Glucose Monitoring Devices: Measuring Blood Glucose to Manage and Control Diabetes PDF
Preview Glucose Monitoring Devices: Measuring Blood Glucose to Manage and Control Diabetes
Glucose Monitoring Devices Measuring Blood Glucose to Manage and Control Diabetes Edited by Chiara Fabris, PhD Assistant Professor Center for Diabetes Technology Department of Psychiatry and Neurobehavioral Sciences University of Virginia Charlottesville, Virginia United States Boris Kovatchev, PhD Professor and Director Center for Diabetes Technology Department of Psychiatry and Neurobehavioral Sciences University of Virginia Charlottesville, Virginia United States AcademicPressisanimprintofElsevier 125LondonWall,LondonEC2Y5AS,UnitedKingdom 525BStreet,Suite1650,SanDiego,CA92101,UnitedStates 50HampshireStreet,5thFloor,Cambridge,MA02139,UnitedStates TheBoulevard,LangfordLane,Kidlington,OxfordOX51GB,UnitedKingdom Copyright©2020ElsevierInc.Allrightsreserved. Nopartofthispublicationmaybereproducedortransmittedinanyformorbyany means,electronicormechanical,includingphotocopying,recording,oranyinformation storageandretrievalsystem,withoutpermissioninwritingfromthepublisher.Detailson howtoseekpermission,furtherinformationaboutthePublisher’spermissionspolicies andourarrangementswithorganizationssuchastheCopyrightClearanceCenterandthe CopyrightLicensingAgency,canbefoundatourwebsite:www.elsevier.com/permissions. Thisbookandtheindividualcontributionscontainedinitareprotectedundercopyright bythePublisher(otherthanasmaybenotedherein). Notices Knowledgeandbestpracticeinthisfieldareconstantlychanging.Asnewresearchand experiencebroadenourunderstanding,changesinresearchmethods,professional practices,ormedicaltreatmentmaybecomenecessary. Practitionersandresearchersmustalwaysrelyontheirownexperienceandknowledgein evaluatingandusinganyinformation,methods,compounds,orexperimentsdescribed herein.Inusingsuchinformationormethodstheyshouldbemindfuloftheirownsafety andthesafetyofothers,includingpartiesforwhomtheyhaveaprofessional responsibility. Tothefullestextentofthelaw,neitherthePublishernortheauthors,contributors,or editors,assumeanyliabilityforanyinjuryand/ordamagetopersonsorpropertyasa matterofproductsliability,negligenceorotherwise,orfromanyuseoroperationofany methods,products,instructions,orideascontainedinthematerialherein. LibraryofCongressCataloging-in-PublicationData AcatalogrecordforthisbookisavailablefromtheLibraryofCongress BritishLibraryCataloguing-in-PublicationData AcataloguerecordforthisbookisavailablefromtheBritishLibrary ISBN:978-0-12-816714-4 ForinformationonallAcademicPresspublicationsvisitourwebsiteat https://www.elsevier.com/books-and-journals Publisher:MaraConner AcquisitionsEditor:FionaGeraghty EditorialProjectManager:IsabellaC.Silva ProductionProjectManager:KiruthikaGovindaraju CoverDesigner:MilesHitchen TypesetbyTNQTechnologies Contributors Giada Acciaroli, PhD Department ofInformation Engineering, University of Padova, Padova, Italy David Ahn,MD ProgramDirector, Mary &Dick Allen DiabetesCenter,Hoag Memorial Hospital Presbyterian, NewportBeach,CA, United States Tadej Battelino, MD, PhD Department ofEndocrinology,Diabetes and Metabolism, University children’s hospitalUniversity Medical CentreLjubljana, Ljubljana,Slovenia; Faculty of Medicine, University ofLjubljana, Ljubljana,Slovenia Rachel Brandt, BSc Illinois Institute ofTechnology,Biomedical Engineering, Chicago,IL, United States Marc D. Breton, PhD AssistantProfessor,Center for DiabetesTechnology,Department of Psychiatry andNeurobehavioralSciences,UniversityofVirginia,Charlottesville,VA,United States Enrique Campos-Na´n˜ez, PhD Principal Algorithm Engineer,Research& Development, DexcomInc, Charlottesville,VA,UnitedStates