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Right Insulin,Right Time, Right Dosefor Type 2 diabetesA toolkit for optimal deliveryEnter the toolkit >www.hin-southlondon.org

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsForewordThe Health Innovation Network (HIN)is a membership organisation, drivinglasting improvements in patientand population health outcomes byspreading the adoption of innovationinto practice across the health system.As the Academic Health Science Networkfor South London our work prioritiseshealth challenges for local communitiesacross a number of clinical areas; includingdiabetes, dementia, musculoskeletal,cancer and alcohol. Our work incorporatescross-cutting innovation themes togenerate wealth and increase the qualityof care in our communities.IntroductionDr Charles Gostling, Clinical Director (Diabetes Programme),Health Innovation Network South London and GP, Lewisham4We are proud to be collaborating withour partner and member organisationsto align; education, clinical research,informatics, innovation, training andeducation in healthcare. We supportknowledge exchange networks toensure the patient is at the heart ofhealthcare delivery and to support earlyadoption of healthcare innovations.Contents and context >Back to contentsReferencesRight Insulin, Right Time, Right Dose 2

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsContents Our approach to diabetes Projects 2014-151 Why a toolkit?2 The right time3 The right insulin4 Myths and barriers5 Insulin management: key facts6 Commissioning for peoplewith Type 2 diabetes7 Medicines optimisation teams8 Community pharmacyOur team has used the Joint Strategic NeedsAssessments of South London boroughs toidentify key areas of variation and risk. We havedeveloped and refined, in consultation with a rangeof stakeholders, our high level priorities below.Supportingbetterself management1 Improving self-management of insulintherapy by improving access to andappropriate use of technologies.2 Improving the integration of carepathways for management of unscheduledcare in hypoglycaemia and hyperglycaemia.3 Right Insulin, Right Time, Right Dose.4 Structured education and relatedsupport for self-management. 29 AcknowledgementsEnabling systemsfor integrationof careAdopting newtechnologiesGuide to symbols!Importantinformation2 Downloads“Whatpeopleare sayingBack to contentsReferencesRight Insulin, Right Time, Right Dose 3

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsThis toolkit was informed by arepresentative group of serviceusers, medicines optimisation teams,commissioners, academic colleaguesand providers who have generouslycontributed resources and sharedtheir experiences and expertise withthe Health Innovation Network to helpsupport change in South London.Why a toolkit?We have known for some time how to effectivelytreat Type 2 diabetes and how to achieve goodglycaemic control using lifestyle interventionsand timely use of therapeutic agents.Unfortunately, despite this knowledge, largenumbers of people fail to achieve personalisedoptimal control. In addition there are largeinequalities across different care settings andbetween populations. This puts many people athigher risk of diabetes-related complications andcan be demoralising for healthcare professionals.There are many underlying reasons for this failurewhich this toolkit seeks to address.The toolkit provides a background to theimportance of early and appropriate medicationintensification and use of the Right Insulin at theRight Time at the Right Dose. It exposes the mythsabout insulin therapy and considers why, for thevast majority of people, human intermediate actinginsulins are preferable for initiation compared tolong and intermediate acting analogue insulins.The toolkit also explores what can go wrong inthe intensification pathway and suggests waysin which this could be improved.Who is the toolkit for?• Healthcare professionals in primarycare and secondary care• Commissioners• Medicines Optimisation Teams• Community PharmacistsUsing the toolkitLinks to useful resources can be found withinthe toolkit. These include exemplar prescribingguidance, audits, evidence reviews, responsibleprescribing messages, useful case studies andexamples of good practice.A number of our resources are from within ourlocal network where colleagues have agreed toshare best practice. The resources offer a menuof options for you to tap into to support patientswith early and appropriate dose escalation andinsulin management to optimise glycaemicoutcomes in a clinical and cost effective way.Although this toolkit focuses on optimisationof glycaemic control, it is important not to forgetthe importance of reducing cardiovascular risk toimprove outcomes for people with Type 2 diabetes 1,2 .Back to contentsReferencesRight Insulin, Right Time, Right Dose 4

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsDiabetes: the national picture£10 billion per yearDiabetes costs the NHS £10 billion per year,accounting for 10% of the NHS budget 3 .£16.9 billion by 2035Public health forecasting predicts that an agingpopulation and rising prevalence of obesity willincrease NHS spending on diabetes to £16.9 billionby 2035, accounting for 17% of the NHS budget 3 .80% preventableIt is a leading cause of blindness in the UK 4and over 100 amputations are carried outeach week in people with diabetes due tocomplications – 80% of which are preventable.24,000 die prematurelyEach year 24,000 people with diabetesdie prematurely 5 .Biggest risk groupsType 2 diabetes is more common in people ofblack and south Asian origin, and tends to presentat a younger age in these ethnic groups.Acting early to prevent the development ofcomplications can both reduce the impact onan individual’s life and save the NHS money 6 .The picture in LondonThere is a rise in both prevalence and theincidence of diabetes in London. In the lastdecade there has been an astonishing 75%increase in people recorded with diabetes bytheir GP! 7 This rise is believed to be due to achange in demography and unhealthy lifestylesleading to obesity.The picture in South LondonThe diabetes prevalence model for localauthorities shows that in 2014 there were 174,627people over the age of 16 on GP diabetes registersin South London and this is expected to rise to249,848 by 2030 7 .Further informationFor more information on diabetesprevalence modelling for yourborough please use the toolprovided by Public Health England.You can download it here.2Back to contentsReferencesRight Insulin, Right Time, Right Dose 5

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9Acknowledgements!Why a toolkit?• Type 2 Diabetes is a progressive long term condition.Management involves optimising glycaemic levels andappropriately managing cardiovascular risk through acombination of interventions such as lifestyle changesand use of appropriate pharmacological agents.• 50% of people with a long term condition do nottake their medication as prescribed 8 .• Optimising non-insulin therapies and initiating insulinat the right time ensures good early glycaemic controland improves outcomes for patients. There is significantevidence that good glycaemic memory reduces patients’risk of developing complications for the rest of their life 9 .• Acting early to prevent complications limits the impacton people’s lives and saves the NHS money 6 .• Local and national studies highlight that there canbe a delay of approximately five to seven yearsbetween somebody requiring insulin therapy andinsulin being started 10,11 .Potential complications of diabetesMacrovascularBrainCerebrovascular disease• Transient ischemic attack• Cerebrovascular accident• Cognitive impairmentHeartCoronary artery disease• Coronary syndrome• Myocardial infarction• Congestive heart failureMicrovascularEyes• Retinopathy• Cataracts• GlaucomaKidneysNephropathy• Microalbuminuria• Gross albuminuria• Kidney failure• Involving users in decisions about their care andimplementation of evidence-based cost-effectiveguidance across a population helps to ensure weachieve value based healthcare for our population.• Self management is a key factor in improving outcomesin Type 2 diabetes.ExtremitiesPeripheral vascular disease• Ulceration• Gangrene• AmputationNervesNeuropathy• Peripheral• Autonomic• Erectile dysfunctionBack to contentsReferencesRight Insulin, Right Time, Right Dose 6

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhat HbA 1clevels should we be aiming for to reduce complications?In the early 1990s the Diabetes Control andComplications Study (DCCT) showed thebenefits of good glycaemic control for peoplewith Type 1 diabetes 15 . Later in the decade thefirst results began to flow from the UnitedKingdom Prospective Diabetes Study (UKPDS),demonstrating a statistically significantreduction in development and progression formicrovascular complications in people withType 2 diabetes, as well as a reduction inmyocardial infarction (although non-significant)between groups allocated to usual care andintensive blood glucose control 16 .UKPDS 35: Significant risk reduction for T2DM complications with each 1% reduction in mean HbA 1cN=3642P

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsShould we be trying to achieve tight control for all?There are a number of factors that we need to take into considerationthat are largely dependent on individual patient circumstances.Treatment should be individualised to take into account patient preference,length of diabetes and presence or absence of complications.Individual treatment goals should consider the following:• reducing symptoms caused by high blood glucose such asthirst, polyuria, lethargy and increased infections.• reducing the risk of life threatening illness through severehyperglycaemia.• achieving tight glycaemic control for those with newlydiagnosed Type 2 diabetes to reduce the development andprogression of both microvascular and macrovascular complications– where it is safe to do so.• achieving safe, but less tight, blood glucose levels in those withlonger duration Type 2 diabetes or those who are at highercardiovascular risk, frail or elderly.The diagram on the right highlights the checks and balances thatmust be made in setting personalised glycaemic targets 20 .All these factors highlight that we need to strike a delicate balancethat will be different in each person and sometimes difficult to achieve.The National Institute for Health and Care Excellence (NICE) advisesavoiding pursuing highly intensive management to levels to less than48mmol/mol (6.5%) 21 .Approach to management of hyperglycemiaPatient attitude andexpected treatment effortsRisks potentially associated withhypoglycemia, other adverse eventsDisease durationLife expectancyImportant co-morbiditiesEstablished vascular complicationsResources, support systemMore stringentHighly motivated,adherent, excellentself-care capacitiesLowNewly diagnosedLongAbsentAbsentInzucchi et al, 2012, Diabetes Care 35 (1364-1379)Readily availableLess stringentLess motivated, non-adherent,poor self-care capacitiesFew / mildFew / mildHighLong-standingShortSevereSevereLimitedBack to contentsReferencesRight Insulin, Right Time, Right Dose 13

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsIntensification to reduce future riskFor many people with newly diagnosed Type 2diabetes we should aim to achieve ‘tight’ glycaemictargets. If we fail to do so we can increase therisk of diabetes related complications in thefuture. Achieving personalised targets requires acollaborative approach between an empoweredperson with diabetes and their skilled andknowledgeable healthcare team.Both the joint American Diabetes Associationand European Association for the Study ofDiabetes guidance 20 and NICE guidance 21 supportconsideration of early lifestyle measures alongsidemetformin (where possible) in the first instance. Ifthis is not successful then treatment is escalated,initially with non-insulin therapies, according toHbA 1cresponse and patient factors. We shouldreview and intensify treatment promptly, regularlyand assertively when glycaemic control deviatessignificantly from target.Person with type 2 diabetesKnowledgeableEmpoweredSelf-careImproved outcomesNeuropathy Retinopathy Nephropathy MyocardialinfarctionHealthcare professionalCollaborationCare planningEnabler of structured educationCardiovascularriskEffective structured education interventionsfollowing diagnosis are an essential ingredientof good diabetes care. When people are diagnosedwith diabetes there is so much information toabsorb and this is a huge challenge. Signpostingto local support groups, such as Diabetes UK, andwritten information, for example the 15 healthcareessentials is invaluable.Back to contentsReferencesRight Insulin, Right Time, Right Dose 14

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsIntensification sounds easy – so what’s the problem?Some healthcare professionals are not goodat educating people with Type 2 diabetes aboutthe progressive nature of the disease. Whilstweight loss, lifestyle change, crash diets andbariatric surgery can bring about remission,this is not the story for most of the peoplewe look after. Ageing, high blood glucose,dyslipidaemia and hypoglycaemic drugs allcontribute to the progressive destruction ofinsulin secreting β cells. This means therapywill need to be escalated regularly and willusually progress to insulin therapy.100B-cell function (%)Progressive loss of beta cell function in T2DM when hyperglycemia is uncontrolledDual therapyLifestyleHbA 1cB-cell functionMonotherapyInsulin + oral drugs1098765HbA 1c(%)0Adapted from Heine RJ et al. BMJ. 2006: 333: 405-12040 Time from diagnosis (years)>150Back to contentsReferencesRight Insulin, Right Time, Right Dose 15

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9Acknowledgements!‘Treating to fail’We are also poor at titrating medication andinitiating insulin at the Right Time 22 . ‘Therapeuticinertia’ is one of our biggest challenges and weoften wait for treatment to fail. This can havea big impact on treatment of Type 2 diabeteswhere progressive loss of β cell function leadsto an increase in HbA 1cas seen on the right.A review undertaken by Khunti 10 showed that:In people with Type 2 diabetes taking one oralantidiabetic drug (OAD) and with an HbA 1cof:• ≥7.0% (≥53mmol/mol) median time tointensification with an additional OAD was2.9 years• ≥7.5% (≥58mmol/mol) median time tointensification with an additional OAD was1.9 years• ≥8.0% (≥64mmol/mol) median time tointensification with an additional OAD was1.6 yearsFor those taking two OAD, median time toadding another OAD was >7 years.Median time for intensification with insulinwas >7.1, >6.1 and >6 years for those taking one,two or three OADs.Stepwise management of T2DM:‘Treat-to-Failure Approach’ – clinical inertiaDiet, exercise, lifestyle...Wait for failureMonotherapy...Wait for failureCombination therapy...Wait for failureBased on failure, consider:Insulin + OAD combination therapy...Back to contentsReferencesRight Insulin, Right Time, Right Dose 16

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9Acknowledgements‘Treating to fail’The Diabetes Modernisation Initiative (DMI)was a Guy’s and St Thomas’ Charity fundedproject across Lambeth and Southwarkworking to bring about system-wide changefor people living with diabetes throughtransforming and improving services 23 .The DMI undertook a local audit in 2012/13which showed that of 23,945 on GP diabetesregisters, 32% had an HbA 1chigher than64mmol/mol. Of these 4% were on nodiabetes medication, 13% were on metforminonly, 3% were on a sulfonylurea only, 23%were taking metformin and a sulfonylurea,16% were taking pioglitazone, gliptins or GLP-1analogue and 41% were prescribed insulin.This data highlights there is huge scopefor improvement at each stage of theprescribing guidance and not just at 3rd and4th line therapy. More intensive therapy withmetformin and sulfonylurea in this samplewould result in an improvement in control ofup to 41% and an absolute increase of up to9% in HbA 1cof less than 64mmol/mol.HbA 1c> 64mmol/mol medication4%13%3%23%16%41%No diabetesmedicationMetformin onlySulfonylureaonlyMetformin andSulfonylureaPioglitazone,gliptins or GLP1inhibitorInsulin!• Lack of knowledge about insulin therapyaccompanied by erroneous beliefs andmisconceptions.• Negative self-perceptions and attitudinal barriers.• Perception of increased burden and stress dueto required lifestyle adaption and restrictions.• Perception of social stigma.It is important to try to avoid negative associationswith insulin therapy. Have we honestly neverthreatened and said something like:“Both people with diabetes and healthcareprofessionals can suffer from a ‘psychologicalinsulin resistance’ 24 . This is characterised by:If you don’t change your lifestyle andtake your tablets on time we will haveto consider insulin!”Alternatively we can collude:Diabetes Modernisation Initiative,2014 Diabetes UK conference poster“Well let’s just add this extra tablet andsee if you can eat less and we’ll see you insix months – I’m sure we can put off insulinfor a bit longer.”Back to contentsReferencesRight Insulin, Right Time, Right Dose 17

