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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Primary outcome measure(s)

• Substudy 1: Mean daytime and nocturnal point-of-care glucose levels — During hospitalization (up to 30 days)
  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
• Substudy 2: Patient-reported outcome on the convenience of glucose monitoring — During hospitalization (up to 30 days)
  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'
• Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring — During hospitalization (up to 30 days)
  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
• Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay — During hospitalization (up to 30 days)
  Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
• Substudy 6: Differences in interstitial and plasma glucose — During hospitalization (up to 30 days)
  Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.

Trial sites (2)

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