Critical Illness, Diabetic Blood Glucose Monitoring, Glucose Metabolism Disorders
Conditions
Brief summary
Critically ill patients are on high risk for increased serum glucose levels, leading to more comorbidity and higher mortality risk. In patients with severe sepsis and septic shock hyperglycemia is a typical finding. However the need of insulin therapy is associated with an increased risk of hypoglycemia. Newly developed technologies for continuous glucose monitoring in critically ill patients may improve glycemic control and reduce glucose variability. The investigators will perform continuous glucose monitoring in critically ill patients on ICU. Measurements will be done for a period of 72h per patient. The investigators aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to arterial blood gas measurements with the blood gas analyzer. The investigators will investigate the influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a questionnaire to identify acceptance.
Interventions
DEVICEContinuous glucose monitoring
Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* critically ill patients with expected ICU stay for more than 72 hours * informed consent by the patients or legal proxy
Exclusion criteria
* age \< 18 * no informed consent by the patients or legal proxy * pregnancy * infaust prognosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of continuous glucose monitoring compared to blood gas analyses | 72 hours | Difference between glucose values of continuous glucose monitoring and blood gas analyses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of continuous glucose monitoring | 72 hours | Problems within the application of sensor and monitoring during ward routine |
| Acceptance of continuous glucose monitoring by physicians and nursing staff | 72 hours | Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical problems with the monitoring | up to 72 hours | Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal. |
Countries
Germany
Outcome results
None listed