Clinical trial NCT06314061: The Effect of Continuous Glucose Monitoring in Surgical Patients with Diabetes.
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus
Dysglycemia
Perioperative Complication
Keywords: Diabetes Mellitus
Continuous glucose monitoring
Perioperative medicine
Medical devices
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Steno Diabetes Center Copenhagen
name: Zealand University Hospital
First posted: 2024-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, 2-group randomised trial blinded for participants
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time in range (TIR) of CGM glucose levels
timeFrame: Perioperatively
Secondary outcomes:
measure: Duration of hypoglycaemia
timeFrame: Perioperatively
measure: Duration of hyperglycaemia
timeFrame: Perioperatively
measure: Number of hypoglycaemia events
timeFrame: Perioperatively
measure: Number of hyperglycaemia events
timeFrame: Perioperatively
measure: Complications
timeFrame: 30 days postoperatively
Other outcomes:
measure: Serious adverse events
timeFrame: 30 days postoperatively
measure: Serious adverse Device-related events
timeFrame: 30 days postoperatively
measure: Adverse events
timeFrame: 30 days postoperatively
measure: Length of stay
timeFrame: Perioperatively
measure: Readmission
timeFrame: 6 months postoperatively
measure: ICU admission
timeFrame: 6 months postoperatively
measure: Days alive and out of hospital
timeFrame: 30 days postoperatively
measure: Patient experience
timeFrame: Perioperatively
measure: Staff experience
timeFrame: Perioperatively
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
state: The Capital Region of Denmark
city: Copenhagen
country: Denmark
facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital
state: The Capital Region of Denmark
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Christian S Meyhoff, MD, PhD
role: STUDY_DIRECTOR
References: