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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296372
• Other study ID #: Charité-MOTAFEE-CGM
• Status: Completed
• Phase: N/A
• First received: November 4, 2014
• Last updated: February 7, 2017
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Diabetic Blood Glucose Monitoring
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Device:
• Continuous glucose monitoring
Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.

Locations

Country	Name	City	State
Germany	Charite University, Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Wollersheim T, Engelhardt LJ, Pachulla J, Moergeli R, Koch S, Spies C, Hiesmayr M, Weber-Carstens S. Accuracy, reliability, feasibility and nurse acceptance of a subcutaneous continuous glucose management system in critically ill patients: a prospective c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical problems with the monitoring	Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.	up to 72 hours
Primary	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	Feasibility of continuous glucose monitoring	Problems within the application of sensor and monitoring during ward routine	72 hours
Secondary	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