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsSummaryWe need to work better with each person with diabetes to optimise their lifestyle interventions and medication to achieve the best outcomes.We need to be more proactive in intensifying treatment options including insulin therapy. We need to discuss the progressive nature of diabetesand the need for insulin from diagnosis and at every review to support people with diabetes manage their care as best as they can.If we make all these changes our pathway will significantly improve and support the use of the Right Insulin, Right Time, Right Dose as shown below.Diagnosis StructurededucationGlycaemiccontroldeterioratesPatientbarriers toinitiating insulinReferred toinitiate insulinSees primarycare healthcareprofessionalfor reviewSelf titration Success:improvedcontrol• Discussionthat diabetesis a progressivecondition• Discussionabout insulinwith patient• GP startsdiscussing insulinand tacklingthe barriers• Need tounderstandboth healthcareprofessionaland patients’barriers to insulin• Support adherenceto currentmedication• Peer supportto deal withthe barriers ofcommencinginsulin• Refer to yourlocal insulininitiationpathway• Supportprimary carein titrationof insulin• Support toolsto encourageself-titrationof insulinKey messages1 Discuss the need for insulin early in the pathway2 Early control of HbA 1cis important for longer term ‘metabolic memory’3 Personalise HbA 1ctargets to strike the balance between safety and tight controlBack to contentsReferencesRight Insulin, Right Time, Right Dose 19

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9Acknowledgements!Right insulin – the evidenceThe current NICE clinical guideline 87 (CG87) 21recommends that human isophane (NPH) insulinis prescribed firstline if insulin is initiated in Type 2diabetes at bedtime or twice daily, i.e. as a basalinsulin. Long Acting Insulin Analogues (LAIA), eg.insulin detemir or insulin glargine, should only beused in specified circumstances, i.e. if:• The person needs assistance from a carer orhealthcare professional to inject insulin and useof LAIA would reduce the frequency of injectionsfrom twice to once daily, or• The person’s lifestyle is restricted by recurrentsymptomatic hypoglycaemic episodes, or• The person would otherwise need twice-dailyNPH insulin injections in combination with oralglucose-lowering drugs, or• The person cannot use the device to injectNPH insulin.It then goes on to add that we should considerswitching to a LAIA from NPH insulin in people:• who do not reach their target HbA 1cbecauseof significant hypoglycaemia, or • who experience significant hypoglycaemia on NPHinsulin irrespective of the level of HbA 1creached, or • who cannot use the device needed to injectNPH insulin but who could administer their owninsulin safely and accurately if a switch to a LAIAwere made, or • who need help from a carer or healthcareprofessional to administer insulin injections andfor whom switching to a LAIA would reduce thenumber of daily injections.What is happening across London?Due to the significant financial implications of intermediate and long acting analogue prescribing, the LondonProcurement Partnership (LPP) and medicines optimisation teams have monitored prescribing levels sinceNICE CG 87 was issued. In 2014/15 the LPP target for increasing intermediate and long acting non-analogueinsulins as a proportion of all insulins was 17.5% 31 . In 2014 the LPP data shows clear geographical variation,with CCGs in South East London achieving a much higher proportion of NPH insulin being prescribed.Non analogue insulin (long and intermediate acting) as apercentage of all insulin (long and intermediate acting)45%40%35%30%25%20%15%10%5%0%London: Non analogue insulin (long and intermediate acting) as a percentageof all insulin (long and intermediate acting). November 2014 to January 2015 (%)z November 2014 to January 2015 z London average z November 2013 to January 2014 z YTDSouthwarkLambethBexleyLewishamGreenwichTower HamletsCity and HackneyBrentWandsworthWaltham ForestNewhamCentral London (Westminster)West London (K&C and QPP)HaringeyCCGEnfieldBromleyCamdenIslingtonKingstonCroydonHillingdonMertonBarking and DagenhamEalingRichmondHammersmith and FulhamSuttonHaveringRedbridgeHarrowBarnetHounslowLondonBack to contentsReferencesRight Insulin, Right Time, Right Dose 20

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhy isn’t isophane (NPH)insulin being used first line?Many people are sceptical about the use of NPHinsulin as first line choice of basal insulin in Type 2diabetes. There is a common belief that NPH insulinis ineffective and might lead to higher rates ofhypoglycaemia. Many healthcare professionals aremore familiar and comfortable with the useof medium and long acting analogue insulins asmany of the training programmes focussed onanalogue use.What is the evidence thatsupports the use of NPHinsulin first line?NICE Clinical Guideline 87 21 is based on evidencefrom two systematic reviews with meta-analysisthat review NPH insulin but come to differentconclusions. The Cochrane review 32 concluded:“Our analysis suggests, if at all only a minorclinical benefit of treatment with longactinginsulin analogues for patients withdiabetes mellitus Type 2 treated with ‘basal’insulin regarding symptomatic nocturnalhypoglycaemic events. Until long-termefficacy and safety data are available, wesuggest a cautious approach to therapy withinsulin glargine or detemir.”This review included six studies comparing NPH toglargine and two studies comparing NPH to detemir.““Metabolic control, measured by glycosylatedhaemoglobin A1c (HbA 1c) as a surrogateendpoint, and adverse effects did not differin a clinical relevant way between treatmentgroups. While no statistically significantdifference for severe hypoglycaemia rateswas shown in any of the trials, the rateof symptomatic, overall and nocturnalhypoglycaemia was statistically significantlylower in patients treated with either insulinglargine or detemir. No evidence for a beneficialeffect of long-acting analogues on patientorientedoutcomes like mortality, morbidity,quality of life or costs could be obtained.”Rosenstock’s findings 33 were somewhat different,suggesting that analogue insulins might favourtighter, safer blood glucose control. However, thedata presented in their meta-analysis shows onlya very small reduction in severe hypoglycaemia(although statistically significant).These results confirmed that insulinglargine given once daily reduces the risk ofhypoglycemia compared with NPH insulin,which can facilitate more aggressive insulintreatment to a HbA 1ctarget of 7.0% in patientswith Type 2 diabetes.”This review was based on four randomised openlabel studies comparing once daily glargine withonce or twice daily NPH. There was no differencein overall glycaemic control between those treatedwith NPH insulin and insulin glargine. However:“The incidence of overall symptomatichypoglycemia, nocturnal hypoglycemia, andsevere hypoglycemia was significantly lowerwith insulin glargine compared with NPH insulin.”Further analysis of severe hypoglycaemic eventsshowed that the rate of severe documentedhypoglycaemic events was 2.6% in the NPH groupcompared to 1.4% in the glargine group (p=0.044).The rate of severe documented nocturnal eventswas 0.9% in the NPH group compared to 0.8% in theglargine group is not statistically significant (p=0.73).SummaryThe NICE guidance for insulin initiation in Type2 diabetes 21 is well constructed. NPH insulin isrecommended for first line use, but clear exceptionsare identified particularly where hypoglycaemia isrecognised as being an issue. As part of the toolkitdevelopment, we commissioned a further review 34 toconsider evidence produced since the publication ofNICE clinical guideline 87. The review also included realworld and economic data. The review concluded that:Based on the currently available evidence to date,NPH insulin should remain the first choice when initiatinginsulin in people with Type 2 diabetes. To ensure the bestvalue for money from limited resources, when initiatinginsulin in Type 2 diabetes the use of long-acting insulinanalogues should be reserved for specific individualpatients who would be most likely to benefit as definedby NICE criteria 34 .A link to the full review can be downloaded here.Back to contentsReferencesRight Insulin, Right Time, Right Dose 21

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsRight insulin – the economics£280,000 to £320,000Cost per Quality Adjusted Life Year for NPH insulincompared with glargine.£188,000 to £412,000Cost per Quality Adjusted Life Year for for glarginecompared with detemir.NPH insulin has a lower acquisition cost thananalogue insulins as shown in the graph onthe right 35 . However, can this be translated intoclinical and quality of life benefits for peoplewith type 2 diabetes and overall economicbenefit to our health service?The Health Technology Assessment 36 supportingNICE CG 87 showed that the cost per QualityAdjusted Life Year (QALY) for NPH insulincompared with glargine was £280,000 to£320,000. The cost per QALY was £188,000 to£412,000 for NPH compared with detemir.Both of these are substantially greater than the£20,000 to £30,000 threshold usually consideredin NICE’s cost effectiveness evaluation.Intermediate and long acting insulinInsuman ® Basalisophane insulinInsulatard ®Isophane insulinHumulin I ®Isophane insulinInsulin glargine(Lantus ®)Insulin detemir(Levemir ®)Insulin degludec(Tresiba ®)£0£20 £40 £60 £80Cost (£) for 5x3ml pre-filled disposable pens 100 units/ml insulinThe use of NPH insulin is clearlyattractive in terms of prescribingcosts, although this must not be thesole determinant for prescribingchoice. Data considering medium andlong acting insulin prescribing andcost from Lewisham CCG shows thepotential cost that could be avoidedthrough increased use of NPH insulinin the right people as outlined by theNICE guidance.Data extracted from EMIS web in 37 Lewisham CCG practices (courtesy Medicines Optimisation team, Lewisham CCG)Insulin typeNumber ofType 2 patientson insulin% patients Assumedaverage monthlycostAnnual cost(monthlycost x 12)Spend per year –annual costx patientsNPH 500 46% £15 £180 £90,000LAIAs 582 54% £30 £360 £209,520£299,520The above data highlights that a cost avoidance of £180 per year per patient can be made when usingNPH insulin rather than LAIA in the right patient. Overleaf are examples of where avoiding costs byusing NPH insulin first line in line with NICE guidance have been used to finance improved diabetes care.Back to contentsReferencesRight Insulin, Right Time, Right Dose 22

Services for patients with diabetes inNorthamptonshire were redesigned based onNICE guidance.1 2 3 4 5 made by using NICE-recommended 6 human 7 8Why a toolkit?The right time The right insulin Mythsand barriersA multidisciplinary team (MDT) of clinicians wascreated to manage the support and servicesrequired. The MDT was funded through savingsNPH insulin for treatment, as opposed toanalogue insulin.Insulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteams“An increase in the use of NICE-recommended humaninsulin resulted in savings of more than £600,000.”Sue Smith, Head of Prescribing and Medicines Management,Nene and Corby Clinical Commissioning GroupsAn example of where avoiding costs by using NPH insulin first, in line with NICE guidance, have been used to finance improved diabetes careCommunitypharmacy9AcknowledgementsNICE Shared Learning Awards 2013How evidence-based insulinprescribing enabled a redesignof diabetes servicesServices for patients with diabetes inNorthamptonshire were redesigned based onNICE guidance.A multidisciplinary team (MDT) of clinicians wascreated to manage the support and servicesrequired. The MDT was funded through savingsmade by using NICE-recommended humanNPH insulin for treatment, as opposed toanalogue insulin.“An increase in the use of NICE-recommended humaninsulin resulted in savings of more than £600,000.”Sue Smith, Head of Prescribing and Medicines Management,Nene and Corby Clinical Commissioning GroupsRemodelling services Using savings from Multi-disciplinaryfor type 2 diabetes implementing NICE team brought severalIncreasing the use of guidance human to insulin redesign in Tower improvementsHamletsInformation from a variety of sources suggestedthat services offered for type 2 diabetes could servicesbe improved The in Northamptonshire. Medicines The aim Management wasteam in Tower Hamlets When the course engagedstarted in September 2010,to redesign these services so that they could The CRG observed that current treatment with human insulin accounted for 15 per cent of allprovide greater broadly consistency of with care, and stakeholders. reduce insulin in Northamptonshire Over contrasted a period with NICE of 24 long and months intermediate acting both insulin. thedependency on treatment in secondary care. guidance. NICE recommends that treatment By July 2012, this had grown to 25 per cent,cost and volume of should prescribed begin with human analogue NPH human insulin, and insulins resulting in has savings comeA clinical reference group (CRG) was set up toof more than down. £600,000.design and deliver a new best practice model of that this should be taken at bedtime or twice dailyJoint working between These savings were used to fund thecare, providing information, support and care to accordingprimaryto need.and secondary care continues,MDT, which in turn has achieved severalpatients sowiththey couldregularmake informedreviewchoices Yet of the prescribing. CRG found that treatment Download with human improvements. the report.about their conditions.The CRG identified the creation of a MDT, tomanage the support and services associatedwith diabetes, as a priority action. The CRGdrew up a ‘wishlist’ of all the services andtypes of professionals that an MDT mightinclude such as consultants, specialist nurses,podiatrists, dietetics, services for psychologicalsupport, and ways of providing care closer tothe homes of patients.However, the group soon realised thatthere would be no extra funding availableto resource such a team, and that existingresources would have to be used differently.In order to overcome the problem, it tookrecommendations from NICE’s guidance onBack to contentsReferencesNPH insulin only accounted for 15 per cent ofthe total amount of long and intermediate actinginsulin used; almost the opposite of what wouldbe expected if NICE guidance was being followed.The group identified that the first-line use ofanalogue insulin cost an estimated additional £1million per year in Northamptonshire. In addition,an audit of practice nurses found that the majorityhad only received training in implementinganalogue insulin.It consequently set up a one-day training coursefor practice nurses run by diabetes specialistnurses and a medicines management pharmacist.This course runs every 6-8 weeks on an ongoingbasis, and explains the practical aspects ofCorby Clinical Commissioning GroupNene Clinical Commissioning GroupThese include a 48 per cent reduction inadmissions, which has resulted in savings of£301,000, mentoring and support for primarycare clinicians to avoid unnecessary referrals,and the use of ‘diabetes specialist workers’ tosupport hard to reach patient groups.The MDT has also implemented greaterintegrated working, with 55 primary carepractices and clinics involving a range ofspecialists, including a consultant diabetologist.A learning point was the impact that havinginput from specialists from a range ofdisciplines had on the project. The team alsobelieve that it was helpful for clinicians to seethat the savings made from following NICERemodelling servicesfor type 2 diabetesInformation from a variety of sources suggestedthat services offered for type 2 diabetes couldbe improved in Northamptonshire. The aim wasto redesign these services so that they couldprovide greater consistency of care, and reducedependency on treatment in secondary care.A clinical reference group (CRG) was set up todesign and deliver a new best practice model ofcare, providing information, support and care topatients so they could make informed choicesabout their conditions.The CRG identified the creation of a MDT, tomanage the support and services associatedwith diabetes, as a priority action. The CRGdrew up a ‘wishlist’ of all the services andtypes of professionals that an MDT mightinclude such as consultants, specialist nurses,podiatrists, dietetics, services for psychologicalsupport, and ways of providing care closer tothe homes of patients.However, the group soon realised thatthere would be no extra funding availableto resource such a team, and that existingresources would have to be used differently.In order to overcome the problem, it tookrecommendations from NICE’s guidance ontype 2 diabetes, and came up with a novelmethod of generating the income required tofund the MDT.Using savings fromimplementing NICEguidance to redesignservicesThe CRG observed that current treatment withinsulin in Northamptonshire contrasted with NICEguidance. NICE recommends that treatmentshould begin with human NPH human insulin, andthat this should be taken at bedtime or twice dailyaccording to need.Yet the CRG found that treatment with humanNPH insulin only accounted for 15 per cent ofthe total amount of long and intermediate actinginsulin used; almost the opposite of what wouldbe expected if NICE guidance was being followed.The group identified that the first-line use ofanalogue insulin cost an estimated additional £1million per year in Northamptonshire. In addition,an audit of practice nurses found that the majorityhad only received training in implementinganalogue insulin.It consequently set up a one-day training coursefor practice nurses run by diabetes specialistnurses and a medicines management pharmacist.This course runs every 6-8 weeks on an ongoingbasis, and explains the practical aspects ofinitiating human NPH insulin and the evidencebase behind its use.Contact: Sue SmithHead of Prescribing and Medicines ManagementNene and Corby Clinical Commissioning GroupsEmail: sue.smith@northants.nhs.ukTelephone: 01604 651360Multi-disciplinaryteam brought severalimprovementsWhen the course started in September 2010,human insulin accounted for 15 per cent of alllong and intermediate acting insulin.By July 2012, this had grown to 25 per cent,resulting in savings of more than £600,000.These savings were used to fund theMDT, which in turn has achieved severalimprovements.These include a 48 per cent reduction inadmissions, which has resulted in savings of£301,000, mentoring and support for primarycare clinicians to avoid unnecessary referrals,and the use of ‘diabetes specialist workers’ tosupport hard to reach patient groups.The MDT has also implemented greaterintegrated working, with 55 primary carepractices and clinics involving a range ofspecialists, including a consultant diabetologist.A learning point was the impact that havinginput from specialists from a range ofdisciplines had on the project. The team alsobelieve that it was helpful for clinicians to seethat the savings made from following NICEguidelines were ring-fenced and reinvested indiabetes services.www.nice.org.ukRight Insulin, Right Time, Right Dose 23

