RecruitingPhase 4NCT06314061

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

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

Sponsor

Christian S. Meyhoff

Enrollment

200 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Perioperative Complication Dysglycemia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria6

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)

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Interventions

DEVICEDexcom 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.