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

NCT06314061 | Completed Phase 4 FDA Device

• 1 other identifier: WARD-glucose RCT v.2.2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus; Dysglycemia; Perioperative Complication

Keywords

Diabetes Mellitus; Continuous glucose monitoring; Perioperative medicine; Medical devices

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of hypoglycaemia

  Perioperatively

• Duration of hyperglycaemia

  Perioperatively

• Number of hypoglycaemia events

  Perioperatively

• Number of hyperglycaemia events

  Perioperatively

• Complications

  30 days postoperatively

Other Outcomes (9)

• Serious adverse events

  30 days postoperatively

• Serious adverse Device-related events

  30 days postoperatively

• Adverse events

  30 days postoperatively

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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.

Interventions

Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) DEVICE

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.

Also known as: Dexcom G7

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zealand University Hospital: collaborator
• Christian S. Meyhoff: lead
• Rigshospitalet, Denmark: collaborator
• Steno Diabetes Center Copenhagen: collaborator

Study Sites (3)

Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet

Copenhagen, The Capital Region of Denmark, 2100, Denmark

Location

Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital

Copenhagen, The Capital Region of Denmark, 2400, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

• Pedersen C, Philipsen A, Norgaard K, Aasvang EK, Meyhoff CS. Continuous Glucose Monitoring With Real-Time Alerts to Achieve Glycaemic Control in Surgical Patients With Diabetes: Protocol for a Multicentre, Randomised, Clinical Trial. Acta Anaesthesiol Scand. 2026 Apr;70(4):e70219. doi: 10.1111/aas.70219.

  PMID: 41821293 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Christian S Meyhoff, MD, PhD

  University Hospital Bispebjerg and Frederiksberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be alerted of dysglycaemia by the Dexcom G7 application, which will be muted. Thus, the alerts on deviating glucose levels will only be given to the care provider (the nursing staff at the ward)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, head of research, MD, PhD

Model Details: Parallel, 2-group randomised trial blinded for participants

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 15, 2024
• Study Start: June 24, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)