RecruitingNot ApplicableNCT06473480

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

Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)


Sponsor

Odense University Hospital

Enrollment

329 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial aims to compare a continuous glucose monitoring system with traditional fingerstick blood glucose monitoring. The study focuses on adult patients in general surgical wards who need regular blood glucose checks due to the risk of low or high blood sugar levels. The goal is to learn if using a continuous glucose monitoring system is better than fingerstick monitoring in managing glucose levels, preventing complications, improving patient satisfaction and experience, reducing nursing staff workload, and improving nursing staff' experience. The study also compares the accuracy of glucose readings from the continuous glucose monitoring system with those from fingerstick tests and blood samples. The hypothesis is that CGMS is accurate and effective for monitoring glucose levels in surgical patients. This could lead to better blood sugar control, fewer complications, shorter hospital stays, and improved experiences for both patients and nursing staff.


Eligibility

Min Age: 18 YearsMax Age: 110 Years

Inclusion Criteria7

  • Hospitalized patients (≥ 18 years old) in surgical wards
  • Glucose measurements at least 4 times (OUH) and 3 times (SUH) daily for at least three days, prescribed by surgeon
  • Expected hospitalization for at least three days
  • Communicates in Danish
  • Signed a declaration of consent to study participation
  • At risk of hypo- and hyperglycemia (with or without a diabetes diagnosis)
  • Nursing staff with at least one month of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system and are registered nurses or certified nursing assistants

Exclusion Criteria5

  • Cognitively impaired patients
  • Indication for glucose monitoring solely because of parenteral nutrition treatment
  • Patients admitted with a CGMS
  • Patients from the point-of-care fingerstick capillary glucose monitoring group cannot be included in the continuous glucose monitoring system group
  • Eligibility criteria solely for substudy 7

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Interventions

DEVICEAbbott FreeStyle Libre System 2 Plus

The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.

DEVICEAbbott Freestyle Libre Pro

The sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.


Locations(2)

Department of Surgery, Zealand University Hospital

Køge, Køge, Denmark

The Department of Surgery, Odense Univeristy Hospital

Odense, Odense, Denmark

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NCT06473480


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