BestPracticeGuidance

Developmentofaformularyfor
bloodglucosetestingdevices

BestPracticeConsensusGroup
July2014

Foreword
WeareallacutelyawareofthesignificantburdendiabetesplacesonpatientsandtheNHS,bothin
termsoftheburdenofdiseaseandalsothefinancialandcapacityburdenonthehealthsystemasa
whole.Supportingpatientstoachievegoodglycaemiccontrolisthereforeapriority,reducingthe
riskofcomplications,A&Eattendances,hospitaladmissionsandprematuredeath.Patientsandtheir
cliniciansreportthatselfmonitoringofbloodglucose,supportedbyongoingpatienteducation,
helpspatientsmakelifestyleandtreatmentchoicesaswellasmonitoringsymptomsofhypoor
hyperglycaemiaandtargetglucoselevels.
Butwithaplethoraoftestingdevicesandstripsonthemarket,GPsinmanyareasdonothave
accesstoahighquality,regularlyupdated,clearandevidencebasedguidancetohelpthemmake
decisionsonappropriatedeviceselectionandtestingregime.Theresultisafurtherburdenonbusy
GPstosiftthroughtheevidencethemselves,andunwarrantedvariationwiththewastedresource
andsuboptimaloutcomesthatresult.
Cliniciansandpatientrepresentativeshavebeenequallyconcernedaboutthisandthepotentiallost
opportunitytoimprovepractice,generatesavingsfortheNHSandimprovethechanceofpeople
withdiabetestobetterselfmanagetheircondition.ThisiswhytheConsensusGroupofpatient
representatives,medicinesmanagementadvisorsandexpertsonmedicaltechnologymetanddrew
uptheseguidelines.
IwelcometheworkoftheConsensusGroupindrawingupthismuchneededguidanceandhope
youfindthemusefulindrawingupformulariesforbloodglucosetestingdevicesthatmeetyour
localneeds,andreducetheburdenofdiabetesonyourpatientsandhealtheconomies.
AdrianSandersMP

Chair,AllPartyParliamentaryGrouponDiabetes

Thisconsensusguidelinehasbeendevelopedthroughanunrestrictedmedicaleducationgrant
fromRocheDiabetesCare.

Page|2

Overview
Selfmonitoringofbloodglucose,supportedbyongoingpatienteducation,offersthepotentialof
healthbenefitsandfinancialsavingsinthereductioninA&Eattendances,hospitaladmissions,cost
ofmanagingcomplicationsandinmoreappropriateuseofhealthcareprofessionals.
Localformulariescanoffersupporttocliniciansinmakingchoicesbetweenthedifferenthealthcare
technologiesavailable,includingmetersandtestingstrips,todeliverthebestoutcomesforpatients
andthemosteffectiveuseofavailableresources.Todoso,formulariesneedtobedeveloped
throughastringentprocessbyasuitablyqualifiedgroupofhealthcareprofessionals,withpatient
supportandadvice.
Thisguidehasbeenpreparedtohelplocalhealtheconomiesdrawupformulariesthatenablethem
totakeaccountoflocalneedsandtheviewsoflocalcliniciansandpatients.Itisbasedonfindingsof
theConsensusGroup,membershipofwhichincludesnationalexpertsondiabetes,diabetestesting
andmedicinesmanagement.ItdoesnotrepresentofficialUKpolicy,butsimplyguidanceongood
practiceNHScommissionersandprovidersmaychoosetofollow.ItdrawsontheNICEMedicines
PracticeGuidelinesupdatedinFebruary2014onthedevelopingandupdatinglocalformularies
(MPG1)andappliesthisspecificallytobloodglucosetesting.
Aformularyshouldbealivingdocument,fluidanddynamictoensureitmeetstheneedsofpatients
andkeepstrackofinnovationintheindustry.Regularauditisrequiredtomonitorwhichdevicesare
actuallybeingused,patientsatisfactionandwhetherthedevicesupportsachievementofthe
requiredoutcome.Therealsoneedstobearapidreviewprocesssoresultsfromlocalauditsandthe
introductionofinnovativenewtechnologycanbeappropriatelyassessedandchangesmadetothe
formularyasquicklyaspracticable.Transparencyandclearcommunicationandengagement
betweenlocalcliniciansandpatients,bothindevelopmentoftheformularyandinusingitin
practice,willmeantheformularywillbeusedappropriatelyandwithconfidence.
Byusingthisdocument,bloodglucosetestingformulariescanbedeveloped,coveringawiderange
ofclinicallyandcosteffectiveproducts,supportedbyaneducationprocessthatcanimprovelocal
diabetescareandclinicaloutcomes.

