Certified Product Trainer INFORMATION MANUAL

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1 Certified Product Trainer INFORMATION MANUAL

2 WELCOME Thank you for your interest in becoming a Medtronic Certified Product Trainer (CPT). We are pleased that you have been selected to partner with us to create an enriching experience for those using Medtronic diabetes therapies. You are a critical part of our team and key in helping us to succeed in providing a customer-focused experience through unparalleled service, education, and access to our therapies. This manual will introduce you to our training program and serve as your guide as you begin your partnership with us. It presents an overview of diabetes management with insulin pump therapy and continuous glucose monitoring (CGM), explains your responsibilities as a CPT, and outlines our training principles and guidelines. We look forward to introducing you to the world of Medtronic diabetes products and the educational resources that will help you provide an extraordinary training experience. We hope that you will embrace this opportunity and join us in our endeavors. In your role as a Medtronic CPT, you will provide a vital service to individuals who have chosen to manage their diabetes using our products. With your help, they will master a new way to achieve better control of their diabetes, better outcomes, and a new-found freedom to live life on their own terms. We sincerely hope that you find your role as a CPT rewarding. We appreciate your help and commitment to providing training and support to Medtronic customers. MEDTRONIC: A REVOLUTIONARY JOURNEY For more than 25 years, Medtronic has been the innovator and leader in diabetes management solutions. We introduced our first insulin pump in In 1999, we launched the world s first professional CGM system for physician use, and in 2004, our first personal CGM system for patient use. In 2006, we integrated insulin pump therapy with real-time CGM for the first time. We continue to advance new technologies and expand our product portfolio to meet the needs of both patients and healthcare professionals (HCPs). MEDTRONIC DIABETES PRODUCT PORTFOLIO Today, Medtronic still offers the world s only truly integrated diabetes management system. This integrated system consists of Insulin Pump Therapy, Continuous Glucose Monitoring, and Therapy Management Software. Together, these provide a person with diabetes and his/her healthcare provider, the most comprehensive way to manage diabetes. A complete description of all current Medtronic diabetes products can be found on our website at: Please familiarize yourself with our therapy options as you begin this certification process. We are very excited that you have decided to join the Medtronic team. We look forward to working with you to provide patients with diabetes the ability to manage their diabetes using Medtronic products. Medtronic Inc./Diabetes

3 Table of Contents Section 1 CPT Requirements and Responsibilities ELIGIBILITY REQUIREMENTS... 1 THE ROLE OF THE MEDTRONIC DIABETES CPT... 2 Training Focus... 2 Communication and Documentation... 2 Scope of Practice... 2 Training Evaluation... 3 PRODUCT TRAINER CERTIFICATION REQUIREMENTS... 3 Section 2 Teaching and Learning Principles ASSESSING EDUCATIONAL NEEDS AND READINESS TO LEARN... 5 TRAINING FORMATS... 6 TRAINING TECHNIQUES... 7 The Cone of Learning... 8 Section 3 Insulin Pump Therapy INSULIN PUMP THERAPY... 9 Basics of Insulin Pump Therapy... 9 Benefits of Insulin Pump Therapy TRAINING GUIDELINES FOR INSULIN PUMP THERAPY Insulin Pump Training Pathway Prior to Training... 13

4 Table of Contents Starting Patients on Insulin Pump Therapy Session 1: Pre-Pump Start Training Understanding Insulin Pump Therapy BG Testing Hypoglycemia Hyperglycemia Diabetic Ketoacidosis Sick Day Management Nutrition Overview Exercise Safety Insulin Pump Therapy Resources Calling The HCP Calling the Medtronic Diabetes 24-Hour HelpLine: Session 2: Pump Start Training Session 3: Follow-up Training CareLink Personal Therapy Management Software for Diabetes Additional Topics Reviewed Documentation Continuing Education (optional) ADDITIONAL TRAINING AND SAFETY INFORMATION Bolusing for Carbohydrates and Corrections The Bolus Wizard Calculator Benefits of the Bolus Wizard Calculator How the Bolus Wizard Calculator Works Meal Bolus Options... 36

5 Table of Contents INFUSION SETS AND SITE MANAGEMENT Infusion Set Choices Infusion Set Inspection Site Selection and Rotation Infusion Set and Site Problems PREVENTING ACUTE PROBLEMS Hypoglycemia Hyperglycemia Diabetic Ketoacidosis (DKA) Illness Section 4 Continuous Glucose Monitoring (CGM) GLUCOSE MONITORING Basics of CGM Benefits of CGM TRAINING GUIDELINES FOR CONTINUOUS GLUCOSE MONITORING Overview of Continuous Glucose Monitoring Training Prior to Training Starting Patients on CGM Follow-up Training Continuing Education (optional)... 62

6 Table of Contents Section 5 CareLink Therapy Management Software for Diabetes CARELINK PERSONAL SOFTWARE Daily Summary Report Sensor Daily Overlay Report Sensor Daily Overlay by Meal Report Important points regarding CareLink Personal Software Section 6 Forms and Handouts Medtronic Diabetes Certified Product Trainer Application Certified Product Trainer Proficiency Checklist Insulin Pump Initiation Settings Pre-Pump Training Checklist Pump Start Training Checklist Pump Follow Up Training Checklist Continuous Glucose Monitoring Initial Settings Continuous Glucose Monitoring Training Checklist Continuous Glucose Monitoring System Follow Up Training Checklist Glucose Sensor Calibration Worksheet Continuation of Care

7 Table of Contents Section 7 Universal Precautions GENERAL PRECAUTIONS BLOODBORNE PATHOGENS PREVENTION AND TREATMENT OF NEEDLESTICKS AND CUTS ADDITIONAL INFORMATION Section 8 References

8 Section 1 CPT Requirements and Responsibilities

9 CPT Requirements and Responsibilities In order to become a Medtronic Diabetes CPT, there are requirements that must be met and responsibilities that must be agreed to. These are outlined in this section. These requirements and responsibilities help to ensure that: All patients receive consistent training. All training meets Medtronic training guidelines. All patients receive a quality training experience. Medtronic reserves the right to consider ineligible any person who has been excluded or otherwise limited by the Medicare Program, or any other authority, from providing services to Medicare patients or other federal beneficiaries. ELIGIBILITY REQUIREMENTS To be eligible to become a Medtronic Diabetes CPT, you must meet either of the following requirements: Hold (and provide a copy of) an active, unrestricted license from the United States or its territories as one of the following: Registered nurse Registered dietitian by the Commission of Dietetic Registration Pharmacist Physician (such as Doctor of Medicine or Doctor of Osteopathy) Physical therapist Licensed occupational therapist Podiatrist Optometrist Licensed vocational or practical nurse Physician assistant Hold a minimum of a master s degree from a United States college or university accredited by a nationally recognized regional accrediting body in one of the following areas (and show proof of your educational credentials): Nutrition Health education Specified areas of study in public health, such as health education, health promotion, health and social behavior, or health communication Social work Clinical psychology Exercise physiology 1

10 CPT Requirements and Responsibilities THE ROLE OF THE MEDTRONIC CPT Training Focus Your most important responsibility as a CPT is to provide patients with proper instruction on the safe use of Medtronic products. We want patients to feel comfortable and confident wearing and using our products. New users are relying on you to start them on their journey of better control. Some patients find the products easy to understand and use; others will rely on you for additional guidance and help. Occasionally, you may need to reassure patients or address concerns about some aspect of the therapy. Therefore, establishing trust with these new patients is important to the training process and to the patient s success. You may find that some patients need basic diabetes education to help them learn how to understand our therapies and use our products. Please consult with your Medtronic clinical representative to discuss what is expected of you in these cases. Communication and Documentation Communication with your Medtronic clinical representative and the patient s HCP regarding training sessions is necessary. Always discuss your training responsibilities with your Medtronic clinical representative before training patients. Make your Medtronic clinical representative aware of any additional time that may be required to meet special training needs uncovered during your assessment of the patient. If any concerns arise during the initial phone call or during a training session, contact your Medtronic clinical representative so that any necessary follow-up with the HCP or the patient can be arranged. Carefully document each patient s progress to ensure continuity of care and accurate, complete training records. Training documentation forms will be provided by your Medtronic clinical representative upon assignment of the patient training. A copy of these records must be provided to both the HCP and the Certified Product Training department. These provide continuity of care with the provider as well as a legal training record. Scope of Practice It is important that you conduct patient education within the guidelines for your scope of practice, as defined by your professional licensing and governing body. Contact your state licensing board for the specific guidelines for your individual licensure in your state of residence and your scope of practice. 2

11 CPT Requirements and Responsibilities Training Evaluation At Medtronic we strive to provide an excellent overall patient experience. We work to exceed each patient s training expectations through professionalism, thorough product knowledge, and an exceptional training experience. We look for you to provide patients with the knowledge and understanding to be successful using our therapies. To help ensure we are meeting our goals, patients are randomly selected to offer feedback on their training, and their continued use of our therapies is evaluated on an ongoing basis. Positive patient experiences and outcomes will be recognized. If any less than favorable feedback is provided, your Medtronic clinical representative will work with you to ensure a positive experience for every patient. Repeated occurrences of unsatisfactory feedback may result in the retraction of CPT status. PRODUCT TRAINER CERTIFICATION REQUIREMENTS To obtain certification, you must take the following steps. These steps must be completed for each Medtronic product for which you become certified: 1. Review this manual in its entirety to ensure that you thoroughly understand Medtronic Diabetes product training and support program. 2. Read the following resources: Insulin Patient Training Workbook Product user guide located at: Instructional CD-ROM Additional e-learning and written references that you will be directed to by your Medtronic clinical representative 3. Meet with your Medtronic clinical representative for hands-on training and observation of one or more patient education and training sessions. 4. Demonstrate your patient training skills by performing one or more patient education and training sessions with your Medtronic clinical representative observing. 5. Complete the certification exam and achieve a score >90%. 3

12 CPT Requirements and Responsibilities 6. Provide the following to your Medtronic clinical representative: A CPT application (initial product certification only) A copy of your current Professional Licensure with expiration date A signed copy of the CPT expectations 7. Review and sign the CPT Proficiency Checklist provided to you by your Medtronic clinical representative Note: CGM and additional product certifications are reserved for more experienced Medtronic CPTs those who have active insulin pump training certification and have demonstrated satisfactory skills in teaching both basic and advanced insulin pump operation. 4

13 Section 2 Teaching and Learning Principles

14 Teaching and Learning Principles An effective training program must consider patients educational needs and readiness to learn. As a CPT, you should be prepared to adjust product training sessions according to patient age, educational level, individual needs, abilities, and cultural background. Use the appropriate training formats and techniques for your particular audience. ASSESSING EDUCATIONAL NEEDS AND READINESS TO LEARN As you prepare for a product training session, assess your patients with respect to the following: 18 Attitude toward diabetes and toward participation in the training process Family and friends support structure, including social, cultural, or religious factors that may influence a patient s educational experience; encourage patients to bring a family member or friend with them to training Preferred style of learning (e.g., through demonstration, printed materials, lecture, or computer) Psychological status Physical or emotional stress level (Note: Severe stress can impair a patient s ability to learn. Patients undergoing stressful situations, such as acute illness, should consider postponing training until circumstances are more conducive to active learning.) Readiness for change Literacy level Physical factors (e.g., age, mobility, visual acuity, hearing loss, and dexterity) Current level of self-care, which can provide insight into a patient s tolerance for complexity in treatment Diabetes requires effort, and patients are often asked to make major lifestyle changes. Patients may need your assistance in learning the following important self-care behaviors as they relate to using insulin pump therapy: 19 Self-monitoring of BG levels Understanding nutritional composition of meals Engaging in physical activity and understanding its effect on insulin needs Managing hypoglycemia and hyperglycemia 5

15 Teaching and Learning Principles TRAINING FORMATS Using effective training formats is just as important as the content of your training sessions. The design of an educational program can affect patients learning experience, as well as their attitude and motivation to learn. Training formats presented in Diabetes Education and Program Management: A CORE Curriculum for Diabetes Educators are described below. 18 Lectures: Brief lectures may be useful for presenting information, but keep in mind that this is a passive learning experience. Facilitate the learning process by balancing lectures with patient interaction and more active training methods. Discussions: Having a discussion with a group of patients provides an active learning experience. Patients can gain knowledge, ask questions, and share personal experiences through discussion. However, discussions can be unpredictable, and the trainer must be able to effectively guide and manage the discussion so that all topics and participants receive adequate attention. Demonstrations: Demonstrations are a very useful method for teaching psychomotor or social skills. A trainer may demonstrate a technique and then ask patients to perform the technique themselves. This method gives patients hands-on practice, with the added benefit of immediate feedback from the trainer. Printed materials: Printed materials reinforce previously learned information, and patients can later refer to them for reference or review. Patients should be shown how to use the Medtronic product user guides and other printed materials that are available to them as resources. For example, it may be helpful to point out materials that feature pictures or step-by-step instructions. However, printed materials are not a replacement for training with a CPT. Audiovisual materials: Audiovisual materials (e.g., slides, flash animation, videos, or food models) help diversify the presentation format, which can help reinforce learning. Computers: Computerized lessons, clinical problems, and simulations can be useful for testing increasing patient knowledge and improving problem-solving skills. The Learning Center ( and the instructional CD-ROM are two examples of computerized methods of training that benefit the patient. Since different people learn in different ways, it is important to vary your instructional methods to meet the needs of your patients. If you feel that what you are teaching or demonstrating is not sinking in, change the way you are presenting it. Present the materials in as many formats as possible. 6

16 Teaching and Learning Principles TRAINING TECHNIQUES Training techniques that may enhance learning appear below: Determine patient expectations for the training session and set expectations of what will be taught during the session. Relate the material being taught to patients own experiences and frames of reference. Assess each patient s knowledge and understanding of the concepts you are presenting by asking questions to gain feedback and gauge understanding. Give patients the opportunity to practice and successfully demonstrate the skills that they have learned to help improve knowledge and skill retention and build confidence. Provide feedback to make patients aware of their incremental progress and encourage their continued learning. Plan your training session for a time when the patient can actually start insulin pump or CGM therapy. When you are training adults, take into account several general observations about adult learners to help you train them more effectively 18 : Adults usually feel a need to learn before they are willing to fully participate in the educational process. Adults tend to want information that will solve specific problems that they might encounter (e.g., how to avoid hypoglycemia) rather than subject-based information (e.g., a study of diabetes). Adults usually prefer active learning, and they tend to learn better when their own experience is incorporated into the educational process. 7

17 Teaching and Learning Principles The Cone of Learning After 2 weeks, we tend to remember I see and I forget. I hear and I remember. I do and I understand. Confucius Reading Hearing Words Seeing Watching a Movie Looking at an Exhibit Watching a Demonstration Seeing it Done on Location 10% of what we READ 20% of what we HEAR 30% of what we SEE 50% of what we SEE & HEAR P A S S I V E Participating in a Discussion Giving a Talk Doing a Dramatic Presentation Simulating the Real Experience Doing the Real Thing 70% of what we SAY Source: Edgar Dale (1969) 90% of what we SAY & DO A C T I V E Edgar Dale s Cone of Learning diagrams effectiveness of learning according to the media involved in learning experiences. As you can see, the more active the learning experience becomes, the more likely we will remember. Having the patient HEAR us talking and SEE us doing is less effective than having them more actively involved. Giving them opportunities to SAY and DO during the training increase the likelihood that they will remember what we are teaching. 20 As we work through the training process in the next chapter, and you begin to observe and perform education and training sessions, please continue to refer to this chapter to ensure a successful learning experience for your patients. 8

18 Section 3 Insulin Pump Therapy

19 Insulin Pump Therapy In your role as a Medtronic CPT, you will have the opportunity to train patients on insulin pump therapy. Below is an introduction to this therapy, which can enable patients to improve their diabetes control. INSULIN PUMP THERAPY The goal of insulin delivery in diabetes is to regulate glucose levels and achieve euglycemia. In a person without diabetes, pancreatic beta cells continuously deliver insulin into the bloodstream. Insulin pump therapy closely mimics this natural pancreatic function by delivering rapid-acting (or short-acting) insulin to the body both continuously, and as needed to accommodate meals and make glucose corrections. Before the advent of insulin pump therapy, the only option for people with diabetes who required insulin was giving injections. Insulin injection regimens consist of various combinations of long, intermediate, and rapid-acting insulin. These various regimens are limited by two major considerations. Injections cannot accommodate for normal variations in basal insulin needs throughout each 24 hour period. Basal insulin requirements typically vary throughout the day and night based on endogenous glucose output and peripheral insulin sensitivity. 1 The inability to adjust for these changing needs limits the ability to reach euglycemia when using insulin injection therapy. The absorption of intermediate- and longer-acting insulin delivered by injection can vary by up to 46%, resulting in a day-to-day variation in blood glucose (BG) levels despite administration of the same amount of insulin. Rapid-acting (U100) insulin has the lowest variability (16%). 2,3 Thus, rapid-acting insulin administered by an insulin pump provides better day-to-day reproducibility, more reliable insulin availability, and fewer unexpected fluctuations in glycemic control. 4 Basics of Insulin Pump Therapy Insulin pumps simulate normal pancreatic function by delivering rapid-acting insulin in two ways: Basal rate: Background insulin delivered continuously by the insulin pump throughout the day and night to cover metabolic need for insulin Bolus: A calculated amount of insulin given when carbohydrate is eaten or to correct high BG values Because the basal rate is programmed to meet the individual s metabolic needs, highs and lows can be avoided. For example, the insulin pump can be set to deliver more insulin in the early morning hours to correct for an increase in BG caused by hormonal activity known as dawn phenomenon. The basal rate can also be adjusted temporarily while exercising, for example to accommodate the temporary change of insulin needs. 9

20 Insulin Pump Therapy Boluses are delivered when extra insulin is needed. The insulin pump user controls the timing and the amount of the bolus. A meal bolus is given after the user determines the carbohydrate content of the meal and the insulin amount needed is calculated. This bolus delivery adaptability enables flexible meal timing and meal size. Boluses are also used to correct high BG levels measured by fingerstick/meter value. Use of the Bolus Wizard calculator is the preferred method of calculating bolus doses. The Bolus Wizard calculator computes personalized bolus doses using predetermined values (carbohydrate ratios, insulin sensitivity factors and BG targets) and values entered by the patient (BG readings and amounts of carbohydrate). The Bolus Wizard calculator also takes into account the amount of active insulin from previous bolus that is still lowering blood glucose. This helps to prevent hypoglycemic episodes that can result from stacking insulin. Benefits of Insulin Pump Therapy Insulin pump therapy is considered the gold standard in diabetes management. In fact, the majority of diabetes specialists who themselves have diabetes and require multiple daily injections use this therapy to manage their diabetes. 4 Insulin pump therapy offers both clinical and lifestyle benefits. Several studies in adults and children have shown that when compared with insulin injections, insulin pump therapy leads to several significant improvements in health and well-being: Decrease in hemoglobin A1C 6-8 Reduction in diabetic ketoacidosis (DKA) 7,9 Fewer episodes of severe hypoglycemia 7,10 Prevention or delay of the onset and progression of diabetic nephropathy, retinopathy, and neuropathy 11 Improved quality of life in adults 6,7,9 and children 12 and coping skills in adolescents 9 10

21 Insulin Pump Therapy These benefits are the result of three distinct advantages of insulin pump therapy: Decreased variability of insulin absorption - The insulin pump uses only rapid-acting insulin, reducing absorption variability by 30% compared with intermediate- and longer-acting insulin given by injection 2. - The infusion set is inserted in one area of the body for 2 to 3 days, thus avoiding interregional variation of insulin absorption. Precise dosing of insulin - The basal rate can be changed every half hour. The ability to adjust frequently allows insulin dosing to be matched to metabolic need. - Boluses can be calculated based on BG levels, the carbohydrate content of the meal, and insulin sensitivity. Doses are delivered immediately or over a period of time (by using the Dual Wave Bolus or Square Wave Bolus option) to compensate for the variation in absorption of different types of food. - Boluses can be delivered in unit increments. - The basal rate can be adjusted in unit increments. - The basal rate can be temporarily increased or decreased during exercise or illness for instance, to prevent hypoglycemia and hyperglycemia. Lifestyle flexibility - Patients do not need to schedule injections, time a meal around the action of a longeracting insulin, or take injections at mealtimes. - Meal/snack timing and size are determined by the user. 11

22 Insulin Pump Therapy TRAINING GUIDELINES FOR INSULIN PUMP THERAPY There are several steps included in the Insulin Pump Training Program. The table below outlines the phases of training with a high level overview of what occurs during each phase. This section provides guidelines to follow throughout each step to help ensure a successful patient training experience. Insulin Pump Training Pathway Phase Format Course Facilitator Requirement PHASE 1 Self-Study Insulin Pump Therapy Workbook Patient Required Prerequisite e-learning module at before The Learning Center attending Instructional video initial training Review of product user guide session PHASE 2 Group Pre-Pump Training CPT Optional Pre-Pump Training Review and Practice of: (if needed) Start Class or 1:1 Insulin pump therapy basics training* Button pushing and programming Infusion set/reservoir change Available resources Pre-Pump and Pump Start may be conducted on the same day with a break in between classes or scheduled on two separate days of training. PHASE 3 Group Pump Start Training CPT Required Pump Start Training Return Demonstration and show of: Class or 1:1 Basic competency in pump training* programming Infusion set/reservoir change Understanding of safety guidelines Troubleshooting PHASE 4A Phone calls Follow-Up Training CPT Required Follow-Up 24 and 72 Discuss BG control hours Review use of bolus wizard following Infusion Set /change Pump Start Using advanced features PHASE 4B 1:1 Training Reinforcement and additional CPT Optional Follow-Up training on information covered (if needed) in Pump Start PHASE 5 Group Offered by local Medtronic Medtronic Highly Continuing Training Representatives; for schedule Clinical recommended Education visit: Representative for all patients com/events/ *Group classes are recommended Prior approval required if exceeds 2 hours 12

23 Insulin Pump Therapy Prior to Training Your Medtronic clinical representative will notify you and provide demographic information for the patient you are asked to train. If for any reason you are unable to conduct the training, please contact your Medtronic clinical representative immediately. We strive to train every patient within a 30-day window after the pump is received. You may be asked to train two to three patients in a group training session. Your Medtronic clinical representative will work with you to set up the necessary accommodations. Once you have accepted a training assignment, please contact the patient promptly, contact the patient (and possibly the HCP) again just prior to training, and ensure that you are clear on the training objectives and the required training documentation, as discussed below. Initial Contact With the Patient Please contact each patient within 48 hours after receiving his or her demographic information. Welcome the patient to Medtronic and insulin pump therapy, answer any questions the patient has, reassure the patient about any concerns, and schedule the training. During your initial phone call, you will need to do the following: 1. Assess the patient s educational level and knowledge of diabetes management and determine whether group or one-on-one training is the best option. Group training is recommended for most patients. Interactive and engaging, group sessions provide facilitator-directed, hands-on, step-by-step training as well as the opportunity to learn from peers. However, the individual option may be better for a patient who needs more intensive one-on-one instruction. Please communicate with your Medtronic clinical representative if the patient has special circumstances that require additional training. 2. Stress the importance of preparing for the training session and ask the patient to open the pump box and check the packing slip. Instruct the patient to review and complete all the self-study materials including: Insulin Pump Therapy Workbook: Encourage the patient to read the workbook, review key learning points, and complete the practice exercises. Learning Modules: The Learning Center at or the instructional DVD: Ask the patient to follow along and complete the buttonpushing exercises. Assure the patient that practicing with the pump and pushing buttons will not damage the pump. Insulin Pump User Guide and A Step-By-Step Guide to the Minimed Paradigm REAL-Time Revel Insulin Pump 13

24 Insulin Pump Therapy 3. Notify the patient that instructions on starting insulin pump therapy from the HCP are needed at the training session. The instructions must include: Initial pump settings (basal rates, insulin-to-carbohydrate ratios, insulin sensitivity factors, target range, active insulin time). Directions for insulin on the day or evening before pump therapy starts. These instructions must be signed and dated by the HCP. (See Insulin Pump Initial Settings form in the Forms and Handouts section.) 4. Ask the patient to bring the following to training: Insulin pump and supplies boxed with it 3 reservoirs 3 infusion sets Infusion set insertion device 3 IV Prep wipes (or 3 alcohol wipes) Transparent dressing (IV3000 ), if shipped with insulin pump A vial of rapid-acting insulin (patient will need to obtain prescription prior to class) Blood glucose meter, test strips, and lancets Insulin Pump Therapy Workbook Insulin Pump User Guide Glucose tablets or some form of fast-acting carbohydrate A snack Family member or friend for support, if desired Blood glucose logbook (with at least the previous week s readings) 5. Review the date, time, and location of training. Be sure to provide your contact information. 14

