Performance Evaluation of a Continuous Glucose Monitoring System under Conditions Similar to Daily Life

Background: This study aimed at evaluating and comparing the performance of a new generation of continuous glucose monitoring (CGM) system versus other CGM systems, under daily lifelike conditions. Methods: A total of 10 subjects (7 female) were enrolled in this study. Each subject wore two Dexcom G4™ CGM systems in parallel for the sensor lifetime specified by the manufacturer (7 days) to allow assessment of sensor-to-sensor precision. Capillary blood glucose (BG) measurements were performed at least once per hour during daytime and once at night. Glucose excursions were induced on two occasions. Performance was assessed by calculating the mean absolute relative difference (MARD) between CGM readings and paired capillary BG readings and precision absolute relative difference (PARD), i.e., differences between paired CGM readings. Results: Overall aggregate MARD was 11.0% (n = 2392). Aggregate MARD for BG >70 mg/dl was 13.7%; for BG between 70 and 180 mg/dl, MARD was 11.4%; and for BG >180 mg/dl, MARD was 8.5%. Aggregate PARD was 7.3%, improving from 11.6% on day 1 to 5.2% on day 7. Conclusions: The Dexcom G4 CGM system showed good overall MARD compared with results reported for other commercially available CGM systems. In the hypoglycemic range, where CGM performance is often reported to be low, the Dexcom G4 CGM system achieved better MARD than that reported for other CGM systems in the hypoglycemic range. In the hyperglycemic range, the MARD was comparable to that reported for other CGM systems, whereas during induced glucose excursions, the MARD was similar or slightly worse than that reported for other CGM systems. Overall PARD was 7.3%, improving markedly with sensor life time.

[1]  Fausto Lucarelli,et al.  Evaluating the Clinical Accuracy of GlucoMen®Day: A Novel Microdialysis-Based Continuous Glucose Monitor , 2010, Journal of diabetes science and technology.

[2]  Martin Holder,et al.  Prevention of hypoglycemia by using low glucose suspend function in sensor-augmented pump therapy. , 2011, Diabetes technology & therapeutics.

[3]  J. Brauker,et al.  Analysis of time lags and other sources of error of the DexCom SEVEN continuous glucose monitor. , 2009, Diabetes technology & therapeutics.

[4]  Howard Zisser,et al.  New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. , 2009, Diabetes technology & therapeutics.

[5]  S. Garg,et al.  Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems. , 2009, Diabetes technology & therapeutics.

[6]  Steven J. Russell,et al.  A Comparative Effectiveness Analysis of Three Continuous Glucose Monitors , 2013, Diabetes Care.

[7]  Claudio Cobelli,et al.  Continuous Glucose Monitoring Accuracy Results Vary between Assessment at Home and Assessment at the Clinical Research Center , 2012, Journal of diabetes science and technology.

[8]  Joan L Parkes,et al.  Evaluation of a Novel Continuous Glucose Measurement Device in Patients with Diabetes Mellitus across the Glycemic Range , 2011, Journal of diabetes science and technology.

[9]  L. Jovanovic,et al.  Relationship of Fasting and Hourly Blood Glucose Levels to HbA1c Values , 2006, Diabetes Care.

[10]  J. Mastrototaro,et al.  The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. , 2008, Diabetes technology & therapeutics.

[11]  C. Cobelli,et al.  Real-Time Improvement of Continuous Glucose Monitoring Accuracy , 2013, Diabetes Care.

[12]  Luigi del Re,et al.  Performance Evaluations of Continuous Glucose Monitoring Systems: Precision Absolute Relative Deviation is Part of the Assessment , 2013, Journal of diabetes science and technology.

[13]  Comparison of the Numerical and Clinical Accuracy of Four Continuous Glucose Monitors , 2008, Diabetes Care.

[14]  Continuous Glucose Monitoring: Changing Diabetes Behavior in Real Time and Retrospectively , 2008, Journal of diabetes science and technology.

[15]  Boris Kovatchev,et al.  Evaluating the clinical accuracy of two continuous glucose sensors using continuous glucose-error grid analysis. , 2005, Diabetes care.

[16]  M. Liebert The accuracy of the Guardian RT continuous glucose monitor in children with type 1 diabetes. , 2008, Diabetes technology & therapeutics.

[17]  Howard C. Zisser,et al.  Accuracy of the SEVEN® Continuous Glucose Monitoring System: Comparison with Frequently Sampled Venous Glucose Measurements , 2009, Journal of diabetes science and technology.

[18]  L Heinemann,et al.  Continuous glucose monitoring: quality of hypoglycaemia detection , 2013, Diabetes, obesity & metabolism.

[19]  George Dailey,et al.  Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. , 2010, The New England journal of medicine.

[20]  J. Jendle,et al.  Continuous glucose monitoring--a study of the Enlite sensor during hypo- and hyperbaric conditions. , 2012, Diabetes technology & therapeutics.

[21]  Michael A. Wood,et al.  Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study , 2011, Diabetes Care.

[22]  R. Brazg,et al.  Accuracy of the 5-Day FreeStyle Navigator Continuous Glucose Monitoring System , 2007, Diabetes Care.

[23]  Guido Freckmann,et al.  Performance Evaluation of Three Continuous Glucose Monitoring Systems: Comparison of Six Sensors Per Subject in Parallel , 2013, Journal of diabetes science and technology.

[24]  Howard Zisser,et al.  Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. , 2006, Diabetes care.

[25]  C. Mathieu,et al.  Sensor‐augmented pump therapy lowers HbA1c in suboptimally controlled Type 1 diabetes; a randomized controlled trial , 2011, Diabetic medicine : a journal of the British Diabetic Association.

[26]  D. Cox,et al.  Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose , 1987, Diabetes Care.

[27]  L Heinemann,et al.  Glucose monitoring by microdialysis: performance in a multicentre study , 2009, Diabetic medicine : a journal of the British Diabetic Association.