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

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders; Critical Illness; Diabetic Blood Glucose Monitoring
• Interventions: Device: Continuous glucose monitoring

• Registration Number: NCT02296372
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-18
• Study First Posted: 2014-11-20
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOFA <7	Continuous glucose monitoring	Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score \< 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.
SOFA >7	Continuous glucose monitoring	Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score \> 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charite University, Berlin, Germany; 🇩🇪 Berlin, Germany