special report – commissioning diabetes management devices

Commissioning Diabetes Management Devices

S p e c i a l R e p o R t

Sponsored by

Published by Global Business Media

Commissioning Devices for Type 1 Diabetes

A Growing Healthcare Issue

Facing the Challenges of Diabetes

Talking About the Money

A Matter of Choice

Round-the-clock support for the very first time

The Paradigm Veo is the only insulin pump that can actively reduce the severity of hypoglycaemia.

Unlike any other pump, the Paradigm Veo uses sensor data to recognise when your glucose levels are dangerously low. It then responds by suspending basal insulin delivery for two hours, giving you the peace of mind you need to live life to the full.

The MiniMed Paradigm® Veo™ System Live More, Worry Lesswww.medtronic-diabetes.co.uk

UC201001627EN

The MiniMed Paradigm® Veo™ System

The freedom you deserve

SPECIAL REPORT: COMMISSIONING DIABETES MANAGEMENT DEVICES


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Contents

Foreword 2 John Hancock, Editor

Commissioning Devices for Type 1 Diabetes 3 Manisha Jethwa, Reimbursement & Commissioning, Medtronic Limited

Current SituationWhat Type 1 Diabetes Costs the NHSWhy Insulin Pumps?Reasons For Variation in NICE TA151 Implementation How to Improve Insulin Pump UptakeEffective Procurement StrategiesClinic Capacity Mapping to Increase Uptake of Insulin PumpsPartnering to Drive Services in the CommunityDelivering Service Efficiencies Though Uptake of Technology Improving Awareness through Education Effective Monitoring on GP RegistersConclusion

A Growing Healthcare Issue 8 Peter Dunwell, Medical Correspondent

Controlling SugarThe Growing IssueThe Prognosis

Facing the Challenges of Diabetes 10 John Hancock, Editor

The Extent of the ChallengeChallenges for CliniciansSpecific ChallengesBroader Healthcare ImplicationsChallenging the Patient

Talking About the Money 12 Peter Dunwell, Medical Correspondent

Economic RealitiesThe Costs of DiabetesTaking Everything Into Account

A Matter of Choice 14 Camilla Slade, Staff Writer

Treating the UntreatableA New Way of Administering InsulinPros and ConsIn Context

References 16

www.PRIMARyCAREREPORTS.CO.uk | 1

Commissioning Diabetes Management Devices

S P E C I A L R E P O R T

Sponsored by


Commissioning Devices for Type 1 Diabetes

A Growing Healthcare Issue

Facing the Challenges of Diabetes

Talking About the Money

A Matter of Choice

Sponsored by


The Paradigm Veo is the only insulin pump that can actively reduce the severity of hypoglycaemia.

Unlike any other pump, the Paradigm Veo uses sensor data to recognise when your glucose levels are dangerously low. It then responds by suspending basal insulin delivery for two hours, giving you the peace of mind you need to live life to the full.

The MiniMed Paradigm® Veo™ System Live More, Worry Lesswww.medtronic-diabetes.co.uk

UC201001627EN

The MiniMed Paradigm® Veo™ System

The freedom you deserve

Foreword

IT IS the case with most healthcare challenges

these days that they are best addressed from a

range of perspectives with a variety of therapies

to create a management programme as near as

possibly tailored to the specifics of the health issue

and the needs of the patient. That is certainly the

case with diabetes in which not only is the condition

itself a healthcare matter, but there are also often a

number of complications and associated conditions

to be avoided, managed, or resolved. So while it is

true that diabetes is probably the fastest growing

healthcare issue in the UK today, complications and

conditions associated with diabetes are likely to put

an even greater strain on the healthcare system.

The opening article in this Special Report looks at

the low level of uptake of insulin pumps in the UK

compared with most other countries of comparable

economic standing and healthcare provision. It goes

on to describe the benefits to Clinical Commissioning

Groups and Commissioners of improving type 1

diabetes services that increase the uptake of insulin

pump therapy to NICE requirements, and gives

reasons for variations in NICE TA151 implementation.

The key to improving the uptake of insulin pumps is

the maximisation of resources and the management

of capacity by service providers.

We go on to consider the growth in diabetes

and associated conditions and how that might be

affecting the priorities of our health care system – in

the case of the UK, the National Health Service (NHS).

We also look at the various levels at which diabetes

challenges our society and economy from the

broadest national economic level down to the impact

on individual people living with diabetes. Something

that cannot be ignored is the financial implications of

diabetes. Costs reach out much wider than simply

the treatment to considerations such as the costs

associated with complications and other conditions,

the cost of absence from work and the less definable

cost to psychological well-being and family life from

the impact of a long-term health condition.

Finally, we look at the way diabetes is treated and, in

particular, at insulin pump therapy and how it fits into

an overall diabetes management programme. It’s not

only the pros and cons of continuous subcutaneous

insulin infusion but how those commissioning

healthcare programmes should integrate it into their

own practices.

John HancockEditor


2 | www.PRIMARyCAREREPORTS.CO.uk

John Hancock has been Editor of Primary Care Reports since launch. A journalist for nearly 25 years, John has written and edited articles, papers and books on a range of medical and management topics. Subjects have included management of long-term conditions, elective and non-elective surgery, Schizophrenia, health risks of travel, local health management and NHS management and reforms – including current changes.



The MiniMedParadigm® Veo™

SystemThe freedom you deserve


The Paradigm Veo is the only insulinpump that can actively reduce theseverity of hypoglycaemia.

Unlike any other pump, theParadigm Veo uses sensor data torecognise when your glucose levelsare dangerously low. It thenresponds by suspending basalinsulin delivery for two hours, givingyou the peace of mind you need tolive life to the full.

