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OpenTrials
Completed

NCT Number: NCT02296372

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University, Berlin, Germany

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring

Device

Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours.

In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.

Other names: CGM

Primary outcomes

  1. 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

  1. Feasibility of continuous glucose monitoring

    Time frame: 72 hours

    Problems within the application of sensor and monitoring during ward routine

  2. Acceptance of continuous glucose monitoring by physicians and nursing staff

    Time frame: 72 hours

    Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire

Other outcomes

  1. Technical problems with the monitoring

    Time frame: up to 72 hours

    Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Feb 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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