search
Back to results

Continuous Glucose Monitoring for Colorectal Cancer (CGM-CRC)

Primary Purpose

Continuous Glucose Monitoring, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
CGM (FreeStyle Libre 3)
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Continuous Glucose Monitoring focused on measuring cgm, Colorectal Cancer, continuous glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCC Division of Oncological, Transplant and General SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

perioperative glycemia
number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level
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

Full Information

First Posted
August 21, 2023
Last Updated
August 30, 2023
Sponsor
Medical University of Gdansk
search

1. Study Identification

Unique Protocol Identification Number
NCT06011473
Brief Title
Continuous Glucose Monitoring for Colorectal Cancer
Acronym
CGM-CRC
Official Title
Continuous Glucose Monitoring for Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Glucose Monitoring, Colorectal Cancer
Keywords
cgm, Colorectal Cancer, continuous glucose monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CGM (FreeStyle Libre 3)
Intervention 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
Primary Outcome Measure Information:
Title
feasibility of CGM system
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
perioperative glycemia
Description
number of hyperglycemia episodes impact of stress and intraoperative interventions on the blood glucose level
Time Frame
10 days
Title
SSI rate
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Antoszewska, MD
Phone
+48698748705
Email
magdalena.antoszewska@gumed.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Spychalski, MD, PhD
Phone
+48 667 843 555
Email
piotr.spychalski@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Antoszewska, MD
Organizational Affiliation
MUG Division of Dermatology, Venereology and Allergology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD, PhD
Organizational Affiliation
MUG Division of General Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jarosław Kobiela, Prof.
Organizational Affiliation
MUG Division of General Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCC Division of Oncological, Transplant and General Surgery
City
Gdańsk
State/Province
Pomeranian
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Antoszewska, MD
Phone
+48698748705
Email
magdalena.antoszewska@gumed.edu.pl
First Name & Middle Initial & Last Name & Degree
Magdalena Antoszewska, MD
First Name & Middle Initial & Last Name & Degree
Piotr Spychalski, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jarosław Kobiela, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19002535
Citation
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.
Results Reference
background

Learn more about this trial

Continuous Glucose Monitoring for Colorectal Cancer

We'll reach out to this number within 24 hrs