None listed
Conditions
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).
Interventions
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 wi
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.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
< 18 years old, non English speaking, are treated with palliative care intent
Outcome results
None listed