Accuracy of a Feasibility Version of an Intravenous Continuous Glucose Monitor in Volunteers with Diabetes and Hospitalized Patients

Foubert, L.; Lecomte, P.; Nobels, Frank; Gulino, Angela M.; Decker, Koen H De

doi:10.1089/dia.2014.0082

Cited by 12 publications

(13 citation statements)

References 22 publications

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“…The CGM device assessed in this study compares well with intravascular sensors that use other techniques, including enzymatic reactions [27], fluorescence [28, 29] and microdialysis [30]. One advantage of the OptiScanner® is that it does not require placement of an additional central catheter, in contrast to other systems that require peripheral venous access [27] or dedicated arterial access [29].…”

Section: Discussionmentioning

confidence: 99%

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Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II)

et al. 2016

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BackgroundIntravascular continuous glucose monitoring (CGM) may facilitate glycemic control in the intensive care unit (ICU). We compared the accuracy of a CGM device (OptiScanner®) with a standard reference method.MethodsAdult patients who had blood glucose (BG) levels >150 mg/dl and required insertion of an arterial and central venous catheter were included. The OptiScanner® was inserted into a multiple-lumen central venous catheter. Patients were treated using a dynamic-scale insulin algorithm to achieve BG values between 80 and 150 mg/dl. The BG values measured by the OptiScanner® were plotted against BG values measured using a reference analyzer. The correlation between the BG values measured using the two methods and the clinical relevance of any differences were assessed using the coefficient of determination (r 2) and the Clarke error grid, respectively; bias was assessed by the mean absolute relative difference (MARD). Three different standards of glucose monitoring were used to assess accuracy. Glycemic control was assessed using the time in range (TIR). Six indices of glycemic variability were calculated.ResultsThe analysis included 929 paired samples from 88 patients, monitored for a total of 2584 hours. Reference BG values ranged between 60 and 484 mg/dl. The r 2 value was 0.89. The percentage of BG values within zones A and B of the Clarke error grid was 99.9%; the MARD was 7.7%. Using the ISO 15197 standard and Food and Drug Administration and consensus standards, respectively, 80.4% of measurements were within 15 mg/dl and 88.2% within 15% of reference values, 40% of measurements were within 7 mg/dl and 72.5% within 10% of reference values, and 65.2% of measurements were within 10 mg/dl and 82.7% within 12.5% of reference values. The TIR was slightly lower with the OptiScanner® than with the reference method. The J-index, standard deviation and maximal glucose change were the indices of glycemic variability least affected by the measurement device.ConclusionsBased on the MARD, the performance of the OptiScanner® is adequate for use in ICU patients. Because recent standards for accuracy were not met, the OptiScanner® should not be used as a sole monitor. The assessment of glycemic variability is influenced by the time interval between BG determinations.Trial registrationClinicaltrials.gov NCT01720381. Registered 31 October 2012.

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Section: Discussionmentioning

confidence: 99%

“…One advantage of the OptiScanner® is that it does not require placement of an additional central catheter, in contrast to other systems that require peripheral venous access [27] or dedicated arterial access [29]. …”

Section: Discussionmentioning

confidence: 99%

Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II)

et al. 2016

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“…The GlucoClear product developed by Edwards Life Science is essentially a hybrid of the in vivo and ex vivo sensing concept (92). The glucose oxidase sensor is placed within a peripheral IV catheter.…”

Section: Design Of Implantable and Ex Vivo Sensor Configurations For mentioning

confidence: 99%

“…edwards.com/eu/products/glucose/Pages/GlucoClear.aspx; see also 92,112). Prototype sensors based on the in vivo concept, whether electrochemical or optical sensor based, suffer from accuracy problems owing to several possible mechanisms.…”

Section: Figurementioning

confidence: 99%

Real-Time Monitoring of Critical Care Analytes in the Bloodstream with Chemical Sensors: Progress and Challenges

Frost

Meyerhoff²

2015

Annual Rev. Anal. Chem.

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We review approaches and challenges in developing chemical sensor-based methods to accurately and continuously monitor levels of key analytes in blood related directly to the status of critically ill hospitalized patients. Electrochemical and optical sensor-based technologies have been pursued to measure important critical care species in blood [i.e., oxygen, carbon dioxide, pH, electrolytes (K(+), Na(+), Cl(-), etc.), glucose, and lactate] in real-time or near real-time. The two main configurations examined to date for achieving this goal have been intravascular catheter sensors and patient attached ex vivo sensors with intermittent blood sampling via an attached indwelling catheter. We discuss the status of these configurations and the main issues affecting the accuracy of the measurements, including cell adhesion and thrombus formation on the surface of the sensors, sensor drift, sensor selectivity, etc. Recent approaches to mitigate these nagging performance issues that have prevented these technologies from clinical use are also discussed.

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“…Obstruction of venous blood flow by thrombus may cause reaspiration of flush solution and a preanalytical dilution error. [112][113][114][115] The OptiScanner® (OptiScan, Inc, Hayward, CA, USA ) is CE Mark approved for monitoring the concentration of plasma glucose in blood sampled from the proximal port of a CVC every 15 minutes for 72 hours. The CGMS automatically transports a small sample of blood from the CVC to a bedside monitor that contains a centrifuge, spectrometer, and data display.…”

Section: Vascular Catheter Blood-sampling Cgms For Hospitalized Patientsmentioning

confidence: 99%

Vascular Glucose Sensor Symposium

Joseph

Torjman

Strasma

2015

J Diabetes Sci Technol

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Hyperglycemia, hypoglycemia, and glycemic variability have been associated with increased morbidity, mortality, length of stay, and cost in a variety of critical care and non-critical care patient populations in the hospital. The results from prospective randomized clinical trials designed to determine the risks and benefits of intensive insulin therapy and tight glycemic control have been confusing; and at times conflicting. The limitations of point-of-care blood glucose (BG) monitoring in the hospital highlight the great clinical need for an automated real-time continuous glucose monitoring system (CGMS) that can accurately measure the concentration of glucose every few minutes. Automation and standardization of the glucose measurement process have the potential to significantly improve BG control, clinical outcome, safety and cost.

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Accuracy of a Feasibility Version of an Intravenous Continuous Glucose Monitor in Volunteers with Diabetes and Hospitalized Patients

Cited by 12 publications

References 22 publications

Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II)

Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II)

Real-Time Monitoring of Critical Care Analytes in the Bloodstream with Chemical Sensors: Progress and Challenges

Vascular Glucose Sensor Symposium

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