Ali Cinar, PhD Professor,Chemical and BiologicalEngineeringDepartment,Illinois Instituteof Technology,Chicago,IL, United States William L. Clarke,MD Profesor, EmeritusofPediatric Endocrinology,Department ofPediatrics, University ofVirginia, Charlottesville, VA, United States Claudio Cobelli,PhD Department ofInformation Engineering, University of Padova, Padova, Italy Andrew DeHennis, PhD Sr.Director ofEngineering, R&D, Product Development Senseonics Incorporated, Germantown, MD, UnitedStates Simone Del Favero, PhD AssistantProfessor,Department ofInformation Engineering, Padova, Italy Laya Ekhlaspour,MD Instructor,PediatricEndocrinology,StanfordUniversity,PaloAlto, CA, United States xiii xiv Contributors Chiara Fabris, PhD AssistantProfessor,Center for DiabetesTechnology,Department ofPsychiatry andNeurobehavioralSciences,UniversityofVirginia,Charlottesville,VA,United States Andrea Facchinetti,PhD Department ofInformation Engineering, University ofPadova, Padova, Italy Gregory P.Forlenza, MD AssistantProfessor,BarbaraDavisCenter,UniversityofColoradoDenver,Aurora, CO, United States Kurt Fortwaengler,PMP Disease Modeling, Global MarketAccess, Roche Diabetes Care, Mannheim, Germany Satish Garg, MD Professor of Pediatrics and Medicine, Barbara Davis Center for Diabetes Adult Clinic, University of Colorado Anschutz Medical Center,Aurora,CO, United States Iman Hajizadeh,MSc Research Assistantand PhD Student,Chemical and BiologicalEngineering, Illinois InstituteofTechnology,Chicago,IL, United States Nicole Hobbs, BSc Graduate Research Assistant,Department ofBiomedicalEngineering, Illinois Instituteof Technology, Chicago,IL, United States David Klonoff,MD, FACP,FRCP (Edin), Fellow AIMBE Medical Director,DiabetesResearch Institute,Mills-Peninsula Medical Center, San Mateo, CA,United States Boris Kovatchev,PhD Professor and Director,Center for Diabetes Technology,Department of PsychiatryandNeurobehavioral Sciences, University of Virginia, Charlottesville, Virginia, United States Mark Mortellaro, PhD DirectorofChemistry,SenseonicsIncorporated,Germantown,MD,UnitedStates Laura M. Nally,MD AssociateProfessor,PediatricEndocrinology,YaleChildren’sDiabetesProgram, Yale University School ofMedicine, New Haven, CT, United States Nick Oliver,FRCP Wynn Professor ofHuman Metabolism, Consultant in Endocrinology, Diabetes and Internal Medicine, ImperialCollege London,St. Mary’s Hospital Medical School Building, London,UnitedKingdom Contributors xv Mudassir Rashid, PhD,BEng SeniorResearchAssociate,DepartmentofChemicalandBiologicalEngineering, Illinois Institute ofTechnology,Chicago, IL,UnitedStates Monika Reddy,MBChB, MRCP (UK), PhD Honorary Senior Clinical Lecturer,Consultant in Endocrinology, Diabetes and Internal Medicine,Imperial College London,St. Mary’s Hospital Medical School Building,London,United Kingdom Amanda Rewers, MD ResearchAssistant,BarbaraDavisCenterforDiabetesAdultClinic,Aurora,CO, United States Sediqeh Samadi,MSc IllinoisInstituteofTechnology,ChemicalandBiologicalEngineering,Chicago,IL, United States Mert Sevil, MSc ResearchAssistantandPhDStudent,BiomedicalEngineering,IllinoisInstituteof Technology,Chicago,IL, United States ViralN.Shah,MD AssistantProfessor ofPediatrics and Medicine,BarbaraDavis Center for DiabetesAdultClinic, University of Colorado Anschutz Medical Center,Aurora, CO, United States JenniferL. Sherr,MD, PhD Instructor,PediatricEndocrinology,Yale Children’sDiabetes Program, Yale University School ofMedicine, New Haven, CT, United States DarjaSmigocSchweiger,MD, PhD Department ofEndocrinology,Diabetes and Metabolism, University children’s hospitalUniversity Medical CentreLjubljana, Ljubljana,Slovenia; Faculty of Medicine, University ofLjubljana, Ljubljana,Slovenia GiovanniSparacino,PhD Department ofInformation Engineering, University of Padova, Padova, Italy Chukwuma Uduku,MBBS, BSc,MRCP ClinicalResearchFellowandSpecialistRegistrarinEndocrinology,Diabetesand Internal Medicine,Imperial College London,St. Mary’s Hospital Medical School Building,London,United Kingdom Martina Vettoretti, PhD Department ofInformation Engineering, University of Padova, Padova, Italy About the Authors Dr.ChiaraFabrisisAssistantProfessorattheUniversityofVirginiaSchoolofMed- icineandmemberofthefacultyattheCenterforDiabetesTechnology.Sheholdsa Master’s and a Doctoral Degree in Bioengineering from the University of Padova (Padova, Italy) and has significant experience in mathematical modeling and simulationdespeciallyregarding theglucose/insulin regulationsystemdand algo- rithmdevelopment.Overthepast4years,Dr.FabrishasbeenawardedanAdvanced PostdoctoralFellowshipandaCareerDevelopmentAwardbytheJuvenileDiabetes ResearchFoundation,whichsupportedthedevelopmentandclinicaltestingofdeci- sionsupportsystemstohelppeoplewithdiabetesmanagetheirdisease.Dr.Fabrisis involvedinseveralprojectsfocusedonoptimizationoftreatmentsfordiabetesand diabetesdata science. Dr. Boris Kovatchev is Professor at the University of Virginia School of Medicine and School of Engineering and founding director of the Center for Diabetes Tech- nology. He has a 30-year track record in mathematical modeling, biosimulation, and algorithm development. Currently, he is Principal Investigator of several pro- jectsdedicatedtoDiabetesDataScienceandthedevelopmentofartificialpancreas anddecisionsupportsystems,includingthelarge-scaleNIHInternationalDiabetes Closed-LoopTrialandtheUVAStrategicInvestmentFundproject“PrecisionIndi- vidualized Medicine for Diabetes”. Dr. Kovatchev is author of over 200 peer-reviewed publications andholds 85patents. xvii CHAPTER 1 Introduction to SMBG Darja Smigoc Schweiger, MD, PhD,Tadej Battelino, MD, PhD DepartmentofEndocrinology,DiabetesandMetabolism,Universitychildren’shospitalUniversity MedicalCentreLjubljana,Ljubljana,Slovenia;FacultyofMedicine,UniversityofLjubljana, Ljubljana,Slovenia Historical perspective and principles of blood glucose control AsBenedictdevelopedacopperreagentforurineglucose,urineglucosetestinghas beenthemainmethodfordiabetesmonitoringfor50years[1].Later,amoreconve- nient and specific “dip-and-read” urineglucose oxidase-based reagent strip (Clini- stix) was introduced [2]. However, urine tests had several well-recognized limitations. High glucose levels were detected only when the renal threshold for glucosewas exceeded over a period of several hours and the results were affected byfluidintakeandurineconcentration.Moreover,thetestdidnotdetectlowglucose levels [3]. In the 1960s, first blood glucose (BG) test strips (Dextrostix) were developed. The exposure to blood resulted in a colorimetric reaction proportional to blood glucose concentration. The color change that occurred was compared to a color chart providing a semiquantitative assessment of blood glucose levels [4]. The first blood glucose meter, the Ames Reflectance Meter, was introduced in 1970. The meter exhibited quantitative blood glucose results based on Dextrostix teststripsandreflectancephotometry,thuseliminatingvisualreadingerrors.There- sultsweredisplayedbyamovingpointeronthreeanalogscales[5].Thedevicewas only available for testing in a doctor’s office and hospital emergency departments [6]. Although the meter was heavy, expensive, and cumbersome to use, it ushered the development in an era of blood glucose monitoring systems. In 1972, more convenient Eyetone glucometer using Dextrostix test strips was