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

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

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 Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Critical Illness; Diabetic Blood Glucose Monitoring
• Intervention / Treatment: Device: Continuous glucose monitoring

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charite University, Berlin, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: SOFA <7; 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; Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.; Other Names: CGM
Other: SOFA >7; 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; Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.; Other Names: CGM

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Steffen Weber-Carstens, MD, Charite University, Berlin, Germany

Publications and helpful links

General Publications

• 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 clinical trial. Ann Intensive Care. 2016 Dec;6(1):70. doi: 10.1186/s13613-016-0167-z. Epub 2016 Jul 21.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: Charité-MOTAFEE-CGM