Fact Sheet / Info

Macleod House 10 Parkway London NW1 7AA Tel 020 7424 1000 Fax 020 7424 1001 Email advocacy @diabetes.org.uk Website www.diabetes.org.uk

of 15 inputinput I Nsulin PUmp Therapy An independent voluntary organisation (C) INPUT 2008

Insulin Pump Therapy What is it and how do I get one? By Melissa P. Ford, Lesley Jordan and John Davis, INPUT

The charity for people with diabetes

Diabetes UK is the operating name of the British Diabetic Association Company limited by guarantee Registered office: 10 Parkway, London NW1 7AA Registered in England no. 339181 Registered charity no. 215199 Fact Sheet Page 2 of 15 Contents

 Introduction

 What is an insulin pump and what does it do?

 How can an insulin pump improve life with insulin-treated diabetes?

 Advantages and disadvantages

 Who is most likely to benefit from using a pump?

 Is insulin pump therapy provided by the NHS?

 How do you get one?

 About INPUT

 About Diabetes UK’s Careline and Advocacy Services

 Local Diabetes UK contact details

 Advocacy Pack feedback form Fact Sheet Page 3 of 15 Introduction

Since the release of the first NICE guidance on insulin pump therapy (TA 57) in 2003, interest in insulin pumps and the better health that they can offer to motivated people with insulin-requiring diabetes has expanded in the UK. In the past five years, the number of pump users in the UK has grown from about 2,000 to almost 7,000 in 2008, and the numbers continue to increase each year.

This article gives brief answers to five common questions about insulin pump therapy:  What is an insulin pump and what does it do?  How can an insulin pump improve life with insulin-treated diabetes?  Who is most likely to benefit from using a pump?  Is insulin pump therapy available within the NHS?  How do you obtain a pump?

Insulin

The word “insulin” comes before the word “pump” so let’s start there. In people with diabetes, insulin treatment (therapy) has three purposes:

First. Insulin must meet the background, or basal, insulin requirements of the body. In a person without insulin-requiring diabetes, the pancreas releases a small amount of insulin constantly, almost like a dripping tap. Basal insulin controls the release of stored glucose from your liver. It also regulates release of free fatty acids by the liver and fat cells. Furthermore, insulin balances other hormones found in the blood and transports amino acids into cells. Insulin may do even more things that haven’t been discovered yet. In people with insulin requiring diabetes, basal insulin is usually replaced by one or two injections of long-acting insulin every day.

Second. Insulin must be used to control blood glucose (sugar) levels around meals. In a person without insulin-requiring diabetes, the pancreas releases a bolus of insulin to help the body process energy from food and drink. When you have eaten, your digestive tract senses the food. In order to get energy out of the food (metabolise it) the body must release several hormones. Insulin is one of these hormones. Its role is to help the body save some energy for later, for instance between meals or overnight. In people with insulin requiring diabetes, this bolus is usually replaced by a mealtime injection of rapid- acting insulin.

Third. When the blood glucose level goes up above a normal level, insulin lowers it to a normal range. In people with and without diabetes, insulin works in two ways to reduce the amount of glucose in the blood. First, it acts on the liver to reduce the amount of glucose being released by the liver into the blood. Second, it helps cells within the body use the glucose for energy. When the body’s cells take up glucose from the blood and use it for energy, the amount of glucose in the blood goes down. Fact Sheet Page 4 of 15 Healthcare professionals agree that the best way to manage insulin requiring diabetes is to imitate how the non-diabetic body regulates glucose levels. Depending on their own body’s needs, some people use two insulin injections a day, others three or four, and others even more. Some people use an insulin pump instead. The goals of insulin therapy are the same whether someone takes injections or uses a pump: 1) provide enough basal insulin; 2) cover glucose levels around meals; 3) reduce glucose levels to a healthier, normal range when they go too high. Fact Sheet Page 5 of 15 What is an insulin pump and what does it do?

An insulin pump is a computerized insulin delivery device a little larger than a pager. CSII pumps are made to be attached to the body from the outside – there is no surgical procedure or “fitting” when someone begins to use a pump. A pump is attached to the body – usually to the abdomen – by a length of clear plastic tubing connected to a single-use infusion set. For information on common types of infusion sets available for use with insulin pumps, see Unomedical’s website http://www.infusion-set.com. A pump user can put the pump in a pocket, clip it to a waistband, or even tuck it in a sock.

An insulin pump is designed and programmed to imitate the way insulin works in someone without diabetes. To replace basal insulin, the pump delivers tiny, precise doses of fast acting insulin at pre-programmed intervals, typically once every three minutes. The basal insulin delivery rates (“basal rates”) are determined by the pump user, in consultation with his or her diabetes care team. Pumps allow you to program different basal rates based on time of day and differing requirements, so you can receive less insulin at night than during the day for example. A pump user (“pumper”) can adjust basal rates for a short term – from 30 minutes to 12 hours – or reset them completely. Basal rate testing and adjustment is done at home, without visiting a doctor or nurse. A key benefit of insulin pump therapy is that pumpers can easily reduce basal insulin levels during exercise, when the body needs less insulin, and increase them during times of illness or stress, when the body needs more insulin.

To meet insulin needs around meals and to correct high glucose levels (“glucose excursions”), a pumper programs the pump to deliver a bolus. Bolus amounts depend on a few factors: 1) the current blood glucose level; 2) the amount and type of food the user intends to eat; 3) the amount of physical activity the pumper expects to have within the next few hours. New pumpers receive training and support from their diabetes care team to help them get to grips with managing their own insulin doses.

How can an insulin pump improve life with insulin-treated diabetes?

Control your diabetes, not the other way round. Pumpers can achieve tight control of diabetes, minimising the risk of high and low glucose swings (“glycaemic fluctuations”) and long term diabetes complications. Pumpers take insulin to meet their bodies’ needs rather than organise life around their diabetes.

As the pump automatically delivers only rapid-acting insulin, at rates designed to meet basal insulin requirements, pumpers do not need to eat meals or snacks at specific times. Pumpers may eat when they like, or not at all, without the need to snack or “feed the insulin.” Pumpers can also exercise without risking dramatic high or low blood glucose levels. Greater flexibility in eating and activity can promote a healthy body weight and sense of well being.

More precise insulin dosing and reliable absorption Pumps deliver insulin much more precisely than anyone can with any available pen or syringe. Some makes of pump can deliver boluses as small as 0.05 unit – one twentieth Fact Sheet Page 6 of 15 of a unit! Basal rates are adjustable down to 0.025 unit or 0.05 unit as well, depending on the make of pump.

Insulin delivered by a pump can work more reliably and consistently than injected insulin. Occasionally insulin injected by pen or syringe is not absorbed properly by the body; when this happens, glucose levels may run low or high for several hours. Injected long-acting insulin that was absorbed too quickly can cause a severe hypo, especially overnight. Many people require less basal insulin at night than during the day. A pump can help prevent overnight hypos by delivering different basal rates over 24 hours.

Here are some advantages and disadvantages of using an insulin pump, according to pump users themselves and medical professionals:

Advantages Disadvantages

Offers a better quality of life and well being Being attached to the pump almost all Freedom from a fixed insulin dose schedule of the time (NB: the pump can Eat what you choose, when you like instantly be disconnected for brief Adjust insulin to meet the body’s needs periods – swimming, showers, sex, Feeling “normal“ etc.) Being more alert & aware Risk of diabetic Ketoacidosis (DKA) Being in control of life as well as diabetes may be higher without frequent Convenience blood glucose testing Easier management of exercise, sport Chance of skin infections, especially if Reliable insulin action the infusion set is not changed after Staying up late, having a lie-in, or 3 days oversleeping without worry Restoration of hypoglycaemia awareness Managing the dawn phenomenon Travelling across time zones without missing or taking too much insulin Tight diabetes control before and during pregnancy Delay or prevention of long term complications

Most experts agree that the advantages of pumping far outweigh the disadvantages. Fact Sheet Page 7 of 15 Who is most likely to benefit from using a pump?

The most common reasons why people go onto insulin pumps are:  Significant highs and lows in daily blood glucose levels and/or  Frequent low glucose levels that require someone else’s help and/or  A continually high HbA1C level …despite the best efforts on injections

Youngsters and women may see unique benefits from using a pump. Children and teenagers may keep better control of their diabetes through the hormone changes of adolescence using a pump compared to injections. Female pumpers can control their glucose levels more closely during the different phases of the menstrual cycle, as well as during pregnancy.

Not all reasons why someone may benefit from pump use are strictly medical. Some people thrive on a pump because it fits their lifestyle. Having a job that requires schedule flexibility (for example, shift work) or regular long-distance travel (for example, business consulting) may be a reason to consider a pump.

Successful pump users (or their carers) must:  Manage diabetes on a day to day basis  Count carbohydrates and adjust insulin doses to cover food  Check blood glucose levels (fingersticks) at the very least 4 times a day, commonly 7 to 8 times

To get the best use out of a pump, pumpers check their glucose levels before eating, taking insulin, or exercising. Most pumpers also check their glucose 2-3 hours after giving a bolus to make sure that their glucose levels are in a normal range.

How do pumpers use glucose tests, basal rates, and boluses in real life? Here is an example: if a hungry pumper – we’ll call her Jane – wants a sandwich before going on a long walk, she will probably: 1) Check her blood glucose level (fingerstick) 2) Decide whether to take any insulin specifically to reduce the glucose level 3) Count the number of carbohydrates in the sandwich using methods taught in the DAFNE course 4) Program a bolus that will allow her to eat the sandwich without getting a high blood glucose level, without great risk of a low blood glucose (hypo) later during her walk 5) Temporarily lower the pump’s basal rate so that she doesn’t get a hypo when her muscles use glucose for energy during her walk

An experienced pumper may need less than 3 minutes to do all that. Jane should check her blood glucose during and after her walk, and again 2 hours after her last bolus, to make sure her glucose levels are under control. Fact Sheet Page 8 of 15 Controlling blood glucose levels tightly takes personal motivation and commitment. However, studies such as the Diabetes Control and Complications Trial (DCCT, published 1997, see http://diabetes.niddk.nih.gov/dm/pubs/control/) have shown that the best way to prevent or delay complications of Type 1 diabetes and live life to the full is to control diabetes intensively. Diabetes complications include blindness, amputation, heart disease, and kidney failure. In addition to the pain that these complications bring, they also cause disability and require expensive treatment. A pump can be a very effective tool for controlling blood glucose levels tightly. While using a pump is more expensive than injection therapy on a day-to-day basis, over the long term tighter diabetes control is likely to keep pumpers healthier and in work, a better result for individuals and society as a whole. Fact Sheet Page 9 of 15 Is insulin pump therapy provided by the NHS?

In a word, yes. However, obtaining an insulin pump on the NHS is not as simple as seeing your GP and asking for it. Sometimes a doctor or diabetes specialist nurse (DSN) first suggests that a patient might benefit from a pump; some people are considered for a pump after asking their diabetes consultant or DSN about it. But before a pump can be prescribed, the patient (or the patient’s carer), the GP, and the diabetes consultant must all agree that a pump is the way forward.

In order to receive a pump and pump supplies bought by the NHS, patients must meet certain criteria. Revised guidance from the National Institute for Health and Clinical Excellence was expected by May 20081. The proposed 2008 guidance on insulin pump therapy says:

Continuous subcutaneous insulin infusion (CSII or ‘insulin pump’) therapy is recommended as a treatment option for adults and children 12 years and older with Type 1 diabetes mellitus provided that:

Attempts to achieve target haemoglobin A1c (HbA1c) levels with multiple daily injections (MDI) result in the person experiencing disabling hypoglycaemia. For the purpose of this guidance, disabling hypoglycaemia is defined as the repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life. or

HbA1c levels have remained high (that is, at 8.5% or above) on MDI therapy (including, if appropriate, the use of long-acting insulin analogues) despite a high level of care.

Regarding children in particular, the NICE guidance says:

CSII therapy is recommended as a treatment option for children younger than 12 years with Type 1 diabetes mellitus provided that MDI therapy is considered to be impractical or inappropriate….

