Using continuous glucose monitoring in surgical patients with diabetes
The Effect of Continuous Glucose Monitoring with Real-time Alerts on Glycaemic Control in Surgical Patients with Diabetes: a Randomised, Clinical Multicentre Trial
PHASE4 · University Hospital Bispebjerg and Frederiksberg · NCT06314061
This study tests if using a continuous glucose monitor can help people with diabetes better manage their blood sugar during and after surgery compared to regular blood tests.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg (other) |
| Locations | 3 sites (Copenhagen, The Capital Region of Denmark and 2 other locations) |
| Trial ID | NCT06314061 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial investigates the impact of continuous glucose monitoring (CGM) using the Dexcom G7 device compared to standard point-of-care blood glucose measurements in surgical patients with diabetes. The study aims to determine if real-time alerts for dysglycemia can improve glucose control during and after surgery. Participants will wear the CGM device for up to 10 days while receiving standard diabetes care. The trial will include 200 patients undergoing various types of surgery at multiple hospitals in Denmark.
Who should consider this trial
Good fit: Ideal candidates are patients with diabetes undergoing elective or acute surgeries lasting more than 45 minutes and requiring at least one night of postoperative hospital stay.
Not a fit: Patients with local skin infections at the sensor site, known allergies to the equipment, or those with certain medical devices like pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better glucose control and reduced complications for surgical patients with diabetes.
How similar studies have performed: Other studies have shown promising results with continuous glucose monitoring in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s) * Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery \>45 minutes * Expected stay for at least one night in the hospital postoperatively 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 * Known allergy to the equipment plaster * Known pregnancy * Patients with pacemaker or implantable cardioverter defibrillator (ICD) device * Previous or currently scheduled for pancreatectomy (complete or partial) * Patients receiving hydroxyurea (these drugs may interfere with CGM readings)
Where this trial is running
Copenhagen, The Capital Region of Denmark and 2 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)
- Zealand University Hospital — Køge, Denmark (RECRUITING)
Study contacts
- Study coordinator: Casper Pedersen, MD
- Email: casper.pedersen@regionh.dk
- Phone: +4526712696
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.
Conditions: Diabetes Mellitus, Dysglycemia, Perioperative Complication, Continuous glucose monitoring, Perioperative medicine, Medical devices