The Effect of Continuous Glucose Monitoring in Surgical Patients with Diabetes.

Phase 4

Recruiting

• Conditions: Diabetes Mellitus; Perioperative Complication; Dysglycemia
• Interventions: Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)

• Registration Number: NCT06314061
• Lead Sponsor: Christian S. Meyhoff

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-15
• Study Start: 2024-06-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s)
• Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery >45 minutes
• Expected stay for at least one night in the hospital postoperatively

Exclusion Criteria

• Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
• Known allergy to the equipment plaster
• Known pregnancy
• Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
• Previous or currently scheduled for pancreatectomy (complete or partial)
• Patients receiving hydroxyurea (these drugs may interfere with CGM readings)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)	Participants in the intervention group will wear the CGM-device Dexcom G7, and real-time alerts on dysglycaemia and rapidly increasing or falling glucose levels will alert the nursing staff.

Primary Outcome Measures

Name	Time	Method
Time in range (TIR) of CGM glucose levels	Perioperatively	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)

Secondary Outcome Measures

Name	Time	Method
Duration of hypoglycaemia	Perioperatively	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)
Number of hyperglycaemia events	Perioperatively	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
Number of hypoglycaemia events	Perioperatively	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
Complications	30 days postoperatively	Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days
Duration of hyperglycaemia	Perioperatively	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)

Trial Locations

Locations (3)

Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet; 🇩🇰 Copenhagen, The Capital Region of Denmark, Denmark

Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital; 🇩🇰 Copenhagen, The Capital Region of Denmark, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark