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

Primary Purpose

Glucose Metabolism Disorders, Diabetic Blood Glucose Monitoring, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Continuous glucose monitoring
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glucose Metabolism Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University, Berlin, Germany

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SOFA <7

SOFA >7

Arm Description

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.

Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.

Outcomes

Primary Outcome Measures

Accuracy of continuous glucose monitoring compared to blood gas analyses
Difference between glucose values of continuous glucose monitoring and blood gas analyses

Secondary Outcome Measures

Feasibility of continuous glucose monitoring
Problems within the application of sensor and monitoring during ward routine
Acceptance of continuous glucose monitoring by physicians and nursing staff
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire

Full Information

First Posted
November 4, 2014
Last Updated
February 7, 2017
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02296372
Brief Title
Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Ill Patients
Official Title
Pilot Observation of Continuous Glucose Monitoring in Critically Ill Patients Under Consideration of Accuracy, Feasibility and Acceptance by Ward Staff
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Diabetic Blood Glucose Monitoring, Critical Illness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOFA <7
Arm Type
Other
Arm Description
Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.
Arm Title
SOFA >7
Arm Type
Other
Arm Description
Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement. Intervention: Measuring continuous glucose monitoring.
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring
Other Intervention Name(s)
CGM
Intervention Description
Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours. In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems.
Primary Outcome Measure Information:
Title
Accuracy of continuous glucose monitoring compared to blood gas analyses
Description
Difference between glucose values of continuous glucose monitoring and blood gas analyses
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Feasibility of continuous glucose monitoring
Description
Problems within the application of sensor and monitoring during ward routine
Time Frame
72 hours
Title
Acceptance of continuous glucose monitoring by physicians and nursing staff
Description
Acceptance and evaluation of the device by physicians and nursing staff evaluated by questionnaire
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Technical problems with the monitoring
Description
Number of needed sensors per patient. Duration of functional sensor. Number and reasons for accidentally sensor removal.
Time Frame
up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Weber-Carstens, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University, Berlin, Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27439710
Citation
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.
Results Reference
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Accuracy, Feasibility and Acceptance of Continuous Glucose Monitoring in Critically Ill Patients

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