The MiniMed Paradigm®Veo™ System

Live More, Worry Less

www.medtronic-diabetes.co.uk

Commissioning Devices for Type 1 Diabetes Manisha Jethwa, Reimbursement & Commissioning, Medtronic Limited

2013 oFFErS Clinical Commissioning Groups and Commissioners an

opportunity to reach the 12% threshold indicated by NICE and improve services for those patients who have type 1 diabetes. Working together in local teams and with good provider partnerships, Commissioners can create effective type 1 diabetes services which include insulin pumps, mandated by NICE TA151. With effective use of existing resources and the implementation of new technology, services can offer patients ‘choice’ and better control of HbA1c and improved quality of life. For Commissioners effective commissioning of type 1 diabetes offers the opportunity to avoid the high costs related to long-term complications of type 1 diabetes.

Current Situation5%1 of people in the UK are currently living with diabetes of which 250,0002 people are affected with type 1 diabetes. Rates of type 1 diabetes have been increasing over time with the greatest increase in children younger than 5 years2. The aspirational uptake of insulin pump therapy is 50%

in the population aged younger than 12 years with type 1 diabetes and 15% aged 12 years and older with type 1 diabetes3.In England NICE (TA151) have recommended the benchmark of 12% of patients with type 1 diabetes4 and 33% of children younger than 12 years old4 who are eligible for insulin pump treatment should have access to one. However in 2010 the INPUT survey5 of insulin pump provision surveyed 152 PCTs across England. The findings showed the average rate of insulin pump provision for people with type 1 diabetes is 3.9% compared to the 12% benchmark recommended by NICE5.

In the INPUT survey for example 17% of patients in Blackburn with Darwen PCT benefit from insulin pump therapy, when compared with only 0.4% in Luton4, leaving tens of thousands of patients with type 1 diabetes with little access to the right treatment from the NHS – a clear postcode lottery.

Even with NICE approval, a legal mandate to reach approved levels, present uptake of insulin pumps in the UK is lower than most other countries of comparable economic standing and healthcare provision6.

PUMP USAGE GrAPH



Even with NICE approval,

a legal mandate to

reach approved levels,

present uptake of insulin

pumps in the UK is

lower than most other

countries of comparable

economic standing and

healthcare provision.

To get a more recent picture of uptake in England it would be useful for CCGs to map their own rates to see if they do any better or worse than their former PCT structure, identifying any particular inequalities.

In NHS Scotland, the picture is different. NHS Boards are required to ensure that 25% of people under 18 years living with type 1 diabetes receive insulin pump therapy by March 201316. In order to support NHS Boards in meeting this key Ministerial commitment, the Scottish Government released funds to purchase insulin pumps and consumables16.

In NHS England, funding and access to insulin pumps can depend on local policy, self-funding and the availability of teams who can support.

What Type 1 Diabetes Costs the NHSShort-term complications of diabetes can be costly. On average a person living with type 1 diabetes will experience 1-2 hypoglycemic episodes per week7,8. Every year nearly 7% or an estimated 17,500 people living with type 1 diabetes in the UK will experience at least one severe hypoglycemic event9. The healthcare costs of severe hypoglycemia are considerable. It is estimated that each hospital admission for severe hypoglycemia costs the NHS around £100010.

Even if hospital admission is not required, significant costs may still be incurred from paramedic service involvement, ambulance use and physician call-out9. Routine care for those with diabetes is expensive but a far greater economic burden is the hospital care required to treat serious diabetes complications, which include amputation, kidney failure, heart attack and stroke.

The current cost to the NHS in the UK of direct patient care (treatment, intervention and complications) for those living with type 1 diabetes is estimated to be approximately £1bn11.

Social costs are also a burden on the current system. For type 1 diabetes Indirect costs (increased death and illness, work loss, informal care) is £0.9bn11.

The incidence of type 1 diabetes is growing at 4% each year12 and Impact Diabetes estimates that by 2035, 650,000 patients will have type 1 diabetes. By 2035 it is estimated that direct costs will increase to over £1.6bn11 and indirect costs increasing to £2.4bn for type 1 diabetes11.

Unless CCGs and Commissioners face the challenge now the NHS will be unable to cope in the long term.

Why Insulin Pumps?To reduce the risks of post-code lottery in the

new NHS, patients and the public will soon be able to see information on how quickly their local hospitals and CCGs are providing NICE-approved technologies. From 2013, hospitals and CCGs in England will be rated by an ‘Innovation Scorecard’, a web based portal allowing patients and the public to see which NHS organisations are adopting the latest NICE-approved technologies.

CCGs and Commissioners will have no excuse but to create services and pathways that provide access to and implement the latest NICE-approved technologies.

The benefits to CCGs and patients of improving type 1 diabetes services that increase the uptake of insulin pump therapy to NICE requirements are: – Improved patient outcomes including better

management of blood glucose levels (HbA1c). – Reduction in the risk of severe hypoglycaemia

and/or diabetic ketoacidosis (DKA).– Reduced risk of complications e.g. heart

disease, stroke, blindness – Better health, improved treatment satisfaction

and improved quality of life due to the accuracy and flexibility of the pumps.

– A reduction in frequency of hospital admissions and planned hospital admissions, potentially leading to cost savings for Commissioners.

Reasons For Variation in NICE TA151 Implementation – In local policies to deliver savings, procurement

functions have used insulin pump and consumable unit cost as a driver and in some cases capping number of insulin pumps available to type 1 patients in a year. This is illegal, against NICE mandate and goes against the NHS constitution to provide patients with “the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate.”14

– Capacity issues in centres that just cannot cope with limited resources with little attempt made to address the issue or refer onto centers with the ability to manage higher capacities.

– There is the possibility that many type 1 diabetes patients are being treated in centers that don’t offer an insulin pump service or clinicians steer suitable patients away from pump therapy because it’s not their preferred therapy of choice. Both may be a reason for the low uptake of insulin pumps.

