Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
NCT06473480 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 329
Last updated 2025-04-03
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.
Conditions
- Diabetes Mellitus
- Hypoglycemia (Diabetic)
- Hypoglycemia Night
- Hyperglycemia
Interventions
- DEVICE
-
Abbott 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.
- DEVICE
-
Abbott 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.
Sponsors & Collaborators
-
Zealand University Hospital
collaborator OTHER -
Odense University Hospital
lead OTHER
Principal Investigators
-
Karoline Schousboe, MD, PhD · Steno Diabetes Center Odense, Odense University Hospital
-
Helen Schultz, RN, PhD · The Department of Surgery, Odense University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 110 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-26
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Device
- Yes
Countries
- Denmark
Study Locations
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