Page|3

Whydevelopaformularyforbloodglucosetesting?
Thebenefitsofusingalocalformularyformedicinesmanagementarealreadywellestablishedand
theiruseroutine.Awelldevelopedlocalformularyforbloodglucosetestingisparticularlyimportant
giventheprevalenceofdiabetes,thepotentialtoreducecomplicationsandachievefinancialand
healthsavingsfromachievingoptimalglucosecontrol.
Thebenefitsofarobustlocalformularyindiabetestestingcouldinclude:

Improvingqualityandpatientoutcomesbyoptimisingtheuseofavailabledevicesandstrips
andcarepathwaysandreducingunwarrantedvariation.Aformularywillhelpcliniciansmake
themostappropriatechoicebetweenthewiderangeofavailabledevices,includingnew
productsthatbecomeavailable.Themostappropriateselectionofadeviceandstrip,
supportedbyeducationforpatients,willsupportpatientstobetterusetheirdevices,
understandtheresultsandtakeactionasaconsequence,includinglifestylechangesand
seekinghealthcareadviceonalteringatreatmentregime.Thisinturnwillreducetheriskof
longtermcomplicationsfromdiabetesdeveloping.Complicationsfrompoormanagementof
diabetespresentasubstantialburdentobothindividualhealthandtotheNHS.

Supportingtheinclusionofpatientfactorsindecisionmaking.Differentpatientshave
differentneeds,forexample,thosethattestinfrequentlytocheckforhypoglycaemiatothose
thattestfrequentlyandwillchangetheirtreatmentonthebasisoftheresults.Agood
formularywillenableeverypatienttogainaccesstoanappropriatedevicethatwillmeettheir
needsandachieveoptimalclinicaloutcomes.

Supportinggoodfinancialmanagement.Throughimprovingaccesstocosteffectiveproducts
butmoresignificantlythroughsegmentingpatienttestingdevicesbasedonclinicalneedto
facilitatingbettermanagementofdiabetes,reducingthecostofmanagingdiabetesandits
complicationsincludingthecostofemergencyhospitalattendancesandadmissions,and
managingsecondaryconditions,includingeyeandfootconditions,cardiovascularandkidney
disease.

Supportingthesupplyarrangementsofbloodglucosetestingdevicesandlancetsacrossalocal
healtheconomy,ensuringasafeandstablesupplychain,availabilityofproductsdirectlyorviaa
wholesaler,particularlyincasesofemergencysupply,outofhoursandatweekends.

Page|4

Thevalueofbloodglucosetesting
TheknowndiagnosedpopulationoftheUKwithdiabetesisapproximately3.2million(DiabetesUK
statistics).Approximately10%ofthepeoplewithdiabeteswillhavetype1diabetes(Diabetesinthe
UK2012).
Whendiabetesisnotwellmanaged,itisassociatedwithseriousandcostlylongtermcomplications,
unplannedA&Eattendancesandhospitaladmissions.

Cardiovasculardiseaseisamajorcauseofdeathanddisabilityinpeoplewithdiabetes.

Almostoneinthreepeoplewithtype2diabetesdevelopovertkidneydisease.

Peoplewithdiabetesare10to20timesmorelikelytogoblindthanpeoplewithoutdiabetes.

100amputationsarecarriedouteachweekbecauseofdiabetes.

Neuropathies(ornervedamage)mayaffectupto50%ofpatientswithdiabetes.

Lifeexpectancyisreducedonaveragebymorethan20yearsinpeoplewithtype1diabetesand
upto10yearsinpeoplewithtype2diabetes.

Over800,000peoplewithdiabetesareathighriskoffuturecomplicationsduetoglucosecontrol
aboverecommendedlevels.

Selfmonitoringofbloodglucoseisanessentialpartofdiabetesmanagement.Aspartofthedayto
dayroutine,itcanhelpwithnecessarylifestyleandtreatmentchoicesaswellashelptomonitor
symptomsofhypoandhyperglycaemia.Monitoringalsohelpsboththepatientsandthehealthcare
teamtoadjusttreatmentandachievebetterclinicaloutcomes.
InarecentsurveybyDiabetesUK,patientsprovidedarangeofwaystheyusedbloodglucoseresults
tomanagetheircondition:

Confirmifhavingahypo.

Checkforhyperglycaemia.

Checklevelsbeforeandwhiledriving.

Monitortheeffectsoffoodintake.

Alterdiabetesmedication.

Makeadjustmentstofoodintake.

