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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• 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)

• Specific for substudy 4 inclusion criteria as above with the following add on: Patients being treated with insulin at discharge and patients residing within the OUH admission area.

• 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

Locations
Other Locations
Denmark
Department of Surgery, Zealand University Hospital
RECRUITING
Køge
The Department of Surgery, Odense Univeristy Hospital
RECRUITING
Odense
Contact Information
Primary
Helen Schultz, RN, PhD
Helen.Schultz@rsyd.dk
+4522401513
Backup
Karoline Schousboe, MD, PhD
Karoline.Schousboe@rsyd.dk
+4524349740
Time Frame
Start Date: 2024-06-26
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 329
Treatments
No_intervention: PERIOD 1: Point-of-care fingerstick glucose monitoring = standard care
Subjects' blood glucose levels are monitored using point-of-care fingerstick capillary glucose monitoring (standard care), which is conducted by surgical ward nurses according to a predefined schedule. Diabetes treatment management is overseen by specific in-house diabetes nurses. Treatment decisions are based on point-of-care fingerstick capillary glucose values.
Active_comparator: PERIOD 2: Glucose monitoring system as point-of-care = study intervention
The sensor from the continuous glucose monitoring system is scanned by surgical nurses as point-of-care according to the predefined schedule, as in standard care. Monitoring is conducted by surgical ward nurses.~Diabetes treatment management is overseen by specific in-house diabetes nurses. Diabetes nurses' treatment decisions are based on the continuous glucose monitoring system values.
Experimental: PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensor
PERIOD 3: Same as for period 1, but with a blinded sensor (FreeStyle Libre Pro). The data from the blinded sensors are concealed from both participants and nurses and will be used for comparison with the experimental arm.~This study period is only conducted at OUH.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: Zealand University Hospital

This content was sourced from clinicaltrials.gov