Randomised study to the efficacy and safety of Continuous Glucose Monitoring by subcutaneous measurement compared to frequent point of care measurement by Accu-Chek in critically ill patients (RESCUE)
Completed
- Conditions
- diabetes mellitussugar disease10018424
- Registration Number
- NL-OMON34710
- Lead Sponsor
- Onze Lieve Vrouwe Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
-ICU patients of 18 years and older
-Expected length of stay longer than 24 hours
-Indication for glucose regulation with insuline. (see appendix study protocol)
Exclusion Criteria
- Participation in another WMO study
- No informed consent
- Contra indication for the use of the AccuChek: (peritoneal dialysis, Hematocrit< 0,20 or > 0,65 , paracetamol intoxication)
- Abdominal abnormalities that inhibit sensor insertion
- Participation of the same study in an earlier ICU admittance.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Number of hypoglycemia or low glucose levels per 24 hour period<br /><br>- Amount of time in which the patient blood glucose levels are in the blood<br /><br>glucose target range.<br /><br><br /><br><br /><br>Definitions:<br /><br>- Hypoglycemia: glucose level< 2,5 mmol/l<br /><br>- Low glucose level: glucose level < 2,5-5,0 mmol/l<br /><br>- Hyperglycemia: glucose level > 9 mol/l<br /><br>- Severe hyperglycemia: glucss > 25 mmol/l</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Amount of time in which the patient blood glucose levels are above or beneath<br /><br>the blood glucose target range.<br /><br>- Variability of the glucose regulation measured with the blood gas analyser.<br /><br>(use of arterial bloodsamples) Expressed as mean Absolute Glucose<br /><br>change per hour (MAG).<br /><br>- Length of stay on the ICU<br /><br>- Mortality<br /><br>- False positive alarms of the Freestyle Navigator<br /><br>- Number of not detected hypoglycemia by the AccuChek.<br /><br>- Number of obtained bloodsamples per day per patient</p><br>