The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes. (WARD-glucose)

The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes: A Randomised, Clinical Multicentre Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Dysglycemia; Perioperative Complication
• Intervention / Treatment: Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian S Meyhoff, MD, PhD; Phone Number: +4524910542; Email: christian.sylvest.meyhoff@regionh.dk
• Study Contact Backup: Name: Casper Pedersen, MD; Phone Number: +4526712696; Email: casper.pedersen@regionh.dk

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Zealand University Hospital
    • Contact: Annelotte Philipsen, MD, PhD; Email: annph@regionsjaelland.dk
  • The Capital Region Of Denmark
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2100
      • Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
    • Copenhagen, The Capital Region Of Denmark, Denmark, 2400
      • Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7); 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.; Other Names: Dexcom G7
No Intervention: Control group; Participants in the control group will wear a blinded CGM device. The nursing staff will monitor glucose levels with standard care using POC blood glucose measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time 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)	Perioperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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	Perioperatively
Complications	Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days	30 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events	Frequency of any serious adverse event within 30 days, defined as any complication fulfilling the Clavien-Dindo classification of > 2	30 days postoperatively
Serious adverse Device-related events	Severe Adverse Device-related Events (SADE) within 30 days	30 days postoperatively
Adverse events	Frequency of any adverse events within 30 days	30 days postoperatively
Length of stay	Postoperative Length of stay (LOS) in days	Perioperatively
Readmission	Readmission within 6 months	6 months postoperatively
ICU admission	ICU admission within 6 months postoperatively	6 months postoperatively
Days alive and out of hospital	Days alive and out of hospital within 30 days	30 days postoperatively
Patient experience	Patient experience (semi-structured questionnaire will be carried out in a subset of randomised patients from both groups with the focus on sense of security and patient comfort)	Perioperatively
Staff experience	Staff experience (semi-structured questionnaire will be carried out during the beginning and towards the end of the trial. It will focus from both groups with the focus on sense of security and patient comfort))	Perioperatively

Collaborators and Investigators

• Sponsor: Christian S. Meyhoff
• Collaborators: Zealand University Hospital; Rigshospitalet, Denmark; Steno Diabetes Center Copenhagen
• Investigators: Study Director: Christian S Meyhoff, MD, PhD, University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Continuous glucose monitoring; Perioperative medicine; Medical devices
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: WARD-glucose RCT v.2.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan making individual patient data available to researchers outside the study group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes