WARD Glucose Validation

WARD Glucose Validation

Principal Investigator

Casper Pedersen, MD PhD student

Study design
Prospective study/cohort
Sample size
58 participants
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 and a reduced peripheral perfusion).

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.

Results

In 58 participants (mean [standard deviation] age 71 [11]yr; 34% female), the median MARD was 10.9% (5.1-19.4%); 1186 of 1212 paired POC and CGM measurements (98%) were within clinically acceptable ranges (CEG zones A and B). MARD was 4.5% higher (95% confidence interval 2.3-6.7%) during periods of hypoperfusion. Given that hypoglycaemia (<4 mM) did not occur, no paired readings were obtained. Bland-Altman analysis showed similar CGM and POC measurements, with a mean difference of -1 mM (95% limits of agreement -5.6 to 3.4 mM).

Outcome

The primary outcome is the accuracy of the CGM device compared to standard POC blood glucose measurements.

Trial registration
NCT06297850

–  Read more