Take a new path. Insulin pump therapy with the Accu-Chek Combo system

Take a new path. Insulin pump therapy with the Accu-Chek Combo system

Contents Discover a more flexible life with insulin pump therapy 3 Gain more freedom and flexibility get more out of life 4 Insulin pump therapy ideal support to master the challenges of diabetes 6 Pump therapy insulin as you need it 8 Accu-Chek Aviva Combo the smart glucose meter that puts you in control 10 Accu-Chek Spirit Combo the insulin pump that works under cover 11 The Accu-Chek Combo system made to be safe 12 Insulin pump therapy can help in making pregnancy easier 16 A more active life for children and adolescents 18 Greater safety for your child 20 The path to your Accu-Chek Combo system help and advice 22 Discover a more flexible life with insulin pump therapy Our goal is to enable people with diabetes to lead a life that is as active and uncomplicated as possible, despite their condition. For over 35 years, this has driven our research efforts to mitigate the challenges that people with diabetes face daily. Among other things, Roche Diabetes Care has worked to develop insulin pump systems that discreetly and seamlessly integrate into everyday life. Today we offer insulin pump systems that provide not only reliable, effective support but also innovative features such as remote control from the meter and a unique bolus advisor, which put optimized diabetes therapy control in the palm of the user s hand. Insulin pumps have become the therapy of choice for optimally managing type 1 diabetes. And for good reason: numerous studies have documented improvements in metabolic control and substantially reduced risks of severe hypoglycemia and complications in insulin pump users 1,2. More and more people with diabetes are deciding to switch from multiple daily injections to an insulin pump and reap the benefits this therapy offers. An insulin pump can help you avoid the rigid regimen and lack of flexibility that used to be associated with diabetes, while tailoring your insulin doses to your needs. You still have to watch how you eat and exercise but the use of an insulin pump lets you do things more spontaneously, easily and free of hassles and stress. An insulin pump makes it easy for you to effectively and flexibly handle everyday situations such as eating meals at different times, irregular work schedules, varying activity levels and changes in blood glucose levels caused by health issues, hormonal swings or medications. The decision to use an insulin pump is not a simple one and should be carefully considered. However, feedback from many pump users, physicians and other healthcare professionals shows that they are very satisfied with the results. With this brochure we would like to help you make your decision. Wearing an insulin pump 24 Frequently asked questions 28 2 3

Gain more freedom and flexibility get more out of life Multiple Daily Injection therapy (MDI) requires a major commitment. Injecting insulin several times a day needs to be carefully planned and incorporated into your daily routine. It is also more difficult to tune the insulin basal rate to accommodate unexpected challenges in everyday life. Life with a portable insulin pump is much simpler and more convenient. The pump can be worn discreetly on the body, for example on a belt or in a pocket. It has an infusion set with a cannula that is inserted into subcutaneous tissue. The pump then delivers a continuous and adjustable dose of regular insulin or fast-acting insulin analog. Before meals, just press a button to deliver a supplemental dose (bolus). There is no longer any need to administer multiple injections every day. This makes you more independent and flexible in how you lead your life. There are many good reasons to take advantage of insulin pump therapy: Insulin pumps are successfully used by children, adolescents 3, pregnant women 4 and women who want to have a child. The use of an insulin pump has been found to enable significantly better metabolic control in children under 10 5. Your diabetes control stays more stable, with better HbA1c values and fewer episodes of hypoglycemia (low blood sugar) 6. You may enjoy greater vitality and more energy, even in times of stress or an irregular work schedule 7. You can eat what you want, when you want and often even as much as you want 8. You can participate in sports whenever you feel like it without having to plan in advance 8. You can go to bed early and sleep late in the morning without worrying 8. Insulin pump data downloads let you or your caregivers objectively evaluate your treatment 5. In short, insulin pump therapy improves metabolic control while giving you greater freedom and enhanced quality of life. 5

Insulin pump therapy ideal support to master the challenges of diabetes Insulin pump therapy helps people with diabetes lead better, more comfortable lives. To understand how, it s important to know how the pancreas responds to Multiple Daily Injection therapy. How the pancreas works The pancreas of someone without diabetes regularly releases small quantities of insulin into the body to regulate blood glucose levels. In the liver as well as in muscle and fat tissue, insulin plays an essential role in permitting the use of glucose as an energy source and stores it in the form of glycogen. The amount of insulin released varies with each individual s internal clock, as well as factors such as physical activity, metabolism, stress and illness. Multiple Daily Injection therapy (MDI) Multiple Daily Injection therapy, in which you inject yourself with insulin more than three times a day, is an improvement over conventional insulin therapy: A long-acting insulin analog is usually injected once a day to meet the basic insulin requirement (light blue in the figure below) and is therefore called basal insulin. Intermediate- or long-acting insulin can also be used as basal insulin. Usually, it is injected twice a day: in the morning and late evening, independently of meals. The increased need for insulin after each meal is met by a supplemental injection of fast-acting insulin (shown in light dark blue). These extra injections are also called boluses and are easy to adjust to the food you eat. When a person eats, the pancreas releases a large burst of insulin to regulate blood glucose levels. In adults, the body s need for insulin is lowest between midnight and 4 a.m. but rises to its highest level in the early morning. This is called the dawn phenomenon and requires people with diabetes to wake up early for a shot of insulin to prevent hyperglycemia. 6 a.m. Noon 6 p.m. Midnight 6 a.m. Time of day Long-acting insulin Fast-acting insulin Normal N insulin requirement 6 a.m. Noon 6 p.m. Midnight 6 a.m. Time of day The chart shows insulin production by the pancreas of someone without diabetes. They are high just after eating, lower between meals and lowest at night. Conventional Insulin Therapy (CT) In conventional insulin therapy, a mixture of basal and bolus insulin is injected at certain times. This makes it necessary to rigidly organize meals and activities around the injection times and doses. Multiple Daily Injection therapy basically tries to imitate the natural rhythm of the pancreas. However, it falls short of this goal and has other drawbacks as well: Nocturnal hypoglycemia. Between midnight and 4 a.m. there is more intermediate- or long-acting insulin in the body than is actually needed. As a result, the blood glucose level drops. This can even trigger a hypoglycemic episode 9. Early morning hyperglycemia. Just as the need for insulin peaks in the early morning (the dawn phenomenon ), the effect of the intermediate- or long-acting insulin administered in the evening wears off. This can cause hyperglycemia: your blood glucose is already too high when you wake up 9. Everyday inconveniences. You need between four and seven injections a day. Your daily schedule has to be precisely timed: you have to plan physical activities such as sports in advance, and you don t have the luxury of sleeping late in the morning. Multiple Daily Injection therapy does not provide the continuous precise insulin delivery of an insulin pump, which most closely mirrors the release of insulin in someone without diabetes. The use of a portable insulin pump makes it easier to master the challenges of diabetes therapy. It gives you greater flexibility in life. 6 7

Pump therapy insulin as you need it Insulin pump therapy is officially called Continuous Subcutaneous Insulin Infusion (CSII) and closely imitates the natural action of the pancreas, providing a constant supply of insulin to the body and extra doses as needed 10. Insulin delivery (insulin units per hour) 10 When using a portable insulin pump, there s no longer any need for injections. Instead, the pump continuously supplies your body with the insulin it requires by way of a subcutaneous cannula. Unlike Multiply Daily Injection therapy, the pump only supplies fast-acting insulin. Supplemental doses (boluses) are still needed. 2.0 1.5 1.0 Physiological insulin requirement 0.5 0.1 Midnight 3 a.m. 6 a.m. 9 a.m. Noon 3 p.m. 6 p.m. 9 p.m. Midnight Time of day 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 The Accu-Chek Spirit Combo insulin pump delivers 480 precise doses per day one dose every three minutes to tailor your basal level to your body s metabolic needs and allow you to sleep, exercise and eat with greater flexibility and peace of mind. This closely matches your physiological insulin needs. 6 a.m. Noon 6 p.m. Midnight 6 a.m. Bolus infusion by the insulin pump Basal rate Time of day Normal insulin requirement The basal rate is the amount of insulin that the body needs independently of ingested food. It is not constant throughout the 24 hours of the day, instead following a naturally fluctuating biorhythm. Typically it is lowest at night and during physical activity. The 24-hour basal rate profile is slightly different in each individual. It can be represented by a curve. Before beginning insulin pump therapy, a healthcare professional determines your insulin requirement by charting your blood sugar levels. The pump is programmed accordingly and can be adjusted on the basis of blood glucose measurements. Around the clock, the pump delivers insulin as programmed to meet your physiological insulin needs. This is essential for stable blood glucose control. Boluses The basal doses provide about half of the total daily insulin requirement. The other half is administered in supplemental doses, or boluses. Like in Multiple Daily Injection therapy, to determine how much insulin is needed you check blood glucose and estimate how much carbohydrates will be eaten beforehand. The difference is that the bolus isn t administered with a syringe or pen. Instead, you simply press a couple of buttons on your insulin pump or blood glucose meter. If the blood glucose level is ever too high, it can be easily corrected with another bolus. Accu-Chek Spirit Combo insulin pumps also permit the administration of an extended bolus to handle rich foods like pizza or beans that are high in fat or carbs. The bolus is stretched out over a period of time that you choose. This prevents blood glucose from rising too far, which would require an extra bolus. In addition, the Accu-Chek Combo system has an integrated bolus advisor that determines how many insulin units should be administered, based on recent blood glucose levels, carb intake, meal status, exercise level, illness and menstrual status. 8 9

Accu-Chek Aviva Combo the smart glucose meter that puts you in control Accu-Chek Spirit Combo the insulin pump that works under cover 10:02 5.8 bg Result 2 Feb 08 mmol/l Accurate blood glucose measuring Testing with Accu-Chek Aviva test strips Colour bar enables quick blood glucose overview Once placed under your clothes, you don t have to touch the insulin pump again for the rest of the day. Complete pump operation via the meter Lowest programmable basal rate of 0.05 units, highest of 50 units an hour Insulin pump buttons designed for easier use Can also be used independently of the blood glucose meter Discreet interactive pump control Control with the blood glucose meter via Bluetooth wireless technology Precise bolus delivery with few keypad touches Insulin pump display can be viewed on the meter Remote programming of advanced features bg Result 10:02 5.8 mmol/l Meal Time Carbs Health Active Insulin --- U Menu Bolus Bolus advisor for easier bolus calculation Designed to minimize after-meal hyperglycemia Various individual factors considered for calculating boluses Customizable settings to meet personal needs Electronic diary for better therapy analysis Automatically stores blood glucose values, insulin doses and carbohydrate intake Advanced color screen brings data and graphs to life 10 11

The Accu-Chek Combo system made to be safe Built-in safety features Key lock function to prevent buttons from being pushed accidentally. Fast occlusion detection. Choice of audio, visual or vibrating reminders to retest after a high or low blood glucose level or change the infusion set. The insulin pump can be operated independently of the blood glucose meter. 13

The infusion set The infusion set connects the pump to the body. It essentially consists of a thin tube with a steel or soft, flexible Teflon cannula that is inserted into subcutaneous tissue. This is usually done in the abdominal area. The dark-blue areas in the figure are recommended; the light-blue areas (such as the thighs) are possible but less suitable. The infusion set and insertion site should be changed every two to three days*. After a little practice, this quickly becomes routine. Accu-Chek infusion sets are available in a variety of designs with different combinations of cannula, needle, tubing lengths and insertion angle (90 or variable between 20 and 45 ) and tubing lengths to accommodate a wide variety of body types, lifestyles and activity levels. So it s important to choose the right one one that is also comfortable at the preferred infusion site and is easy to insert. If you want to temporarily remove the insulin pump at times (for example, to play sports), there are also sets that let you disconnect the tubing from the cannula which remains in place (Accu-Chek FlexLink, Accu-Chek Rapid-D Link and Accu-Chek TenderLink). Accu-Chek infusion sets Accu-Chek FlexLink: Easy to use from the word go. This is the infusion set for all insulin pump users. It can be inserted either manually or automatically with Accu-Chek LinkAssist (see below). Accu-Chek FlexLink is disconnectable. Accu-Chek TenderLink: The disconnectable infusion set for active insulin pump users. Accu-Chek Rapid-D Link and Accu-Chek RapidLink: Extra-thin steel needle. The infusion sets for sensitive insulin pump users. The Accu-Chek Rapid-D Link is disconnectable. The Accu-Chek LinkAssist insertion device Accu-Chek LinkAssist is an automatic insertion device for the Accu-Chek FlexLink soft cannula infusion set. It lets you easily and almost painlessly insert the cannula into subcutaneous fatty tissue in a single, smooth motion. The major benefit is that it helps you overcome psychological barriers to inserting the infusion set. The device also lets you access hard-to-reach infusion sites and ensures consistent placement 11. Accu-Chek RapidLink Accu-Chek Rapid-D Link Accu-Chek TenderLink Recommended Possible The advantages of disconnectable infusion sets: Greater flexibility and comfort. The cannula remains in place. To change the cannula, you don t need to replace the entire tube and refill it with insulin*. Accu-Chek FlexLinkPlus Accu-Chek LinkAssistPlus * Be sure to follow the instructions for use of your infusion set. 14 15

The advantages of using an insulin pump during pregnancy An insulin pump supports you throughout your pregnancy from planning to delivery and very often long after that as well. It helps you keep your blood glucose under control and enjoy this unique time of your life without fear or anxiety. So if you are planning a pregnancy, the sooner you decide to switch to an insulin pump, the better. Your basic insulin requirement is optimally met you can program up to 24 variable hourly basal rates. These can be easily adjusted if your insulin needs change during your pregnancy. There is no need for you to worry about hypoglycemia, because the body constantly receives the right amount of insulin 4. You can sleep late in the morning instead of getting up early to inject yourself with insulin. The insulin pump can help you manage the sudden cravings, fluctuating appetite and morning sickness that frequently accompany a pregnancy. It is very important to get enough exercise when you are pregnant. The insulin pump helps you control your blood glucose levels and stay physically active. The sooner you start using a pump, the better If you have diabetes, you need to carefully plan and prepare for your pregnancy. Ideally, you should normalize your blood glucose levels before getting pregnant 12. So the earlier you start using an insulin pump, the better. If necessary, however, you can also begin using one during pregnancy 4. Insulin pump therapy can help in making pregnancy easier Nowadays pregnant women with diabetes do not run significantly greater risks than those without it. However, you must have your blood glucose levels under control 12. Your need for insulin changes several times during pregnancy and after delivery: During the first few weeks of pregnancy, the need for insulin decreases and many women complain of hypoglycemia (low blood sugar), especially during the early evening hours 12. In women with type 1 diabetes, there may be a period of increased insulin sensitivity between the 10th and 14th weeks. After that, the insulin requirement usually rises steadily, with considerable individual variation and often leveling off or declining after 35 weeks 12. The insulin requirement drops dramatically during labor and is considerably lower after giving birth than before the pregnancy. It then gradually begins climbing again over the next first few days and weeks. Eventually it usually levels out at a value similar to the one before the pregnancy 13. If you choose to breastfeed, your insulin needs may be lower during this period than before the pregnancy because some glucose is diverted into your milk 14. After birth Almost all women with diabetes who have decided to use an insulin pump, either before or during their pregnancy, continue to do so after the birth of their child 4. Besides providing the full flexibility you need while the new arrival is turning your everyday life upside down, an insulin pump also makes it easier for you to balance out the sometimes drastic fluctuations in your insulin requirement that breastfeeding can cause 15. Benefits of the Accu-Chek Combo system The Accu-Chek Combo system helps to give you more peace of mind, letting you enjoy life with a new baby: The meter lets you program reminders for changing the infusion set, for making doctor and lab visits, or for retesting after meals or out-of-range blood glucose values. This way you don t have to keep track of everything in your head. Plus, you don t have to get the pump out to check. The integrated bolus advisor makes it a cinch to go from your blood glucose level to administration of the right amount of insulin to prevent highs after meals important for protecting the fetus during pregnancy and staying in the right range while breastfeeding. 16 17

Insulin pump therapy offers children many benefits An insulin pump can give children and adolescents greater flexibility and freedom in their everyday lives. Like with adults, insulin pump therapy is also a proven way to reduce the risk of severe hypoglycemic episodes (low blood glucose) and improve metabolic control in children 3 : The advantages include: 3,17 A reduced risk of excessively high or low blood glucose. Basal rates can be easily adjusted to meet changing insulin needs as your child grows. Low basic insulin needs can also be met by administering small amounts. Sleeping late is allowed; there is no longer any need to wake your child at night for an injection. 18 Greater freedom for your child to eat what he or she wants. Children need to accept the pump and receive support from adults The success of insulin pump therapy depends on your child s accepting the pump. He or she must want to use it and be willing to wear it every day. As a parent, you also need to familiarize yourself with the basics of insulin pump therapy, such as blood glucose testing, adjusting insulin doses to food intake and other factors such as physical activity, and correcting basal doses. In order to successfully use an insulin pump, children need help and support. It is therefore also important for teachers, trainers, medical personnel and other responsible individuals to feel comfortable dealing with children who use an insulin pump 13. A more active life for children and adolescents The transition from childhood and puberty to adulthood can be a difficult time, especially for those with type 1 diabetes. No minimum age There is no minimum age for insulin pump therapy. In many cases, even infants and toddlers can use a pump 19. Experience has shown that children above the age of about 10 can manage an insulin pump quite well on their own if they can count on their parents support. Special training is available for children and adolescents; they can quickly learn to use their pumps and manage their therapy themselves. The insulin requirement of children is often so low that it can t be easily met by injecting with a pen or syringe 16. 13 Rapid growth and hormonal changes during puberty cause high, fluctuating blood glucose levels that can also be difficult to control with injections. A desire for independence, spontaneous activities and infrequent meals can cause them to neglect blood glucose testing, carb counting and bolusing. This makes controlling their blood glucose extremely problematic 13. The limitations that diabetes puts on doing things with friends such as camping, staying up late or playing sports can be very frustrating and negatively impact a child s psychosocial development. 18 19

The many integrated features of the Accu-Chek Spirit Combo insulin pump make it especially suitable for children: An integrated key lock prevents unintentional insulin delivery. The pump includes sophisticated, highly sensitive occlusion detection to ensure continuous, reliable insulin delivery and help improve blood glucose control. An easy-to-learn menu-driven operating system that allows to limit the maximum bolus and locks in the basal rate to prevent overdoses. Comprehensive alarm and safety system warnings when, for example, the remaining insulin in the cartridge gets low or the battery needs to be replaced. Benefits for the parents of diabetic kids Your role as a parent may be easier when your child wears an insulin pump. You may experience less stress, because your child quickly learns how to manage his or her diabetes without your help. The Accu-Chek Aviva Combo meter lets you remotely control the insulin pump worn by your child. You can allow your child to be more spontaneous, for example with regard to food, sports and activities with friends. You no longer have to wake your child in the middle of the night or early in the morning to give him or her an injection. Convenient access to information: the electronic diary in the meter stores key data to let you check highs, lows and insulin delivery at a glance. You can be sure that your child will grow up receiving one of the best possible therapies. Greater safety for your child The Accu-Chek Spirit Combo insulin pump is extremely robust and stands up to most activities. However, it should occasionally be removed to protect the child from injury and the pump from damage. Most children take off their pumps to play contact sports, do gymnastics, go swimming or take a bath.* For these situations, we offer disconnectable infusion sets. If you are a parent of a child with diabetes and are interested in learning more about this therapy, we will be happy to meet with you to answer your questions. A small hourly basal rate (0.05 units per hour) delivered in doses every three minutes is suitable for meeting the needs of over 99 percent of pumpers especially considering that the Accu-Chek Spirit Combo insulin pump can evenly spread it over time instead of administering just a few doses an hour. This applies especially to children. * Please be sure to familiarize yourself with the warning notices and safety measures described in your Accu-Chek Spirit Combo pump s instruction manual. 20 21

Accu-Chek products support your insulin pump therapy Training in operation of the pump: To help you learn more about pump therapy and the Accu-Chek Combo system, we offer a variety of training programs. They include computer-aided training, one-on-one instruction and classes for groups. Your local Accu-Chek customer service representative is available to answer any questions you may have. Easy programming It s quick and easy to program your Accu-Chek Spirit Combo with the Accu-Chek 360 Insulin Pump Configuration Software. The path to your Accu-Chek Combo system help and advice The first step is to consult your physician or other healthcare professional to determine whether an insulin pump is right for you or your child. You already meet a number of the prerequisites: You know about Multiple Daily Injection therapy. You are familiar with the basic principles of diabetes self-management and able to measure blood glucose at least four times a day and adjust the administered insulin doses accordingly. You realize that it is necessary to become familiar with the basics of insulin pump therapy and to participate in a training program that introduces you to the additional information you need. Outstanding benefits: Easy to use for configuring Accu-Chek Spirit and Accu-Chek Spirit Combo insulin pumps Fast wireless data transfer between your PC and the insulin pump via an infrared interface Wizard for defining up to 5 basal rate profiles All-in-one solution: interfaces with the Accu-Chek 360º Diabetes Management System Focus on safety: review settings before actually making changes to the pump Customizable menu Quick archiving of data Conversion of Accu-Chek Spirit settings The software is compatible with the following Microsoft Windows operating systems: XP Home XP Professional Vista 2003 Server 2008 Server It is a good idea to get in touch with a diabetes association, a self-help group or other insulin pump users who are willing to share their experiences with you. There are also many relevant blogs and discussion forums on the Internet. 22 23

Wearing an insulin pump You might think that wearing an insulin pump day after day would be a nuisance. But the fact is that those who opt for one soon come to accept it as a constant companion. It only weighs 110 to 120 grams (including the batteries) and is so small that it can be easily worn on the belt or carried in a pants pocket. At night, you can simply clip it to your pajamas or hide it under the pillow. A large selection of carrying systems including elastic belts, protective pouches and cases makes it as easy and comfortable as possible to wear the pump. Carrying systems Clip case Quick and flexible. Easy to attach to your waistband. The transparent clip case has a rotating clip on the back, which you can use to fix your Accu-Chek Spirit Combo insulin pump in a variety of positions. Alcantara pouch Made of soft Alcantara, this multifunctional case has a cord and a belt loop on the back, and is available in several different colors. It lets you wear your Accu-Chek Spirit Combo insulin pump around your neck, on your belt, or on a strap under your clothing. Neoprene pouch Ideal for playing sports. Made of rugged, fast-drying material, it is available in various colors. A loop on the back lets you slip it onto the sports belt. Sports belt An elastic belt with snap closure, specially developed for combining with the neoprene pouch. Leather case with clip An elegant pouch made of top-quality black leather, with a clip on the back. For comfortably and discreetly wearing an Accu-Chek Spirit Combo insulin pump on a belt or waistband. Thigh pouch Made of polyester and incorporating an insulin pump pouch, this black elastic thigh strap can be worn discreetly under your clothes. Protective cotton cover Especially practical under close-fitting garments, this protective pouch can be worn on a bra, around the neck or on a belt or briefs. Waist and arm straps Elastic straps for attaching pouches are available for around the waist (long) and upper arm (short). Velcro fasteners permit flexible adjustment. Pleasant to wear underneath clothing. 24 25

Kids line Styles for the young and young at heart Blue dog case A cool accessory that turns the Accu-Chek Spirit Combo insulin pump into your best friend. Made of neoprene, with a magnetic closure and a belt loop on the back. Candy pink case A new carrying system with cover with a very trendy candy pink look. Made of shiny material, with a magnetic closure and belt loop on the back. Blue jeans case A new carrying system with cover in a absolutely timeless blue jeans design. Made of denim, with a magnetic closure and a belt loop on the back. Pump stickers If you prefer colorful and fun styles, our Accu-Chek Spirit Combo insulin pump stickers offer a wide range of designs from basketball to butterfly themes. Yellow duck backpack A cute backpack for wearing the insulin pump in front or back, specially designed for toddlers. Pump skins These colorful skins made of smooth silicone let you harmonize your insulin pump s outfit with your clothing or mood. Available in black and a range of colors. 26 27

Frequently asked questions 1. General topics What support do I get when I start on my insulin pump? Accu-Chek provide 24hr technical assitance from a UK based Careline. We provide you an electronic training program, workbooks and quick user guides to support your training by your healthcare proffessional. Our dedicated Technical Specialist are also avilable to support you and your healthcare team. How old do you have to be to start insulin pump therapy, and when is one considered too old for it? Insulin pump therapy is not a question of age, but of motivation. The sooner one begins insulin pump therapy, the smaller the risk of developing long-term complications. Insulin pump therapy is successfully used by people of all age groups, from young children to adolescents and young adults to senior citizens 20. How can I get an Accu-Chek Spirit Combo insulin pump for myself or for my child? Talk to your physician, who is best-qualified to decide whether insulin pump therapy is right for you or your child. Your health insurance may cover the cost of the Accu-Chek Spirit Combo insulin pump and accessories; please inquire. How often should the infusion set be changed, and how is it done? You should change the infusion set every two to three days. To see the recommended time interval, please check the instructions for using the infusion set. After inserting the cannula, affix it with the integrated pad. With a little practice, which you will get during training in how to use the pump, this will soon become routine. There are also Accu-Chek Combo infusion sets with cannulas that you can disconnect for greater flexibility. Will using an insulin pump affect the frequency of hypoglycemic episodes? One of the disadvantages of Multiple Daily Injection therapy with an insulin pen or syringe is occasional hypoglycemic episodes, especially in the middle of the night 9. The Accu-Chek Spirit Combo insulin pump lets you program custom basal rates to considerably reduce their occurrence 6. Can cell phones, x-rays, computer tomography, or magnetic resonance imaging devices affect an insulin pump? We can t completely rule out the chance that a cell phone may somehow influence the proper functioning of an insulin pump. To be on the safe side, keep cell phones at least four inches from the insulin pump at all times. If it did affect the Accu-Chek Spirit Combo insulin pump, the supply of insulin would be automatically interrupted and the insulin pump would alert you to possible problems by displaying warning or error messages and beeping. The pump is protected against ordinary electromagnetic radiation. However, the Accu-Chek Spirit Combo insulin pump, like any other medical device, should not be used around x-ray, MRI or CT equipment. Make sure to remove the insulin pump before being x-rayed or having a MRI or CT. This also applies in the vicinity of military radar equipment. Security scanners in businesses or airports will not influence the operation of the Accu-Chek Spirit Combo insulin pump. Can I or my child participate in sports while wearing an Accu-Chek Spirit Combo insulin pump? You can engage in any kind of physical activity while wearing an insulin pump. However, for sports involving intensive body contact and water sports we recommend temporarily disconnecting the insulin pump.* How reliable is the Accu-Chek Spirit Combo insulin pump? Accu-Chek Spirit Combo insulin pumps are developed and manufactured to comply with strict standards of quality and strength and are therefore extremely tough and sturdy. They are able to withstand a variety of stresses that are part of everyday life. Automatic function tests (nine million a day) and warning functions also make sure that your pump is working properly. How does the bolus advisor work? The bolus advisor determines how many insulin units to administer, based on your or your child s blood glucose level, expected carbohydrate consumption, your or your child s state of health and various predefined settings such as the insulin to carbohydrate ratio, insulin sensitivity and others that help optimize blood glucose management. What is the lowest possible basal rate? The lowest basal rate you can set on the Accu-Chek Spirit Combo insulin pump is 0.05 units per hour, delivered in 20 portions (one every three minutes). The basal rate can be adjusted by 0.01 units so you can make very fine alterations for tighter control. What test strips does the Accu-Chek Aviva Combo meter use? The Accu-Chek Aviva Combo meter uses the standard Accu-Chek Aviva test strips. 2. Questions concerning your child Is my child old enough for insulin pump therapy? Insulin pumps have been used successfully all over the world by both small children and adolescents 19. Insulin pump therapy requires your child to have a certain amount of discipline and willingness to learn and follow the basic rules of the therapy. They have to be able to measure their blood glucose four times a day and calculate their carbohydrate consumption. They also need the support of their parents or another qualified adult 13. With small children, their parents are initially in charge of the therapy. How well will my child sleep with an Accu-Chek Spirit Combo insulin pump? Children very quickly notice how comfortable and secure the insulin pump is to wear at night. They soon stop thinking about it and resume sleeping normally. They can simply place the pump under the pillow. Will my child accept an Accu-Chek Spirit Combo insulin pump? Some children are somewhat upset when they find out that they are supposed to wear an insulin pump. In most cases, however, they quickly notice that the pump is not a problem and actually makes their lives easier, * Please carefully read the warnings and safety precautions in your insulin pump s instruction manual. 28 29