– Long waiting lists for patients to find places on carbohydrate counting courses such as DAFNE. This may artificially restrict the number of patients considered eligible for pump therapy.

– Lack of information and awareness of the advantages of Insulin Pumps by both clinicians and type 1 patients.



Enlite®Sensor

CONTINUOUSGLUCOSE

MONITORING

It feels more like a6th sense than a sensor.

Better protectionfrom hypoglycemia1

• 98% of all hypoglycemic eventswere detected with Enlite® whenused with the MiniMed Paradigm®Veo™ System1

• The accuracy inthe hypo rangeimproved by26%.ll

• Predictive alertscan be set to tellpatients up to 30minutes before they reach a presetlow or high limit*

1. Enlite Sensor Performance addendum to user guide.II In a home-use study of adult patients, Enlite hypo (2.22-4.44mmol/L) mean absolute difference was found to be 0.69 mmol/Lvs 0.93 mmol/L with SofSensor. *Predictive alerts are only availableon MiniMed Paradigm® Veo™ System and Guardian® REAL-TimeCGM System.

How to Improve Insulin Pump UptakeTo achieve required NICE insulin pump threshold of 12% and 33%4, CCGs, Commissioners and clinical teams should take the opportunity to develop partnerships with suppliers that they traditionally might not have involved when considering service development providers.

In December 2011, the Department of Health published “Innovation Health and Wealth: accelerating adoption and diffusion in the NHS”13

The document indicates the accelerated level of support for partnership working.

“..simply doing more of what we have always done is no longer an option. We need to do things differently. We need to radically transform the way we deliver services.” Sir David Nicholson, Chief Executive of the NHS in England. (p4)13.

“We need to create a system for innovation that continually scans for new ideas, and takes them through to widespread use. In order to do this we must work with industry, academia, staff and patients, to set an agenda for change and delivery.” (p7)13.

Developing effective partnerships with providers can support the CCG and local commissioning teams in finding cost efficiencies and help deliver its strategic objectives for choice, innovation and service development for type 1 patients.

Effective Procurement StrategiesTo support savings strategies, procurement teams have, in some cases, limited choice to both patients and clinicians. When considering choice for insulin pump patients, besides looking at unit costs of insulin pump and consumables, procurement teams should consider the “value” of services and support offered by providers.

By increasing the weightings for “value” on tenders, CCGs and procurement teams open up opportunities in creating more effective managed services for type 1 diabetes or risk-sharing options

to drive efficiencies and encourage uptake of insulin pumps.

Clinic Capacity Mapping to Increase Uptake of Insulin PumpsMaximising resource and managing capacity in this current climate of budget cuts will be key if type 1 diabetes services are to improve the uptake of insulin pumps.

Providers, working in partnership with GP Commissioners and clinicians, can support local teams to carry out needs assessment to determine current and future need. Access to and utilisation of tools and services will allow GPs and Commissioners to gain a better understanding of what pump uptake would be required to meet NICE requirements of 12% and 33%4.

Services will need to ensure that they have the correct number of staff required in type 1 diabetes services to initiate large numbers of new patients on pump therapy whist maintaining the levels of service for normal activities of the department.

Provider partnerships can support local teams achieve targets by developing care pathways, which allow clinics to utilise resources in the most efficient way, which increases capacity with the same resource.

This model has been used successfully in NHS Scotland where partnerships between providers and local NHS teams have led to improved capacity and an increase in the uptake of insulin pumps.

Partnering to Drive Services in the CommunityIn managing increased capacity, Commissioners might also want to consider partnering with suppliers or AQPs (Any Qualified Provider) to develop intermediate care clinics for those living with type 1 diabetes, in the community,

CArELINK DASHBoArD GrAPH



closer to patients. This will support increased choice for patients and potential cost savings for CCGs and Commissioners.

Delivering Service Efficiencies Though Uptake of Technology The NHS is encouraging the uptake of home monitoring technology for patients with chronic conditions as it allows the patient to better manage their condition in a setting closer to home and deliver cost savings for the NHS. With improving technology, patients who are on insulin pumps can now manage their own diabetes closer to home.

Many providers already support type 1 diabetes services with 24-hour emergency cover for existing patients on insulin pumps, but with improved technology, providers can now offer type 1 diabetes services home monitoring services. With use of a simple software package, insulin pump patients can now securely upload data from their insulin pump onto a computer at home. This allows patients to have a better understanding of their glycaemic patterns and have greater understanding of the effects of insulin, food and activity on glucose levels.

The local clinician can download the data from the patient and generate a report before the patient attends a clinic. The clinician can then support the patient make the required changes either via phone or in-clinic. This can help improve patient compliance and better HbA1c control in patients with type 1 diabetes.

For Commissioners, cost efficiencies can be realised as remote monitoring avoids in-clinics visits and the burden of scheduled and unscheduled follow-up can be reduced.

Improving Awareness through Education GPs, consultants and nurses should encourage all patients with type 1 diabetes to participate in structured education. It is key for delivering maximum outcomes and helping patients self-manage their diabetes.

Currently, access to structured education is often sporadic in certain areas or delivered by larger centers therefore limiting access for many patients. It is not right that that structured education from trained nurses or expert patients should be limited by location.

Provider partnerships can support current type 1 diabetes services deliver structured education and sharing of best practice for those patients

that are waiting for insulin pumps. Fully qualified diabetes nurses and dieticians can support existing clinics and improve the uptake of insulin pumps by ensuring that those waiting for insulin pumps are effectively informed of their choices, educated on carb counting and are then fully managed through the process of pump initiation, regular follow ups and provide on-going support to both the patient and clinical teams.

Effective Monitoring on GP RegistersIn NHS England, currently there are no registers (GP or Hospital) highlighting the number of patients (adults or children) who have type 1 diabetes or those that are on insulin pumps. In NHS Scotland it is different. Each health board is required to develop a local action plan which identifies the risks to achieving insulin pump targets, including capacity, infrastructure, staff resources and training risks16. Each board plan can tell you the numbers of patients, adults and children who are living with type 1 diabetes, numbers of patients with type 1 diabetes who are on insulin pumps and each board is able to track patients, making auditing easier15.

Taking a lead from NHS Scotland, GPs and Commissioners in NHS England should consider including patients with type 1 diabetes and those who are on insulin pumps to existing GP registers for diabetes. GPs registers for type 1 patients will ensure that when patients move they continue to receive equality of care, regardless of where they live or the centre where they are managed. Registers for type 1 diabetes and those on insulin pumps will allow easier auditing and ensure type 1 patients are receiving the best appropriate care at the right time.

ConclusionInsulin Pumps are effective devices that support patients manage their diabetes.

The good news is that most GPs, Commissioners, consultants and nurses in NHS England acknowledge that there is a shortfall in current type 1 diabetes services and are actively looking at ways in which to improve insulin pump uptake.

Taking their lead from NHS Scotland, in 2013 CCGs and Commissioners are truly offered the chance to improve capacity and increase the uptake of insulin pumps to meet NICE requirements. CCGs and Commissioners would be wise to engage with providers now.

Provider partnerships

can support current

type 1 diabetes services

deliver structured

education and sharing of

best practice for those

patients that are waiting

for insulin pumps.











references:1 Health and Social Care Information Centre. International Diabetes Audit 2010-11. Available

at: http://www.ic.nhs.uk/webfiles/Services/NCASP/Diabetes/201011%20annual%20reports/

National_Diabetes_Audit_2010_2011_Report1_Care_Processes_And_Treatment_Targets.pdf

Date accessed June 2012

2 http://www.nice.org.uk/usingguidance/commissioningguides/insulinpumps/assumptions.jsp

3 NICE Technology Appraisal Guidance 151: Continuous subcutaneous insulin infusion for the

treatment of diabetes mellitus (http://www.nice.org.uk/nicemedia/live/12014/41300/41300.pdf)

4 NICE Benchmark

(http://www.nice.org.uk/usingguidance/commissioningguides/insulinpumps/determininglocalservicelevelsinsulinpumps.jsp)

5 INPUT Insulin Pump Therapy Audit Report, July 2010, Medical Technology Group, available at

www.mtg.org

6 Study by MAPI on behalf of Medtronic Ltd, 2012

7 Pramming S et al Symptomatic hypoglycaemia in 411 type 1 diabetic patients.

Diabet Med 1991;8:217–222

8 Pramming et al. Severe hypoglycaemia in unselected patients with type 1 diabetes:

a cross-sectional multicentre survey (Abstract). Diabetologia 2000;43(Suppl 1):A194

9 Leese GP, Wang J et al. Frequency of severe hypoglycemia requiring emergency treatment in

Type 1 and Type 2 diabetes. Diabetes Care 2003:26;1176-1180

10 Amiel SA et al Hypoglycaemia in Type 2 diabetes. Diabet Med 2008;25:245–54

11 Impact Diabetes Report, 2012, Hex, N., Bartlett, C., Wright, D., Taylor, M., Varley, D. Estimating

the current and future costs of Type 1 and Type2 diabetes in the United Kingdom, including

direct health costs and indirect societal and productivity costs. Diabetic Medicine. Taken from

http://www.diabetes.org.uk 5/12/12, 14.51pm

12 Patterson CC et al. EURODIAB Study Group. Incidence trends for childhood type 1 diabetes

in Europe during 1989-2008 and predicted new cases 2005-2020: a multicentre prospective

registration study. Lancet 2009;373:2027-3

13 Innovation Health and Wealth,

http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_134597.pdf

14 The NHS Constitution, http://www.dh.gov.uk

15 http://www.diabetesinscotland.org.uk/Publications.aspx?catId=6

16 http://www.sehd.scot.nhs.uk/mels/CEL2012_04.pdf



A Growing Healthcare Issue Peter Dunwell, Medical Correspondent

BECAUSE THErE are as yet no absolute answers as to why people are affected by

diabetes, it is difficult to say with any certainty why the increasing incidence of diabetes is set to become the greatest healthcare challenge of the 21st-century. Diabetes (diabetes mellitus, to give it its full name) “is a condition in which the amount of glucose (sugar) in the blood is too high because the body cannot use it properly.”1 This succinct explanation can be found in the NICE (National Institute for Health and Clinical Excellence) technology appraisal guidance 151 on ‘Insulin pump therapy for diabetes’.

Controlling SugarGlucose or sugar is vital to the body and comes from the digestion of starchy foods, from sugar and other sweet foods, and from the liver which makes glucose. To help get the glucose from the liver into the cells that need it, the pancreas produces the hormone insulin. The problem for diabetics is that their pancreas either does not produce (type 1) or does not produce enough insulin (type 2) so that the sugar in their body cannot be properly processed. Therefore, they need to administer insulin into their body, usually by injection. It is the growing prevalence of this condition which makes it so important for clinicians and healthcare authorities to develop the most effective and efficient means of managing diabetes.

The Growing IssuePatient.co.uk summarised the prevalence of diabetes within the UK population2.

Prevalence• In 2011 there were 2.9 million people with

diabetes. It is estimated that five million people will have diabetes in the UK by 2025.

• It is estimated that there are around 850,000 people in the UK who have diabetes but have not been diagnosed.

• The average prevalence of diabetes in the UK is 4.45% but there are variations between countries and regions (see below).

• The proportion of people with diabetes increases with age.

• However, the incidence of diabetes is increasing in all age groups. Type 1 diabetes is increasing in children (especially those aged under 5 years), and type 2 diabetes is increasing, particularly in black and minority ethnic groups.

UK health statistics are collected and published by the NHS Quality and Outcomes Framework (QOF) which records Diabetes prevalence rates for the UK and each of its constituent parts3

Prevalence of Diabetes in the UK

Country Prevalence Number of peopleEngland 5.5 per cent 2,455,937Northern Ireland 3.8 per cent 72,693Scotland 4.3 per cent 223,494Wales 5.0 per cent 160,533UK total 5.3 per cent* 2,912,657*Source: Diabetes UK from QOF returns except –

*extrapolated by author

According to a report ‘Diabetes in the UK 2004’ (no longer available) the incidence of diabetes in the UK has roughly doubled every 20 years since 1945.

UK prevalence statistics for diabetes 1940-2010

year Prevalence of all diabetes1940 200,0001960 400,0001980 800,0001996 1,400,0002004 1,800,0002010 3,000,000Source: Diabetes UK. ‘Diabetes in the UK 2004’

By far the majority of diabetes patients in the above numbers have type 2 diabetes which is often associated with other health conditions such as obesity or with the onset of old age – itself a growing reality these days. The pancreases of type 2 diabetics produce insulin but not in

It is the growing

prevalence of this

condition which makes

it so important for

clinicians and healthcare

authorities to develop

the most effective and

efficient means of

managing diabetes.

Diabetes: a condition whose prevalence is growing and whose treatment is an increasing healthcare priority



Enlite®Sensor

CONTINUOUSGLUCOSE

MONITORING







sufficient quantities: therefore the therapies to treat their condition do not often require insulin injections. However, those with type 1 diabetes produce no insulin themselves and therefore are dependent on administering the hormone. While type 1 diabetics are a minority, they are minority in a large and growing group and usually become diabetic during their childhood which means that they will need to manage the condition over their whole lifetime. The differing proportions of the two main types of diabetes are4…

Of adults with diabetes• 10% have type 1 diabetes.• 90% have type 2 diabetes.

Of children with diabetes• 98% have type 1 diabetes.• 2% have type 2 diabetes.

While the combined figures for adults and children are…• 15% have type 1 diabetes.• 85% have type 2 diabetes.

In straightforward terms, 250,000 people in the UK today, or 0.45% of the population, are living with type 1 diabetes, the prevalence of which continues to increase especially among children under five years old. But also, the impact of new people entering the group is cumulative with the effectiveness of modern management technologies and techniques helping to avoid the early deaths that were once the prognosis, and a generally lengthening life expectancy ensuring that patients will need treatment for ever longer times. This success has generated its own challenges as noted in ‘Diabetes in the UK 2012’5; “The figures are alarming and

confirm that diabetes is one of the biggest health challenges facing the UK today. If we are to curb this growing health crisis and see a reduction in the number of people dying from diabetes and its complications, we need to increase awareness of the risks, bring about wholesale changes in lifestyle, improve self-management among people with diabetes and improve access to integrated diabetes care services.” For those with type 1 diabetes this most certainly includes access to the best possible systems for administering their insulin requirement.

The PrognosisAccording to Patient.co.uk6, the prognosis for type 1 diabetes is that over 60% of patients have reasonably good health but many of the remainder develop blindness end-stage renal disease and in some cases early death. Against this, if a person with type 1 diabetes survives the period 10 to 20 years after the onset of the disease without on-going complications they have a good chance of reasonably good health. Controlling blood glucose, lipids, blood pressure and weight are important prognostic factors.

“Eventually, type 1 diabetes is fatal unless treated with insulin. Injection is the most common method of administering insulin although other methods are insulin pumps and inhaled insulin. Other alternatives are Pancreatic transplants that have been used and also pancreatic islet cell transplantation. Transplantation is experimental yet growing.”7 In the light of these statistics, common sense suggests that any improvements in the quality and capability of techniques and devices used in the management of diabetes should be actively pursued by healthcare authorities and clinicians.



Facing the Challenges of Diabetes John Hancock

The Extent of the Challenge“Diabetes mellitus is a chronic metabolic disorder caused by insufficient activity of the hormone insulin and a subsequent loss of control of blood glucose levels. There may be a lack of the hormone itself or resistance to its action... The onset of type 1 diabetes mellitus usually occurs in children and young adults, with an estimated prevalence in the UK in 2005 of 0.42% (approximately 250,000 people). The incidence has been increasing over time, with the greatest increase in children younger than 5 years.” This definition of diabetes in the National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance 151 ‘Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus’8 highlights the extent of challenges to clinicians, healthcare systems and to patients themselves in managing diabetes.

Highlighting the critical nature of the need to manage, particularly, type 1 diabetes, Bernard Higgins MD FRCP director, National Collaborating Centre for Chronic Conditions wrote, “Type 1 diabetes can, if poorly controlled, produced devastating problems in both the short and the long term. Good control of blood glucose levels reduces the risk of these problems arising but can be very difficult for patients and carers to achieve. This guideline9 emphasises that the NHS should provide all patients with the means – and the necessary understanding – to control their diabetes, and that it should help patients integrate the disease management without other activities and goals.” On page 17 of the same guideline there is an excellent flowchart to guide clinicians in a type 1 diabetes care algorithm.

