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:
Information provided by (Responsible Party):
PHJ van der Voort, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT01526044
First received: February 1, 2012
Last updated: June 26, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®) [ Designated as safety issue: No ]
    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®) [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]

    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 [ Designated as safety issue: No ]
  • Mortality [ Designated as safety issue: No ]
  • False positive frequency of alarms of the Freestyle Navigator® [ Designated as safety issue: No ]
    Verified by the glucose level measurements by blood gas analyzer

  • Number of undesirable low glucose levels per 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    blood glucose levels between 2,5 and 5 mmol/l

  • Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®) [ Designated as safety issue: No ]
  • Number of blood samples per day [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 1, 2012
Last Updated: June 26, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on August 28, 2014