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsRight Insulin – outcomesWhat are the London outcomes when NPH insulin is used in line with NICE guidance?We have reviewed the evidence and looked at the financial benefits but it is important to review theoutcomes for our local patients. Datasets available from LPP 31 and the Quality and Outcomes Framework 37(QoF) suggest that use of NPH insulin is not associated with poorer outcomes in terms of glycaemic control.The graphs below show NPH insulin use for the year 2013/14 and the QoF indicator for proportion of peoplewith diabetes achieving an HbA 1cof less than 64mmol/mol for the year 2013/14. Many CGGs with high NPHuse are also amongst those with best performance against QoF.Key messages1 NPH has been shown to be an effective first linetreatment for the majority of people with Type 2diabetes starting insulin therapy2 Use of NPH insulin as first line treatment (wheninsulin is required) in line with NICE CG 87 cancontribute to effective use of resources in diabetes3 Use of NPH insulin first line in line with NICECG87 does not affect population control of HbA 1cThe percentage of patients with diabetes, on the register, in whom the last IFCC-HBA 1cwas≤64mmol/mol in the preceding 12 months across London in 2013-14 (excluding exceptions)Prescribing non analogue insulin (long and intermediate acting) as a percentageof all insulin (long and intermediate acting) across London in 2013-14Percentage of patients withIFCC-HBA 1c≤64mmol/mol80%75%70%65%60%55%50%BexleyBarnetRichmondCity and HackneyCamdenSouthwarkCentral London (Westminster)South London CCGsNational averageHarrowBromleyKingstonTower HamletsEnfieldWandsworthLambethCCGSuttonHaveringHillingdonMertonCroydonHaringeyOther London CCGsPan-London averageNewhamIslingtonWest LondonLewishamHammersmith and FulhamGreenwichBrentRedbridgeBarking and DagenhamHounslowEalingWaltham ForestNon analogue insulin (long andintermediate acting) as a % of all insulin(long and intermediate acting)45%40%35%30%25%20%15%10%5%0%SouthwarkLambethLewishamBexleyGreenwichBrentCentral London (Westminster)South London CCGsWaltham ForestCity and HackneyTower HamletsIslingtonBromleyWest London (K&C, QPP)CamdenSth London averageCCGHaringeyEnfieldNewhamWandsworthKingstonMertonOther London CCGsLPP target Prescribing 2012-13Pan-London averageCroydonEalingRichmondSuttonHaveringHillingdonHammersmith and FulhamHarrowRedbridgeBarking and DagenhamBarnetHounslowBack to contentsReferencesRight Insulin, Right Time, Right Dose 24

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMyths and barriers (healthcare professionals)Each individual healthcare professional has differentexperience and beliefs about insulin and a numberof myths exist around both the use and choice ofinsulin. Despite the evidence that early use of insulinhas long term benefits there are significant barriersto initiation and titration. This can result in healthcareprofessionals and patients colluding to delay startingor titrating insulin which can have an impact oncomplications and patient outcomes.The reasons behind these barriers can be multifactorial.Healthcare professionals’ previousexperience with insulin, confidence and competenceto initiate or titrate insulin, as well as clinical inertia,can all play a part. It is important to address thesemyths to prevent a delay in starting and titratinginsulin in the right patients.Some of the healthcare professional myths that wehave come across are listed below. Click on the linkto uncover the evidence and decide whether thefollowing statements are actually truth or myths!“Myth:“Myth:“We don’t need to start insulinearly now we have new drugs like GLP-1analogues.”Click here to see the evidence“Analogue insulins are better atcontrolling HbA 1cthan the older isophaneinsulins.”Further myths and myth busting statements developedin conjunction with the Medicines Information Teamat Guy’s and St Thomas’ Hospital can be found in theMedicines Optimisation tab.Click here to see the evidence“Myth:“For most people long and mediumacting analogue insulins cause lesshypoglycaemia and cause less weight gain.”Click here to see the evidenceBack to contentsReferencesRight Insulin, Right Time, Right Dose 25

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMyths and barriers (healthcare professionals)“Myth:4“We don’t need to start insulinearly now we have new drugs like GLP-1analogues.”Back to myths• GLP-1 analogues work on different pathwayswithin the body. They can reduce appetite,regulate gastric emptying and enhance glucosedependent insulin secretion 38 . When combinedwith diet and exercise interventions, reductionsin HbA 1cand weight can be achieved howeverin practice we do not see this in all patients 40 .Insulin on the other hand is effective at reducingHbA 1clevels irrespective of the level beta cellfunction 40 . Studies have shown that after nineyears of diagnosis, a substantial number, possiblythe majority of patients will need the addition ofinsulin therapy 39 .• No published studies were identified thatcompared liraglutide/lixisenatide with NPHinsulin. The comparative data below are forexenatide and insulins:- Glycaemic control: When glycaemic controlwith exenatide is compared with variousinsulin regimens, the results are similar,suggesting noninferiority, although very fewstudies evaluated NPH insulin and the issueof non-optimisation of the insulin treatmentremains a concern. Furthermore, long termdata are not available 36 .- Weight: Most studies have reported weightloss with exanatide compared with insulinalthough in routine care, this has not alwaysbeen demonstrated 36 .- Other outcome data: No studies evaluatingother mortality or cardiovascular datawere identified 36 .- Hypoglycaemia: Hypoglycaemia is perceivedto be less of a problem with exanatide, butthe differences in the trials were not marked 36 .• Both insulin and GLP-1 analogues havetheir individual place in the pathway of themanagement of hyperglycaemia and choice ofagent should be directed by patient factors 40 .• In the right patient at the right time, GLP-1analogues are important adjuncts to other oralhypoglycaemic agents (and insulin in somepatients), and can support both weight lossand HbA 1creduction 40 .• However, GLP-1 analogues cannot be used insteadof insulin in those patients that require insulin.Thinking about the principles of the right timeand the right patient, it is incredibly importantthat we identify the right diabetes treatment tobe given to the patient and review on a frequentbasis in order to ensure optimal outcomes 40 . SIGNguidance emphasises the need to apply carefulclinical judgement in those people with a longduration of type 2 diabetes on established oralglucose-lowering drugs with poor glycaemiccontrol (>10 years) as these individuals are poorlyrepresented in published studies, and to ensureinsulin therapy is not delayed inappropriately forthe perceived benefits of GLP-1 analogues 41 .Back to contentsReferencesRight Insulin, Right Time, Right Dose 26

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMyths and barriers (healthcare professionals)“Myth:“Analogue insulins are better atcontrolling HbA 1cthan the older isophaneinsulins.”“Myth:“For most people long and medium acting analogue insulinscause less hypoglycaemia and cause less weight gain.”A systematic review found no differencein HbA 1clevel between insulin glargineand NPH insulin, and only a small nonsignificantdifference in trials of insulindetemir versus NPH insulin (HbA 1clevelwas higher with detemir by 0.08%; 95%CI –0.03 to 0.19). Overall, the systematicreview concluded that “insulin glargine andinsulin detemir are equivalent to NPH interms of glycaemic control as reflected inHbA 1clevel” 36 .• Hypoglycaemia – No differences in the frequency of severehypoglycaemia between the insulin analogues and NPH insulinwere found, but, overall, hypoglycaemia was less frequent with bothinsulin glargine (OR 0.74, 95% CI 0.63 to 0.89) and insulin detemir(OR 0.51, 95% CI 0.35 to 0.76). The systematic review concludedthat insulin analogues have modest advantages in terms ofhypoglycaemia, especially nocturnal 36 .• Weight – Insulin therapy is likely to increase body weight by 2-4kgon average and usually greatest during early stages of insulin use 16 .Strategies to minimise weight gain should be discussed at insulininitiation and periodically throughout therapy to minimise weightgain. Weight gain in patients on insulin glargine was slightly lessthan in patients on NPH insulin (0.28 kg; 95% CI –0.72 to 0.15) butthis was neither clinically nor statistically significant. On detemir, thedifference was a little greater (1.2 kg; 95% CI –1.6 to –0.8) but againunlikely to be clinically significant 36 .4Back to mythsBack to contentsReferencesRight Insulin, Right Time, Right Dose 27

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMyths and barriers (healthcare professionals)This film shows a scenario you may be familiar with.Different interactions between patients and cliniciansmay lead to very different outcomes. What approachesand tactics are most likely to achieve positive change?41 Argue and reiterate the rationale for change2 Give lots of suggestions how to go about change3 Point out the dangers of not changing4 Listen reflectively to why it is undesirable tothis patient at this time5 Listen reflectively to the difficulties the patientforesees6 Ask them how they see the pros and consof changing7 Acknowledge that they have a choice whetherto change or notBack to contentsReferencesRight Insulin, Right Time, Right Dose 28

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMyths and barriers (patient perspective)Common patient barriers andperceptions regarding insulin therapyand suggestions of how to addressMedication is one aspect of diabetes selfmanagementand for many people, diabetesis one of several long-term conditions they haveto deal with day to day.For patients, barriers may include fear ofhypoglycaemia, needle phobia, friends or family’sprevious experience with insulin, fear that theirdiabetes is now ‘very bad’ or a fear of a negativeimpact on their lifestyle 42,43,44 . All of these areimportant factors and must be identified andaddressed to ensure insulin therapy will be effective.Needle phobia Weight gain Fear of hypoglycaemiaDriving restrictionsFear that diabetesis now ‘very bad’People living with diabetesInsulin is for Type 1 diabetesImpact on lifestylePatient feedbackFeedback from South London patient engagementgroups 45 concluded that people with Type 2diabetes want to feel that they have received all theinformation they need to understand their diabetesand self-manage effectively.They want to talk about the options from thebeginning. “I’d like to be able to ‘look ahead’ to seewhat’s coming next.” – Person living with diabetesWhen starting new medication, they want to be toldabout the benefits to controlling their diabetes aswell as the possible side effects.Insulin leads to furthercomplicationsPersonal failure tomanage own conditionClick on the boxes above and get some for ideas for responsesFriends and family(stigma)Back to contentsReferencesRight Insulin, Right Time, Right Dose 29