Checklevelswhenundertakingphysicalactivity.

Formotivationtofollowahealthierlifestyle.

Monitorbloodglucoseduringanillness.

Statement
Over800,000peoplewithdiabetesareathighriskoffuturecomplicationsduetoglucosecontrol
aboverecommendedlevels.Selfmonitoringofbloodglucoseisanessentialpartofdiabetes
management.
Page|5

Whatcangowrong?
In2013,DiabetesUKpublishedareport:Accesstoteststripsapostcodelottery.DiabetesUKwere
concernedthatpeoplewithdiabeteswereexperiencingrestrictionsintheiraccesstoglucosetest
stripsandmeterswhichtheyfeltwereessentialtoselfmanagementoftheircondition.
DiabetesUKfound:

39%ofrespondentshadeitherbeenrefusedaprescriptionforbloodglucosetestingstripsorhad
theirprescriptionrestricted.

Therestrictionshadaconsiderableimpactontheabilityofpeoplewithdiabetestomanagetheir
diabetesandpeoplewereconcernedfortheirimmediatesafetyandfuturehealth.

Morethan2,000peoplewithdiabetesrespondedtothesurvey,with58%oftherespondentshaving
type1diabetesversus40%withtype2.
TheDepartmentofHealthwrotetoGPs,commissionersandpharmacistsinFebruary2013andre
emphasised:
Theirlivesdependoninsulininjectionorpumptreatment.Theycarryoutselfbloodglucose
measurementandfingerprickteststoadjusttheirinsulindosageaccordingtofood,exerciseand
otherdailyevents.SMBGisessentialforsafetycheckswhenfeelingunwell,orinsituationswhere
bloodglucosemayfalltoolowortoohigh.
InsummaryitisessentialthatpeoplewithType1diabetesareprescribedsufficienttestingstripsfor
theirclinicalneeds.Thisenablespeoplewithdiabetestoselfmanage,includingunderstandingsick
dayrules,recognisingthesymptomsofDKA,earlyactionandhowtoseekhelpandanyspecific
considerationsinlightofanyjobtheymaycarryout,especiallyifitinvolvesdriving.
Reference:SafecareofpeoplewithType1diabetes,DHGatewayreference18678

PublicHealthEnglandhaspublisheddataintheNHSAtlasofVariationinDiagnosticServices,
indicatingahugevariationindiabetesselftestingacrossEngland.Itisunclearwhetherthisvariation
israndom,duetotrueclinicalvariationorcausedbyotherfactorssuchaspooraccesstoservicesor
needforeducation.Weknowthatthereisalsosubstantialvariationindiabetescomplicationand
hospitaladmissionrates.Commissionersmaywanttoquestionwhetherthereisalinkbetween
accesstoappropriatetestingandcomplicationrates.

Statement
Glucoseteststripsareanessentialpartofselfmanagementofdiabetes.Patientswithdiabetes
shouldbeprescribedsufficienttestingstripsfortheirclinicalneed.
Page|6

Stakeholderinvolvement
Engagingwithamixofhealthcareprofessionalsandpatientscanprovideawiderangeofdifferent
perspectivesthatwillresultinahigherqualityformulary,whichcommandstheconfidenceofall
partiesandisthereforemorelikelytobesuccessfullyimplemented.Themixwouldhavetobe
determinedlocallyandmaybeaffectedbythewillingnesstoengage.Thefollowingstakeholders
shouldbeencouragedtoattend:

Patientrepresentative/patientadvocacygroupmember(arepresentativecrosssectionofusers).

Diabetologyteammember,adultsandpaediatrics(consultantordiabetesspecialistnurse).

GPwithaninterestindiabetesorClinicalCommissioningGroup(CCG)diabeteslead.

Intermediatediabetesserviceprovider.

Nursesrepresentingprimarycare,secondarycare,communitycare.

Medicinesmanagement/optimisationlead.

Healthcareindustry/manufacturers.

Thecoreteammayalsowishtoconsiderinputfrom:

Communitypharmacists.

Biochemists.

Dieticians.

Thoserunninglocaldiabeteseducationprograms.

Withinawiderimplementationprogram,awiderstakeholdergroupshouldbeinvolved.

