Continuous Glucose Monitoring for Colorectal Cancer

Trial Title: Continuous Glucose Monitoring for Colorectal Cancer

NCT ID: NCT06011473

Condition: Continuous Glucose Monitoring
Colorectal Cancer

Conditions: Official terms:
Colorectal Neoplasms

Conditions: Keywords:
cgm
Colorectal Cancer
continuous glucose monitoring

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: CGM (FreeStyle Libre 3)
Description: 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
Arm group label: Experimental

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - written informed consent - confirmed colorectal cancer qualified for surgery Exclusion Criteria: - patients who will be unable or will refuse to express informed concern - pregnant women - people undergoing dialysis treatment

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCC Division of Oncological, Transplant and General Surgery

Address:
City: Gdańsk
Zip: 80-214
Country: Poland

Status: Recruiting

Contact:
Last name: Magdalena Antoszewska, MD

Phone: +48698748705
Email: magdalena.antoszewska@gumed.edu.pl

Investigator:
Last name: Magdalena Antoszewska, MD
Email: Principal Investigator

Investigator:
Last name: Piotr Spychalski, MD, PhD
Email: Principal Investigator

Investigator:
Last name: Jarosław Kobiela, Prof.
Email: Principal Investigator

Start date: August 27, 2023

Completion date: August 31, 2024

Lead sponsor:
Agency: Medical University of Gdansk
Agency class: Other

Source: Medical University of Gdansk

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06011473