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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

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

Scientific title

The Role of Continuous Glucose Monitoring on Glucose Management in Hospitalised Patients with Insulin-Requiring Type 2 Diabetes Having an operation

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Individuals with type-2 diabetes undergoing surgery

Type-2 diabetes

Glycaemic control in hospital

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Prevention

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.

Control group

Active

Outcomes

Primary outcome [1]

Glycaemic control

Timepoint [1]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [1]

Glucose variability

Timepoint [1]

Variability measured from real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [2]

Hyperglycaemic episodes

Timepoint [2]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [3]

Average time lag between detection of hypoglycaemic or hyperglycaemic episodes between by CGM and POC

Timepoint [3]

Timepoints at which episodes occur over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [4]

28 day hospital readmission rate

Timepoint [4]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [5]

Time with blood glucose levels above range

Timepoint [5]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [6]

Mean glucose

Timepoint [6]

Average measured from real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [7]

Hospital length of stay

Timepoint [7]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [8]

Hypoglycaemic episodes

Timepoint [8]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [9]

Percent days with hyperglycaemia

Timepoint [9]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [10]

Time in healthy blood glucose level range (4.0 - 10.0 mmol/L)

Timepoint [10]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [11]

Mortality during admission

Timepoint [11]

Cumulative data will be assessed at the conclusion of the study

Secondary outcome [12]

Percent days with hypoglycaemia

Timepoint [12]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [13]

Time with blood glucose levels below range

Timepoint [13]

Real-time data over 15-day wear of CGM, extracted after sensor is removed

Secondary outcome [14]

Number of timepoints for which blood glucose levels would trigger a change in management between CGM and POC

Timepoint [14]

Timepoints recorded in electronic medical records for total length of stay in hospital

Secondary outcome [15]

ICU length of stay

Timepoint [15]

Cumulative data will be assessed at the conclusion of the study

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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

< 18 years old, non English speaking, are treated with palliative care intent

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

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.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified randomisation based on site.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

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

14/07/2025

Actual

Date of last participant enrolment

Anticipated

13/03/2026

Actual

Date of last data collection

Anticipated

6/07/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

2747 - Kingswood

Recruitment postcode(s) [2]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Diabetes Society

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Ramsay Research Grant Scheme

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Northern Sydney Local Health District

Address

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Nepean Blue Mountains Local Health District

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/04/2024

Approval date [1]

27/06/2024

Ethics approval number [1]

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).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Sarah Glastras

Address

Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065

Country

Australia

Phone

+61294631680

Fax

[email protected]

Contact person for public queries

Name

Carys Campbell

Address

Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065

Country

Australia

Phone

+61 2 99264751

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Glastras

Address

Department of Diabetes, Endocrinology & Metabolism, Royal North Shore Hospital, Reserve Rd, St. Leonards, NSW 2065

Country

Australia

Phone

+61294631680

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically