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Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526044
First Posted: February 3, 2012
Last Update Posted: June 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PHJ van der Voort, Onze Lieve Vrouwe Gasthuis
  Purpose
The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

Condition Intervention
Hyperglycaemia Hypoglycaemia Device: Freestyle Navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)

Resource links provided by NLM:


Further study details as provided by PHJ van der Voort, Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l

Secondary Outcome Measures:
  • Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
    The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol

  • Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
    The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol

  • - Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)

    Mean Absolute Glucose change per hour:

    ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours.


  • Length of stay in the ICU
  • Mortality
  • False positive frequency of alarms of the Freestyle Navigator®
    Verified by the glucose level measurements by blood gas analyzer

  • Number of undesirable low glucose levels per 24 hours [ Time Frame: 24 hours ]
    blood glucose levels between 2,5 and 5 mmol/l

  • Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
  • Number of blood samples per day [ Time Frame: 24 hours ]

Enrollment: 178
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
Device: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Other Name: Freestyle Navigator, Abbott Diabetes Care
Active Comparator: AccuChek group
Glucose levels are being measured by the AccuChek. Patients also get a Freestyle Navigator, which will be blinded. The device will stay on the patient up to 5 days, or until discharge from the ICU.
Device: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Other Name: Freestyle Navigator, Abbott Diabetes Care

Detailed Description:

Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:

  • Better insight in the alterations of the blood glucose levels
  • Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
  • Fewer blood samples
  • Decreased workload for the nursing staff

In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.

Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.

The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.

In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.

Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ICU-patients > 18 years
  • Expected length of stay on the ICU > 24 hours
  • Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
  • Availability of the Freestyle Navigator

Exclusion Criteria:

  • Participation in another trial subject to the WMO
  • Lack of informed consent
  • Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
  • Contraindication for placement of the subcutaneous glucose sensor
  • Participation in this trial during previous ICU admittance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526044


Locations
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
Principal Investigator: P HJ van der Voort, MD, PhD Onze Lieve Vrouwe Gasthuis
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PHJ van der Voort, PHJ van der Voort, MD, PhD, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01526044     History of Changes
Other Study ID Numbers: NL33495.100.10
First Submitted: February 1, 2012
First Posted: February 3, 2012
Last Update Posted: June 27, 2012
Last Verified: June 2012

Keywords provided by PHJ van der Voort, Onze Lieve Vrouwe Gasthuis:
hyperglycemia
hypoglycemia
insulin
critical illness
intensive insulin therapy
continuous glucose monitoring
CGM
interstitial fluid glucose
intensive care unit
Blood glucose

Additional relevant MeSH terms:
Critical Illness
Hypoglycemia
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases