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

Diabetes Mellitus Clinical Trial

— WARD-glucose  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314061
• Other study ID #: WARD-glucose RCT v.2.2
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Casper Pedersen, MD
• Phone: +4526712696
• Email: casper.pedersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dysglycemia
• Perioperative Complication

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital	Copenhagen	The Capital Region Of Denmark
Denmark	Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet	Copenhagen	The Capital Region Of Denmark
Denmark	Zealand University Hospital	Køge

Sponsors (4)

Lead Sponsor	Collaborator
Christian S. Meyhoff	Rigshospitalet, Denmark, Steno Diabetes Center Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Serious adverse Device-related events	Severe Adverse Device-related Events (SADE) within 30 days	30 days postoperatively
Other	Adverse events	Frequency of any adverse events within 30 days	30 days postoperatively
Other	Length of stay	Postoperative Length of stay (LOS) in days	Perioperatively
Other	Readmission	Readmission within 6 months	6 months postoperatively
Other	ICU admission	ICU admission within 6 months postoperatively	6 months postoperatively
Other	Days alive and out of hospital	Days alive and out of hospital within 30 days	30 days postoperatively
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications	Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days	30 days postoperatively