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

NCT02296372 | Completed DMC

• 1 other identifier: Charité-MOTAFEE-CGM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism Disorders; Diabetic Blood Glucose Monitoring; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility of continuous glucose monitoring

  72 hours

• Acceptance of continuous glucose monitoring by physicians and nursing staff

  72 hours

Other Outcomes (1)

• Technical problems with the monitoring

  up to 72 hours

Study Arms (2)

SOFA <7

OTHER

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

SOFA >7

OTHER

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

Interventions

Continuous glucose monitoring DEVICE

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

Also known as: CGM

SOFA <7; SOFA >7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• critically ill patients with expected ICU stay for more than 72 hours
• informed consent by the patients or legal proxy

You may not qualify if:

• age \< 18
• no informed consent by the patients or legal proxy
• pregnancy
• infaust prognosis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite University, Berlin, Germany

Berlin, 13353, Germany

Location

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

  PMID: 27439710 RESULT

MeSH Terms

Conditions

Glucose Metabolism Disorders; Critical Illness

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Steffen Weber-Carstens, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Steffen Weber-Carstens

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

DE (1)