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Manual vs. Automated moNitoring Accuracy of GlucosE.


- candidate number9345
- NTR NumberNTR2864
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2011
- Secondary IDs10/281 # 10.17.1900 METC AMC
- Public TitleManual vs. Automated moNitoring Accuracy of GlucosE.
- Scientific TitleManual vs. Automated moNitoring Accuracy of GlucosE.
- ACRONYMMANAGE
- hypothesisThe OptiScanner provides accurate blood glucose levels in critically ill patients.
- Healt Condition(s) or Problem(s) studiedBlood glucose regulation, Critically ill patients
- Inclusion criteria1. Signed Informed consent;
2. Age ≥ 18 years;
3. Admitted to the ICU of the Academic Medical Center or Gelre Hospitals Apeldoorn;
4. Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by Principle Investigators);
5. APACHE II score of ≥ 10, within the first 24 hours of ICU admission;
6. Existing central venous catheter + arterial catheter;
7. No participation in any other investigational interventional study while enrolled in this study.
- Exclusion criteria1. Have received any investigational product or been treated with an investigational device within the past 30 days;
2. Pregnancy;
3. Untreatable colonization with multi–resistant bacteria (e.g. methicillin–resistant Staphylococcus aureus).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2011
- planned closingdate1-aug-2011
- Target number of participants75
- InterventionsThe OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.

Next to this, 6 blood samples per day will be drawn to be compared with measurements with a ysi 2300 stat plus, Accu-Check Inform and RAPIDlab blood gas analyser.
- Primary outcome1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood;
3. Linearity between the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood.
- Secondary outcome1. Glucose prediction error, defined as the results of the YSI versus the RAPIDlab and Accu-Chek meters, using arterial blood;
2. Clarke error grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI and the RAPIDlab and Accu-Chek meters, using arterial blood;
3. Linearity between the results of the YSI versus the RAPIDlab and Accu-Chek meters, using arterial blood;
4. Glucose prediction error, Clarke error grid analysis, and linearity for each of the YSI, RAPIDlab, and Accu-Chek meters, comparing results from central venous blood versus arterial blood.
- TimepointsEvery day (for a maximum of 3 days), 6 blood samples (total of 18) will be drawn to be compared to the OptiScanner measurements.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. M.J. Schultz
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), OptiScan Biomedical Corporation Hayward (CA) United States of America
- PublicationsN/A
- Brief summaryHyperglycemia, hypoglycemia, and glycemic variability are all associated with morbidity and mortality of critically ill patients. Blood glucose control with insulin prevents hyperglycemia but is associated with a higher incidence of hypoglycemia and may not decrease 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, which suffer from a variety of error sources that can put these patients at risk for insulin over– and/or under–dosing. Continuous or near–continuous blood glucose monitoring devices have 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 decrease blood glucose variability) of blood glucose control with insulin in critically ill patients. OptiScan Biomedical Corporation has developed a near–continuous glucose monitoring technology, called the OptiScanner, which provides accurate blood glucose measurements at a wide range of glucose concentrations.

Hypotheses:
The OptiScanner provides accurate blood glucose levels in critically ill patients.

Study design:
This is an investigator–initiated observational study comparing the OptiScanner with 3 standard blood glucose meters in critically ill patients subjected to glucose control with insulin.

Objectives:
The objective of this study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus (Yellow Springs Instruments) reading. The study will also compare readings taken from the OptiScanner to whole blood glucose measurements by the RAPIDlab 1265 (Siemens) and the Accu-Chek Inform (Roche) meters.

Study population:
Patients admitted to the intensive care units of the Academic Medical Center, Amsterdam or the Gelre Hospitals Apeldoorn, the Netherlands, with an expected length of stay ≥ 3 days.

Intervention:
The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.

Main study parameters/endpoints:
1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood;
3. Linearity between the results of the YSI versus the OptiScanner, as well as versus the RAPIDlab and Accu-Chek meters, using central venous blood.


