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In silico assessment of biomedical products: The conundrum of rare but not so rare events in two case studies

Marco Viceconti, Claudio Cobelli, Tarek Haddad, Adam Himes, Boris Kovatchev, Mark Palmer
2017 Proceedings of the Institution of mechanical engineers. Part H, journal of engineering in medicine  
replacement for animal testing in the pre-clinical assessment of artificial pancreas technologies, and the second an investigation of the probability of cardiac lead fracture, where a Bayesian network  ...  was used to combine in vivo and in silico observations, suggesting a whole new strategy of in silico-augmented clinical trials, to be used to increase the numerosity where recruitment is impossible, or  ...  variability of key metabolic parameters in the general population of people with type 1 and type 2 diabetes.  ... 
doi:10.1177/0954411917702931 pmid:28427321 fatcat:2z4im3je4zcvhg5e7gblfqsiv4

Modeling and Control of Diabetes: Towards the Artificial Pancreas

Giuseppe De Nicolao, Lalo Magni, Chiara Dalla Man, Claudio Cobelli
2011 IFAC Proceedings Volumes  
The main topics include the role of large-scale simulation models used to carry out in silico trials, the discussion of the specific features of the glucose control problem, the layered architecture of  ...  The paper offers a survey of some major simulation and control issues associated with the development of an Artificial Pancreas.  ...  development and in vivo validation of algorithms for blood glucose control'  ... 
doi:10.3182/20110828-6-it-1002.03036 fatcat:qw25jnrblbbdpdznzzuum7eieu

Improving glycemic control in critically ill patients: personalized care to mimic the endocrine pancreas

J. Geoffrey Chase, Thomas Desaive, Julien Bohe, Miriam Cnop, Christophe De Block, Jan Gunst, Roman Hovorka, Pierre Kalfon, James Krinsley, Eric Renard, Jean-Charles Preiser
2018 Critical Care  
Indeed, recent evidence suggests GC is difficult to safely and effectively achieve for all patients.  ...  Finally, we provide a set of concise recommendations to advance the safety, quality, consistency, and clinical uptake of GC in critical care.  ...  type 1 diabetes [4] .  ... 
doi:10.1186/s13054-018-2110-1 pmid:30071851 pmcid:PMC6091026 fatcat:wvgjjvm36zfavmubpfbrpnjjna

In Silico Preclinical Trials: Methodology and Engineering Guide to Closed-Loop Control in Type 1 Diabetes Mellitus

Stephen D. Patek, B. Wayne Bequette, Marc Breton, Bruce A. Buckingham, Eyal Dassau, Francis J. Doyle, John Lum, Lalo Magni, Howard Zisser
2009 Journal of Diabetes Science and Technology  
Boris Kovatchev for many helpful suggestions in preparing this manuscript.  ...  Acknowledgements: The authors gratefully acknowledge financial support from the Juvenile Diabetes Research Foundation Artificial Pancreas Project. We thank Dr.  ...  The consortium is focused on the development of an artificial pancreas for the control of type 1 diabetes mellitus (T1DM) to be built from off-theshelf interstitial continuous glucose monitoring (CGM)  ... 
doi:10.1177/193229680900300207 pmid:20144358 pmcid:PMC2771529 fatcat:vhlywd7q4zfvpasthuh4yhrvha

Simulation Environment to Evaluate Closed-Loop Insulin Delivery Systems in Type 1 Diabetes

Malgorzata E. Wilinska, Ludovic J. Chassin, Carlo L. Acerini, Janet M. Allen, David B. Dunger, Roman Hovorka
2010 Journal of Diabetes Science and Technology  
We present a simulation environment designed to support the development and testing of closed-loop insulin delivery systems in type 1 diabetes mellitus (T1DM).  ...  monitoring need to be evaluated in humans, but progress can be accelerated with the use of in silico testing.  ...  Acknowledgements: Support by the Clincip Project, the Juvenile Diabetes Research Foundation, Diabetes UK, MRC CORD, and NIHR Cambridge Biomedical Research Centre is acknowledged.  ... 
doi:10.1177/193229681000400117 pmid:20167177 pmcid:PMC2825634 fatcat:7hcyyh3v7bcwrcnv4rlfnbvk3m