Statement
TheCCGshouldconveneamultidisciplinaryteamwithsignificantpatientinputtodeliver
appropriateformularyguidancefortheirarea.
Page|7

Whatareyouhopingtoachieve?
Beforestartingtheprocess,itmaybeimportanttodiscussanddecidewhatthefinaloutcomeofthe
formularyprocesswillbe.Thereisawidevarietyofbloodglucosetestingequipmentonthemarket
andmanyhavebeendevelopedwithdiversitytoalignwithspecificclinicalandpatientneeds.Itis
wrongtoassumethatallpatientscouldorshouldusethesamemeter.Thereisaneedtodecideon
thesimplicityorcomplexityoftheformularyandwhoitwillbeapplicableto,forexample60%of
patientsor90%ofpatients.
TheConsensusGrouprecognisesthatthereisafinelinebetweenofferingpatientschoiceand
deliveringconsistenthighqualitycare.
Hereareafewsuggestionsastowhatyoumightwanttoachieve:

Arecommendationforallpatients(type2andtype1)whoareonfixedtreatmentregimens.

Arecommendationforallpatients(usuallytype1)whoareonvariabletreatmentregimens
wherethebloodglucoseresultwouldinfluencethedoseofmedicationadministered.

Arecommendationforpatientswhodrivefrequentlyorforemployment,recognisingDVLA
testingguidelines.

Arecommendationforpatientswhohavebeentaughttocarbohydratecount.

Arecommendationforpatientsthatmayneedtotestforketones.

Arecommendationforspecialgroupsincludingvisualimpairment,dexterityissues,pregnancy
andneedlephobia.

Arecommendationforpatientswherealinkedsystemwhichautomaticallyrecordsand
transmitsresultstoadatabase.

Arecommendationforpatientsusinginsulinpumpswithorwithoutcontinualglucose
monitoring.

Statement
Thestakeholdergroupshoulddefinethescopeandapplicationoftherecommendationstheyare
goingtomake.
Page|8

Developinganactionplan
Thecoreteamshoulddiscussandagreetimelinesforactivities.Thisactionplanshouldallow
sufficienttimeforpatientanduserinputaswellasmanufacturerfeedback,butsetfixeddeadlines
fordelivery.Theactionplanmaycontainthefollowingsections:

Termsofreferenceandreportingmechanism:thecoregroupwilldefinetheirtermsof
reference,includingthedelegatedauthorityforactionandthereportingmechanisms.

Initialunderstandingofpatternsofuse:thecoregroupshouldidentifythecurrentpatternsof
useandcomparethistobothcostsandoutcomes.Thismayidentifypotentialearlysolutionsand
issues.

Evidencecollectionandassimilation:thecoregroupshouldcollectevidencefrommanufacturers
andassimilatethisevidenceintocomparativetables,e.g.publishedpatientclinicaloutcome
data.

Evaluation:thecoregroupmustsetcriteriaforevaluationofproducts,whichmayincludea
scoringsystemandindividualpatientandhealthcareprofessionalassessments.

Creationofformulary:thecoregroupshouldsetadeadlineforpublicationofadraftformulary
forconsultation.

Approval,publicationandcommunication:thecoregroupshouldagreeaprovisionaldatefor
publicationwhichtakesintoaccounttheapprovalprocessandacommunicationstrategy.

Implementation:thecoregroupshouldworkcollaborativelywithmanufacturers,healthcare
professionalsandpatientrepresentativestodevelopanimplantationplantosupporttherollout
ofthenewformulary.

Review:thecoregroupshouldagreewhethertheformularyisongoingorfixedandwhenit
shouldbereviewed.

Statement
Thecoregroupshouldproduceacomprehensiveactionplanwithtasksanddeadlinesanddefine
theirtermsofreferenceandreportingmechanism.
Page|9

Curreentpatte
ernsofusse
Beforesselectingpro
oductsonafo
ormulary,it maybeimpo
ortanttoestablishcurrenntpractice.T
There
mayalso
obeaneedttomakecom
mparisonswi thotherareasorbetwee
enpractices withinyourown
area.Thesecompariisonswillbeabletooffe raninsightintousethattmightsuppoortthereaso
onsfor
formularydevelopm
ment,butwilllnevergiveaadefinitiveaanswer.
Thefollo
owinghaveb
beensuggesttedassuitabblecomparisons:

Costbaasedcompaarisons
Thepresscriptionanaalysistoolsavailablecan differentiate
ebetweenpracticesandbetweenCC
CGson
thebasisofcostperrprescribingunit.Althou ghthismayseemcrude,,itwillallow
wyoutoseew
whether
yourareeaismoreorrlessexpensivethatotheerareas.

TheNHSScostofeachbloodglucosetestingsstripwillbeaavailable.Thesecostscannbeplottedona
barcharrtandthenccomparedtoyourlocalu se.Pleaseno
otethatthessepricesmayychangedueto
localdiscount/rebatteschemes.

