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

Hypoglycaemia Clinical Trial

— RESCUEII  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526044
• Other study ID #: NL33495.100.10
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: June 26, 2012
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycaemia
• Hyperglycemia
• Hypoglycaemia
• Hypoglycemia

Intervention

Device:
• Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l			Yes
Secondary	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		No
Secondary	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		No
Secondary	- 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: ?BGA / ?time 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.		No
Secondary	Length of stay in the ICU			No
Secondary	Mortality			No
Secondary	False positive frequency of alarms of the Freestyle Navigator®	Verified by the glucose level measurements by blood gas analyzer		No
Secondary	Number of undesirable low glucose levels per 24 hours	blood glucose levels between 2,5 and 5 mmol/l	24 hours	No
Secondary	Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)			No
Secondary	Number of blood samples per day		24 hours	No