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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freestyle group | Experimental | Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU |
|
| AccuChek group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Navigator | Device | Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l |
| Measure | Description | Time Frame |
|---|---|---|
| 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®) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| P HJ van der Voort, MD, PhD | Onze Lieve Vrouwe Gasthuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25139609 | Derived | Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9. |
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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 | blood glucose levels between 2,5 and 5 mmol/l | 24 hours |
| Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®) |
| Number of blood samples per day | 24 hours |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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