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsNeedle phobiaWeight gainDriving restrictionsFear that diabetesis now ‘really bad’Insulin leads to furthercomplicationsImpact on lifestyleConcern or fear about injectinginsulin is common but trueneedle phobia is rare. Advisepatients that insulin injectionsare not considered painful andare usually less uncomfortablethan the finger-prickingperformed for blood glucosemonitoring 46 .Insulin is for Type 1 diabetesOh no it’s not! Type 2 diabetesis a progressive condition andthe underlying cause is insulinresistance, the body initiallyattempts to compensate forthis by producing more insulin,however ultimately it canbecome tired and it’s at thistime when the body is unableto produce sufficient insulin,that insulin is required. Thereis a limit to what medicationcan do and for some patientsinsulin is all that we have tocombat the insulin resistance.This is a common adverseeffect of insulin treatmentand can increase the person’sbody weight by 2–4 kg.Weight gain can be minimisedby appropriate lifestyle anddietary changes and continuingwith metformin (if tolerated) 46 .A number of studies haveshown there is less weight gainwhen started on a basal insulinregimen than on a biphasic orbasal bolus regimens 47,48 .Fear of hypoglycaemiaOffer reassurance that mostepisodes of hypoglycaemia canbe self-managed. Additionallyhypoglycaemia is minimisedas patients are initiated ona low dose of insulin, withgradual dose titration. Aneducation package providedto individuals who startinsulin may also go throughmanagement and preventionof hypoglycaemia 46 .The Driver and VehicleLicensing Agency (DVLA)highlight the regulations inplace for those people withtype 2 diabetes and who useinsulin. Using insulin does notautomatically mean peoplewith Type 2 diabetes won’tbe able to drive. A numberof factors are taken intoconsideration including thetype of licence held, frequencyand severity of hypoglycaemiaand presence or absenceof any eye complications 49 .The healthcare professionalinitiating the insulin will discusscurrent driving needs andprovide individual advice onDVLA requirements. A guidefor healthcare professionalscan be found here.Fear that diabetes is nowreally bad AND personal failureto manage own condition– discussion points:• Type 2 diabetes is aprogressive disease and overtime the body producesless insulin. As less insulin isproduced by the body, moremedication and lifestylechanges will need to bemade to control HbA 1clevels.• There are many effectivetherapies for themanagement of type 2diabetes, including insulin 21 .• Insulin treatment is the nextlogical step in treatmentwhen other diabetestherapies are not controllingglucose levels or where wethink insulin would be thebest option for the patient.Therefore the right timefor insulin will differ in eachindividual.• Insulin should not be seen asthe last resort in optimisingglycaemic control or asfailure by the patient tocontrol their diabetes.Insulin should be seen as anoption in care to optimiseglycaemic control to preventlonger term complications.Discussion points:• Complications are causedby high blood glucose levelsalong with other adversemetabolic factors over along period of time 52 .• Insulin, along with othermedications used to reduceHbA1c levels help to reducethe complications bycontrolling blood glucoselevels.• If we can control bloodglucose levels effectivelyover time, we can reducecomplications 14 .Discussion points:• There are lots of differentinsulin preparations andregimes available 50 .• The healthcare professionalstarting insulin will lookat the appropriate insulinregime for the individual,taking into account theirlifestyle, driving requirementsand occupation 38,46 .• It is likely that insulin willbe started as a once-dailyinsulin at night time withminimal need for bloodglucose testing 47,48 .Stigma/friends and familyDiscussion points:With consent from theperson with Type 2 diabetes,carers and family memberswould be welcome to attendappointments and educationsessions to learn more aboutType 2 diabetes and how tosupport family members/people they care for.Back to contentsReferencesRight Insulin, Right Time, Right Dose 30

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin management – key factsWe have talked a great deal about the importance of optimisation ofboth medication and lifestyle interventions and as discussed by Dr Thomas,Dr Doherty and Dr Chamley we need to ensure we use the Right therapyat the Right time at the Right dose. Insulin is no exception to this. But, howdo we know when it’s the Right time is to start insulin?In this section we cover indications for insulin initiation, individualisationof insulin treatment and the practical aspects of supporting a person withType 2 diabetes with their insulin therapy.Back to contentsReferencesRight Insulin, Right Time, Right Dose 31

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsAims of insulin therapyThe overall aim of insulin treatment in Type 2diabetes is to mimic normal insulin secretion in orderto achieve normoglycaemia without causing weightgain or hypoglycaemia 20 . In order to decide whichinsulin regime may be best for your patient, it isimportant to consider a number of factors including:7060Normal insulin secretionShort-lived, rapidly generatedmeal-related insulin peaksPathophysiology factorsNormal insulin secretion and underlying defectsin Type 2 diabetesIn healthy adults, normal insulin secretion has twokey elements: rapidly secreted insulin in responseto food intake, alongside a low level of basal insulinto control glucose between meals. The amount ofinsulin secreted depends on a number of factorsincluding activity, eating, stress and hormones 52 .In Type 2 diabetes, there are problems with bothelements of insulin secretion: the rapidly secretedinsulin as well as the basal insulin secretion whichresults in hyperglycaemia 53 .Insulin (! U/ml)504030201006:0010:00 14:00 18:00 22:00 2:00 6:00Polonsky KS et al. J Clin Invest. 1988;81: 442-8Time of dayLow, steady, basalinsulin profileBack to contentsReferencesRight Insulin, Right Time, Right Dose 33

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right InsulinNow that we have looked at the factors weneed to consider before starting insulin, we arenow ready to think about which regime we mightstart in the individual.There are three main regimes that we use inType 2 diabetes:1 Basal insulin (once or twice daily)2 Biphasic insulin3 Multiple daily injections such as basal bolusregimesThe different regimes are described on thefollowing pages.NICE guidance recommends starting with humanNPH basal insulin injected at bedtime or twice dailyaccording to need 21 . Evidence from the 4-T trialhighlighted that basal insulin was associated withless weight gain and less hypoglycaemia comparedto both biphasic insulin and prandial insulin 47 .Back to contentsReferencesRight Insulin, Right Time, Right Dose 36

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right Insulin1 Basal insulinNPH basal insulin (intermediate acting insulin)Type Insulin Manufacturer Preparations availableInsulin ActivityOnset: 2-4 hrsPeak: 4-8 hrsDuration: 14-16 hrs0 2 4 6 8 10 12 14 16 185 20 22 24HoursIntermediate acting humanisophane (NPH) insulinHumulin I®100 units/mlInsulatard®100 units/mlLillyNovo Nordisk• 10ml vial• 3ml cartridge (for Autopen® Classic orHumaPen®)• 3ml Humulin I KwikPen® pre-filleddisposable injection devices• 10ml vial• 3ml Insulatard Penfill® cartridge (forNovopen® devices)• 3ml Insulatard InnoLet® pre-filleddisposable injection devicesIntermediate Acting Insulin can be used oncedaily (usually injected before bedtime*) or twicedaily (usually injected before bed and in themorning*). These insulins are cloudy and resuspensionof this type of insulin is important,otherwise hypo/hyperglycaemia may occur 55 .Examples are Humulin I® 58 , Insulatard® 59 andInsuman Basal® 60,61,62 and are summarised in thetable to the right 35,58,59,60,61,62 .Insuman Basal®100 units/mlSanofi–Aventis• 5ml vial• 3ml cartridge (for ClikSTAR® andAutopen® 24)• 3ml Insuman® Basal Solostar® prefilleddisposable injection devices* Timings of administration differ between preparations.Check with your local diabetes team or in the specificlicense for the insulin for more information.Back to contentsReferencesRight Insulin, Right Time, Right Dose 37

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right InsulinInsulin ActivityAnalogue basal insulin (longer acting insulin)Onset: 0-2 hrsPeak: NoneDuration: 18-42 hrs0 2 4 6 8 10 12 14 16 185 20 22 24HoursLonger acting insulins such as insulin glargine(Lantus®) 35 , insulin detemir (Levemir®) 35 andinsulin degludec (Tresiba®) 35 have a flatter profilei.e. they are less peaked. They provide acontinuous level of insulin and duration isslightly different for each brand 55 .When would we use basal long acting insulinanalogues (LAIA) over isophane (NPH) insulin?In line with NICE guidance 21 we would considerusing insulin glargine or insulin detemir if:• The person needs assistance from a carer orhealthcare professional to inject insulin, anduse of LAIA would reduce the frequency ofinjections from twice to once daily, or• The person’s lifestyle is restricted by recurrentsymptomatic hypoglycaemic episodes, or• The person would otherwise need twice-dailyNPH insulin injections in combination with oralglucose-lowering drugs, or• The person cannot use the device to injectNPH insulin.We should consider switching to a LAIA fromNPH insulin in people 21 :• Who do not reach their target HbA 1cbecauseof significant hypoglycaemia, or • Who experience significant hypoglycaemiaon NPH insulin irrespective of the level of HbA 1creached, or • Who cannot use the device needed to injectNPH insulin but who could administer their owninsulin safely and accurately if a switch to aLAIA were made, or • Who need help from a carer or healthcareprofessional to administer insulin injectionsand for whom switching to a LAIA wouldreduce the number of daily injections.Back to contentsReferencesRight Insulin, Right Time, Right Dose 38

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right Insulin2 Biphasic insulinInsulin ActivityBiphasic insulin (or pre-mixed insulin) containsa mixture of two components, generally a rapidor short acting insulin along with a longer actingcomponent. The different types of pre-mixedinsulin are detailed below.Pre-mixed isophane Insulin – Humulin® M3 35 , Insuman®Comb 15 35 , Insuman® Comb 25 35 , Insuman® Comb 50 35LongactingShortactingOnset: 30 minsPeak: 2-8 hrsDuration: up to 24hrs0 2 4 6 8 10 12 14 16 185 20 22 24Hours of actionThese contain mixtures of short acting andisophane insulin. These are usually injected upto 30 minutes before a meal 63 .Insulin ActivityPre-mixed Analogues – NovoMix® 30 64 , Humalog®RapidOnset: 5-15 hrsMix25 65 , Humalog® Mix50 65actingPeak: 1-4 hrsDuration: 24 hrsLongacting0 2 4 6 8 10 12 14 16 185 20 22 24Hours of actionPre-mixed analogues are a mixture of rapidactinginsulin analogue (insulin aspart orinsulin lispro) and the same rapid-acting insulinanalogue attached to protamine. Protamineprolongs its absorption so that it transformsinto an intermediate-acting insulin with NPH-likepharmacokinetics. This insulin can be injectedimmediately before or right after a meal 64,65 .When might more complex regimes bemore appropriate than basal regime?There are several indications when to considerinitiating a more complex insulin regimen suchas a biphasic preparation or basal-bolus regime:• Current HbA 1cis >2% higher than the targetHbA 1c• If the fasting glucose levels have improvedhowever HbA 1cremains significantly elevateddue to post-prandial hyperglycaemia 20,21,50• Hypoglycaemia is a concern 20,50• Patients preference for greater flexibility inan insulin regime i.e due to work, exercise,erratic lifestyle• In those with both high fasting and mealtimeblood glucose readings 46,50• In patients who maintain a fairly constantroutine of meals (timing and content ofcarbohydrate) and lifestyle 38,46Back to contentsReferencesRight Insulin, Right Time, Right Dose 39

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right Insulin3 Multiple daily injectionsThe most commonly used multiple dailyinjection regime is basal-bolus. This uses acombination of intermediate or long actinginsulin as a basal insulin injected once ortwice daily with the addition of a rapid orshorter acting insulin used as a bolus to covermeal times. We have already discussed theintermediate and long acting insulins and sowill focus on the ‘bolus’ insulin preparationshere of which there are two main types.• Rapid Acting• Short ActingBasal Bolus treatment regimePlasma InsulinBreakfast Lunch DinnerShort/rapid acting insulinBasal insulin, ie. Isophane4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00TimeBack to contentsReferencesRight Insulin, Right Time, Right Dose 40

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsInsulin regimes – using the Right InsulinRapid Acting Insulin Action– NovoRapid® 66 , Apidra® 67,68,69 , Humalog® 70Short Acting Insulin Action– Actrapid® 71 , Humulin S® 58 , Insuman® Rapid 72Are there other multiple dailyinjection regimes?Insulin ActivityOnset: 5-15 minsPeak: 0.5-1.5 hrsDuration: 3-5 hrsInsulin ActivityOnset: 30 minsPeak: 2-4 hrsDuration: 6-8 hrsA basal plus regime is also an option for someindividuals. Basal plus involves a combinationof intermediate or long acting insulin as a basalinsulin injected once or twice daily with theaddition of a rapid or shorter acting insulin usedas a bolus to cover the meal with the highestcarbohydrate content 20 .0 2 4 6 8 10 12 14 16 185 20 22 240 2 4 6 8 10 12 14 16 185 20 22 24Hours of actionHours of actionRapid Acting insulin onset is within 5-15 minutes.It should be taken just before eating or with fooddue to its rapid and short action 66,67,68,69,70 .Short Acting Insulin onset is approx. 30 minutesafter injection. It can be injected several timesduring the day. It is not frequently used as it canincrease the risk of hypoglycaemia in the morningor early hours of the night. Generally it should beinjected up to 30 minutes before food althougheach preparation differs. See licensing informationfor further information.Back to contentsReferencesRight Insulin, Right Time, Right Dose 41

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsSummary of the differences between the various injection regimesWe have discussed the different regimes available. Below is a summary of some of the pros and cons of the different regimes in the table below:Summary of the pros and cons of the different insulin regimes for Type 2 diabetes 20,35,47,50,55,73Insulin type Pros ConsBasal insulinBiphasic insulinBasal Bolus• Once or twice daily injections• Easy for patients to use• Less weight gain than other regimes• Less hypoglycaemia than other regimes• Easiest if patient is dependent on District Nurses/carers to administer insulin• Once or twice daily injections one with breakfast, second dose withevening meal• Easy for patients to use• Relatively easy to teach and simple for the patient to understand• Better post prandial control than basal alone• More likely to reach HbA 1cTarget if HbA 1c>8.5-9%• Closely mimics normal insulin physiology• Allows mealtime and activity flexibility• Adjustments can be made to individual doses• Suitable for patients with a very active lifestyle and high variability ineating habits• Doesn’t address post prandial excursions in glucose• May progress quickly to other regimes• Require fixed meal times, meal carbohydrates and daily activity• Unable to titrate individual doses of rapid/short or longer acting insulin• More weight gain than basal insulin• Hypoglycaemia risk higher than basal• Minimum four injections per day as well as frequent blood glucose testing– may affect adherence• More weight gain than basal insulin• Hypoglycaemia risk higher than basal• Requires the patient to be highly motivated and compliantBack to contentsReferencesRight Insulin, Right Time, Right Dose 42