developed, which wasmoreprecise,lighter,andeasiertooperate[7].In1974,BoehringerMannheim launchedReflomat,areflectancemeterwithmodifiedreagentteststrips(Reflotest), equippedtoacceptsmallervolumesofblood,whichwasremovedmoreeasilyand thus more suitable for at-home self-monitoring of blood glucose (SMBG) [6]. Dextrometer and Glucochek launched, in 1980, were the first glucometers with digitaldisplay[8].Technologicaladvancesduring1980smadeglucometerssmaller and easier to use with built-in software to store and retrieve results [6]. The One Touch meter introduced in 1987 was regarded as the first second-generation blood glucose meter because it utilized an improved sampling procedure that eliminated 3 GlucoseMonitoringDevices.https://doi.org/10.1016/B978-0-12-816714-4.00001-6 Copyright©2020ElsevierInc.Allrightsreserved. 4 CHAPTER 1 Introduction to SMBG bloodremovalstepandtheneedfortimereactions[9].Towardtheendofthe1980s, test strips changed dramaticallywhenelectrochemicalprinciples tomeasure blood glucosewereintroduced.Furthermore,theintroductionofelectrochemicaltechnol- ogy led to the development of the third generation of glucose monitoring systems [10]. The landmark in glucose self-monitoring was the release of the first electro- chemical blood glucose monitor, ExacTech by Medisense, in 1987. The device used an enzyme electrode strip containing glucose oxidase and ferrocene as an electron transfer mediator. A current generated at the electrode was detected by anamperometricsensor[11]. Today, most glucometersare electrochemical,using commercial screen-printed stripsbasedonthesameprinciple.Theyrequireasmallerbloodsampleandprovide resultsinafewseconds.Glucoseoxidaseandglucosedehydrogenasearetwotypes ofenzymesthathavebeenusedforcommercialelectrochemicalbloodglucosetest strips. Test strips using glucose oxidase technology are susceptible to dissolved oxygenconcentrationsandcanonlybeusedwithcapillarybloodinanormalrange of oxygen levels. Glucose dehydrogenase-based test strips are not sensitive to oxygen[12].However,coenzymepyrroloquinolinequinoneandglucosedehydroge- nase containing test strips lack specificity as they cross-react with maltose, galactose, and xylose. Therefore they must not be used by patients on peritoneal dialysis [13]. The most common electrochemical detection methods for glucose measurement are amperometry and coulometry [12]. Coulometric strips have demonstrated to operate over the wider ranges of hematocrit values and with the minimized effect of temperature, high concentrations of paracetamol, uric acid, and vitamin C [14]. The performance of glucometers has further improved with simplified sampling and testing procedures to minimize user interaction errors. Meters using no-coding technology are precalibrated to report whole blood or plasmaequivalentresults[15].Mostcurrentmetersareplasmacalibratedandauto- matically convertresults into plasma equivalentresults [16].Modern electrochem- ical blood glucose test strips use the capillary gap to automatically draw blood into the test surface, which requires only a small volume of blood (just about 0.3mL) and has automatic fill detection ensuring that sufficient volume of blood is provided to the strip. The average test time has been reduced to just less than 5s [17]. In addition, lower blood volume requirements allow alternative sites for blood glucose testing such as arm or thigh that are likely to be less painful and providesimilarresultstothefingertip[18].However,whenbloodglucoseischang- ingrapidly,significantdifferencesinbloodglucoseresultscanbeanticipateddueto thetimelagofupto20minatalternativesites[19].Thereforetestingatalternative sitesisnotrecommendedwithintheearlypostmealperiod,immediatelyafterexer- cise