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

Not Applicable

Completed

• Conditions: Hyperglycaemia; Hypoglycaemia
• Interventions: Device: Freestyle Navigator

• Registration Number: NCT01526044
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Primary Completion: 2012-04
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Freestyle group	Freestyle Navigator	Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
AccuChek group	Freestyle Navigator	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.

Primary Outcome Measures

Name	Time	Method
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l

Secondary Outcome Measures

Name	Time	Method
Mortality
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
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	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	24 hours

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands