NCT06011473

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 21, 2023

Last Update Submit

August 30, 2023

Conditions

Continuous Glucose MonitoringColorectal Cancer

Keywords

cgmColorectal Cancercontinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • perioperative glycemia

    10 days

  • SSI rate

    30 days

Study Arms (1)

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)

Interventions

CGM (FreeStyle Libre 3)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

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • confirmed colorectal cancer qualified for surgery

You may not qualify if:

  • patients who will be unable or will refuse to express informed concern
  • pregnant women
  • people undergoing dialysis treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCC Division of Oncological, Transplant and General Surgery

Gdansk, Pomeranian, 80-214, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19002535BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Study Officials

  • Magdalena Antoszewska, MD

    MUG Division of Dermatology, Venereology and Allergology

    PRINCIPAL INVESTIGATOR

  • Piotr Spychalski, MD, PhD

    MUG Division of General Surgery

    PRINCIPAL INVESTIGATOR

  • Jarosław Kobiela, Prof.

    MUG Division of General Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Antoszewska, MD

CONTACT

+48698748705magdalena.antoszewska@gumed.edu.pl

Piotr Spychalski, MD, PhD

CONTACT

+48 667 843 555piotr.spychalski@gumed.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

August 27, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)