Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Observation of Continuous Glucose Monitoring in Critically Ill Patients Under Consideration of Accuracy, Feasibility and Acceptance by Ward Staff

Conditions
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Glucose Metabolism Disorders, Diabetic Blood Glucose Monitoring, Critical Illness

Intervention / Treatment
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* Device: Continuous glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SOFA <7<br>Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring. | Device: Continuous glucose monitoring<br>* Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.<br>* Other names: CGM;|
| Other: SOFA >7<br>Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring. | Device: Continuous glucose monitoring<br>* Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.<br>* Other names: CGM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of continuous glucose monitoring compared to blood gas analyses | Difference between glucose values of continuous glucose monitoring and blood gas analyses | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of continuous glucose monitoring | Problems within the application of sensor and monitoring during ward routine | 72 hours | 
| Acceptance of continuous glucose monitoring by physicians and nursing staff | Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire | 72 hours |