NCT06011473

Continuous Glucose Monitoring for Colorectal Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. The primary aim of our project is to assess the feasibility of the use of continuous glucose monitoring in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Detailed description

Hyperglycemia commonly occurs during surgery due to a reaction to metabolic stress and trauma. It has been shown that improper glycemia control leads to impaired wound healing and a higher risk of other postoperative complications. However, glucose levels measured in patients before surgery are taken infrequently, and there remains controversy regarding optimal management. Usually, a blood glucose meter is used to measure non-fasted blood glucose concentrations, and a single-point measurement can easily misrepresent the actual glycemic control. Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control and is providing insights into glucose regulation in patients, demonstrating significant periods of clinically silent hypoglycemia and hyperglycemia. The primary aim of our project is to assess the feasibility of the use of CGM in measuring blood glucose levels in patients undergoing colorectal cancer surgery. The secondary aim is to analyze changes in perioperative blood glucose levels to understand the effects of stress and intraoperative interventions on the blood glucose level. The tertiary goal is to assess the predictive value of hyperglycemia for surgical site infection.

Conditions

• Continuous Glucose Monitoring
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	CGM (FreeStyle Libre 3)	FreeStyle Libre 3 system consists of a sensor that measures interstitial glycemia every minute and a dedicated application on mobile phone. Measurements are transmitted via Bluetooth to a mobile phone, that collects the data in the mobile application. Moreover, the study subject's application is connected to the doctor's application which allows remote real-time glycemia monitoring on another device. Other Name: continuous glucose monitoring, CGM, FreeStyle Libre 3

Timeline

• Start date: 2023-08-27
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-08-25
• Last updated: 2023-08-31

Locations

1 site across 1 country: Poland