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NCT Number: NCT01526044

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

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.

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Key information

Conditions

Hyperglycaemia Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Hypoglycaemia Hypoglycemia Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freestyle Navigator

Device

Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

Other names: Freestyle Navigator, Abbott Diabetes Care

Primary outcomes

  1. Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l

Secondary outcomes

  1. 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

  2. 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

  3. - 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.

  4. Length of stay in the ICU

  5. Mortality

  6. False positive frequency of alarms of the Freestyle Navigator®

    Verified by the glucose level measurements by blood gas analyzer

  7. Number of undesirable low glucose levels per 24 hours

    Time frame: 24 hours

    blood glucose levels between 2,5 and 5 mmol/l

  8. Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)

  9. Number of blood samples per day

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Registry information

Official study 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)

Acronym: RESCUEII

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 3, 2012
Registry last updated
Jun 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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