The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients. The main question it aims to answer is: • Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes? Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge.
This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet, Copenhagen University, Bispebjerg and Frederiksberg Hospital, Copenhagen University, and Zealand University Hospital, Køge, Denmark The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control. The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia (hypo- and hyperglycaemia) to mobile devices held by the nursing staff. Patients will wear the CGM before, during and up to 10 days postoperatively. The study will include 200 patients. This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
A continuous glucose monitor which through a sensor in the skin registers glucose levels every 5 minutes. Glucose levels are shown by connecting the sensor to a mobile device or the Dexcom G7 Receiver where realtime alerts on deviating glucose levels will be sent.
Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
Copenhagen, The Capital Region of Denmark, Denmark
RECRUITINGDepartment of Anaesthesiology and Intensive Care, Bispebjerg Hospital
Copenhagen, The Capital Region of Denmark, Denmark
RECRUITINGZealand University Hospital
Køge, Denmark
RECRUITINGTime in range (TIR) of CGM glucose levels
Time in range (TIR) of CGM glucose levels (6.0-10.0 mmol/l) in minutes per 24 hours after discharge from the post-anaesthesia care unit (PACU) until 10 days postoperative (or until discharge)
Time frame: Perioperatively
Duration of hypoglycaemia
Duration of hypoglycaemia (\<3.9 mmol/L (\<70 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge)
Time frame: Perioperatively
Duration of hyperglycaemia
Duration of hyperglycaemia (\>10.0 mmol/L (\>180 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge)
Time frame: Perioperatively
Number of hypoglycaemia events
Number of hypoglycaemia (\<3.9 mmol/L (\<70 mg/dL) events lasting \> 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level
Time frame: Perioperatively
Number of hyperglycaemia events
Number of hyperglycaemia (\>10.0 mmol/L (\>180 mg/dL) events lasting \> 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level
Time frame: Perioperatively
Complications
Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days
Time frame: 30 days postoperatively
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