The NICE guidance does not mean that a person’s HbA1C must be higher than 8.5% in order to have a pump. It mentions 8.5% because when a person has an HbA1C level of 8.5% or higher, he or she is likely to require much more care from the NHS than is usually needed by someone with an HbA1C below 8.5%. Based on the results of the DCCT, most doctors now agree that it is best for all people with diabetes to keep an HbA1C level below 7% to prevent or delay complications of diabetes.

Also, it is important to note that severe hypoglycaemia is not only classified as when an ambulance is called or a person needs glucagon. According to the NICE guidance, needing help from another person to treat a hypo or being unable to do daily activities because of hypos, or fear of hypos, means hypoglycaemia is disabling.

1 The guidance is currently being finalised following an appeal from the British Dietetic Association and should be available by early July. The above is based on the final appraisal determination. Fact Sheet Page 10 of 15 The NICE guidance is intended to help doctors, patients, and PCTs understand when a pump may be appropriate for a given patient. The final decision whether to go on a pump rests with the diabetes specialist (“diabetologist” or “diabetes consultant”) and the patient. If a diabetologist recommends insulin pump therapy, a PCT cannot refuse to fund insulin pump therapy on grounds of cost. PCTs are also not allowed to create “waiting lists” for pump therapy. Anyone who has heard from a PCT employee rather than a practicing doctor that he or she is not eligible for a pump, or who has been placed on a “waiting list” to begin insulin pump therapy, is requested to contact INPUT for advice.

The Secretary of State for Health expects that PCTs will pay for insulin pump therapy for all patients for whom a pump is recommended by a doctor. Anyone who is self-funding their own insulin pump therapy is requested to contact INPUT for advice on whether they may be entitled to PCT funding.

How do you obtain a pump?

If you’re keen to pursue insulin pump therapy, or have more questions, here are some next steps you might take:

First, it should be remembered that insulin pump therapy may not be suitable for everyone. You have to be motivated, motivated enough to want to manage your own diabetes! If you have this motivation, then you are a prime candidate for a pump. Subject, of course, to you meeting the NICE criteria!

First steps:

Speak with your GP to arrange a referral to a diabetologist if you don’t see a diabetologist regularly now (“Regularly” for people with Type 1 diabetes means seeing a diabetologist at least twice a year).

Optimise your blood glucose control. This may mean taking 4 or more injections a day, 4 or more blood glucose readings a day (and knowing how to act on the results), carbohydrate counting and understanding how to adjust your insulin dose depending on your blood glucose results, carbohydrate intake, exercise, illness etc. You may need to go on a structured education programme such as DAFNE.

Insulin pumps have to be prescribed by a consultant, so it is vital you have a consultant’s support. Tell your consultant or Diabetes Specialist Nurse that you are interested in getting a pump. You may need to explain why you think it will help, and show that you have considered the drawbacks as well as the benefits.

Then one of 3 things will happen:

A. They will support your need for a pump and obtain funding for it. You will be given a start date for insulin pump therapy and any other structured education they think will help. Fact Sheet Page 11 of 15 B. They will support your need for a pump but warn that funding is very difficult to obtain or say that there is a long waiting list. Point out that that NICE Technology Appraisals are NHS Core Standards and therefore mandatory, so the PCT is obliged to provide funding as long as the consultant agrees that you meet the criteria and require a pump. Invite the consultant / DSN to contact INPUT for assistance if they are having trouble with PCTs.

C. They will not support your need for a pump. This may be because they think you do not meet the criteria. Don’t just accept it if you think you do meet the criteria; ask questions, be in control of your own healthcare.

They may think insulin pump therapy is unnecessary or unsafe. Again, don’t just accept it; ask them what up-to-date research they have to support their view; offer to provide recent clinical evidence that insulin pump therapy is safe and effective (available from INPUT).

If you cannot reach agreement with your current consultant, ask if there is another consultant within the clinic who does support insulin pump therapy and ask to see them instead. If there is no such consultant at your clinic, ask your GP to refer you to another clinic. You have the right to receive diabetes care from whatever hospital you choose. (NHS Choices – see www.nhs.uk/choices or telephone 0845 608888). If you don’t know your nearest hospital offering insulin pump therapy, contact INPUT (www.input.me.uk or telephone 01590 677911).

