Comparing continuous glucose monitoring to fingerstick blood sugar checks
Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)
This study tests if a continuous glucose monitoring system can help adult surgical patients manage their blood sugar better than traditional fingerstick tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 329 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Køge, Køge and 1 other locations) |
| Trial ID | NCT06473480 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of a continuous glucose monitoring system (CGMS) with traditional fingerstick blood glucose monitoring in adult surgical patients. The study aims to determine if CGMS can provide better glucose management, reduce complications, and enhance patient and nursing staff experiences. Participants will have their glucose levels monitored continuously via a subcutaneous sensor, while the accuracy of CGMS readings will be compared to those obtained from fingerstick tests. The trial also seeks to evaluate the impact on nursing workload and patient satisfaction.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults in surgical wards at risk of hypo- and hyperglycemia who can communicate in Danish.
Not a fit: Patients who are cognitively impaired or those whose glucose monitoring is solely due to parenteral nutrition treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood sugar control and enhanced experiences for both patients and nursing staff in surgical settings.
How similar studies have performed: Previous studies have shown that continuous glucose monitoring systems are accurate and effective compared to fingerstick monitoring, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Køge, Køge and 1 other locations
- Department of Surgery, Zealand University Hospital — Køge, Køge, Denmark (Recruiting)
- The Department of Surgery, Odense Univeristy Hospital — Odense, Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Helen Schultz, RN, PhD
- Email: Helen.Schultz@rsyd.dk
- Phone: +4522401513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.