Continuous Glucose Monitoring for Colorectal Cancer

NCT ID: NCT06011473

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-27

Study Completion Date

2024-08-31

Brief Summary

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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

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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

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Continuous Glucose Monitoring Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CGM (FreeStyle Libre 3)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magdalena Antoszewska, MD

Role: PRINCIPAL_INVESTIGATOR

MUG Division of Dermatology, Venereology and Allergology

Piotr Spychalski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MUG Division of General Surgery

Jarosław Kobiela, Prof.

Role: PRINCIPAL_INVESTIGATOR

MUG Division of General Surgery

Locations

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UCC Division of Oncological, Transplant and General Surgery

Gdansk, Pomeranian, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Magdalena Antoszewska, MD

Role: CONTACT

+48698748705

Piotr Spychalski, MD, PhD

Role: CONTACT

+48 667 843 555

Facility Contacts

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Magdalena Antoszewska, MD

Role: primary

+48698748705

References

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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.

Reference Type BACKGROUND
PMID: 19002535 (View on PubMed)

Other Identifiers

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NKBBN/780/2022

Identifier Type: -

Identifier Source: org_study_id

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