Page|10
P

Qualitybasedcomparisons
ManyqualitybasedcomparisonsmaybebasedonaBostonMatrix.Theseattempttocompareareas
orpracticesbasedonbothcostandoutcome.Thisassumesthatproperuseofappropriate
equipmentmaybeabletodriveupclinicaloutcomesandreduceoratleastcontaincosts.

%ofpatientswithanHbA1cwithintarget

Costofbloodglucosetestingstrips

YourCCG

Wemaybeabletoassumethatappropriateuseofbloodglucosetestingstripsisanimportant
elementofdiabetesmanagementandachievementofgoodresponses.

Statement
Comparisonsareagoodtoolinunderstandingvariationinusagecostsandclinicaloutcomes.
Page|11

Collectionofevidence
Beforeevidencecanbecollected,twodecisionsarerequired:

Willyoucollectevidenceonalloftheavailableproducts?Wehaveseenexampleswherethe
numberofproductsinthefirstevidencecollectionhasbeenreducedeitherbasedonlistpriceor
oncurrentusagepatterns.Wefeelthattheserestrictionsarelessthanidealinanareawhere
productsarecontinuouslybeingdeveloped/improvedandwherelistpricemaynotalwaysreflect
currentcommercialarrangements.

Whatevidencewillyoucollect?Thisisanextremelyimportantareatoconsiderandtoengage
patientsandclinicalstaffatanearlystage.Youreallyneedtoconsiderfirstyourevaluation
criteriaandwhatisimportanttoeachstakeholderbeforeyoustartcollectingevidence,e.g.
publishedpatientclinicaloutcomedata.Itisimportanttofollowinthepatientsfootstepsto
reallyunderstandhowproductsareusedandwhatfeaturesarevalued,e.g.comfortoflancing
device.

Thecollectionofevidencealsorelatestoyourobjectivesfortheformularyasdescribedbefore.
Beingclearaboutwhatyouintendtoincludewithinyourformularywillinfluencewhatevidenceyou
collect.
Onceanevidencematrixhasbeendesigned,themanufacturersshouldbeinvitedtocompletethe
information.Itwouldbepreferabletoinvitethemforafacetofacediscussionastheirproductsmay
haveadditionalfeaturesnotincludedwithinyourmatrixortheymayhavecommercialschemesor
valuepropositionstoaidepatient/devicesegmentation.
Youmaywishtoconsiderthefollowingareas:

AccuracypublishedclinicaloutcomedataandcompliancewiththeInternationalOrganization
forStandardization(ISO)15197:2003standardandprogresstowardstherevised15197:2013
standard.

Costincludingcostofmeter,testingstrips,associatedlancetsandbatteries.

Qualitycontrolandsupportincludingcostandavailabilityofcontrolsolutions,recognitionof
controltest,internalandexternalqualitycontrolandavailabilityofatechnicalhelpline.

Productdescriptionincludingmeterweight,metersize,storageconditions,memory,display
andbacklight.

Performanceenzymesystem,mmol/lreading,underfilldetection,measurementrange,
operatingtemperature,haematocritrange,alarmremindersandstripejection.

Patientpreference/acceptabilityknowledgeofdeviceandcommitmenttoselfmonitoring.

ConnectabilityBluetooth,cables,PCdownloadsoftware,linkstopumpsetc.

Specialapplications(forexamplecarbohydratecounting).

Thisisnotintendedtobeadefinitivelist,butasetofsuggestionsforlocaldevelopment.

Statement
Developanevidencematrixdependingondesiredoutcomes.Askmanufacturerstocompletethe
matrixandmeetfacetofaceforfurtherdiscussionandexplanation.
Page|12

Productevaluation
Thestakeholdergroupshouldgettogethertoevaluatetheproductsfromtheevidencegathered.
Theymaywishtodothisinthreestages:

StageonePaperbasedevaluation
Tocompletethisevaluation,theymayneedtodevelopasetofcriteriaandaweightedscoring
system.Thegroupmustconsiderthecriteriathattheywillusetoevaluatetheproducts.These
criteriamayinclude:

Accuracyandprecisioninuse,e.g.independentdatareviewofcompliancetoISO15197:2013
accuracystandardandreviewofmanufacturerspublishedevidenceofattainmentofISO
15197:2013standard.

Costofproductandassociatedequipment.

Safetyofproductandassociatedequipment(sharpsinjurypreventionandbloodcontamination
areimportant).

Continuityofsupply.

Easytosetupanduse.

Instructionbooklets,patientsupportmaterialsandhelpline.

