Continuous Glucose Monitoring for Colorectal Cancer (CGM-CRC)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Continuous Glucose Monitoring
• Intervention / Treatment: Device: CGM (FreeStyle Libre 3)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magdalena Antoszewska, MD; Phone Number: +48698748705; Email: magdalena.antoszewska@gumed.edu.pl
• Study Contact Backup: Name: Piotr Spychalski, MD, PhD; Phone Number: +48 667 843 555; Email: piotr.spychalski@gumed.edu.pl

Study Locations

• Poland
  • Pomeranian
    • Gdańsk, Pomeranian, Poland, 80-214
      • Recruiting
      • UCC Division of Oncological, Transplant and General Surgery
      • Contact: Magdalena Antoszewska, MD; Phone Number: +48698748705; Email: magdalena.antoszewska@gumed.edu.pl
      • Principal Investigator: Magdalena Antoszewska, MD
      • Principal Investigator: Piotr Spychalski, MD, PhD
      • Principal Investigator: Jarosław Kobiela, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Study subjects submitted to the General Surgery Clinic for colorectal surgery. On admission day, patients will have a CGM sensor placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Glycemia will be continuously monitored for 10 days. The CGM sensor will be taken off during visit in Outpatient Clinic.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility of CGM system	measured as the drop-out rate caused by non-adherence of both patients and medical staff due to system detaching, problems with the receiving device (low battery. distance beyond Bluetooth communication range) etc.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative glycemia	number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level	10 days
SSI rate	Surgical Site Infection according to Centre for Disease Control criteria: Infection occurring within the first 30 post-operative days with at least one of the following: Purulent drainage from the incision Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision Incision is deliberately opened by a surgeon AND at least one of the following signs/symptoms of infection: Pain or tenderness Localized swelling Redness Heat Diagnosis of SSI by the surgeon or attending physician	30 days

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Piotr Spychalski, MD, PhD, MUG Division of General Surgery; Principal Investigator: Magdalena Antoszewska, MD, MUG Division of Dermatology, Venereology and Allergology; Principal Investigator: Jarosław Kobiela, Prof., MUG Division of General Surgery

Publications and helpful links

General Publications

• McConnell YJ, Johnson PM, Porter GA. Surgical site infections following colorectal surgery in patients with diabetes: association with postoperative hyperglycemia. J Gastrointest Surg. 2009 Mar;13(3):508-15. doi: 10.1007/s11605-008-0734-1. Epub 2008 Nov 11.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal Cancer; continuous glucose monitoring; cgm
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NKBBN/780/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No