Actively Recruiting

Phase Not Applicable
Age: 18Years - 110Years
All Genders
ID06473480

Continuous GLUCOse Monitoring System Compared to Fingerstick Glucose Monitoring in Surgical Wards to Evaluate Glucose Control and Patient Experience

Led by Odense University Hospital · Updated on 2025-04-03

329

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

Z

Zealand University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a continuous glucose monitoring system (CGMS) compared to traditional fingerstick blood glucose monitoring in adult patients hospitalized in general surgical wards who require regular blood sugar checks due to risks of low or high glucose levels. The study aims to assess if CGMS provides better glucose management, reduces complications, improves patient and nursing staff experiences, and shortens hospital stays. The trial also examines the accuracy of glucose readings from CGMS versus fingerstick tests and blood samples. Participants will be monitored using either the standard fingerstick capillary glucose method or the CGMS device, with measurements taken by surgical ward nurses according to a set schedule. The CGMS sensor is inserted just under the skin on the upper arm and scanned regularly. The study includes three periods: standard fingerstick monitoring, CGMS monitoring, and a blinded sensor period where CGMS data are collected but not shared with patients or nurses. Diabetes nurses oversee treatment decisions based on the glucose monitoring method used. During the study, participants will undergo glucose level measurements, insulin dose tracking, and complication monitoring throughout their hospital stay, which can last up to 30 days. Patient satisfaction and nursing workload related to glucose monitoring will be evaluated, along with the accuracy of CGMS readings compared to standard methods. Follow-up continues for up to three months after discharge to assess longer-term glucose control and patient experience.

CONDITIONS

Brief Title

Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized patients aged 18 years or older in surgical wards
  • Required glucose measurements at least 4 times daily (OUH) or 3 times daily (SUH) for at least three days as prescribed by a surgeon
  • Expected hospital stay of at least three days
  • Able to communicate in Danish
  • Signed informed consent for study participation
  • At risk of low or high blood sugar, with or without diabetes diagnosis
  • For substudy 4, patients treated with insulin at discharge and residing within OUH admission area
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • Glucose monitoring only due to parenteral nutrition treatment
  • Currently admitted with a continuous glucose monitoring system
  • Patients in the fingerstick glucose monitoring group cannot join the continuous glucose monitoring group
  • For substudy 7, nursing staff must have at least one month experience with both glucose monitoring methods and be registered nurses or certified nursing assistants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 days (duration of hospital stay)

Participants undergo glucose monitoring using either standard fingerstick capillary glucose monitoring, continuous glucose monitoring system sensors, or a combination including blinded sensors during hospitalization to evaluate glucose control and patient experience.

Multiple daily glucose monitoring visits during hospitalization

Follow-up

Duration - Up to 3 months after discharge

Participants are monitored for glucose control, complications, and patient experience up to three months after discharge from the hospital.

Periodic follow-up assessments after hospital discharge

Trial Site Locations

Total: 2 locations

1

Department of Surgery, Zealand University Hospital

Køge, Køge, Denmark, 4600

Actively Recruiting

2

The Department of Surgery, Odense Univeristy Hospital

Odense, Odense, Denmark, 5000

Actively Recruiting

Loading map...

Research Team

H

Helen Schultz, RN, PhD

K

Karoline Schousboe, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

"Smart Family Doctor" Assisted Comprehensive Management of S...

Post Coronary Artery Bypass Grafting

Actively Recruiting

1 location

A Randomized, Parallel, Open-label Clinical Study on the Bio...

Diabetes Mellitus

Actively Recruiting

1 location

A Phase Ia Clinical Trial to Assess Safety, Tolerability, an...

Hyperglycemia

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.

Sandra I Berríos-Torres, Craig A Umscheid, Dale W Bratzler...

https://pubmed.ncbi.nlm.nih.gov/28467526

Prevalence of type 1 and type 2 diabetes in children and adolescents in Germany from 2002 to 2020: A study based on electronic health record data from the DPV registry.

Anna Stahl-Pehe, Clemens Kamrath, Nicole Prinz...

https://pubmed.ncbi.nlm.nih.gov/36515004

Comparison of the FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System and Point-of-Care Capillary Glucose Testing in Hospitalized Patients With Type 2 Diabetes Treated With Basal-Bolus Insulin Regimen.

Rodolfo J Galindo, Alexandra L Migdal, Georgia M Davis...

https://pubmed.ncbi.nlm.nih.gov/32641372