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Clinical Trials/NCT02296372
NCT02296372CompletedNot Applicable

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

Charite University, Berlin, Germany2 sites in 1 country20 target enrollmentStarted: November 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Accuracy of continuous glucose monitoring compared to blood gas analyses

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Accuracy of continuous glucose monitoring compared to blood gas analyses

Time Frame: 72 hours

Difference between glucose values of continuous glucose monitoring and blood gas analyses

Secondary Outcomes

  • Feasibility of continuous glucose monitoring(72 hours)
  • Acceptance of continuous glucose monitoring by physicians and nursing staff(72 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Steffen Weber-Carstens

PD Dr. med. Steffen Weber-Carstens

Charite University, Berlin, Germany

Study Sites (2)

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