WARD-Glucose RCT
Official title:
The effect of continuous glucose monitoring with real-time alerts on glycaemic control in surgical patients with diabetes. A randomised, clinical multicentre trial.
Study design:
A two-group parallel prospective, randomised, controlled trial.
Sample size:
200 participants
Study Sites:
Rigshospitalet, Bispebjerg Hospital, and Zealand University Hospital Køge
Inclusion criteria:
Adult patients with medically treated diabetes mellitus who undergo acute or planned surgery lasting >45 minutes and are expected to stay at least one night in the hospital postoperatively.
Study Procedures:
Included patients will wear a continuous glucose monitoring (CGM) device (Dexcom G7) during the stay at the hospital (up to 10 days). Through a sensor placed subcutaneously, the CGM device measures glucose levels every 5 minutes and transmit readings to a receiver at the patient bed. In the intervention group, the glucose readings will be sent to a smart device held by the nursing staff providing them with real-time continuous glucose measurements. Notifications on hyperglycaemia (>10.0 mmol/l), low glucose (<5.0 mmol/l), or urgent low glucose levels (<3.1 mmol/l) will alert the nursing staff thus enabling them to provide adequate treatment. The CGM device will be blinded in the control group. For all patients, routine monitoring with point-of-care (POC) blood glucose measurements will be performed 4-6 times per day, and the treatment of deviating glucose levels will follow existing local guidelines. Postoperatively, patients will also be asked to wear wireless sensor that record vital parameters (heart rate, single-lead ECG, respiratory rate, and peripheral blood oxygen).
Outcome:
The primary outcome is Time in range (TIR) of CGM glucose levels (6.0-10.0 mmol/l) in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Secondary outcomes include durations of hypoglycaemia and hyperglycaemia alongside assessment of postoperative complications.
Primary Investigators:
Casper Pedersen, MD PhD student
NCT: NCT06314061