Tests on a virtual patient for an observer-based, closed-loop control of plasma glycemia

P. Palumbo, G. Pizzichelli, S. Panunzi, P. Pepe, A. De Gaetano
2011 IEEE Conference on Decision and Control and European Control Conference  
That means: a minimal model of the glucose-insulin system to design the insulin therapy, and a different, more detailed, comprehensive model to test in silico the control scheme.  ...  for the closed-loop control and to show in fact the robustness of the proposed approach.  ...  In [24] we do take into account spontaneous pancreatic IDR, thereby treating healthy, Type 2 diabetic and Type 1 diabetic patients in a unified fashion.  ... 
doi:10.1109/cdc.2011.6160534 dblp:conf/cdc/PalumboPPPG11 fatcat:2l7wrlkwkvdydmczjvpiw3t6iq

Artificial Pancreas: Past, Present, Future

Claudio Cobelli, Eric Renard, Boris Kovatchev
2011 Diabetes  
In silico preclinical trials: a proof of concept in closed-loop control of type 1 diabetes. J Diabetes Sci Tech 2009;3:44-55 33.  ...  FIG. 5 . 5 Principal component of the type 1 diabetes simulator: a model of the glucose-insulin system, a model of the sensor, a model of the insulin pump and subcutaneous insulin kinetics, and the controller  ... 
doi:10.2337/db11-0654 pmid:22025773 pmcid:PMC3198099 fatcat:czfotohmczeprif5mxrbmqtphi

Proposed Clinical Application for Tuning Fuzzy Logic Controller of artificial Pancreas Utilizing a Personalization Factor

Richard Mauseth, Youqing Wang, Eyal Dassau, Robert Kircher, Donald Matheson, Howard Zisser, Lois Jovanovič, Francis J. Doyle
2010 Journal of Diabetes Science and Technology  
The proposed method was developed using a database of results from 30 University of Virginia/Padova Metabolic Simulator in silico subjects (10 adults, 10 adolescents, and 10 children).  ...  Results: Three examples of a wide variation in diabetes situations are given to illustrate the physician's thought process when initially configuring the AP system for a specific patient.  ...  The use of the in silico simulation results aids in patient instruction and initial decision making.  ... 
doi:10.1177/193229681000400422 pmid:20663457 pmcid:PMC2909525 fatcat:wos4esq7hvgunbktpxm6u2qipi

In-Silico Trials for Glucose Control in Hospitalized Patients with Type 2 Diabetes

Karam Choi, Tae Jung Oh, Jung Chan Lee, Myungjoon Kim, Hee Chan Kim, Young Min Cho, Sungwan Kim
2016 Journal of Korean medical science  
with type 2 diabetes (T2D).  ...  Although various basal-bolus insulin therapy (BBIT) protocols have been used in the clinical environment, safer and more effective BBIT protocols are required for glucose control in hospitalized patients  ...  DISCLOSURE All authors declare no conflicts of interest. AUTHOR CONTRIBUTION  ... 
doi:10.3346/jkms.2016.31.2.231 pmid:26839477 pmcid:PMC4729503 fatcat:x32szfgs7rdf5icghinhqswgjy

Clinical Implications of Accuracy Measurements of Continuous Glucose Sensors

Timothy S. Bailey
2017 Diabetes Technology & Therapeutics  
The accuracy of a continuous glucose monitor (CGM) now supports its use by persons with diabetes and clinicians caring for them.  ...  This article reviews measures of CGM accuracy, factors contributing to accuracy, comparative accuracy assessment, clinical implications of CGM sensor accuracy, and recent clinical trials that have demonstrated  ...  Recent Clinical Trials The adjunctive use of CGM with type 1 diabetes is now well accepted, particularly in patients using insulin pumps.  ... 
doi:10.1089/dia.2017.0050 pmid:28541134 pmcid:PMC5444490 fatcat:ahmadg6oovaz7gzyoa3cazsobq

