glucose monitoring sensor
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged 18-85 - Diagnosed with diabetes mellitus - Able to give written informed consent - Planned for laparotomy or cardiac surgery - Will receive arterial line for standard patient care - Planned postoperative stay at PACU or ICU
Exclusion criteria
Exclusion criteria: - Any condition that the local investigator feels would interfere with trial participation or the evaluation of results - Allergy for heparin - Known heparin induced thrombocytopenia - Planned total panceatectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the difference in median glucose 1 hour after surgery, as a measure of glycaemic control during surgery. Furthermore, the time spent in the target range, time spent above the target range and time spent below the target range will be calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include the accuracy of the GCM, measured by the mean absolute relative difference (MARD= (CGM value*POC/POC)). Furthermore, Clarke error grid and Bland-Altman analyses, MARD in the lower glycaemic (glucose 10 mmol/l) ranges. The ranges are according to the AMC protocol. The MARD during cardiopulmonary bypass and during the use of vasopressors will also be calculated. We will record the number of false alarms, the number of times the intravenous line has to be replaced due to failure of the device or clotting error. Also, the glucose variability, the amount of insulin used and the occurrence hypoglycaemic events (glucose | — |
Countries
Netherlands
Outcome results
None listed