diabetes
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age * 18 years; Expected to be admitted to the ICU after elective cardiac surgery and expected to require glycemic control; Expected to have a radial arterial catheter placed for invasive pressure monitoring or frequent arterial blood sampling; Willing to have one GluCath sensor inserted by a health care professional through a standard radial artery catheter inserted either preoperatively or within six hours after admission to the ICU to provide routine care; Willing to permit hourly arterial blood samples;
Exclusion criteria
Exclusion criteria: An expected ICU stay of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters will include reference analyzer blood glucose values, GluCath System glucose values and duration of sensor use. Difference statistics will include mean difference, standard deviation of the differences, mean relative difference, and mean absolute relative difference, stratified by glucose ranges. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional analyses will include the percentage of points compliant with current and proposed accuracy standards (ISO 15197 and TNO Glucose Meters Quality Standards) stratified by glucose ranges, Modified Bland-Altman plot analysis and Clarke Error Grid analysis. | — |
Countries
Netherlands
Outcome results
None listed