Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring (NCT06473480) | Clinical Trial Compass
RecruitingNot Applicable
Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
Denmark329 participantsStarted 2024-06-26
Plain-language 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.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Inclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Substudy 1: Mean daytime and nocturnal point-of-care glucose levels
Timeframe: During hospitalization (up to 30 days)
2
Substudy 2: Patient-reported outcome on the convenience of glucose monitoring
Timeframe: During hospitalization (up to 30 days)
3
Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring
Timeframe: 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
Timeframe: During hospitalization (up to 30 days)
5
Substudy 6: Differences in interstitial and plasma glucose