Clinical trial NCT01526044: Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycaemia
Hypoglycaemia
Keywords: hyperglycemia
hypoglycemia
insulin
critical illness
intensive insulin therapy
continuous glucose monitoring
CGM
interstitial fluid glucose
intensive care unit
Blood glucose
Lead sponsor: Onze Lieve Vrouwe Gasthuis
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
Secondary outcomes:
measure: Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
measure: Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
measure: - Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
measure: Length of stay in the ICU
measure: Mortality
measure: False positive frequency of alarms of the Freestyle Navigator®
measure: Number of undesirable low glucose levels per 24 hours
timeFrame: 24 hours
measure: Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
measure: Number of blood samples per day
timeFrame: 24 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
Study officials:
affiliation: Onze Lieve Vrouwe Gasthuis
name: P HJ van der Voort, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.