WARD-glucose validation

Official title: Validation of the accuracy of continuous glucose monitoring using the Dexcom G7 in surgical patients with diabetes. A prospective observational study.

Study design:

Prospective observational cohort

Sample size:

80 participants (40 surgical patients + 40 patients from the intensive care unit)

Study Sites:

Rigshospitalet and Bispebjerg Hospital

Inclusion criteria:

Adult patients with diabetes mellitus who a) undergo surgery lasting >45 minutes or b) are admitted to the intensive care unit (ICU) with circulatory impairment (requiring continuous infusion of vasopressors to maintain a mean arterial pressure (MAP) >65 mmHg, after fluid optimization)

Study Procedures:

Included patients will wear a continuous glucose monitoring (CGM) device (Dexcom G7) during the stay at the hospital (up to 10 days). Through a sensor placed subcutaneously, the Dexcom G7 measures glucose levels every 5 minutes and transmit readings this to a receiver at the patient bed. The glucose readings will be blinded to the patients and nursing staff. Thus, the patients’ glucose levels will be monitored through standard practice with point-of-care (POC) blood glucose measurements. After the study period, the accuracy of CGM readings will be assessed by comparing these to POC blood glucose measurements.

Outcome:

The primary outcome is the accuracy of the CGM device compared to standard POC blood glucose measurements for surgical patients with diabetes. The secondary outcome is the accuracy of the CGM device in patients at the ICU who experience circulatory impairment.

Primary Investigators:

Casper Pedersen, MD PhD student

NCT:

Pending