Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-110
SponsorOdense University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Abbott FreeStyle Libre System 2 Plus
DeviceThe sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
Abbott Freestyle Libre Pro
DeviceThe sensor is placed subcutaneously at the back of the participant's upper arm with one insertion and measures the subcutaneous glucose concentration.
Treatment groups
329 Participants
are divided into 3 treatment groupsGroup A: PERIOD 1: Point-of-care fingerstick glucose monitoring = standard careNo intervention 0 interventions
Group B: PERIOD 2: Glucose monitoring system as point-of-care = study interventionActive comparator 1 intervention
Group C: PERIOD 3: Point-of care fingerstick glucose monitoring = standard care + blinded sensorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Substudy 1: Mean daytime and nocturnal point-of-care glucose levels
Point-of-care glucose levels measured by point-of-care continuous glucose monitoring system (CGMS) or point-of-care fingerstick capillary glucose monitoring (FSGM) Arm allocation: Period 1: FSGM Period 2: CGMS Number of measurements: minimum four times daily, hourly if fasting. Blood glucose measurement: mmol/L
Time frame
During hospitalization (up to 30 days)2
Substudy 2: Patient-reported outcome on the convenience of glucose monitoring
Using the validated Danish version of the 22-item questionnaire: The Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP), item 4: How convenient did you think the diabetes treatment was at hospitalization? Ranging from 0 - 6 0 represents 'At no time' 6 represents 'At most of the time'
Time frame
During hospitalization (up to 30 days)3
Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring
Mean time: minutes. Data include: * Profession * Preparation (gathering materials, handwashing, disinfecting hands, putting on gloves, etc.) * Time for fingerstick or scanning of the continuous glucose monitor sensor * Display time of glucose level on device * Glucose level (mmol/L) * Actions taken after measurement (insulin injection, handwashing, documentation, disinfection, etc.) * Time for leaving the room * Time for completed procedure including documentation * Other observations made during the measurement
Time frame
During hospitalization (up to 30 days)4
Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
Time frame
During hospitalization (up to 30 days)Secondary outcomes
1
Substudy 1: • Mean dose of short-acting insulin (IE)
Unit: International units (IE)
Time frame
During hospitalization (up to 30 days)2
Substudy 1: Mean dose of long-acting insulin (IE)
Unit: International units (IE)
Time frame
During hospitalization (up to 30 days)3
eGFR
Estimated Glomerular Filtration Rate
Time frame
During hospitalization (up to 30 days)4
Substudy 1: Complication: Sepsis
Defined as suspected or confirmed infection, as well as organ damage
Time frame
During hospitalization (up to 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Zealand University Hospital
Collaborator
Source ClinicalTrials.gov