Challenges for CliniciansFor clinicians, the challenge of delivering any healthcare management programme has been to ensure the best quality for the programme both in terms of the condition which is being treated and the patient to whom the treatment is applied. Under the new arrangements in the NHS, this basic tenet does not alter but, of course, with the

advent of Clinical Commissioning Groups (CCGs) clinicians’ practices will move from handing the process over to another part of the service to managing that process themselves. There are some key messages in the guideline ‘Type 1 diabetes in adults’ (see above for reference) to help clinicians in this delivery process. Particular emphasis is given to the fact that the patient and their preferences must be central to any care programme if it is to succeed in the longer term. Equally, any programme, whatever its central treatment, i.e. insulin administered by injection or by pump, must be part of an overall management package including elements such as education about diabetes, understanding and applying good nutrition, therapeutics to assist with other related conditions, the identification and management of complications, foot care, counselling and psychological care.

At the moment, the provision of such high quality and comprehensive care is by no means universal. In an article in the Nursing Times11

on 6 March 2012 ‘Improving Diabetes Care’ it was noted that, “In the recent National Diabetes Inpatient audit it was shown that 31% of sites had no inpatient DSN [Diabetes Specialist Nurse] which means the diabetes specialist input to each patient is low. People with diabetes now account for more than 15% of all occupied [hospital] beds and have substantially longer lengths of hospital stay (eight nights instead of five nights on average). Additionally, medication errors are worryingly common and are associated with poor outcomes.”

Specific ChallengesWhile there is not the space in this paper to deal with every particular diabetes management challenge, there is one that is common enough for clinicians to mark it as an area of special emphasis. It is also a challenge peculiar to a transiently vulnerable group at a time in their lives when long-term damage could curtail their life prospects. Teenagers with diabetes present

For clinicians,

the challenge of

delivering any

healthcare management

programme has been to

ensure the best quality

for the programme both

in terms of the condition

which is being treated

and the patient to whom

the treatment is applied.

Identifying what has to be done and doing it.











all of the behaviour and attitude problems that define a difficult and transitional time of life. The Australian Family Physician12 publication ran an article in 2006 entitled ‘Teenagers with diabetes – management challenges’.

This article said that deteriorating metabolic control of diabetes during adolescence is a relatively common event and that increasing insulin resistance during adolescence is usual for both sexes. Adolescents may increasingly resent parental supervision of their diabetes care, and also rebel against the restrictive nature of diabetes treatment regimens with acceptance of medical advice and adherence to treatment regimens diminishing. Diabetes may interfere with conformity to a peer group and increase the likelihood of risk taking behaviours and fluctuating glycaemia may increase the likelihood of an adverse outcome. Physical risk taking, binge drinking, recreational drug use and unplanned sexual activity all present particular problems for adolescents with diabetes. Eating disorders are more common in adolescent females with type 1 diabetes than in their non-diabetic peers. The most helpful thing for a healthcare professional to do is to maintain a mutually respectful relationship with an adolescent who is struggling to control their diabetes, and encourage family support, and praise.

This all reinforces the need for any management programme to be within the context of a specialist patient-centred diabetes care unit in the practice delivering care.

Broader Healthcare ImplicationsOf course, in these times of finite resources and budgetary constraints, we cannot simply look on any condition, including diabetes, in terms of its clinical impact. There is no doubt that the

management of a growing diabetic population, including those with type 1 diabetes, is one of the National Health Service’s greatest challenges today and into the future. “… diabetes care is typically complex and time-consuming. The necessary lifestyle changes, the complexities of management and the side-effects of therapy makes self-monitoring and education for people with diabetes central parts of management.”10

Further on in the Nursing Times article referenced above, it states that “The hospital should have systems in place to ensure that their clinical team is competent to use all equipment needed to deliver the [diabetes care] service.” The article also emphasises the importance of access to the latest technology and equipment. In the early part of this century, PCTs worked within a number of diabetes frameworks which outlined the standards for diabetic care. While care programmes will in future be managed by general practices in the new health service structure, it is nonetheless important to maintain and improve upon those standards.

Challenging the PatientFrom the point of view of the patient with diabetes, whether type 1 or type 2, the challenges are significant. We have already looked at the particular challenges of being a teenager with diabetes but at any stage in life diabetes poses a number of challenges. Whether it’s for the child having to understand the importance of and remember a routine that may set them apart from their peers or a teenager or an adult having to organise their life and work around the requirements of their condition, the challenges of diabetes for individuals are significant. Any technology or therapy development which can help to manage those challenges better has to be worth further consideration.



Talking About the Money Peter Dunwell, Medical Correspondent

Economic RealitiesIt is the reality of our times that everything has a price. Even when talking about health care issues and the impacts that they can have on the lives of those affected, there still has to be a cost consideration: resources are not infinite. Given that diabetes is set to become the most significant single healthcare issue in the UK during the next 25 years, its economic impact and considerations cannot be ignored. As early as 2004, the Royal College of Physicians in ‘Type 1 diabetes in adults’13 stated under the heading ‘Health and resource burden’, “Type 1 diabetes can result in a wide range of complications, and these affect both the individual patient and the National Health Service”. The economic impact of the disease includes:• Direct cost to the NHS;• Indirect cost to the economy, including the

effects of early mortality;• Personal impact of diabetes and subsequent

complications on patients and their families. However, it may not be fair to conflate all of these as one singular cost to the economy. For instance, what are categorised as direct costs to the NHS may well have the effect of reducing the indirect cost to the economy and the effects of early mortality. But then reduction in early mortality might add a further burden with the increase in patients needing treatment. And while the impact on patients and their families is described as personal, the fallout from those personal complications can end up costing the state significantly, so that the cost of a management or therapeutic intervention might balance out in favour of the economy overall. It is a complex area and perhaps the only fair statement is to say that the matter of economics and cost has to be viewed in the round.