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhat insulin preparationsare currently available?There are a number of different insulinpreparations on the UK market. Link to DiabetesUK website for latest information.Although the majority of insulin we prescribeis human insulin, other forms of insulin suchas porcine and bovine are still available. Somepatients may be prescribed animal insulin if it isthought that the human insulin has caused the lossof hypoglycaemia warning symptoms 35 or wherethey feel it works better for them than human 74 .For further information on these preparations,see www.evidence.nhs.uk/formulary/bnf/currentor www.medicines.org.ukAs the management of diabetes is an everchanging landscape, it is likely over the next fewyears that new insulin preparations will come to themarket. These will be reviewed by national bodiesand local formulary committees and decisionsmade on their likely place in therapy. Contact yourlocal medicines optimisation team or pharmacyteam for local formulary information.Who can initiate insulin?Initiating insulin is not straightforward andshould be undertaken by an appropriately trainedand competent healthcare professional 55,75 .The NICE Quality Standard for Diabetes inAdults 54 recommends:“Trained healthcare professionals initiate andmanage therapy with insulin within a structuredprogramme that includes dose titration by theperson with diabetes.”In most areas, initiation of insulin is undertakenby specialist teams either in the communityor hospital setting. In some local areas, basalinsulin initiation is undertaken by healthcareprofessionals in primary care who have completedan appropriate level of training.There are a number of national trainingprogrammes for insulin initiation and titration,for example:Optimising Glycaemic Control,University of Warwick – go to websiteandPITstop (Programme for Injectable Therapies)– go to websiteModule 1: Supporting People on GLP-1 & StartingGLP-1 anonistsModule 2: Starting & Supporting Patients duringthe first 6 months of insulin therapyModule 3: Reflect on progress & CarbohydrateAwareness/InsulinSimilar training programmes may be available inyour local community.If you are not trained in insulin initiation, pleaserefer all patients to your locally commissionedspecialist team. Please contact your local CCGfor further information on the pathway for insulininitiation in your area.If you currently initiate basal insulin and yourpatient requires a more complex insulin regimethen they should be referred to the local specialistservice either in community or acute settings forreview.Back to contentsReferencesRight Insulin, Right Time, Right Dose 43

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhat should be included within an insulin initiation structured programme?When starting insulin therapy, we need toprovide people with a supportive and structuredpackage of care, usually delivered through aneducation programme either in a group or onan individual basis. This may be based on whereinitiation needs to take place, patient needs andcommissioning arrangements.It is important that the benefits, risks and aimsof insulin therapy are carefully discussed withindividuals 21 and all fears, concerns and barriersneed to be identified and addressed wherepossible. Insulin therapy should only be started ifthe individual agrees to initiation 21 . It is importantto ensure both the insulin regime and subsequentdelivery device are tailored to the individual’sneed and preference 55 and there is understandingthat both the regime and the dose may changeover time. Contents of a structured educationprogramme may vary however should cover thefollowing 20,21,38,49,55,54,76,77,78,79,80 :What should be included within aninsulin initiation structured programme?• Dose titration to targetand the principle ofindividualised targetsand goals• Recognition, managementand the avoidance ofhypoglycaemia. Wherenecessary, educationregarding the administrationof glucagon shouldbe taught to carers andfamily members• Management of acutechanges in plasmaglucose control includingadvice on what to do duringillness, and any changesto timing of insulin whenlifestyle changes• Impact of diet and exercisechanges• How to test bloodglucose and frequencyof self-monitoring• Injection technique including:– preparation of insulinbefore injection– appropriate sites forinjection– timing of injections inrelation to food, and– the importance of rotatinginjection sites• Ensuring the device isappropriate for the individual• Storage of insulin• Safe sharps disposal• Information on Type 2diabetes and the need forinsulin therapy• Benefits and challengesof insulin therapy• Dietary understanding• Insulin safety includingall patients have an insulinpassport – see NPSA website –and carry identificationhighlighting that they useinsulinImplications for the individual,including:• Employment• Driving: insurance and DVLAregulations: see DVLA website,download TREND leaflet• Holiday insurance: see website• Alcohol• Cultural considerations,such as Ramadan• Travel and holidays• Continuing telephonesupport including contactnumbers for support froman appropriately trainedand experienced healthcareprofessional• The person starting insulinmay also want a carer to bepresent at the educationsessions for support• It is important to note thateducation is a continuingprocess and should begiven at initiation and on aregular basis as needed bythe individualBack to contentsReferencesRight Insulin, Right Time, Right Dose 44

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhat are typical startingdoses of basal insulin?As documented above, in line with NICEguidance, NPH basal insulin is the first line insulinin Type 2 diabetes unless the individual meetscriteria for other insulin regimes or preparations 21 .In the majority of cases, patients will be referredto their local Diabetes Intermediate teams forInsulin initiation and the information below isprovided as an example only as initial doses maydiffer dependent on patient factors.It is usually the case that the basal insulin willbe started within the range of 0.1-0.2units/kg/day however some patients may need higherdoses (0.3-0.4units/kg/day) in more severehyperglycaemia 20 . In practice, 10 units of basalinsulin is a common starting dose 81 .At initiation, contact numbers and details ofa key healthcare professional that can becontacted in times of need will be provided topatients. Generally, insulin initiation in Type 2diabetes is a planned procedure; therefore peopleshould not be started on insulin on Friday unlessabsolutely essential 55 .In the majority of people with Type 2 diabetes,10 units of basal insulin is unlikely to controlHbA 1clevels and gradual titration of the dosewill be needed.What about titrationof basal insulin doses?As stated, it is unlikely (but not impossible) thatstarting doses of basal insulin will control HbA 1cor blood glucose to the desired levels. In order toachieve optimal glycaemic control it is vital thatboth healthcare professionals and patients activelytitrate basal insulin doses until pre-determinedindividualised glucose targets are reached. Aswith insulin initiation, insulin titration should befacilitated by an appropriately trained healthcareprofessional 54 .Supporting patients to self titrate is an importantpart of self care however titration can causeanxiety for people with Type 2 diabetes and it isimportant that frequent contact with healthcareprofessionals involved in their diabetes care ismaintained 20 .Here are some pointers from our own Dr Patelon essentials to remember when titrating.“Dr P’s 7 Titration Rules 82Rule 1Blood glucose targets shouldbe individualised and documented.Rule 2Eliminate hypoglycaemia first prior tomanaging episodes of hyperglycaemia– the hyperglycaemia could be rebound.Rule 3Never INCREASE insulin dose based onONE high blood glucose reading.Rule 4Adjust one insulin at a time – aim to correctfasting glucose readings first (ensure thatthe individual has not had a hypo overnightwith a resulting rebound hyperglycaemia inthe morning).Rule 5Every action has a consequence – make onlyone change at a time and wait for 3 days priorto making any further changes.Rule 6Adjust insulin dose in line with your localguidance.Rule 7Nightmares, restless sleep, headache on waking,and wet pillow or sheets may be signs ofsleeping through an episode of hypoglycaemia.Back to contentsReferencesRight Insulin, Right Time, Right Dose 45

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsHow frequently will people need to undertake blood glucose monitoring?Blood glucose monitoring is often a controversial area in Type 2diabetes. Self-testing of blood glucose should be undertaken tosupport the management of the individual’s care. It is importantthat all people who are prescribed insulin have the right accessto blood glucose monitoring 21 . It is likely that people who maybe starting insulin will be asked to undertake blood glucosemonitoring for at least 2–4 weeks prior to the initiation of insulintherapy to ensure the healthcare professional who is starting theinsulin has a good background of current readings. Once insulin isinitiated, a guide on frequency of testing for each insulin regimeis provided below however please refer to your local guidance onfrequency of blood glucose testing. This will be available from yourMedicines Optimisation Team.Insulin regimeBasal Insulin – once daily (night time)Basal insulin – twice dailyBiphasic insulin – twice dailyBasal BolusMinimum blood glucosetesting requirements 86Pre-breakfast i.e. fasting* bloodglucosePre-breakfast and either beforebed or before evening meal(fasting* blood glucose)Prior to each injectionPrior to each injection andpre-bedtime*Different times of the day may apply to shift workers whose fasting timeswill differ. Contact your diabetes team for more information.It is also important to note circumstances where additional testing may be required:Circumstances where additional testing may be requiredAdditional blood glucose testing needs to be considered in a number ofother circumstances such as:• Lifestyle changes 21,84 /Disruptions to routine 21,84 /Driving 21 (refer toDVLA advice 51,79 , including for Group 2 drivers)• Intercurrent illness 21• When therapy or dosing is changed 21• If steroids are co-prescribed (depends on type of steroid please discusswith diabetes team) 85• Patients with persistent hyperglycaemia over 24-48 hours (Pre >7 & ± Post>9) 85• Pregnancy/Pre-conception and breast-feeding 84• Certain patient groups who are at increased risk of developing hypoglycaemiae.g. elderly 84 , the hypo-unaware 87 , impaired renal function 85 . Refer to NHSDiabetes hypoglycaemia guide for list of at risk groups 84 .Which meter and test strips to use?There are over 50 different test strips and associated meters currently availableon the UK market 86 . The test strips can range between £7 and £17 for 50 86 anda number of areas have worked collaboratively across primary and acute teamsto develop a preferred list of blood glucose test strips and meters that meetInternational Standards 87 . Contact your Medicines Optimisation team for moreinformation.Back to contentsReferencesRight Insulin, Right Time, Right Dose 46

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsWhat blood glucose levelsshould we be aiming for?As we’ve discussed earlierin the toolkit this should beindividualised however asmentioned in “Individualisingtreatment” under ‘bloodglucose profile’, in mostpatients, it would be reasonableto aim for a fasting glucoselevel of 4-7mmol/L or pre-meal5-7mmol/L, pre-bedtime of6-8mmol/L and a post-prandial(i.e. 2 hours after a main meal)level between 6-8.5mmol/l /lbut this will depend on theindividual 16,20,55,57 . Patients withoverall higher HbA 1ctargetsas documented earlier in thetoolkit will also have higherblood glucose target levels 20 .“HypoglycaemiaWhen reviewing an individual who hascommenced insulin Dr P says remember 82,88 :• People worry about it• Ensure individual can identify symptoms,potential causes and know how to treat• The individual knows when to ask forhelp and from whomEmployment• Diabetes is covered by the DisabilityDiscrimination Act 1995• Certain occupations are limited for thoseon insulin, eg. Emergency Services,Forces. Contact Diabetes UK Carelinefor more details• Shift patterns and activity levels willneed to be considered• Further information is available fromDiabetes UK CarelineOngoing care• Insulin requirements can changeover time• Individualise the care with the individual• Encourage self management inappropriate individuals• Ensure regular follow up has beenplannedExercise• All types of activity effect glucose levels• Ensure advice has been provided to preventhypoglycaemia• There should be no reason not to exercise,the only sports that are restricted are deepsea diving, freefall parachutingAlcohol• Alcoholic beverages have different effectson blood glucose levels – the glucose levelscan initially rise and then drop – hence therisk of delayed hypoglycaemia needs to bediscussed• Where alcoholic intake exceedsrecommended levels, people needappropriate advice to minimise risksDriving• Implications for driving and insurance• Possible loss of livelihood• Ensure that the individual understands theirresponsibilities when behind a wheel• Ensure individual has access to sufficientnumber of capillary testing strips (as nowrequired by law). Go to gov.uk website• Download an example of a patient leafletdeveloped by TRENDTravelBeing on insulin should not affect travel opportunities,however planning is required – i.e.• The individual will need to carry adequateidentification and a supporting letter explaining theneed to carry insulin and devices onto the plane• Consider destination, climate (heat can make thebody more sensitive to insulin), illness, change inactivity, mode of travel, time zones availability andstorage of suppliesInjection sites• Inspect injection sites at each visit for lipohypertrophy– ‘lumpy sites’• Encourage the individual to rotate between siteson a weekly basis• Lipohypertrophy can affect the absorption of insulinleading to erratic control.• Arms should be used with caution due to rapidonset of action – only use 4mm needles.• Human Insulin is absorbed more rapidly from theabdomen than the thighs.• There should be no need to prescribe needleslonger than 6mmSick day rules• Insulin doses may need adjusting during illness• Patients may require additional support• More frequent monitoring may be required• Generally insulin should never be stopped in Type 2diabetes• If vomiting stop metforminBack to contentsReferencesRight Insulin, Right Time, Right Dose 47

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsHypoglycaemia 82,89Weight gainhttp://richthediabetic.com/wp-content/uploads/2014/04/hypoglycemia.jpgSymptomsCausesInsulin/SecretagogueDose may need to bedecreased or medicationchangedHypoglycaemiaaware4321}Onset ofautonomicsymptoms}}Medication administrationconcernsReduced vision > incorrectdoses of insulin or medicationHypoglycaemia unaware• Older patients• Patients with frequent hypoglycemic episodes• Patients with diabetic autonomic neuropathy{Onsetof CNSdysfunctionComa/seizure{}Onset ofautonomicsymptomsAdapted from Holt and Hanley 2007Hypoglycaemia: Glucose

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsHow to commission quality diabetes servicesThis toolkit has been developed to support delivery of theRight Insulin, Right Time, Right Dose project. The objectives are:• Improvement in population outcomes in South Londonfor HbA 1cmanagement• Number of South London CCGs which achieve, maintainor increase LPP thresholds on % non-analogue insulin(long and intermediate acting) prescribing• Number of South London Medicines Optimisation teamswith robust plans for implementation of the projectThis section focuses on how intelligent commissioning cansupport the first two outcomes and drive change at a patient,practice / service and population level.Commissioning of diabetes services is often undertaken on amulti-tiered approach 90 and different models exist across SouthLondon. This means that measures should be collected across allproviders of diabetes care: acute hospitals, community servicesand general practice.Services must be commissioned to reflect the individualisationof blood glucose targets supported by NICE Quality Standards 54and the population control of blood glucose to support the publichealth need of our local people.The measures described below will support tighter control ofHbA 1c, intensification of therapy and use of the Right Insulin atthe Right Time at the Right Dose.Back to contentsReferencesRight Insulin, Right Time, Right Dose 50

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsHow to commission quality diabetes servicesRight Insulin – population measureSuggested measure% non analogue insulin (long and intermediate acting) as a % of all insulin(long and intermediate acting)Key thoughtsIt is important to measure the use of insulin of the whole population using GP data.Consider setting the same target for community and acute teams.Consider setting target above London Procurement Partnership (LPP) of 17.5%.as some providers already perform above this target.Track lost opportunities and cost avoidance data through the LPP website.This measure is in line with NICE Clinical guideline 87 21 .Data can be shared with practices, neighbourhoods, localities and service providers.Right Insulin – individual patient measureSuggested measure% patients with Type 2 diabetes on analogue insulin (long and intermediate acting)that have been reviewed in the last 12 months and have a documented reason forchoice of insulinKey thoughtsCollaborative care planning supports patients and health professionals to agreeand document health goals.All patients with diabetes should have at least an annual review of HbA 1c.It is important to measure individualised care provided by specialised services.Audit required in primary care as data not documented systematically.Right Insulin – reducing variationSuggested measureVariation of % non analogue insulin (long and intermediate acting)as a % of all insulin (long and intermediate acting) at a provider levelKey thoughtsIt is important to reduce variation across GP practices.Reducing variation, whilst maintaining or increasing population targets,will increase equity of service.Consider setting the same target for community and acute teams.Consider how initiation of insulin services can be provided across GP practices,neighbourhoods, localities and community services.Data can be shared with practices, neighbourhoods, localities and service providers.Get involvedThe Network appreciates that many of the commissioning teams andservice providers are already providing local quality and performanceinitiatives and delivering best practice. We would welcome your feedbackand support in developing our key commissioning indicators to improvehealth outcomes and in sharing our resources across South London.Back to contentsReferencesRight Insulin, Right Time, Right Dose 52

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsMedicines optimisationMedicines play a key role in themanagement of Type 2 diabetes,and work alongside lifestyleinterventions. Medicines optimisationencompasses a patient centredapproach to prescribing ensuringwe obtain the best outcomes forpatients for the investment we makein medicines 91,92 . This includes makingjoint decisions about medication,supporting compliance, reducingwaste, reducing unnecessarymedication and improving safety 91,92 .The Royal Pharmaceutical Societyhighlight four key principles ofmedicines optimisation 91 as shownbelow. Ensuring we prescribe theRight Insulin at the Right Time at theRight Dose supports all four principlesof medicines optimisation.This toolkit highlights how the fourprinciples of medicines optimisationhave been the cornerstones of theproject and resources we havedeveloped.Principle 1To understand thepatient experience• Engagement withlocal diabetesforums andundertaking focusgroups has shapedthe project andallowed us to havebetter insight andunderstandingof people withType 2 diabetes’perspectives,fears and barriersto medicinesoptimisation andinsulin use. Thesehave helped toshape this toolkitand associatedresources.• User involvementat a local level willbring this toolkitto life and developthis work further.Principle 4Make medicinesoptimisation partof routine practice• This toolkitprovides resourcesfor commissionersand healthcareprofessionals touse and embedinto every daypractice.Principle 3Medicines use isas safe as possible• Optimising carewith the rightmedication at theRight Time withthe Right Dosepromotes thesafe optimisationof appropriatemedication.Principle 2Evidence-basedchoice of medicine• Optimisationof therapy andusing the RightInsulin at the RightTime at the RightDose promotesadherence toevidence-basedNICE guidance 21,52 .• Commissioninga review of theevidence for use ofNPH insulin in Type2 diabetes postNICE guidancehas confirmed theproject aims areconsistent with thecurrent evidencefor choice ofinsulin in Type 2diabetes 34 .Back to contentsReferencesRight Insulin, Right Time, Right Dose 53

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsThe evidence in practiceA toolkit of takeaway resources have been developed to support theimplementation of this project locally. The toolkit of resources centres aroundthe four principles and can be used by all healthcare professionals involved inthe commissioning or provision of services to patients. Each resource is listedbelow with a summary and a link to download the resource.Resource A First line insulin therapy choice in Type 2 diabetes -Evidence ReviewResource BThe London Medicines Evaluation Network reviewedthe evidence for first line insulin therapy choice inType 2 diabetes. They have concluded that ‘basedon the currently available evidence to date, NPHinsulin should remain the first choice when initiatinginsulin in people with Type 2 diabetes. To ensurethe best value for money from limited resources,when initiating insulin in Type 2 diabetes the use oflong-acting insulin analogues should be reserved forspecific individual patients who would be most likelyto benefit as defined by NICE criteria 34 .’ The full reviewis available here.Insulin in Type 2 Diabetes Myth Buster!We have worked with people with Type 2 diabetesand healthcare professional colleagues across SouthLondon to collect views about barriers to insulin use.We shared these with the Medicines InformationTeam at Guy’s and St Thomas’ NHS Foundation Trustwho have summarised the evidence to bust someof those myths! The Insulin in Type 2 Diabetes MythBuster can be used to support discussions withhealthcare professionals and people with Type 2diabetes and is available here.Resources C & DType 2 Diabetes Responsible Prescribing Messagesand value pyramidThe South London Health Innovation Networkworked with Medicines Optimisation colleaguesin Surrey Downs CCG to develop responsibleprescribing messages and a value pyramid forType 2 diabetes. Whilst the responsible prescribingmessages primarily concentrate on the managementof HbA 1c, the value pyramid combines the evidencefor cardiovascular risk reduction alongside HbA 1cinterventions. These resources can be used tosupport Medicines Optimisation teams, diabetesteams and commissioners.The responsible prescribing messages come togetherto form the acronym TITRATION UP. This fits with ouroverall project aim to ensure the right patient getsthe Right Insulin at the Right Time. The TITRATION UPmessages are available here.The value pyramid describes the relative value ofdifferent interventions for Type 2 diabetes whenapplied to a population. The calculations usedto develop the value pyramid look at the clinicaleffectiveness using cost per quality adjusted life year(QALY) using NICE health economic data. A QALYgives an idea of how many extra months or years oflife of a reasonable quality a person might gain as aresult of treatment taking account of benefits andrisks of therapy. Additionally, the value bar chart looksat the incremental cost and benefits of using differenttherapies for reducing HbA 1cat different steps of thepathway. The Type 2 diabetes value pyramid and barchart is available here.Back to contentsReferencesRight Insulin, Right Time, Right Dose 54

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsThe evidence in practiceResource EGuidelines for the management of HbA 1cResource GExample prescribing audits and reviewsResource FThe example guidelines for the managementof HbA 1cdiscussed earlier by Drs Chamley,Doherty and Thomas can be downloaded here.For a word version for local adaptation, pleasecontact lamccg.medicinesoptimisation@nhs.netPowerPoint Slides for Type 2 diabetesA set of PowerPoint slides to support theimplementation of the Right Insulin, Right Time, RightDose are available to support delivery. The slide packincludes all the key messages for this project andare designed to be used by healthcare professionalsinvolved in commissioning or provider roles to ensurewe have consistent messages across South London.The slide pack is available by clicking here or fromlindabriant@nhs.netGet involvedThe Network appreciates that many of the Medicines Optimisationteams are already undertaking local reviews and audits and deliveringbest practice. Please feel free to share reviews and audits with us fordissemination to others via the toolkit.A number of local CCGs have shared audits and reviews that have ledto improved outcomes in local populations. These are shared below fordownload in word format for local adaptation where necessary.Review 1: This review supports practices to look at the practice Type 2diabetes population with an HbA 1c> 64mmol/mol and optimise treatmentin line with prescribing guidelines to improve the overall % of practicediabetes population with an HbA 1c≤ 64 mmol/mol. Click here to downloada copy of the review for local adaptation. Information about EMIS websearches developed to support this review is available here. For informationabout access to EMIS web searches contact lindabriant@nhs.netReview 2: This is a review tool to assess whether the prescribing ofnewer agents for Type 2 Diabetes is in accordance with NICE guidance.Click here to download a copy of the review for local adaptation.Resource HDiabetes Outcome Versus Expenditure (DOVE) ToolThis tool is available on the Public Health England website and looks atthe relationship between spending on diabetes care (prescribing datacomes from Health and Social Care Information Centre) and clinicaloutcomes (using QOF data). This data is available at a CCG level andcomparisons can be made with all other CCGs including those with similarpopulations. The tool also identifies the potential changes to costs thatwould result from changing outcomes or expenditure to benchmarkedlevels. The tool is available from here.Back to contentsReferencesRight Insulin, Right Time, Right Dose 55

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsCommunity Pharmacysupporting people livingwith Type 2 diabetesThe pharmacy profession is the third largesthealth profession and with a wide and easilyaccessible community based service, therefore ina time when the primary care workforce is facinghuge challenges, partnership working betweenGP practices and Community pharmacy, offerssignificant opportunities for delivery of integratedcare for patients with diabetes 93,94 .Pharmacists are highly skilled professionalswho historically, have been underutilised whenit comes to the management of patients withlong term conditions (LTC) 93 . This section ofthe toolkit aims to highlight the important rolecommunity pharmacy can play in supportingpatients with Type 2 diabetes around selfmanagementof their condition.Community pharmacy is recognised to be themost accessible element of the NHS for patients.Around 89.2% of the population in Englandis estimated to have access to a communitypharmacy within a 20 minutes’ walk from theirhome 95 with 84% of adults in England visitinga pharmacy at least once each year 93 .Accessibility, along with their expertise, makescommunity pharmacists ideally situated toplay an expanded role in direct patient care,in addition to the tasks they already perform,such as reinforcement of lifestyle advice andtreatment goals. Traditionally, the predominantrole of community pharmacy was the supplyof medicines, however over time; the role ofcommunity pharmacy has extended to the deliveryof advanced and enhanced services that can beutilised by patients with Type 2 diabetes.Advanced ServicesMedicines Use Reviews and the New MedicinesService are two examples of advanced servicesthat accredited community pharmacists can deliverto support patients with Type 2 diabetes to achievethe best outcomes from their medicines.What is a Medicines Use Review?A Medicines Use Review (MUR) is an advancedservice offered by community pharmacies, inaddition to their standard NHS communitypharmacy contract. MURs are conductedby accredited pharmacists within a privateconsultation room in the pharmacy and involvechecking the patients understanding of theirmedications, adherence with the prescribeddirections and whether medicines are being usedcorrectly and effectively.When MURs were introduced into the pharmacycontract, community pharmacies were expectedto ensure that at least 50% of MURs were forpatients in the following three national targetgroups:• Patients taking high risk medicines;• Patients recently discharged from hospitalwho had changes made to their medicineswhile they were in hospital• Patients with respiratory disease.From January 2015, a fourth target group hasbeen added: patients at risk of or diagnosedwith cardiovascular disease and regularly beingprescribed at least four medicines. Since April2015, community pharmacies have been requiredto ensure that at least 70% of MURs are forpatients falling within one of the four nationaltarget groups 96 .Back to contentsReferencesRight Insulin, Right Time, Right Dose 56

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsCommunity Pharmacy supporting people with Type 2 diabetesHow can MURs be beneficial in patientswith Type 2 diabetes?By targeting MURs in patients with type 2diabetes, community pharmacists can:• Improve non-adherence by increasing patients’understanding of their medicines and helpreinforce their importance in keeping thepatient’s condition stable.• Identify problems the patient may have withtaking their medicines as the prescriber intendedand work in partnership with the patient, GPand the patient to suggest possible solutions.• Reduce medicines wastage, through betteruse and storage of medications (e.g. insulinpens, blood glucose test strips etc.) and byencouraging the patient to only order themedicines they need.It is important to note that MURs are not clinicalreviews as the pharmacist will not be undertakingan assessment or examination of the patient’shealth status or results.New Medicines ServiceThe New Medicine Service (NMS) is an advancedservice that was initially introduced within thecommunity pharmacy NHS contract as a pilot in2011. Following publication of an evaluation of thepilot 97 which confirmed that the NMS deliveredbetter patient outcomes at a reduced cost to theNHS, it has been made a permanent component ofthe NHS pharmacy contract.The NMS allows community pharmacists toprovide extra support for patients prescribednew medicines, from an agreed list, for themanagement of one of the following long termconditions:• asthma and COPD• diabetes (Type 2)• antiplatelet / anticoagulant therapy• hypertensionPatients are eligible to receive this service if theyhave one of the above LTCs/therapies and arenewly prescribed one of the listed medicines forthat condition. Click here for list of medicines 98Eligible patients need not have visited thepharmacy previously and the NMS can be providedin a consultation area of the pharmacy or over thephone. The pharmacy contract does not allow fordelivery of the NMS within the patient’s home.The NMS is split into three stages:Stage 1: Patient engagementFollowing the prescribing of a new medicinecovered by the service, patients may be recruitedto the service by prescriber referral (which couldinclude referral for medicines prescribed to thepatient as a hospital inpatient or outpatient) oropportunistically by the community pharmacy.The patient will be asked to consent forinformation to be shared with their GP, asnecessary and the pharmacy will dispense theprescription and provide initial advice, as itnormally would.Stage 2: InterventionBetween 7 and 14 days after stage 1, thepharmacist will use an interview schedule toassess the patient’s adherence, identify problemsand the patient’s need for further informationand support which the pharmacist will provide.Stage 3: Follow-upThe pharmacist will follow up with the patient14 to 21 days after the intervention (again face toface or by telephone) to discuss how the patientis getting on with their medicine. They will alsoprovide advice, if required.If at either the intervention or follow up stages,the pharmacist identifies a problem whichrequires the prescriber to review the prescription,the pharmacist will complete an NMS feedbackform to inform the GP of the issue and providethem with any detail they require.Back to contentsReferencesRight Insulin, Right Time, Right Dose 57

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsCommunity Pharmacy supporting people with Type 2 diabetesCommunity Pharmacy Enhanced ServicesThe vast majority of community pharmacies nowalso offer a number of locally commissionedenhanced services that can be accessed bypatients with diabetes to help them manage theircondition and their general well-being. Box 1 listsjust some of the services available.Box 1Smoking Cessation ServicesWeight Management ServicesHealth Coaching & MotivationalInterview Consultations for Patientswith Non Adherence IssuesFlu VaccinationMinor Ailment ServicesNHS Health ChecksWaste Management SchemesNeedle Exchange ServicesSubstance MisuseEmergency Hormonal Contraceptive(EHC) ServicesResources for Providers of PharmaceuticalServices for Patients with DiabetesThe Royal Pharmaceutical Society (RPS) hasproduced a diabetes support tool for its membersthat provide useful resources for pharmacistsdelivering diabetes services99. The resourcesinclude:• A Checklist of ‘Practical Tips’ for theDevelopment and Approval of a PharmacyDiabetes Service Business Case• Implementation Checklist for PharmacyService Providers• Supporting People using Insulin PensThe resources may also be useful for managerswithin organisations responsible for commissioningservices for people with diabetes.Back to contentsReferencesRight Insulin, Right Time, Right Dose 58

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsAcknowledgementsThe Health Innovation Network wouldlike to thank the following individualsand organisations for their input to thistoolkit through sharing their resources,best practice, time and knowledge.Sedina Agama, Chief Pharmacist, Merton ClinicalCommissioning GroupDr Farooq Ahmad, GP Colliers Wood, Clinical Directorfor Diabetes and Dementia NHS MertonRena Amin, Joint Chief Pharmacist, Greenwich ClinicalCommissioning GroupNeel Basudev, GP LambethVanessa Burgess, Chief Pharmacist, Lambeth ClinicalCommissioning GroupSheila Burmiston, Diabetes Nurse Specialist, Guy’sand St Thomas’ NHS Foundation TrustDr Mark Chamley, GP with Special Interest in Diabetes,Lambeth Diabetes Intermediate Care Team, GP andPartner, Crowndale Medical Centre, LambethBarry Coker, Chair, Diabetes UK Lambeth and SouthwarkVoluntary GroupRajiv Dhir, Senior Prescribing Advisor, WandsworthClinical Commissioning GroupDr Jane Doherty, Partner, Princess Street Group Practice,SouthwarkDavid Erskine, Director of Medicines InformationService for London and South East, Guy’s andSt Thomas’ NHS Foundation TrustClare Fernee, Chief Pharmacist, Bexley ClinicalCommissioning GroupAngus Forbes, Professor of Nursing, Florence NightingaleSchool of Nursing and Midwifery KingsKaren Hong, Chief Pharmacist, Bromley ClinicalCommissioning GroupJas Khambh, Pharmacy and Medicines OptimisationLead, Primary Care, London Procurement PartnershipMaeve Kinsey, Senior Prescribing Adviser, BromleyClinical Commissioning GroupYasmine Korimbux, Senior Prescribing Advisor,Medicines Management Team – Tower Hamlets,NEL Commissioning Support UnitSheetal Ladva, Medicines Information Pharmacist,Guy’s and St Thomas’ NHS Foundation TrustMari Longhurst, Commissioning and Service ImprovementManager, NHS Merton Clinical Commissioning GroupHelen Marlow, Lead Primary Care Pharmacist andNICE Medicines and Prescribing Centre Associate,Surrey Downs Clinical Commissioning GroupEfa Mortty, Deputy Head of Medicines Management,Haringey Clinical Commissioning Group (CCG)Sadhna Murphy, Joint Chief Pharmacist, GreenwichClinical Commissioning GroupTukyia Mutupa, Intern for Informatics andCommunications, Health Innovation NetworkBethany Nelson, Data Assistant, Health InnovationNetworkHelen Noakes, Diabetes Specialist Nurse Lewishamand GreenwichShelpa Parmar, Senior Prescribing Adviser– Primary Care Medicines Commissioning Lead,Lewisham Clinical Commissioning GroupKushali Patel, Practice Pharmacist, MedicinesOptimisation Team, Richmond Clinical CommissioningGroupShaistah Qureshi, Senior Pharmacist, Richmond ClinicalCommissioning GroupRishi Rampersad, Information Manager, Pharmacy,London Procurement PartnershipBack to contentsReferencesRight Insulin, Right Time, Right Dose 59

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsAcknowledgementsEmma Richmond, Chief Pharmacist, Richmond ClinicalCommissioning GroupRoz Rosenblatt, London Region Manager, Diabetes UKDevika Sennik, Senior Pharmaceutical Advisor, SouthwarkClinical Commissioning Group and Medicines InformationPharmacist, Guy’s and St Thomas’ NHS Foundation TrustJenny Sivaganam, Senior Clinical CommissioningPharmacist, Lambeth Clinical Commissioning GroupAshok Soni OBE, President of the Royal PharmaceuticalSociety and Community Pharmacist, LambethLaura Spratling, Senior Programme Manager,Health Innovation NetworkJanice Steel, Chief Pharmacist, Croydon ClinicalCommissioning GroupJane Stopher, Deputy Director, Adult Local ServicesProgramme, Guys’s and St Thomas’ Trust (formerDirector, Diabetes Modernisation Initiative)Bernie Stribling, Diabetes Transformation Manager,University Hospitals of Leicester NHS TrustSarah Taylor, Chief Pharmacist, Sutton ClinicalCommissioning GroupDr Stephen Thomas, Diabetologist, Guy’s and St Thomas’NHS Foundation TrustBrigitte Vanderzanden, South West London LeadCommissioning Pharmacist, South East CommissioningSupport UnitMel Ward, Informatics Lead, Health Innovation NetworkLondon Diabetes Strategic Clinical NetworkNene and Corby Clinical Commissioning Group,Sue Smith, Head of Prescribing and MedicinesManagementNHS Lambeth Clinical Commissioning Group andNHS Southwark Clinical Commissioning Group DiabetesPrescribing GroupAuthors:Dr Natasha H Patel, Clinical Director (Diabetes),Health Innovation Network and Diabetologist,Guy’s and St Thomas’ NHS Foundation TrustDr Charles Gostling, Clinical Director (Diabetes),Health Innovation Network and GP, LewishamAnna Hodgkinson, Clinical Lead (Diabetes), HealthInnovation Network and Senior Clinical CommissioningPharmacist, Lambeth Clinical Commissioning GroupRebecca Dallmeyer, Clinical Commissioning Consultantand PharmacistClaudette Allerdyce, Principal Pharmacist and ClinicalNetwork Coordinator for the Thornton Heath Network,Croydon Clinical Commissioning GroupLinda Briant, Senior Project Manager, Health InnovationNetworkThe Health Innovation Network is one of 15 AcademicHealth Science Networks (AHSN) across England.As a membership organisation, we are focused on lastingsystem-wide improvements in patient and populationhealth, strengthening relationships, and capitalising onteaching and research strengths across South London.www.hin-southlondon.org@HINSouthLondonThis guide was first produced in April 2015.The information shown is correct at time of publicationand is subject to change We welcome contributionsand comments to Linda Briant, Senior Project Managerlindabriant@nhs.netDesign: RaffCreativeFilms: Rocking Horse PicturesBack to contentsReferencesRight Insulin, Right Time, Right Dose 60

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsReferences1. United Kingdom Prospective Diabetes Study Group(1998). Tight blood pressure control and risk ofmacrovascular and microvascular complications inType 2 diabetes: UKPDS 38. British Medical Journal317: 703-13.2. Heart Protection Study Collaborative Group (2002).MRC/BHF Heart Protection Study of cholesterollowering with simvastatin in 20,536 high-riskindividuals: a randomised placebo-controlled trial.Lancet 360: 7-22.3. Hex N., Barlett C., Wright D., Taylor M. & VarleyD. (2012) Estimating the current and futurecosts of Type 1 and Type 2 diabetes in the UK,including direct health costs and indirect societaland productivity costs. Diabetic Medicine DOI:10.1111/j.1464-5491.2012.03698.x4. NHS England (2014) Action for Diabetes.Retrieved from: http://www.england.nhs.uk/wpcontent/uploads/2014/01/act-for-diabetes.pdfDecember 20145. The Information Centre for Health and Social Care(2013). National Diabetes Audit 2011 – 2012. Report 2complications and Mortality. Retrieved fromhttp://www.hscic.gov.uk/catalogue/PUB12738/natidiab-audi-11-12-mort-comp-rep.pdfDecember 20146. Deakin T., Cade J., Williams R. & Greenwood DC. (June 2006) Structured patient education:the Diabetes X-PERT Programme makes adifference. Diabetic Medicine 23(9): pp.994-547. London Assembly Health Committee (2014).Blood Sugar Rush; Diabetes time bomb in London.Retrieved from: http://www.london.gov.uk/sites/default/files/14004-03-Diabetes-report-FINAL-No-Embargo.pdf December 20148. World Health Organization (2003) Adherence tolong term therapies, evidence for action. WorldHealth Organization, Geneva9. Holman R.R., Paul S.K., Bethel A., Matthews D.R& Neil A.W. (2008). 10 year follow up of intensiveglucose control in Type 2 diabetes. New EnglandJournal of Medicine, 359: 1577-158910. Khunti K., Wolden M.L., Thorsted B.L., Anderson M.& Davies M.J. (2013) Clinical Inertia in People WithType 2 Diabetes A retrospective cohort study ofmore than 80,000 people. Diabetes Care 36, 3411-3417.11. Continuing research undertaken with the I3diabetes tem programme within King’s HealthPartners www.i3diabetes.org.uk12. Brown J.B., Nichols G.A. & Perry A. (2004)The burden of treatment failure in Type 2 diabetes.Diabetes Care :27:1535-154013. Williams R., Van Gaal L., Lucioni C & CODE-IIadvisory board (2002) Assessing the impact ofcomplications on the costs of Type II diabetes.Diabetologia 45: S13–S17.14. Stratton, I., Adler, A., Neil, H., Matthews, D.,Manley, S., Cull, C., Hadden, D., Turner, R. andHolman, R. (2000). Association of glycaemia withmacrovascular and microvascular complicationsof Type 2 diabetes (UKPDS 35): prospectiveobservational study. BMJ, 321: 405-1215. The Diabetes Control and Complications TrialResearch Group (1993). The effect of intensivetreatment of diabetes on the development andprogression of long-term complications in insulindependentdiabetes mellitus. New England Journalof Medicine 329(14): 977-986.16. United Kingdom Prospective Diabetes StudyGroup (1998) Intensive blood-glucose controlwith sulphonylureas or insulin compared withconventional treatment and risk of complicationsin patients with type 2 diabetes (UKPDS 33).Lancet, 352, 837-53.17. Duckworth, Abraira C., Mortitz T., Reda D., EmanueleN., Reaven P.D., Zieve F.J., Marks J., Davis S.N.,Hayward R., Warren J.D., Goldman S., McCarren M.,Vitek M.E., Henderson W.G., Huang GD., for VADRinvestigators (2009). Glucose control and vascularcomplications in veterans with Type 2 diabetes. NewEngland Journal of Medicine 360(2): 129-139.18. The Advance Collaborative Group (2008) Intensiveblood glucose control and vascular outcomes inpatients with Type 2 diabetes. New England Journalof Medicine 358(24): 2560-2572.19. Action to control cardiovascular risk in Type 2diabetes Study Group (2008) Effects of intensiveglucose lowering in Type 2 diabetes. New EnglandJournal of Medicine 358(24): 2545-2559.20. Inzucchi S.E, Bergenstal R.M, Buse J.B, DiamantM., Ferrannini E., Nauck M., Peters A.L., Tsapas A.,Wender R. & Matthews D.R. (2012) Management ofhyperglycaemia in type 2 diabetes: a patient centredapproach. Diabetes Care 35, 1364-1379.21. National Institute for Health and Care Excellence(2009) Type 2 diabetes, the management of Type 2diabetes. Clinical guideline 87. National Institute forClinical Excellence, London.22. Brown J.B., Nicholls G.A. & Perry A. (2004) Theburden of treatment failure in Type 2 diabetes.Diabetes Care 27 (7), 1535-1540.Back to contentsReferencesRight Insulin, Right Time, Right Dose 61

