Continuous Glucose Monitoring With Real-Time Alerts to Achieve Glycaemic Control in Surgical Patients With Diabetes: Protocol for a Multicentre, Randomised, Clinical Trial.

Abstract

Background: Perioperative glucose monitoring traditionally relies on intermittent point-of-care (POC) testing, whereas continuous glucose monitoring (CGM) enables real-time glucose assessment with automated alerts for dysglycaemia. CGM remains understudied in hospitalised surgical patients with diabetes. This protocol outlines a clinical trial designed to evaluate the effect of CGM on achieving normoglycaemia in surgical patients with diabetes.

Methods: A multicentre, two-group, randomised controlled trial (NCT06314061). Eligible patients are adults with Type 1 or Type 2 diabetes undergoing surgery lasting more than 45 min with an expected hospital stay of at least one night. Patients in the intervention group will be monitored using CGM (Dexcom G7, Dexcom Inc., CA, USA) with active alerts for hyperglycaemia and hypoglycaemia for up to 10 days after surgery during hospitalisation. Patients in the control group will wear a CGM device with glucose values and alerts concealed from the patient and clinical staff. All patients will receive routine diabetes care, including intermittent POC glucose testing, in addition to CGM. The primary outcome is CGM time-in-range between 6.0 and 10.0 mmol/L. Secondary outcomes include the frequency and cumulative duration of hypoglycaemia and hyperglycaemia as well as postoperative complications. A sample size of 200 patients will allow 90% power to detect a 15% relative difference in the primary outcome between groups, with an expected 10% dropout. To ensure standardised use of CGM and to support clinical decision-making during the trial, a trial-specific guideline has been developed, integrating CGM with insulin treatment and POC tests. The guideline recommends intervention for glucose levels < 5.0 mmol/L when trending downward. For CGM glucose levels > 10.0 mmol/L, rapid-acting insulin may be administered according to a sliding scale regimen rather than delaying treatment until the next scheduled POC test.

Conclusion: This randomised controlled trial will provide clinical evidence for CGM use by clinical staff to enhance perioperative glycaemic control in surgical patients with diabetes.

Trial registration: NCT06314061.