Investigating the accuracy of continuous glucose monitoring in diabetes patients
Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients with Diabetes in Situations with Circulatory Impairment. a Prospective Observational Study
This study is testing how accurate the Dexcom G7 continuous glucose monitor is for people with diabetes compared to regular blood sugar tests while they are in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 4 sites (Copenhagen, The Capital Region of Denmark and 3 other locations) |
| Trial ID | NCT06297850 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of continuous glucose monitoring (CGM) using the Dexcom G7 device compared to standard point-of-care blood glucose measurements in patients with diabetes. Participants will wear the CGM device during their hospital stay, particularly focusing on those undergoing surgery or admitted to the ICU with circulatory impairment. The study will include 60 patients and will last for up to 10 days, with the goal of identifying any discrepancies in glucose readings during periods of circulatory compromise. The findings could enhance perioperative care by improving the management of dysglycemia and related complications.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diabetes requiring antidiabetic medications who are undergoing surgery or are admitted to the ICU with circulatory impairment.
Not a fit: Patients with local skin infections or contraindications to skin puncture will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of blood glucose levels in diabetic patients during critical hospital stays.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring for diabetes management, but this specific approach in the context of circulatory impairment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical history with diabetes mellitus requiring antidiabetic drugs * Age ≥18 years * Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR * Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index \<1.5 Exclusion Criteria: * Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area * Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc) * Known allergy to plaster used in the CGM device
Where this trial is running
Copenhagen, The Capital Region of Denmark and 3 other locations
- Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet — Copenhagen, The Capital Region of Denmark, Denmark (Recruiting)
- Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital — Copenhagen, The Capital Region of Denmark, Denmark (Recruiting)
- Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital — Copenhagen, The Capital Region of Denmark, Denmark (Recruiting)
- Surgical department, Bispebjerg and Frederiksberg Hospital, — Copenhagen, The Capital Region of Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Casper Pedersen, MD
- Email: casper.pedersen@regionh.dk
- Phone: 004526712696
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.