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

NCT ID: NCT02296372

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SOFA <7

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement.

Intervention: Measuring continuous glucose monitoring.

Group Type: OTHER

Continuous glucose monitoring

Intervention Type: DEVICE

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

In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.

SOFA >7

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement.

Intervention: Measuring continuous glucose monitoring.

Group Type: OTHER

Continuous glucose monitoring

Intervention Type: DEVICE

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

In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.

Interventions

Continuous glucose monitoring

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

In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.

Intervention Type: DEVICE

Other Intervention Names

CGM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Steffen Weber-Carstens

PD Dr. med. Steffen Weber-Carstens

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Weber-Carstens, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charite University, Berlin, Germany

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 27439710 (View on PubMed)

Other Identifiers

Charité-MOTAFEE-CGM

Identifier Type: -

Identifier Source: org_study_id