The Costs of DiabetesIn 2010, Diabetes.co.uk14 looked at the costs that might be attributed to diabetes including the cost of absenteeism, early retirement and social

benefits. The conclusion was that, “ The following annual costs result from diabetes:• Cost of absenteeism: £8.4 billion per year;• Cost of early retirement: £6.9 billion per year;• Cost of social benefits: £0.152 billion.Of course, costs like those can be difficult to establish as there will be a degree of assumption and subjectivity involved in their calculation but the direct costs to the health service are more easily quantified and the NHS15 expects that in 25 years, by 2035/6 the cost to the NHS of direct care for [diabetes] patients will rise to £16.9 billion of which £1.8 billion will be for type 1 diabetes while the indirect costs associated with diabetes would increase to approximately £22.9 billion of which £2.4 billion will be attributed to type 1 diabetes.

By 2010, according to the Diabetes.co.uk report, the cost of diabetes to the NHS was over £1.5 million an hour or 10% of the NHS budget for England and Wales. This equated to over £25,000 being spent on diabetes every minute. And according to the NHS information Centre16, in 2012 Diabetes prescriptions topped 40 million for the first time, a rise of nearly 50 per cent on six years previous. The net cost of diabetes drugs also rose by just under 50 per cent in the same period.This growth is faster and greater than for prescriptions overall, where items increased by 33 per cent and net ingredient cost rose by just under 11 per cent in the same period. Today’s report, which focuses on primary care, shows diabetes drugs are taking up a bigger share of both total drugs dispensed and the total net cost to the NHS each year. It also shows that, while the overall cost of all drugs to the NHS fell last year by just over one per cent, the diabetes drugs bill increased by nearly five per cent.

Taking Everything Into AccountIn total, an estimated £14 billion is spent a year on treating diabetes and its complications with the cost of treating complications representing the higher component. According to some estimates, the cost of prescribing medication for diabetes associated complications is 3 to 4

In 25 years, by 2035/6

the cost to the NHS

of direct care for

[diabetes] patients will

rise to £16.9 billion of

which £1.8 billion will

be for type 1 diabetes

while the indirect costs

associated with diabetes

would increase to

approximately £22.9

billion of which £2.4

billion will be attributed

to type 1 diabetes.

Direct and indirect costs incurred when treating diabetes and its associated conditions.



times the cost of prescribing diabetes medication. The prevalence of diabetes is estimated to rise to 4 million by 2025.

These facts, the cost of treating complications and the rise in numbers suffering from diabetes make the economics of the condition even more complicated; if any therapy or device can make managing the condition safer and more reliable, then its overall economic impact would need to be taken into account when considering the cost of the therapy or device itself. As long ago as 2004, Diabetes UK estimated that people with diabetes were spending 1.1 million days in hospital each year and that, “in many cases these could and should have been prevented.” This is just one consideration that has to be taken into account in any effort to address the cost-benefits of a proposed new therapy or device.

For instance, in its 2011 report ‘Insulin Pump Therapy’, Diabetes UK, when looking at the

cost of buying and maintaining these devices, while estimating the additional cost of pump therapy over separate injections to be between £1091 and £1680 per year, also makes the comment that, “Use of pump therapy appears to derive opportunity cost benefits to local health services through a reduction in primary care contacts, reduction in hospital admissions and hospital outpatient contacts.” The report also added that improvements in HbA1c (one of the benefits of pump therapy) would lead to reductions in a number of the expensive-to-treat conditions associated with diabetes.

As commissioning and management responsibilities are devolved to practice level, these kind of long term and balanced considerations will have to form part of any commissioner’s deliberations when constructing policy for the management of diabetes care.

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A Matter of Choice Camilla Slade, Staff Writer

Treating the UntreatableAs recently as January 1922, the first injection of insulin was administered to a 14-year-old boy with diabetes in Toronto Canada. Since 1922, whatever treatment and or management regimes for diabetes have been devised and applied, at the heart of any programme for all type 1 diabetics and for some type 2 diabetics has been this insulin replacement therapy.

A New Way of Administering InsulinFor most of that time the method of administering insulin has been via subcutaneous injection along with attention to dietary management, typically including carbohydrate tracking and careful monitoring of blood glucose levels using glucose meters17. That routine of injecting either at multiple times during the day or at mealtimes has often been perceived as a socially challenging aspect of the condition while poor management of the routine has often led to further complications from which diabetics can suffer. But the relatively recent arrival of an insulin pump or continuous subcutaneous insulin infusion (CSII), has introduced new possibilities into the management of type 1 diabetes especially and the freeing of diabetics from some of the more intrusive routines associated with the condition.

Although the first insulin pump appeared in prototype form in 1963, its size was similar to a backpack and it was 1973 before the first conveniently sized wearable pump was developed. Yet take up rates have not reflected the pump’s and its associated CSII therapy’s apparent promise. Currently, according to Diabetes.co.uk18, around one in 1000 people with diabetes wears an insulin pump, of which there are six models available in the UK.

Insulin pump therapy makes use of an external pump that delivers insulin continuously from a refillable storage reservoir by means of a cannula placed under the skin. The pump can be programmed to deliver a basal rate of insulin throughout the day, with higher infusion rates triggered by the push of a button at meal

times19. The continuous delivery rate (basal rate) can be varied for, say, daytime and night-time use. In particular, this has helped those with diabetes to reduce the incidence of ‘disabling hypoglycaemia’ from a failure to reach target haemoglobin (HbA1c) levels with multiple daily injections. This is very important, not only for the physiological benefit of minimising hypoglycaemic episodes but also, as NICE explains20, “disabling hypoglycaemia is when hypoglycaemic episodes occur frequently or without warning so that the person is constantly anxious about another episode occurring, which has a negative impact on the quality of life.”

Pros and ConsA NICE appraisal committee set to review CSII therapy21, “concluded that CSII therapy had a valuable effect on blood glucose control. HbA1c levels were reduced, particularly when these levels were high at baseline (approximately 9.0%)... [the committee] was also persuaded that CSII therapy could reduce the rate of hypoglycaemic episodes, and it heard from the patient experts that when hypoglycaemia occurs in people using CSII therapy, it does so gradually and with sufficient time for the pump user to take remedial action.”