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsReferences23. Diabetes Modernisation Initiative (2014) Review ofprescribing patterns for two clinical commissioninggroups’ (CCGs) diabetes population with an HbA1cgreater than 64mmol/mol in primary care. PosterPresentation, Diabetes UK conference, 201424. Brod M., Kongso J.H., Lessard S. & Christensen S.L.(2009) Psychological insulin resistance: patientbeliefs and implications for diabetes management.Quality of Life Research 18 (1), 23-32.25. National Institute for Health and Care Excellence(2010) Liraglutide for the treatment of type2diabetes mellitus. Retrieved from http://www.nice.org.uk/ta20326. National Institute for Health and Care Excellence(2012) Exenatide prolonged release suspensionfor injection in combination with oral antidiabetictherapy for the treatment of type 2 diabetes.Retrieved from http://www.nice.org.uk/ta24827. National Institute for Health and Care Excellence(2013) Dapagliflozin in combination therapy fortreating type 2 diabetes. NICE technology appraisal288. Retrieved from http://www.nice.org.uk/ta288on 20 April 201528. National Institute for Health and Care Excellence(2014) Canagliflozin in combination therapy fortreating type 2 diabetes. NICE technology appraisal315. Retrieved from http://www.nice.org.uk/ta315on 20 April 201529. National Institute for Health and Care Excellence(2015) Empagliflozin in combination therapy fortreating type 2 diabetes. NICE technology appraisal336. Retrieved from http://www.nice.org.uk/ta336on 20 April 201530. Nathan D.M., Buse J.M., Davidson M.B., Ferrannini E.,Holman R.R., Sherwin R. & Zinman B. (2009) Medicalmanagement of hyperglycaemia in Type 2 diabetes:a consensus algorithm for the initiation andadjustment of therapy. Diabetes Care 32, 193-203.31. NHS London Procurement Partnership. MedicinesOptimisation and Pharmacy Procurement Resources.Retrieved from http://www.lpp.nhs.uk32. Horvath K, Jeitler K, Berghold A, Ebrahim SH,Gratzer TW, Plank J, Kaiser T, Pieber TR, SiebenhoferA. Long-acting insulin analogues versus NPHinsulin (human isophane insulin) for type 2 diabetesmellitus. Cochrane Database of SystematicReviews 2007, Issue 2. Art. No.: CD005613. DOI:10.1002/14651858.CD005613.pub3.33. Rosenstock J., Dailey G., Massi-Benedetti M.,Fritsche A., Lin Z. & Salzman A. (2005). Reducedhypoglycaemia risk with insulin glargine. DiabetesCare 28(4), 950-955.34. London Medicines Evaluation Network Review(2014) First line insulin therapy choice in type 2diabetes:NPH (isophane) insulin or a long actinginsulin analogue (insulin detemir/insulin glargine)?Retrieved from www.medicinesresources.nhs.uk/GetDocument.aspx?pageld=792184 on 22 December201435. British Medical Association and The RoyalPharmaceutical Society Joint Formulary Committee(2015) British National Formulary. Retrieved fromhttp://www.evidence.nhs.uk/formulary/bnf/current36. Waugh N., Cummins E., Royle P., Clar C., Marien M.,Richter B. & Philip S. (2010) et al. Newer agents forblood glucose control in type 2 diabetes: systematicreview and economic evaluation. Health TechnologyAssessment 14(36), 1-248.37. Quality and Outcomes Framework (QOF), 2012/1338. Royal College of Nursing (2012) Startinginjectable treatment in adults with type 2diabetes. RCN guidance for nurses. Retrievedfrom http://www.rcn.org.uk/__data/assets/pdf_file/0009/78606/002254.pdf39. Turner R.C., Cull C.A., Frighi V., & Holman R.R. forthe UK Prospective Diabetes study (UKPDS) group(1999) Glycaemic Control with diet, sulfonylurea,metformin, or insulin in patients with type 2 diabetesmellitus. Progressive requirement for multipletherapies (UKPDS 49). Journal of the AmericanMedical Association 281: 2005-201240. Health Innovation Network Clinician Opinion41. Scottish Intercollegiate Guidelines Network (2010)SIGN Clinical Guideline 116. Management of diabetes.Retrieved from: http://www.sign.ac.uk/pdf/sign116.pdf on 16.2.1542. Davies M.J, Gagliardino J.J, Gray L.J., Khunti K.,Mohan V. & Hughes R. (2013) Real-world factorsaffecting adherence to insulin therapy in patientswith Type 1 or Type 2 diabetes mellitus: a systematicreview. Diabetic Medicine 30, 512–524.43. Funnell G. (2007) Overcoming barriers to theinitiation of insulin therapy. Clinical Diabetes 25(1),36-38.44. Larkin M.E., Capasso V.A., Chen C.L., Mahoney E.K.,Hazard B., Cagliero E. & Nathan D. (2008) Measuringpsychological insulin resistance: barriers to insulinuse. The Diabetes Educator 34, 511–51745. South London Health Innovation Network (2014)Extracts from patient focus group (data held on file).Back to contentsReferencesRight Insulin, Right Time, Right Dose 62

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsReferences46. Clinical Knowledge Summaries (2010) Insulintherapy in type 2 diabetes. Retrieved from http://cks.nice.org.uk/insulin-therapy-in-type-2-diabetes47. Holman R.R., Thorne K.I., Farmer A.J., Davies M.J.,Keenan J.F., Paul S. & Levy J.C. for the 4-T StudyGroup (2007) Addition of biphasic, prandial, orbasal insulin to oral therapy in type 2 diabetes.New England Journal of Medicine 357(17), 1716–1730.48. Yki-Jarvinen H., Kauppila M., Kujansuu E., Lathi J.,Marjanen T., Niskanen L., Rajala S., Ryysy L., SaloS., Seppala P., Tulokas T., Vikiari J., Karjalainen J. &Taskinen M. (1992) Comparison of insulin regimensin patients with non-insulin-dependent diabetesmellitus. New England Journal of Medicine 327(20),1426-1433.49. Driver and Vehicle Licensing Agency (2014)A Guide to Insulin Treated Diabetes and DrivingDrivers. Retrieved from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/313214/DIABINF.pdf March 2015.50. American Diabetes Association (2011) PracticalInsulin: A guide for prescribing providers. 3rdedition. American Diabetes Association, Virginia.51. Management of Hyperglycaemia and Steroid(Glucocorticoid) Therapy. Retrieved from http://www.diabetologists-abcd.org.uk/JBDS/JBDS_IP_Steroids.pdf52. Polonsky K. S., Given B.D. & Van Cauter E. (1988)Twenty-four hour profiles and pulsatile patternsof insulin secretion in normal and obese subjects.Journal of Clinical Investigation 81(2), 442–448.53. Alsahli M. & Gerich J.E. (2010) Abnormalitiesof insulin secretion and β cell defects in type 2diabetes. In Textbook of Diabetes. 4th edition (HoltR.I.G., Cockram C.S., Flyvbjerg A. & Goldstein B.J.ed.) pp. 160-173. John Wiley & Sons, Chichester.54. National Institute for Health and Care Excellence(2011) Diabetes in Adults quality standards. NICEquality standard 6. National Institute for Health andCare Excellence, Manchester.55. University Hospitals of Leicester NHS Trust(2013) Leicestershire Diabetes Guidelines:Insulin Therapy. Retrieved from http://www.leicestershirediabetes.org.uk/uploads//documents/Insulin_Guidelines_080114.pdf56. Monnier L., Lapinski H. & Colette C. (2003)Contributions of fasting and postprandialplasma glucose increments to the overall diurnalhyperglycemia of type 2 diabetic patients: variationswith increasing levels of HbA(1c). Diabetes Care 26(3), 881-885.57. International Diabetes Federation (2006) Guidelinefor the management of post meal glucose.International Diabetes Federation, Brussels, Belgium.58. Eli Lilly and Company Limited (2012) Summary ofproduct characteristics. Humulin Vials, Cartridgesand KwikPens. Retrieved from: https://www.medicines.org.uk/emc/medicine/3425 on 16.2.1559. Novo Nordisk Limited (2014) Summary of productcharacteristics. Insulatard 100 international units/ml, Insulatard Penfill 100 international units/ml, Insulatard InnoLet 100 international units/ml.Retrieved from https://www.medicines.org.uk/emc/medicine/3512 on 16.2.1560. Sanofi (2013) Summary of product characteristics.Insuman Basal 100 IU/ml suspension for injection ina cartridge. Retrieved from https://www.medicines.org.uk/emc/medicine/26468 on 16.2.1561. Sanofi (2013) Summary of product characteristics.Insuman Basal 100 IU/ml suspension for injection ina vial. Retrieved from https://www.medicines.org.uk/emc/medicine/26474 on 16.2.1562. Sanofi (2013) Summary of product characteristics.Insuman Basal SoloStar 100 IU/ml suspension forinjection in a pre filled pen. Retrieved from https://www.medicines.org.uk/emc/medicine/26475 on16.2.1563. Pharmacology for Pharmacy and the HealthSciences: A Patient-centred Approach By MichaelBoarder, David Newby, Phyllis Navti OxfordUnivesirty Press 2010. Management of DiabetesMellitus pg 36164. Novo Nordisk (2014) Summary of ProductCharacteristics NovoMix 30 Penfill 100 units/ml,NovoMix 30 FlexPen 100 units/ml. Retrieved from:https://www.medicines.org.uk/emc/medicine/8591on 16.2.1565. Eli Lilly and Company Limited (2013) Summary ofProduct Characteristics Humalog Mix25 100U/mlsuspension for injection in vial/cartridge/KwikPen.Humalog Mix50 100U/ml suspension for injectionin cartridge/KwikPen. Retrieved from: https://www.medicines.org.uk/emc/medicine/3203 on 16.2.1566. Novo Nordisk (2015) Summary of productcharacteristics. NovoRapid 100 units/ml in a vial,NovoRapid Penfill 100 units/ml, NovoRapid FlexPen100 units/ml, NovoRapid FlexTouch 100 units/ml.Retrieved from https://www.medicines.org.uk/emc/medicine/25033 on 19.4.1567. Sanofi (2013) Summary of product characteristics.Apidra 100 Units/ml, solution for injection in acartridge. Retrieved from https://www.medicines.org.uk/emc/medicine/26476 on 19.4.1568. Sanofi (2013) Summary of product characteristics.Apidra 100 Units/ml, solution for injection in a vial.Retrieved from https://www.medicines.org.uk/emc/medicine/26478 on 19.4.15Back to contentsReferencesRight Insulin, Right Time, Right Dose 63

1 2 3 4 5 6 7 8Why a toolkit?The right time The right insulin Mythsand barriersInsulin management:key factsCommissioning forpeople with Type 2diabetesMedicinesoptimisationteamsCommunitypharmacy9AcknowledgementsReferences69. Sanofi (2013) Summary of product characteristics.Apidra Solostar 100 Units/ml solution for injectionin a pre-filled pen. Retrieved from https://www.medicines.org.uk/emc/medicine/20124 on 19.4.1570. Eli Lilly and Company Limited (2014) Summary ofproduct characteristics. Humalog 100U/ml, solutionfor injection in vial, Humalog 100U/ml, solution forinjection in Cartridge, Humalog KwikPen 100U/ml,solution for injection. Retrieved from https://www.medicines.org.uk/emc/medicine/9314 on 19.4.1571. Novo Nordisk (2104) Summary of productcharacteristics. Actrapid 100 international units/ml,Solution for Injection in a vial. Retrieved from https://www.medicines.org.uk/emc/medicine/3513 on 19.4.1572. Sanofi (2013) Summary of product characteristics.Insuman Rapid (100 IU/ml). Retrieved from https://www.medicines.org.uk/emc/medicine/3561 on 19.4.1573. Giugliano D., Maiorino M.I., Bellastella G., ChiodiniP., Ceriello A. & Esposito K. (2011) Efficacy of insulinanalogs in achieving the hemoglobin A1c target of,7% in type 2 diabetes: meta-analysis of randomizedcontrolled trials. Diabetes Care 34:510–51774. Diabetes UK (2015) Diabetes treatments. Retrievedfrom http://www.diabetes.org.uk/Guide-to-diabetes/What-is-diabetes/Diabetes-treatments/ on 20 April201575. Training, Research and Education for Nursesin Diabetes (2011) An Integrated Career andCompetency Framework for Diabetes Nursing.Retrieved from http://www.trend-uk.org/documents/TREND_3rd.pdf February 201576. National Patient Safety Agency (2011) Theadult patient’s passport to safer use of insulin.Retrieved from http://www.nrls.npsa.nhs.uk/resources/?EntryId45=130397 March 2015.77. American Diabetes Association website.Hypoglycemia (Low Blood Glucose). Retrievedfrom http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html March 201578. American Diabetes Association website. BloodGlucose Control and Exercise retrieved from: http://www.diabetes.org/food-and-fitness/fitness/getstarted-safely/blood-glucose-control-and-exercise.html March 201579. Training, Research and Education for Nurses inDiabetes (2012) Diabetes: safe driving and theDVLA. Retrieved from http://www.trend-uk.org/documents/Driving%20leafletAA%20logo%20added-V1.pdf March 2015.80. Diabetes UK. Travel insurance. Retrieved from: http://www.diabetes.org.uk/How_we_help/Financial_services/Travel_insurance/ March 201581. Yki-Jarvinen H., Kauppinen-Makelin R., TiikkainenM., Vahatalo M., Virtamo H., Nikkila K., Tulokas T.,Hulme S., Hardy K., McNulty S., Hanninen J., LevanenH., Lahdenpera S., Lehtonen R. & Ryysy L. (2006)Insulin glargine or NPH combined with metforminin type 2 diabetes: the LANMET study. Diabetologia49(3), 442-451.82. Dr Natasha H Patel, Consultant Diabetologist,Guy’s and St Thomas’ NHS Foundation Trust83. Hirsch I.B., Bergenstal R.M., Parkin C.G., Wright E. Jr& Buse B. (2005) A real-world approach to insulintherapy in primary care practice. Clinical Diabetes23(2), 78-86.84. NHS Diabetes (2011) Recognition, treatment andprevention of hypoglycaemia in the community.Retrieved from http://www.trend-uk.org/documents/Trend_report_to_print.pdf March 201585. NHS Lambeth Clinical Commissioning Group andNHS Southwark Clinical Commissioning Group(2012) Guidance for self monitoring of bloodglucose.86. NHS Business Services Authority (2015) The April2015 electronic Drug Tariff. Retrieved from http://www.nhsbsa.nhs.uk/PrescriptionServices/4940.aspxApril 201587. International Organisation for Standardisationrecommendations ISO 15197:2013. Retrieved fromhttp://www.iso.org/iso/home.htm March 201588. University Hospitals of Leicester NHS Trust (2008)Leicestershire Insulin initiation guidelines. Retrievedfrom http://www.leicestershirediabetes.org.uk/uploads/123/documents/3.%20Leicestershire%20DMInsulin%20Guidelines%202008.pdf89. Holt RIG, Hanley NA (2007): Essential Endocrinologyand Diabetes. 5th Edition. Blackwell Publishing.(ISBN: 978-1-4052-3648-8)90. Healthcare for London. Diabetes Care for London.Retrieved from http://www.londonprogrammes.nhs.uk/wp-content/uploads/2011/03/Diabetes-Guide.pdfon 19 April 201591. Royal Pharmaceutical Society (2013) MedicinesOptimisation. Helping patients to make the most ofmedicines. Good practice guidance for healthcareprofessionals in England. Retrieved from https://www.rpharms.com/promoting-pharmacy-pdfs/helping-patients-make-the-most-of-their-medicines.pdf January 201592. Royal Pharmaceutical Society MedicinesOptimisation: The evidence in practice. Retrievedfrom https://www.rpharms.com/promotingpharmacy-pdfs/mo---evidence-in-practice.pdfJanuary 2015Back to contentsReferencesRight Insulin, Right Time, Right Dose 64

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