NCT06473480 Continuous Bloodsugar Monitoring System With a Sensor Compared to Fingerstick Bloodsugar Monitoring
| NCT ID | NCT06473480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 329 participants |
| Start Date | 2024-06-26 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 329 participants in total. It began in 2024-06-26 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Karoline Schousboe, MD, PhD
STUDY CHAIR
Steno Diabetes Center Odense, Odense University Hospital
Frequently Asked Questions
Who can join the NCT06473480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06473480 currently recruiting?
Yes, NCT06473480 is actively recruiting participants. Contact the research team at Helen.Schultz@rsyd.dk for enrollment information.
Where is the NCT06473480 trial being conducted?
This trial is being conducted at Køge, Denmark, Odense, Denmark.
Who is sponsoring the NCT06473480 clinical trial?
NCT06473480 is sponsored by Odense University Hospital. The principal investigator is Karoline Schousboe, MD, PhD at Steno Diabetes Center Odense, Odense University Hospital. The trial plans to enroll 329 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.