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

NCT ID: NCT01526044

Last Updated: 2012-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Hyperglycaemia; Hypoglycaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Freestyle group

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

Group Type: EXPERIMENTAL

Freestyle Navigator

Intervention Type: DEVICE

Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

AccuChek group

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.

Group Type: ACTIVE_COMPARATOR

Freestyle Navigator

Intervention Type: DEVICE

Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

Interventions

Freestyle Navigator

Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

Intervention Type: DEVICE

Other Intervention Names

Freestyle Navigator, Abbott Diabetes Care

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onze Lieve Vrouwe Gasthuis

OTHER

Sponsor Role: lead

Responsible Party

PHJ van der Voort

PHJ van der Voort, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P HJ van der Voort, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Onze Lieve Vrouwe Gasthuis

Locations

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 25139609 (View on PubMed)

Other Identifiers

NL33495.100.10

Identifier Type: -

Identifier Source: org_study_id