The only letter that needs to be sent to your PCT is from your consultant, stating that you meet the NICE criteria in xxx way, insulin pump therapy will begin on xxx date, and funding will be required from that date. Your consultant should not "ask" for funding, and there is no need for you, the patient, to write to the PCT making your case. Fact Sheet Page 12 of 15 About INPUT

INPUT is a patient led support group for people using insulin pumps to control their diabetes. We are an independent organisation that offers no allegiance to any manufacturer. Our prime objectives are to increase the awareness and understanding of insulin pump therapy. We feel strongly that people should be given the opportunity to choose the best care for their diabetes. In our opinion the insulin pump is the best tool currently available to help well-motivated people with diabetes to achieve improved control and quality of life.

INPUT, founded in 1998 by John Davis, a pump user himself since 1997, serves as a clearing house for information on insulin pump therapy and an advocacy group for consistent funding for insulin pump therapy across the UK. NHS Primary Care Trusts must comply with NICE Technology Appraisals, but inadequate governmental supervision of their implementation and little support from the Department of Health to establish best practices have made the NICE guidance on insulin pump therapy very difficult to enforce. INPUT works with Diabetes UK, the JDRF, the Department of Health, members of Parliament, the diabetes care industry, consultant diabetologists, diabetes specialist nurses, general practitioners, and Pump Management for Professionals (PUMP) to bring about full adoption of the NICE guidance on insulin pump therapy.

Contact INPUT: e-mail: [email protected] On the web: http://www.input.me.uk Or by phone: 01590 677911

Some useful websites: http://www.accu-chek.co.uk http://www.animascorp.com http://www.cozmore.com http://www.medtronic.com http://www.infusion-set.com

Diabetes UK Careline and Advocacy Service

Diabetes UK Careline provides support and information to people with diabetes as well as friends, family and carers. We can provide information to help you learn more about the condition and how to manage it. The Careline is staffed by trained counsellors who can provide a listening ear and the time to talk things through. The Advocacy Service provides basic advocacy, in the form of letter writing and phone calls on your behalf, if you are having a problem with your diabetes care.

By telephone Diabetes UK Careline: 0845 120 2960, Monday-Friday, 9am-5pm Diabetes Advocacy Service: 0207 424 1000

By email Send your questions by email to: [email protected]. Or [email protected] By post Send your letters to: Diabetes UK Careline/or Advocacy Macleod House 10 Parkway London NW1 7AA. Fact Sheet Page 14 of 15

Your local Diabetes UK contact details:

Central Office Diabetes UK North West 10 Parkway, Tel: 01925 653 281 London Email: [email protected] NW1 7AA Tel: 020 7424 1000 Email: [email protected]

Diabetes UK Cymru Diabetes UK Northern and Yorkshire Tel: 029 2066 8276 Tel: 01325 488606 Email: [email protected] Email: [email protected]

Diabetes UK Northern Ireland Diabetes UK South East Tel: 028 9066 6646 Tel: 01372 720148 Email: [email protected] Email: [email protected]

Diabetes UK Scotland Diabetes UK South West Tel: 0141332 2700 Tel: 01823 324007 Email: [email protected] Email: [email protected]

Diabetes UK Eastern Diabetes UK West Midlands Tel: 01376 501 390 Tel: 01922 614500 Email: [email protected] Email: [email protected]

Diabetes UK East Midlands Diabetes UK Careline Tel: 0115 950 7147 Tel: 0845 120 2960 Email: [email protected] Email: [email protected]

Diabetes UK London Diabetes UK Careline Scotland Tel: 020 7424 1116 Tel: 0845 120 2960 Email: [email protected] Email: [email protected] Fact Sheet Page 15 of 15 Advocacy Pack Feedback Form Could you please take the time to fill out this evaluation form and return it to the Freepost address (at the bottom of this form). This will help us make our Factsheets more helpful and useful for future readers!

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