or when blood glucose is suspected to be low [20]. Some fully automated devices have integral lacing device and extract blood by drawing a vacuum over a lanced site [21].Newermetersofferdata-storagesoftware thatcan bedownloaded and used by diabetes management systems for the graphical display of trends, statistics,andsharingofreports[22].Downloadinginformationfrombloodglucose meters enables the analysis of large amounts of data that reveal glycemic patterns The evidence base for SMBG in type 1 diabetes 5 andsupportpersonswithdiabetesandhealthcareprofessionalstomakeappropriate management strategies [23]. Data retrieval has further improved with wireless connectivity to smartphone apps [24]. The analytical quality of personal blood glucosemetersusedforat-homemonitoringisimportantasappropriatetherapeutic decisionsrelyonaccurateglucosereadings.Standardizedqualityamongmanufac- turers is required by the regulatory recommendations and analytical performance criteria. In 2003, the International Organization for Standardization (ISO) criteria for glucose meters were introduced. The ISO 15197: 2003 standard recommended an allowable error of (cid:1)15mg/dL for blood glucose levels <75mg/dL and (cid:1)20% for blood glucose levels (cid:3)75mg/dL [25]. These criteria were updated in ISO 15197:2013 standard, which required an allowable error of (cid:1)15mg/dL for BG concentrations <100mg/dL and (cid:1)15% for BG concentrations (cid:3)100mg/dL [26]. In the United States, the Food and Drug Administration (FDA) standard finalized in 2016 recommended that at least 95% of measurement results shall fall within (cid:1)15% of the reference value at blood glucose concentrations <100mg/dL and (cid:1)15% at (cid:3)100mg/dL, thus requiring greater hypoglycemia accuracy than the ISO 15197:2013 [27]. The evidence base for SMBG in type 1 diabetes RichardBernsteinwasthefirstreportedpersonwithtype1diabetes(T1D)toadopta glucometerforpersonaluse.Withfrequentglucosemonitoring,hewasabletorefine insulin doses and diet regimen to maintain essentiallynormal blood glucose levels and prevent hypoglycemia. However, he failed to publish his personal experience usingSMBGuntil heearneda medicaldegreeinthe early 1980s [28].In the mid- 1970s, peoplewith diabetes for the first time started using reflectance glucometers Eyetone and Reflomat at home for SMBG. In 1978, first experiences in teaching peoplewithinsulin-dependentdiabetestomeasuretheirownbloodglucoseconcen- trations were published [29e34]. Direct measurement of blood glucose by people with diabetes at home provided sufficiently accurate results for easier and more predictable adjustment of insulin doses over the urine-glucose analysis [35]. Frequent SMBG as a guide to multiple injections of insulin has considerably improved metabolic control and could guard against undue hypoglycemia [36]; it was well accepted by persons with diabetes and improved their understanding of diabetes and motivation to become more involved in their own care [37]. Due to the growing evidence in the late 1970s that chronic complications of diabetes can be minimized with glycemic control, daily SMBG gained wider acceptance [38]. In addition, improved glycemic control could objectively be assessed by the measurement of glycated hemoglobin levels [39]. Over the next decade, SMBG proved tobe one ofthe major technological advances inaddition tomultiple daily insulininjectionsandthenewlydevelopedinsulinpumpsthatestablishedintensive insulin therapy, a therapeutic strategy that has become increasingly used in an attempt to achieve near-normal glycemia [40,41]. In the 1980s, smaller, more
The list of books you might like