Secondary study parameters/endpoints:
1. Glucose prediction error, defined as the results of the YSI versus the RAPIDlab and Accu-Chek meters, using arterial blood;
2. Clarke error grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI and the RAPIDlab and Accu-Chek meters, using arterial blood;
3. Linearity between the results of the YSI versus the RAPIDlab and Accu-Chek meters, using arterial blood;
4. Glucose prediction error, Clarke error grid analysis, and linearity for each of the YSI, RAPIDlab, and Accu-Chek meters, comparing results from central venous blood versus arterial blood.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The OptiScanner has been tested and validated in a number of pre–clinical and clinical studies, and has been found to be both safe and accurate. Potential benefits include reduced risk of hypoglycemia, and decreased glycemic variability.
- Main changes (audit trail)13-Aug-2012: The protocol has undergone several changes in accordance with the METC. These changes are the following:

Interventions:
The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.

Next to this, 12 blood samples per day will be drawn to be compared with measurements with a ysi 2300 stat plus, and RAPIDlab blood gas analyser.

Primary outcome:
1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, using arterial blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, using arterial blood;
3. Linearity between the results of the YSI versus the OptiScanner, using arterial blood.

Secondary outcome:
1. Glucose prediction error, defined as the results of the OptiScanner, versus the RAPIDlab, using arterial blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the OptiScanner versus the RAPIDlab, using arterial blood;
3. Linearity between the results of the OptiScanner versus the RAPIDlab, using arterial blood.

Timepoints:
Every day (for a maximum of 3 days), 12 blood samples (total of 36) will be drawn to be compared to the OptiScanner measurements.

Summary:
Introduction:
Hyperglycemia, hypoglycemia, and glycemic variability are all associated with morbidity and mortality of critically ill patients. Blood glucose control with insulin prevents hyperglycemia but is associated with a higher incidence of hypoglycemia and may not decrease 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, which suffer from a variety of error sources that can put these patients at risk for insulin over– and/or under–dosing. Continuous or near–continuous blood glucose monitoring devices have 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 decrease blood glucose variability) of blood glucose control with insulin in critically ill patients. OptiScan Biomedical Corporation has developed a near–continuous glucose monitoring technology, called the OptiScanner, which provides accurate blood glucose measurements at a wide range of glucose concentrations.
Hypotheses:
The OptiScanner provides accurate blood glucose levels in critically ill patients.
Study design:
This is an investigator–initiated observational study comparing the OptiScanner with 3 standard blood glucose meters in critically ill patients subjected to glucose control with insulin.
Objectives:
The objective of this study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus (Yellow Springs Instruments) reading. The study will also compare readings taken from the OptiScanner to whole blood glucose measurements by the RAPIDlab 1265 (Siemens).
Study population:
Patients admitted to the intensive care units of the Academic Medical Center, Amsterdam or the Gelre Hospitals Apeldoorn, the Netherlands, with an expected length of stay ≥ 3 days.
Intervention:
The OptiScanner is a point of care device for measurement of blood glucose as well as other analytes. It works by measuring the optical infrared absorption of glucose in a very small amount of plasma. Blood is drawn into the measurement engine of the device, a mid–infrared spectrometer, on a near–continuous basis.
Main study parameters/endpoints:
1. Glucose prediction error, defined as the results of the YSI versus the OptiScanner, using arterial blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the YSI versus the OptiScanner, using arterial blood;
3. Linearity between the results of the YSI versus the OptiScanner, using arterial blood.
Secondary study parameters/endpoints:
1. Glucose prediction error, defined as the results of the OptiScanner, versus the RAPIDlab, using arterial blood;
2. Clarke Error Grid analysis showing the percentage of paired data values falling within each zone between the results of the OptiScanner versus the RAPIDlab, using arterial blood;
3. Linearity between the results of the OptiScanner versus the RAPIDlab, using arterial blood.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The OptiScanner has been tested and validated in a number of pre–clinical and clinical studies, and has been found to be both safe and accurate. Potential benefits include reduced risk of hypoglycemia, and decreased glycemic variability.

The start- and enddate were 20-Sep-2011 and 08-Jun-2012.
- RECORD18-apr-2011 - 13-aug-2012


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