Flash Continuous Glucose Monitoring and its IMPACT to REPLACE Blood Glucose Monitoring in the Management of Type 1 and Type 2 Diabetes

Stephen M Twigg, Mahmood R Kazemi, Maria E Craig
2017 US Endocrinology  
Methods: Two recent six-month, prospective, multicenter, randomized controlled trials in type 1 (IMPACT; NCT02232698) and type 2 (REPLACE; NCT02082184) diabetes compared flash CGM with SMBG under otherwise  ...  The purpose of this article is to critically review the recent outcome data from randomized controlled trials that assessed the efficacy and safety of flash CGM to replace routine SMBG in diabetes management  ...  These benefits were accompanied by significant decreases in blood glucose testing and effective replacement of sensor readings for SMBG in treatment decisions.  ... 
doi:10.17925/use.2017.13.02.57 fatcat:aus3zod5hbhl5mviljwparwmjq

Exploring the Power and Promise of In Silico Clinical Trials with Application in COVID-19 Infection

Abdelrahman H. Abdelmoneim, Safinaz I. Khalil, Hiba Awadelkareem Osman Fadl, Ayesan Rewane, Sahar G. Elbager
2021 Sudan Journal of Medical Sciences  
Methods: Using the PubMed database, we analyzed six relevant scientific articles regarding the possible application of in silico clinical trials in testing the therapeutic and investigational methods of  ...  Results: Successful use of in silico trials was observed in many of the reviewed evidence. Conclusion: In silico clinical trials can be used in refining clinical trials for COVID-19 infection.  ...  Acknowledgements The authors would like to thank Israa Isam for helping in designing Figure 1 . Ethical Considerations Not required.  ... 
doi:10.18502/sjms.v16i3.9697 fatcat:qmaw3blnqrfcti2o3mwmbmujru

Continuous Glucose Monitoring Sensors: Past, Present and Future Algorithmic Challenges

Andrea Facchinetti
2016 Sensors  
CGM sensors have revolutionized Type 1 diabetes (T1D) management, improving glucose control when used adjunctively to self-monitoring blood glucose systems.  ...  episodes based on the prediction of future glucose concentration, automatic basal insulin attenuation methods for hypoglycemia prevention, and the artificial pancreas.  ...  carbohydrate IG interstitial glucose ISCT in silico clinical trial MARD mean absolute relative difference SMBG self-monitoring blood glucose T1D Type 1 diabetes T1D-  ... 
doi:10.3390/s16122093 pmid:27941663 pmcid:PMC5191073 fatcat:4yxftwnybvfrnec67cv4nyo4nu

Diabetes: Models, Signals and control

C Cobelli
2010 Journal of Physics, Conference Series  
architecture for building closed-loop control systems, including insulin delivery and patient safety supervision layers.  ...  It began with modeling of the insulin-glucose system, and progressed to large-scale in silico experiments, and automated closed-loop control (artificial pancreas).  ...  Type 1 Diabetes Simulator A type 1 diabetes version of the simulator would be critical for the preclinical testing of control strategies in artificial pancreas studies.  ... 
doi:10.1088/1742-6596/238/1/012003 fatcat:qztkq6ec2fgipecz5j6hdogm7m

Diabetes: Models, Signals, and Control

C. Cobelli, C. Dalla Man, G. Sparacino, L. Magni, G. De Nicolao, B.P. Kovatchev
2009 IEEE Reviews in Biomedical Engineering  
architecture for building closed-loop control systems, including insulin delivery and patient safety supervision layers.  ...  It began with modeling of the insulin-glucose system, and progressed to large-scale in silico experiments, and automated closed-loop control (artificial pancreas).  ...  Type 1 Diabetes Simulator A type 1 diabetes version of the simulator would be critical for the preclinical testing of control strategies in artificial pancreas studies.  ... 
doi:10.1109/rbme.2009.2036073 pmid:20936056 pmcid:PMC2951686 fatcat:odoyz3bmardblfvaqplvzesmei
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