
Timepoint [10]
448416
0
Timepoints recorded in electronic medical records for total length of stay in hospital
Query!
Secondary outcome [11]
448418
0
Average time lag between detection of hypoglycaemic or hyperglycaemic episodes between by CGM and POC
Query!
Assessment method [11]
448418
0
Average time taken to detect hypoglycaemic or hyperglycaemic episodes in CGM-arm and POC-arm, assessed through blinded/unblinded sensor data after 15-day use and episodes logged in electronic medical records
Query!
Timepoint [11]
448418
0
Timepoints at which episodes occur over 15-day wear of CGM, extracted after sensor is removed
Query!
Secondary outcome [12]
448419
0
Hospital length of stay
Query!
Assessment method [12]
448419
0
Assessed by data extracted from electronic medical records
Query!
Timepoint [12]
448419
0
Cumulative data will be assessed at the conclusion of the study
Query!
Secondary outcome [13]
448420
0
ICU length of stay
Query!
Assessment method [13]
448420
0
Assessed by data extracted from electronic medical records
Query!
Timepoint [13]
448420
0
Cumulative data will be assessed at the conclusion of the study
Query!
Secondary outcome [14]
448421
0
28 day hospital readmission rate
Query!
Assessment method [14]
448421
0
Assessed by data extracted from electronic medical records
Query!
Timepoint [14]
448421
0
Cumulative data will be assessed at the conclusion of the study
Query!
Secondary outcome [15]
448426
0
Mortality during admission
Query!
Assessment method [15]
448426
0
Assessed by data extracted from electronic medical records
Query!
Timepoint [15]
448426
0
Cumulative data will be assessed at the conclusion of the study
Query!
Eligibility
Key inclusion criteria
Adult patients (18+ years old) with type-2 diabetes, diagnosed >3 months prior to hospital admission, undergoing either:
1. Cardiothoracic surgery - coronary artery bypass surgery
2. Orthopaedic surgery - joint replacement
3. Open gastrointestinal surgery
With expected admission duration >24 hours, and who are on insulin therapy at time of recruitment.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
< 18 years old, non English speaking, are treated with palliative care intent
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Allocation will be concealed as it is done through randomisation via REDCap.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation based on site.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
14/07/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
13/03/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
6/07/2026
Query!
Actual
Query!
Sample size
Target
90
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
28000
0
Royal North Shore Hospital - St Leonards
Query!
Recruitment hospital [2]
28001
0
Nepean Hospital - Kingswood
Query!
Recruitment postcode(s) [1]
44202
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
44203
0
2747 - Kingswood
Query!
Funding & Sponsors
Funding source category [1]
319129
0
Charities/Societies/Foundations
Query!
Name [1]
319129
0
Ramsay Research Grant Scheme
Query!
Address [1]
319129
0
Query!
Country [1]
319129
0
Australia
Query!
Funding source category [2]
319137
0
Charities/Societies/Foundations
Query!
Name [2]
319137
0
Australian Diabetes Society
Query!
Address [2]
319137
0
Query!
Country [2]
319137
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Northern Sydney Local Health District
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
321593
0
Government body
Query!
Name [1]
321593
0
Nepean Blue Mountains Local Health District
Query!
Address [1]
321593
0
Query!
Country [1]
321593
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
317723
0
Northern Sydney Local Health District Human Research Ethics Committee
Query!
Ethics committee address [1]
317723
0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Query!
Ethics committee country [1]
317723
0
Australia
Query!
Date submitted for ethics approval [1]
317723
0
16/04/2024
Query!
Approval date [1]
317723
0
27/06/2024
Query!
Ethics approval number [1]
317723
0
Query!
Summary
Brief summary
Operation Glucose is a clinical trial exploring whether continuous glucose monitors (CGMs) can improve diabetes management in hospitalised patients with insulin-requiring type 2 diabetes who are undergoing surgery. People with diabetes face a higher risk of complications during the surgical period, often due to fluctuations in blood glucose levels. This study aims to assess whether CGMs can help reduce these fluctuations (known as glycaemic variability), to support better blood glucose control and improved clinical outcomes. Participants will be randomly assigned to one of two groups. One group will wear a CGM device (Libre 2 Plus) that displays real-time glucose data to both the patient and the clinical team. This data, alongside regular finger-prick testing, will be used to guide treatment. The other group will wear a blinded CGM device (Libre ProIQ) which does not display glucose data. This group will rely on standard finger-prick testing alone for treatment decisions. The primary outcome will be the percentage of time that a patient's blood glucose levels remain within the healthy target range (4.0 - 10.0 mmol/L).
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
141938
0
A/Prof Sarah Glastras
Query!
Address
141938
0
Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065
Query!
Country
141938
0
Australia
Query!
Phone
141938
0
+61294631680
Query!
Fax
141938
0
Query!
Email
141938
0
[email protected]
Query!
Contact person for public queries
Name
141939
0
Carys Campbell
Query!
Address
141939
0
Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065
Query!
Country
141939
0
Australia
Query!
Phone
141939
0
+61 2 99264751
Query!
Fax
141939
0
Query!
Email
141939
0
[email protected]
Query!
Contact person for scientific queries
Name
141940
0
Sarah Glastras
Query!
Address
141940
0
Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065
Query!
Country
141940
0
Australia
Query!
Phone
141940
0
+61294631680
Query!
Fax
141940
0
Query!
Email
141940
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
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
No additional documents have been identified.
Download to PDF