Easytoconnectanddownloaddata.

Foreachcriterionthereisaneedtoweighttheirimportance.Forexample,accuracyandprecisionin
useandavailableclinicaloutcomedatamaybeconsideredmoreimportantthanconnectabilityand
thereforewouldattractahigherweightingscore.Preventingsharpsinjuriesandblood
contaminationareimportantissuesforhealthandsafety.
Eachmemberoftheevaluationteamshouldscoretheelement,perhapsona0to5scalewhere0
meanscompletefailureand5meansmeetingthecriterionexactlyorexcellent.
Frommultiplyingthescorewiththeweightandaddingupalloftheindividualweightedscoresa
totalevaluationscorecanbecalculated.

StagetwoAccuracyandprecisionconfirmation
Thestakeholdergroupmaywishtoengagethehelpofalocalbiochemistandpathologydepartment
toensurethattheaccuracyandprecisionofresultsarecompatibleinroutinepractice.

StagethreePatientevaluation
Althoughindividualpatientshavebeenincludedinthestakeholdergroup,theConsensusGroup
recommendsaselectionofpatientsareapproachedandaskedtheirviewontheproposedmeters.
Patientsneedtofeelcomfortablewiththeproposeddeviceandmayhaveusefulfeedbackonease
ofuse,aswellaseaseofrecording,storingandinterpretingresults.Itisalsoimportantthattype1
and2diabetespatientsaresegmentedaccordingtotreatmentregime,asthiswilltheirimpactblood
glucosetestinganduseofmeters.

Statement
Evaluateproductsagainstagreedcriteria.Reviewdecisionswithbiochemistrydepartmentand
patients.
Page|13

Formularycreationandcommunication
Oncethedecisionhasbeenmade,theformularymustbecreated.CCGsshouldbetransparentand
publishallrelevantlocalformularyinformationonline,inaclear,simpleandtransparentway,so
thatpatients,thepublicandstakeholderscaneasilyunderstandit.Thisincludesformularypolicies,
minutesofmeetings,decisionoutcomesandassociateddecisionoutputs.Theformularymustbe
writteninsuchawaythatidentifiesthepatientgroupandthepreferredproductsinaclearmanner.
Theformularyshouldalsobelinkedtotheevaluationsothatcliniciansandpatientscanseethatan
evaluationprocesshasbeencompletedthatsupportsthelocalchoiceandthatawiderangeof
stakeholdershavebeenincluded.
ThenewformularyshouldbesupplementedbyalocalcommunicationstrategythroughGP
champions,practicenursediabetesleadsandtheintermediateandspecialistclinicianssothatall
cliniciansareawarethatthenewproductsareavailable.Ensurethattheformularyisincorporated
intoregulartrainingsessionsforcliniciansandpatients.Tosupportpatients,aclearstatementabout
whoisresponsibleandwhotogotolocallyifthereisaproblemwiththeformularyshouldbe
included.
Thecreationandcommunicationofaformularyprovidesanopportunitytosupportfurther
educationaroundappropriatebloodglucosetestingtoachievebetteroutcomes.TheConsensus
Groupbelievethattherearemanypatientswhomaybemeasuringbloodglucosewherethereis
littlevaluetotheircare.Theysimilarlybelievethatmanypatientscouldgainincreasedbenefitfrom
moreregularoradditionaltestingandunderstandingbetterhowtochangetheirdiet,lifestyleor
treatmentrelatedtotheirbloodglucoseresulttoimproveoutcomes.Theremaybenovaluein
testingbloodglucoseunlessapatientunderstandstheinformationandwhattodoaboutit.
Includecommunitypharmaciesandallotherplaceswhereproductsaregoingtobesuppliedand
patientswilluseasaresourceforinformation.Ensurethatpatientscanhaveaccesstoamemberof
thestakeholdergrouptodiscussissuesastheyarise.
Theintroductionshouldbestagedtoensurethatwastageiskepttoaminimumandpatientsare
properlyengagedwithintheprocessateverystageofimplementation.
Considercommissioningcommunitypharmacytosupplymetersinanemergencytopatientswith
diabeteswhentheirexistingmeterorinsulinpumpfails.
Theformularymustbewritteninsuchawaythatidentifiesthepatientgroupandthepreferred
productsinaclearmanner.Theformularyshouldalsobelinkedtotheevaluationsothatclinicians
andpatientscanseethatanevaluationprocesshasbeencompletedthatsupportsthelocalchoice
andthatawiderangeofstakeholdershavebeenincluded.

