Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients (RESCUEII)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hyperglycaemia Hypoglycaemia |
Device: Freestyle Navigator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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) |
- Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l [ Designated as safety issue: Yes ]
- Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®) [ Designated as safety issue: No ]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®) [ Designated as safety issue: No ]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) [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
- Mortality [ Designated as safety issue: No ]
- False positive frequency of alarms of the Freestyle Navigator® [ Designated as safety issue: No ]Verified by the glucose level measurements by blood gas analyzer
- Number of undesirable low glucose levels per 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]blood glucose levels between 2,5 and 5 mmol/l
- Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®) [ Designated as safety issue: No ]
- Number of blood samples per day [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 178 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Freestyle group
Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU
|
Device: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Other Name: Freestyle Navigator, Abbott Diabetes Care
|
|
Active Comparator: 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.
|
Device: Freestyle Navigator
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
Other Name: Freestyle Navigator, Abbott Diabetes Care
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | PHJ van der Voort, PHJ van der Voort, MD, PhD, Onze Lieve Vrouwe Gasthuis |
| ClinicalTrials.gov Identifier: | NCT01526044 History of Changes |
| Other Study ID Numbers: | NL33495.100.10 |
| Study First Received: | February 1, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Onze Lieve Vrouwe Gasthuis:
|
hyperglycemia hypoglycemia insulin critical illness intensive insulin therapy continuous glucose monitoring |
CGM interstitial fluid glucose intensive care unit Blood glucose Intensive insulin therapy |
Additional relevant MeSH terms:
|
Critical Illness Hyperglycemia Hypoglycemia Disease Attributes |
Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013