Literature DB >> 28745098

Analysis of the Accuracy and Performance of a Continuous Glucose Monitoring Sensor Prototype: An In-Silico Study Using the UVA/PADOVA Type 1 Diabetes Simulator.

Marc D Breton1, Rolf Hinzmann2, Enrique Campos-Nañez1, Susan Riddle3, Michael Schoemaker2, Guenther Schmelzeisen-Redeker2.   

Abstract

BACKGROUND: Computer simulation has been shown over the past decade to be a powerful tool to study the impact of medical devices characteristics on clinical outcomes. Specifically, in type 1 diabetes (T1D), computer simulation platforms have all but replaced preclinical studies and are commonly used to study the impact of measurement errors on glycemia.
METHOD: We use complex mathematical models to represent the characteristics of 3 continuous glucose monitoring systems using previously acquired data. Leveraging these models within the framework of the UVa/Padova T1D simulator, we study the impact of CGM errors in 6 simulation scenarios designed to generate a wide variety of glycemic conditions. Assessment of the simulated accuracy of each different CGM systems is performed using mean absolute relative deviation (MARD) and precision absolute relative deviation (PARD). We also quantify the capacity of each system to detect hypoglycemic events.
RESULTS: The simulated Roche CGM sensor prototype (RCGM) outperformed the 2 alternate systems (CGM-1 & CGM-2) in accuracy (MARD = 8% vs 11.4% vs 18%) and precision (PARD = 6.4% vs 9.4% vs 14.1%). These results held for all studied glucose and rate of change ranges. Moreover, it detected more than 90% of hypoglycemia, with a mean time lag less than 4 minutes (CGM-1: 86%/15 min, CGM-2: 57%/24 min).
CONCLUSION: The RCGM system model led to strong performances in these simulation studies, with higher accuracy and precision than alternate systems. Its characteristics placed it firmly as a strong candidate for CGM based therapy, and should be confirmed in large clinical studies.

Entities:  

Keywords:  continuous glucose monitors; glucose measurements accuracy; in-silico study; simulation

Mesh:

Year:  2016        PMID: 28745098      PMCID: PMC5505429          DOI: 10.1177/1932296816680633

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  50 in total

1.  Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study.

Authors:  Marc D Breton; Boris P Kovatchev
Journal:  J Diabetes Sci Technol       Date:  2010-05-01

2.  Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 Diabetes in Canada.

Authors:  R Brett McQueen; Marc D Breton; Markus Ott; Helena Koa; Bruce Beamer; Jonathan D Campbell
Journal:  J Diabetes Sci Technol       Date:  2015-08-14

Review 3.  Continuous glucose monitoring: roadmap for 21st century diabetes therapy.

Authors:  David C Klonoff
Journal:  Diabetes Care       Date:  2005-05       Impact factor: 19.112

4.  Peculiarities of the continuous glucose monitoring data stream and their impact on developing closed-loop control technology.

Authors:  Boris Kovatchev; William Clarke
Journal:  J Diabetes Sci Technol       Date:  2008-01

5.  Hypoglycemia Reduction and Accuracy of Continuous Glucose Monitoring.

Authors:  Boris P Kovatchev
Journal:  Diabetes Technol Ther       Date:  2015-05-15       Impact factor: 6.118

6.  The UVA/PADOVA Type 1 Diabetes Simulator: New Features.

Authors:  Chiara Dalla Man; Francesco Micheletto; Dayu Lv; Marc Breton; Boris Kovatchev; Claudio Cobelli
Journal:  J Diabetes Sci Technol       Date:  2014-01-01

7.  Evaluation of the performance of a novel system for continuous glucose monitoring.

Authors:  Eva Zschornack; Christina Schmid; Stefan Pleus; Manuela Link; Hans-Martin Klötzer; Karin Obermaier; Michael Schoemaker; Monika Strasser; Gerhard Frisch; Günther Schmelzeisen-Redeker; Cornelia Haug; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2013-07-01

8.  Performance comparison of the medtronic sof-sensor and enlite glucose sensors in inpatient studies of individuals with type 1 diabetes.

Authors:  Peter Calhoun; John Lum; Roy W Beck; Craig Kollman
Journal:  Diabetes Technol Ther       Date:  2013-05-31       Impact factor: 6.118

9.  Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems.

Authors:  Satish K Garg; James Smith; Christie Beatson; Benita Lopez-Baca; Mary Voelmle; Peter A Gottlieb
Journal:  Diabetes Technol Ther       Date:  2009-02       Impact factor: 6.118

10.  Accuracy of Continuous Glucose Monitoring During Three Closed-Loop Home Studies Under Free-Living Conditions.

Authors:  Hood Thabit; Lalantha Leelarathna; Malgorzata E Wilinska; Daniella Elleri; Janet M Allen; Alexandra Lubina-Solomon; Emma Walkinshaw; Marietta Stadler; Pratik Choudhary; Julia K Mader; Sibylle Dellweg; Carsten Benesch; Thomas R Pieber; Sabine Arnolds; Simon R Heller; Stephanie A Amiel; David Dunger; Mark L Evans; Roman Hovorka
Journal:  Diabetes Technol Ther       Date:  2015-08-04       Impact factor: 6.118

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  2 in total

Review 1.  Toward a Framework for Outcome-Based Analytical Performance Specifications: A Methodology Review of Indirect Methods for Evaluating the Impact of Measurement Uncertainty on Clinical Outcomes.

Authors:  Alison F Smith; Bethany Shinkins; Peter S Hall; Claire T Hulme; Mike P Messenger
Journal:  Clin Chem       Date:  2019-08-23       Impact factor: 8.327

2.  Mathematical Models of Meal Amount and Timing Variability With Implementation in the Type-1 Diabetes Patient Decision Simulator.

Authors:  Nunzio Camerlingo; Martina Vettoretti; Simone Del Favero; Andrea Facchinetti; Giovanni Sparacino
Journal:  J Diabetes Sci Technol       Date:  2020-09-17
  2 in total

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