|- candidate number||14295|
|- NTR Number||NTR3827|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-jan-2013|
|- Secondary IDs||NL41498.018.12 / 2012_211; CCMO / METC AMC|
|- Public Title||Usability of Subcutaneous Continuous Glucose Monitoring in Critically Ill Patients.|
|- Scientific Title||Usability of Subcutaneous Continuous Glucose Monitoring in Critically Ill Patients.|
|- hypothesis||The aim of this study is to test the accuracy and usability of the Medtronic Continuous Glucose Monitoring System (Sentrino®) in an ICU–environment, and includes testing the usability of all the components.|
|- Healt Condition(s) or Problem(s) studied||Blood glucose, Monitoring, Critically ill patients|
|- Inclusion criteria||1. Patient is at least 18 years old;|
2. Patient is admitted to the ICU of the Academic Medical Center, The Netherlands;
3. Patient has anticipated life expectancy greater than 96 hours;
4. Patient has recent platelet count greater than 30,000 per micro-liter.
|- Exclusion criteria||1. Patient currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the patient from completing the study;|
2. Patient is currently participating in another investigational drug or device study;
3. Patient is pregnant, as determined by hospital admission.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||19-okt-2012|
|- planned closingdate||1-sep-2013|
|- Target number of participants||50|
|- Interventions||The intervention exists of use of Sentrino®.|
|- Primary outcome||The primary objective of this study is to determine the accuracy of subcutaneous CGM glucose measurements as compared with current standard of care blood glucose levels measurements.|
|- Secondary outcome||The secondary objective of this study is to train healthcare workers to use of the Medtronic Sentrino® system, and to obtain feedback from the users on the usability of the Medtronic Sentrino® system.|
|- Timepoints||For the purpose of this study, the Sentrino can be used for a maximum of 30 days. A single sensor can be used for a 72–hour period, and replaced with subsequent sensors each used for up to a 72–hour period for the patient’s stay in ICU. The total duration of time that the patient is on the Sentrino system (through multiple sensors each for 72-hours) may not exceed 30 days.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.J. Schultz|
|- CONTACT for SCIENTIFIC QUERIES|| R.T.M. Hooijdonk, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam|
|- Brief summary||Introduction:|
Hyperglycemia, hypoglycemia, and glycemic variability are all independently associated with morbidity and mortality of critically ill patients. Blood glucose control with insulin prevents hyperglycemia but is associated with an increased incidence of hypoglycemia and may not affect blood glucose variability. Implementation strategies of blood glucose control with insulin in critically ill patients have mainly used manually operated whole blood portable glucose meters. These meters are impracticable, possibly unsafe, and time– and blood–consuming. Utilization of subcutaneous continuous glucose monitoring has the potential to improve the safety (i.e., prevention of hypoglycemia) and effectiveness (i.e., obtain a higher percent of values in the therapeutic range and less blood glucose variability) of insulin titration in critically ill patients. In addition, utilization of subcutaneous continuous glucose monitoring devices is less time– and blood–consuming than the use of manually operated whole blood portable glucose meters. Medtronic has developed a subcutaneous continuous glucose–monitoring system especially for critically ill patients, called the Sentrino®.
1. The primary objective of this study is to determine the accuracy of subcutaneous CGM glucose measurements as compared with current standard of care blood glucose levels measurements;
2. The secondary objective of this study is to train healthcare workers to use of the Medtronic Sentrino® system, and to obtain feedback from the users on the usability of the Medtronic Sentrino® system.
This study concerns an investigator–initiated observational implementation study in critically ill patients subjected to blood glucose control with insulin, aiming at a blood glucose level between 90 and 150 mg/dL.
Critically ill patients admitted to the intensive care units (ICU) of the Academic Medical Center at the University of Amsterdam, Amsterdam, The Netherlands.
The intervention exists of use of Sentrino®.
Main study parameters/endpoints:
The main study parameter is the accuracy of subcutaneous CGM glucose measurements.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The Sentrino® has been tested and validated in a number of pre–clinical and clinical studies in patients outside the intensive care unit (ICU), and has been found to be safe and accurate for trend. Potential benefits include reduced risk of hypoglycemia, and decreased glycemic variability. Burden and risks include local irritations, bleeding and infection at the site of the sensor.
|- Main changes (audit trail)|
|- RECORD||30-jan-2013 - 9-feb-2013|