Diabetes UK (see reference 18 above) sums up the benefits,” Using an insulin pump has several key advantages. For instance, diabetics can instantly change insulin dose, meaning that changes are quicker to be felt. Furthermore, fast-acting insulin is more easily absorbed by the body, and it is more predictable than long-acting insulin. Because the body gets a constant, regular flow of insulin, the effect of the insulin is more constant… A diabetic with an insulin pump does not necessarily have to rise at a certain time to take insulin. When it comes to the diabetes diet, insulin pumps allow diabetics to be more flexible with that they eat, if they are used in the correct way.”

Of course, as with any therapy, CSII is not without its own complications. These include reactions in and, occasionally, infections at

Although the first insulin

pump appeared in

prototype form in 1963,

its size was similar to a

backpack and it

was 1973 before the

first conveniently

sized wearable pump

was developed.

Diabetics can choose whether to use injections or a continuous delivery system.











the cannula site, tube blockage and pump malfunction. While these might not be reasons for ceasing CSII therapy, NICE recommends that, where no discernible clinical benefit could be identified from a move to CSII therapy, clinicians should consider ending the therapy as the additional cost will not be justified by any improvement in the patient’s condition.

NICE has undertaken considerable research for the NHS into a consideration of when and how to apply CSII and that has culminated in technology appraisal TA 151 ‘Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus.’ as referenced in 18 above.

In ContextWhen commissioning or specifying an insulin pump therapy service, NHS recommends key components as…• Identifying people suitable for insulin pump

therapy [NICE offer plenty of guidance on this];

• Ensuring appropriate composition of the specialist team;

• Monitoring and supporting patients using insulin pumps.

As with any therapy including the management of diabetes, the use of an insulin pump does not obviate the need for a full programme to manage the condition.

NICE, while broadly supportive of this device, sets down some guidelines as to the context in which it should be used and some conditions which should govern its continued use. Once again, in the paper referenced at 18 above, NICE states, “Insulin pump therapy should only be started by a trained specialist team. This team should include a doctor who specialises in insulin pump therapy, a diabetes nurse and a dietician... This team should provide structured education programmes and advice...” and, further on, “insulin pump therapy should only be continued if it results in a sustained improvement in glycaemic control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes.”

The overall conclusion seems to be that CSII or insulin pump therapy might well be of value for some diabetes patients, especially those with type 1. But it must still be operated within an overall diabetes management programme to achieve optimum effectiveness.



references:1 K1 NICE technology appraisal guidance 151 on ‘Insulin pump therapy for diabetes’ http://www.nice.org.uk/nicemedia/live/12014/41303/41303.pdf

2 Patient.co.uk ‘Diabetes Mellitus‘ http://www.patient.co.uk/doctor/diabetes-mellitus

3 http://www.diabetes.org.uk/Professionals/Publications-reports-and-resources/Reports-statistics-and-case-studies/Reports/Diabetes-prevalence-2011-Oct-20111/

4 Diabetes.co.uk http://www.diabetes.co.uk/diabetes-prevalence.html

5 ‘Diabetes in the UK 2012’, Introduction http://www.diabetes.org.uk/Documents/Reports/Diabetes-in-the-UK-2012.pdf

6 Patient.co.uk, ‘Diabetes Mellitus’ http://www.patient.co.uk/doctor/diabetes-mellitus

7 Wikipedia http://en.wikipedia.org/wiki/Diabetes_mellitus_type_1

8 (NICE) technology appraisal guidance 151 ‘Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus’

http://www.nice.org.uk/nicemedia/live/12014/41300/41300.pdf

9 Type 1 diabetes in Adults. Published by Royal College of Physicians

http://www.nice.org.uk/nicemedia/pdf/CG015_fullguideline_adults_development_section.pdf

10 NICE cost impact and commissioning assessment for diabetes in adults

http://www.nice.org.uk/media/109/95/CostingCommissioningImpactAssessmentFinal.pdf

11 Nursing Times ‘Improving diabetes care’

http://www.nursingtimes.net/nursing-practice/clinical-specialisms/diabetes/improving-diabetes-care/5042317.article

12 The Australian Family Physician ‘Teenagers with diabetes – management challenges’ http://www.ncbi.nlm.nih.gov/pubmed/16751852

13 Royal College of Physicians ‘Type 1 diabetes in adults’ http://www.nice.org.uk/nicemedia/pdf/CG015_fullguideline_adults_development_section.pdf

14 Diabetes.co.uk http://www.diabetes.co.uk/cost-of-diabetes.html

15 Diabetes UK ‘Care connect campaign’

http://www.diabetes.org.uk/About_us/News_Landing_Page/NHS-spending-on-diabetes-to-reach-169-billion-by-2035/

16 NHS information Centre http://www.ic.nhs.uk/article/2102/Diabetes-prescriptions-top-40-million-in-England-after-50-per-cent-rise-in-six-years

17 Wikipedia http://en.wikipedia.org/wiki/Diabetes_mellitus_type_1

18 Diabetes.co.uk http://www.diabetes.co.uk/insulin/Insulin-pumps.html

19 NHS ‘Insulin pump therapy service, Commissioning guide’ http://www.nice.org.uk/media/87F/E2/InsulinPumpsToolDevelopmentUpdate.pdf

20 NICE ‘Insulin pump therapy for diabetes’ http://www.nice.org.uk/nicemedia/live/12014/41303/41303.pdf

21 (NICE) technology appraisal guidance 151 ‘Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus’

http://www.nice.org.uk/nicemedia/live/12014/41300/41300.pdf

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special report – commissioning diabetes management devices

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