Statement
Createformulary,publicationandcommunicationplans.Insertintocurrentandfuture
training/educationopportunitiesandfocusonenablingpatientstogetthebestresultfromblood
glucosetesting.
Page|14

Continualassessment
Theformularyprocessshouldbedynamic.Theareacanmeasureuptakecomparedtoexpectations
onaregularbasesandlinktobothexpenditureandclinicalimprovement.Thiswillidentifyfurther
directedactionthatcanbetaken.Patientsshouldbeaskedtoevaluatetheirnewproductfromtime
totimetoseewhetheritmeetspatientsexpectationsandneeds.Smallbatchauditsmayidentify
whethertheformularyhasbeenimplementedsensitivelyandwhetherpatientsdogainthe
improvementsthatthestakeholdergroupbelievesareachievable.
Companiesregularlyupdateandimprovetheirproducts.Althoughtheremaybenoneedforthe
stakeholdergrouptobemaintainedtheyshouldagreeaprocesswherebyaneworupdatedproduct
canbeevaluatedagainstthesetcriteria.Whentheneworupdatedproductisconsidereda
significantadvance,thentheformularyshouldbeupdatedandtheguidance/recommendations
changed.

Statement
Regularmonitoringandevaluationwilldeterminetheextentofimplementationandthe
achievementsofinitialobjectives.Theformularyshouldbeconsidereddynamicandaprocess
shouldbeestablishedforevaluationofneworupdatedproductsandrapidintroductioncould
meansignificantlocalbenefits.
Page|15

Appendix1

EvaluationofbloodglucosemeterProcessflowchart

Considertheneedsandbenefitsforaformulary

Puttogetheracorestakeholdergroup

Definetheoutcomesforthegroup

Developactionplanincludingtermsofreference
andreportingarrangements

Reviewandinvestigatecurrentpatternsofuse
andperformance

Collectiveevidence

Productevaluation

Createformularywitheducationalsupport
packageandcommunicate

Continualassessmentandmonitoring

Page|16

Appendix2

Comparisontemplate
Feature

Product1

Product2

Product3

Manufacturer

Enzymesystem

Independentreviewof

compliancewithISO15197:2003
andprogresstowards
15197:2013

Publishedclinicaloutcomedata

Weightofbloodglucosemeter

Sizeofbloodglucosemeter

Lancetdevice(comfortand
easeofuse)

Backlight*

Displaysize

Memorycapacity

Measurementrange

Devicestorageconditions

Operatingtemperature

Measuresonlyinmmol/Lunits
(MHRAguidance)

Setuprequired(dateandtime)

Codingrequired

Samplesize

Underfilldetection

Measurementtime

Haematocritrange

Abilitytoflagpreandpost
prandialresults

Alarmreminders

Ketonewarningifglucoseis
high

Talkingmeter

Meterfreetopatient

Costofteststrips(50)

Freereplacementbatteries,log
books,lancingpens

Controlsolutionfreetopatient

PCdownloadandsoftware

Selfejectstrip

Expirydateofteststrips
(minimum6monthsfrom
opening)

Page|17

Patienthelpline

Educationmaterial

Supportmaterialandmeter
trainingfreeforhealthcare
professionals

Unabletodeletereadingsfrom
memory

*YellowandblackbacklightingrecommendedbyRNIB
**Productevaluationsshouldcarriedoutseparatelyforpatientwithtype1and2diabetesanddependingontheirtreatmentregime,
ensuringmetersarecomparedlikeforlike.

Page|18

Appendix3

Meterevaluationform
Patientmeterevaluationform
Score

MeterName:

Dateofevaluation:

Performance

Meetsthestandardexactlyasspecified
(excellent)

Meetsthestandardwell,butnotexactly
(good)

Meetsthestandardinmostaspects,
meetsitinsome

Failsthestandardinmostaspects,
meetsitinsome

Significantlyfailstomeetthestandard
(poor)

Completelyfailstomeetthestandard
ornoresponse

Nameofthoseevaluating:

Totalpossiblescore=500

Scoring
Weight

Factor

Details

Score

Weighted Notes
Score

Accuracy/
precisionand
clinicalevidence

BasedupontheproposedISO
variationof15%andpublished
clinicaloutcomedata

15

Cost

Pricepertestshouldbe
evaluatedwiththecheapest
rankedhighest

15

Lancet

Thelancetshouldbeeasyto
use,ofsufficientdepthand
adjustabletoreducepatient
discomfort

10

Weightandsize
ofmeter

Themeterincluding,control
solution,lancetsandstrips
mustbecontainedwithina
caseforeaseofuse(where
applicable).Asmallerweight
andsizeispreferred

