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      Measurement delay associated with the Guardian® RT continuous glucose monitoring system

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          Abstract

          Aims

          Using compartment modelling, we assessed the time delay between blood glucose and sensor glucose measured by the Guardian® RT continuous glucose monitoring system in young subjects with Type 1 diabetes (T1D).

          Methods

          Twelve children and adolescents with T1D treated by continuous subcutaneous insulin infusion (male/female 7/5; age 13.1 ± 4.2 years; body mass index 21.9 ± 4.3 kg/m 2; mean ± sd) were studied over 19 h in a Clinical Research Facility. Guardian® RT was calibrated every 6 h and sensor glucose measured every 5 min. Reference blood glucose was measured every 15 min using a YSI 2300 STAT Plus Analyser. A population compartment model of sensor glucose–blood glucose kinetics was adopted to estimate the time delay, the calibration scale and the calibration shift.

          Results

          The population median of the time delay was 15.8 (interquartile range 15.2, 16.5) min, which was corroborated by correlation analysis between blood glucose and 15-min delayed sensor glucose. The delay has a relatively low intersubject variability, with 95% of individuals predicted to have delays between 10.4 and 24.3 min. Population medians (interquartile range) for the scale and shift are 0.800 (0.777, 0.823) (unitless) and 1.66 (1.47, 1.84) mmol/l, respectively.

          Conclusions

          In young subjects with T1D, the total time delay associated with the Guardian® RT system was approximately 15 min. This is twice that expected on physiological grounds, suggesting a 5- to 10-min delay because of data processing. Delays above 25 min are rarely to be observed.

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          Most cited references29

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          Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring.

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            Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial.

            Hypoglycemia and wide glucose excursions continue to be major obstacles to achieving target HbA(1c) values and the associated reductions in long-term complications (and economic costs) in people with insulin-treated diabetes. In this study we evaluated the accuracy, safety, and clinical effectiveness of a continuous glucose-sensing device. A total of 91 insulin-requiring patients with type 1 (n = 75) and type 2 (n = 16) diabetes were enrolled in this multicenter randomized study. Subjects wore a transcutaneous, 3-day, continuous glucose-sensing system for three consecutive 72-h periods. Subjects were randomly assigned (1:1 ratio) to either a control group (continuous glucose data not provided) or a display group (continuous glucose data not provided during period 1 but displayed during periods 2 and 3). During periods 2 and 3, patients in the display group had real-time access to sensor glucose values, could review glucose trends over the preceding 1, 3, and 9 h, and were provided with high (> or = 200 mg/dl) and low ( or = 240 mg/dl), and 26% more time in the target (81-140 mg/dl) glucose range (P < 0.001 for each comparison). Nocturnal (10:00 p.m. to 6:00 a.m.) hypoglycemia, as assessed at two thresholds, was also reduced by 38% (<55 mg/dl; P < 0.001) and 33% (55-80 mg/dl; P < 0.001) in the display group compared with control subjects. We conclude that real-time continuous glucose monitoring for periods up to 72 h is accurate and safe in insulin-requiring subjects with type 1 and type 2 diabetes. This study demonstrates that availability of real-time, continuously measured glucose levels can significantly improve glycemic excursions by reducing exposure to hyperglycemia without increasing the risk of hypoglycemia, which may reduce long-term diabetes complications and their associated economic costs.
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              Continuous glucose monitoring and closed-loop systems.

              R Hovorka (2005)
              The last two decades have witnessed unprecedented technological progress in the development of continuous glucose sensors, resulting in the first generation of commercial glucose monitors. This has fuelled the development of prototypes of a closed-loop system based on the combination of a continuous monitor, a control algorithm, and an insulin pump. A review of electromechanical closed-loop approaches is presented. This is followed by a review of existing prototypes and associated glucose sensors. A literature review was undertaken from 1960 to 2004. Two main approaches exist. The extracorporeal s.c.-s.c. approach employs subcutaneous glucose monitoring and subcutaneous insulin delivery. The implantable i.v.-i.p. approach adopts intravenous sampling and intraperitoneal insulin delivery. Feasibility of both solutions has been demonstrated in small-scale laboratory studies using either the classical proportional-integral-derivative controller or a model predictive controller. Performance in the home setting has yet to be demonstrated. The glucose monitor remains the main limiting factor in the development of a commercially viable closed-loop system, as presently available monitors fail to demonstrate satisfactory characteristics in terms of reliability and/or accuracy. Regulatory issues are the second limiting factor. Closed-loop systems are likely to be used first by health-care professionals in controlled environments such as intensive care units.
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                Author and article information

                Journal
                Diabet Med
                Diabet. Med
                dme
                Diabetic Medicine
                Blackwell Publishing Ltd (Oxford, UK )
                0742-3071
                1464-5491
                January 2010
                : 27
                : 1
                : 117-122
                Affiliations
                [* ]simpleMRC Biostatistics Unit, Institute of Public Health, Department of Paediatrics, University of Cambridge Cambridge, UK
                []simpleMRC Biostatistics Unit, Institute of Public Health, Institute of Metabolic Science, University of Cambridge Cambridge, UK
                Author notes
                Correspondence to: Dr Chen Wei, MRC Biostatistics Unit, Institute of Public Health, University Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK. E-mail: chen.wei@ 123456mrc-bsu.cam.ac.uk

                Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms

                Article
                10.1111/j.1464-5491.2009.02887.x
                3427888
                20121899
                669b6f90-2594-4038-9bbf-eb312e68a268
                © 2010 The Authors. Journal compilation © 2010 Diabetes UK

                Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.

                History
                : 04 November 2009
                Categories
                Short Reports

                Endocrinology & Diabetes
                guardian® rt,continuous glucose monitoring,calibration,minimal model
                Endocrinology & Diabetes
                guardian® rt, continuous glucose monitoring, calibration, minimal model

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