because they are more flexible and enjoy greater freedom. The Accu-Chek Spirit Combo insulin pump is so small and light that it can be carried in a jeans pocket. For children, we recommend our carrying cases that are specially designed for their needs. We also offer a wide range of other carrying systems and pouches that make wearing an insulin pump very easy, comfortable and inconspicuous. What do we as parents need to learn about the Accu-Chek Spirit Combo insulin pump? Basically everything, because, depending on how old your child is, you have to learn how to perform the therapy yourself. You will have the opportunity to receive intensive training to learn all about insulin pump therapy and the Accu-Chek Spirit Combo insulin pump. It isn t complicated to use, and you can count on receiving assistance if you experience any problems. Your physician and we as the manufacturer will support you. 3. Questions concerning pregnancy If I am pregnant, when should I begin insulin pump therapy? The sooner you start using an insulin pump, the better, preferably before getting pregnant. But you can also switch to a pump during the pregnancy 21. Will my insulin needs change during pregnancy? Yes, your insulin needs will change several times during pregnancy and after delivery. During the first few weeks of pregnancy, the need for insulin decreases and many women complain of hypoglycemia (low blood sugar), especially during the early evening hours 12. In women with type 1 diabetes, there may be a period of increased insulin sensitivity between the 10th and 14th weeks. After that, the insulin requirement usually rises steadily, with considerable individual variation and often leveling off or declining after 35 weeks 12. The insulin requirement drops dramatically during labor and is considerably lower after giving birth than before the pregnancy. It then gradually begins climbing again over the next first few days and weeks. Eventually it usually levels out at a value similar to the one before the pregnancy 13. If you choose to breastfeed, your insulin needs may be lower during this period than before the pregnancy because some glucose is diverted into your milk 14. Because of these fluctuations, you need a flexible insulin therapy that optimally meets your needs. Insulin pump therapy can help. What happens after giving birth? Almost all women with diabetes who have decided to use an insulin pump, either before or during their pregnancy, continue to do so after the birth of their child. One reason is that it does such a good job leveling the sometimes drastic fluctuations in your insulin requirement that breastfeeding can cause 15. Another is that the new arrival turns the daily routine upside down and requires you to be a lot more flexible. The Accu-Chek Spirit Combo insulin pump helps you to cope better with the challenges of life with a new baby. 1 Jeitler K et al. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis. Diabetologia 2008; 51: 941-51 2 Pickup JC et al. Severe hypoglycaemia and glycaemic control in Type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion Diabetic Medicine 2008; 25: 765 774 3 Doyle EA et al. A Randomized, Prospective Trial Comparing the Efficacy of Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections Using Insulin Glargine. Diabetes Care 2004; 27: 1554-1558 4 Gabbe SG et al. Benefits, risks, costs, and patients satisfaction associated with insulin pump therapy for the pregnancy complicated by type 1 diabetes mellitus. Am J Obstet Gynecol 2000; 182: 1283-1291 5 Pankowska E et al. Memory of Insulin Pumps and Their Record as a Source of Information About Insulin Therapy in Children and Adolescents with Type 1 Diabetes. Diabetes Technology & Therapeutics 2005; 7 (2): 308-314 6 Linkeschova R et al. Less severe hypoglycemia, better metabolic control, and improved quality of life in Type 1 diabetes mellitus with continuous subcutaneous insulin infusion (CSII) therapy; an observational study of 100 consecutive patients followed for a mean of 2 years. Diabet Med 2002; 19 (9): 746-751 7 Liebl A et al. Long-term results of insulin pump therapy (CSII) in adolescents and adults with type 1 diabetes mellitus in Germany. Diabetologia polska 2003; 10 (1): 179-185 8 Lenhard MJ et al. Continuous subcutaneous insulin infusion: a comprehensive review of insulin pump therapy. Arch Intern Med 2001; 161 (19): 2293-2300 9 Bolli GB: How to ameliorate the problem of hypoglycemia in intensive as well as non-intensive treatment of type 1 diabetes. Diabetes Care 1999; 22 (Suppl 2): B 43-52 10 Wolpert H et al. Smart Pumping for people with diabetes. A practical approach to mastering the insulin pump. American Diabetes Association. Alexandria, Virginia. 2000 11 Liebl A et al. Clinical benefits of automatic insertion of infusion sets in CSII (Abstract). EuDTT Meeting 4. 7. Feb. 2007 Montpellier: PS-27 12 Kitzmiller JL et al. Managing Preexisting Diabetes and Pregnancy. Diabetes Care 2008; 31 (5), 1060-1079 13 Walsh J et al. Pumping Insulin. Everything you need for Success with an Insulin Pump. Torrey Pines Press. San Diego, CA: 2006 (4th edition) 14 Yang JQ et al. Breast-feeding in reducing regular insulin requirements in postpartum for insulin dependent diabetes mellitus and gestational diabetes mellitus. Zhonghua Fu Chan Ke Za Zhi 1994; 29 (3): 135-137 15 Walker M. Breastfeeding with diabetes: yes, you can. International Lactation Consultant Association. J Hum Lact. 2006; 22 (3): 345-346 16 National Institute for Health and Clinical Excellence. NICE technology appraisal guidance 151. 2008; 17-18 17 Weintrob N et al. Glycemic patterns detected by continuous subcutaneous glucose sensing in children and adolescents with type 1 diabetes mellitus treated by multiple daily injections vs continuous subcutaneous insulin infusion. Arch Pediatr Adolesc Med 2004; 158 (7): 677-684 18 Grylli et al. Disturbed eating attitudes, coping styles, and subjective quality of life in adolescents with Type 1 diabetes. J Psychosom Res. 2005; 59 (2): 65-72 19 Phillip M et al. Use of Insulin Pump Therapy in the Pediatric Age-Group: Consensus statement from the European Society for Paediatric Endocrinology, the Lawson Wilkins Pediatric Endocrine Society, and the International Society for Pediatric and Adolescent Diabetes, endorsed by the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2007; 30 (6): 1653-1662 20 Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329 (14): 977-986 21 Jornsay DL: Continuous Subcutaneous Insulin Infusion (CSII) Therapy during Pregnancy. Diabetes Spectrum 1998; 11 (Suppl 1): 26-32 30 31

For an easy, quick and discreet solution, find out more about the Accu-Chek Combo system. Find out more about the new ACCU-CHEK Combo system, by calling UK 0800 731 22 91, IRELAND 1800 88 23 51 online at www. Accu-Chek.co.uk/combo or speak to your diabetes care team. 1 Data on file at Roche Diagnostics 2 Email customer feedback on file 05945461001 ACCU-CHEK, ACCU-CHEK AVIVA COMBO, ACCU-CHEK FLEXLINK, ACCU-CHEK LINKASSIST, ACCU-CHEK MULTICLIX, ACCU-CHEK RAPIDLINK, ACCU-CHEK RAPID-D LINK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK TENDERLINK and ACCU-CHEK 360 are trademarks of Roche. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Roche is under license. 2009 Roche Diagnostics www.accu-chek.co.uk/combo Roche Diagnostics GmbH Burgess Hill, West Sussex, RH15 9RY