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

Onze Lieve Vrouwe Gasthuis

Status: Completed

Conditions: Hyperglycaemia; Hypoglycaemia

Treatments: Device: Freestyle Navigator

Study type: Interventional

Funder types: Other

Identifiers

NCT01526044

NL33495.100.10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Freestyle group

Experimental group

Description:

Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU

Treatment:

Device: Freestyle Navigator

AccuChek group

Active Comparator group

Description:

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.

Treatment:

Device: Freestyle Navigator