Memory

Themetershouldhave
sufficientmemoryfor3
monthsglucosemeteruse,in
linewithDVLArequirements

Easeofuse

Thereshouldbenooperator
stepsaftertheapplicationof
thebloodsample,procedures
shouldbesimpleandminimal.
Ergonomicsofstripsandmeter
shouldbetakenintoaccount

Setuprequired

Thereshouldbeminimalsetup
(e.g.dateandtime)required

Page|19

Instruction
booklet

Instructionbookletsshouldbe
availableandeasytofollow.
Theuseofpicturesis
recommended.Information
shouldbeavailableinother
languages

FOCbatteries/
controlsolution

Batteriesandcontrolsolution
shouldbeavailablefreeof
chargeandeasytoordereither
onlineorbyphonehelpline

Online/phone
support

Themetercompanyshould

providebothonlineandphone
supportintheeventof
problemswiththemeter

Backlight

Themetershouldhave

backlighttoallowtestinginthe
dark

Teststripstability Theteststripsshouldbestable
foraminimumof3months
afteropening

PCdownload

Themetershouldpreferably

haveanoptiontodownload
datatoaPC.Costofthe
softwareandhardwareshould
beconsidered

Displaysize

Thedisplaysizeshouldbe
adequateforgeneralvision

Controltest

Itispreferablethatcontrol
resultscanbeautomatically
recognisedorflaggedonthe
meter

Flagpre/post
prandial

Itispreferablethatpreand
postprandialresultscanbe
flaggedonthemeter

Healthcare
profession
support

Supportmaterialandmeter
trainingforallhealthcare
professionalsprovidedfreeof
charge

Patientandcarer Trainingandsupportmaterial
support
forallpatientsandcarers
providedfreeofcharge

Formulary
support

Manufacturertoworkin
partnershipwithCCGto
implementformulary,
providingpatientmeter
reviewsanddeviceswitches

Totalscore:
AdaptedfromtheformusedbyBedfordshireClinicalCommissioningGroupandGreaterManchesterCommissioningSupportUnit
Theproposedmeterevaluationisnotsuitableforbolusadvisorsorinsulinpumps.

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Appendix4

Patientfeedbackform
FeedbackformTestmeters
Thankyoufortriallingthetestglucosemeter.Wewouldbegratefulifyoucouldtakeaminuteto
completeandreturnthefollowingform.
Whichtypeofdiabetesdoyouhave?(pleasetick)
Typeone

Typetwo

Howmanypackofteststripsdoyouuseamonth?(pleasecircle)
1/2/3/4/5/6other.....
Nameofyourpreviousmeter..........................................................................................
Pleasecouldyouratethefollowingonascaleof1to10(pleasetick)

Worst

12 345

Best

67 8910

Thecustomersupportline
Howeasythemeterwastouse
Howyoulikethelancetdevice
Easeofreadingtheresults
Easeofviewingpastresults
Speedofappearanceofresult
Sizeofbloodsampleneeded
Howeasyitwastocarryaround

Preferprevious

Prefertestmeter

Howeasythemeterwastouse
Canyousuggestanythingaboutthetestmeterthatyouwouldliketochange?

Wewouldwelcomeanyadditionalcomments,suggestionsorfeedback.

AdaptedfromtheformusedinBedfordshireClinicalCommissioningGroup

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Appendix5

Consensusgroupmembers

MichaelSobanja,DirectorofPolicy,NHSAllianceandChairoftheConsensusGroup

MarkRobinson,Pharmacist,MedicinesManagementPartnershipandauthorofthisguidance

AndrewDavies,MarketAccessDirector,ABHI

PaulBristow,MedicalTechnologyGroup

JohnGrumitt,ManagingDirector,Metapath,VicePresidentDiabetesUKandInternational
DiabetesFederation

MsClairHuckerby(Dudley),PharmaceuticalAdviserDudleyCCGandTheOfficeofPublicHealth
DudleyMetropolitanBoroughCouncil

FionaGarnett,PharmaceuticalAdvisor,BedfordshireClinicalCommissioningGroup

SarahJohnson,DirectorofPolicyandCommunications,JDRF

DrLauraHalpin,PolicyExecutive,INPUT

TheConsensusGroupwouldalsoliketothankthefollowingstakeholderswhoprovidedadditional
commentsontheguidance:
PaulBuchanan,Founder,#gbdoc
NikkiJoule,PolicyManager,DiabetesUK
SusanDown,NurseConsultant
BIVDA
MHRA
DepartmentofHealth

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