25 Insulin Pump Therapy Additional Contact With the Patient and HCP Prior to Training 1. Call the patient the day prior to training. Ask if self-study has been completed and if he or she feels ready to begin. It is okay to re-schedule the training if the patient needs more time to complete. If the patient seems nervous or apprehensive, offer reassurance. Let the patient know that you will be covering details and answering questions about operating the insulin pump during the training session. 2. Ask the patient if the HCP has provided him or her with signed insulin pump start instructions. a. Be sure that the instructions have not expired; if they have, you must request a new copy before starting the patient on insulin in the pump. b. Ensure directions for current insulin prior to pump start are included. If the patient has not received, contact the patient s HCP to obtain these instructions. You CANNOT start any patient on insulin pump therapy without signed orders from the patient s prescriber. 3. Make sure patient has a vial of rapid acting insulin. Instruct them to contact HCP to obtain if necessary. Some providers may not change the patient s insulin dose prior to training and instead will use the temporary basal rate option to complete the duration of long- or intermediate-acting insulin. If so, you will need to assist the patient with setting a temporary basal rate when starting insulin in the pump. Understanding the Training Objectives It is important that training provides each patient with a sound foundation and the basic knowledge to begin insulin pump therapy. After the training is complete, patients should: Show competency in programming and operating the insulin pump and be able to set initial insulin pump settings. Be able to fill a reservoir and change an infusion set. Performing a site change can be one of the more challenging steps for patients. We want to ensure patients are comfortable and confident with this process. They should know what tools are available to help them: - Insulin Pump User Guide - Instructional CD-ROM - Understand individual basal rate, insulin-to-carbohydrate ratio, insulin sensitivity factor, and how to change these settings when instructed to do so. Be sure to have patients record their settings in the Insulin Pump User Guide or in another place where they can refer to it when needed. 15

26 Insulin Pump Therapy Understand the need to regularly check BG levels and individual BG monitoring schedule. Know their BG target ranges and how to manage highs and lows. Know when to ask for help with diabetes management issues and how to contact the appropriate source of assistance (HCP, CPT, or Medtronic HelpLine). Have a plan for follow-up with the HCP. Know how to call the Medtronic Diabetes 24-Hour HelpLine ( ) for technical assistance. This information is also found on the back of the insulin pump. Know how and when to reorder infusion sets and reservoirs. Understanding Documentation Requirements Whether training is conducted in a group or an individual setting, it must follow the Medtronic training guidelines. Upon your acceptance of each patient s training, the training checklists will be provided. It is not expected that patients will know everything on the checklists following the training. However, it is expected that they will be able to demonstrate proficiency in the core concepts of insulin pump therapy and basic pump operations when training is complete. The completed checklists and/or progress notes confirm that you have reviewed and explained the checklist topics before a patient starts on insulin. The checklists are your record of the training and serve as the legal documentation for the training that was provided. Check the items that were covered and that patient understanding was demonstrated during the training. The documents must be signed by both the patient and you as the trainer. Forward all documentation to Medtronic Diabetes and to each patient s HCP to verify that the patient has been properly trained. Keep a copy of each patient s training documentation for your personal records. Keep a copy of the Prescriber s Instructions to Patient, signed and dated by the HCP. 16

27 Insulin Pump Therapy Starting Patients on Insulin Pump Therapy Your training sessions provide the foundation for insulin pump therapy and set the stage for long-term therapy success. You can help ensure your patient s success by setting clear expectations up-front. Before you begin the actual training, the following steps are recommended: Describe your role and responsibilities. Remind patients that the written HCP s orders to the patient should be strictly followed and that any changes are to be made only with the express written approval of the HCP. Tell patients that they can call the Medtronic 24-Hour HelpLine ( , located on the back of the insulin pump) with any and all technical questions about operating the insulin pump. Explain that you will be using checklists to document each patient s ability to understand and use the insulin pump and that they will be given a copy of these checklists. Also let them know that the checklists will be forwarded to Medtronic as a record of training and sent to the prescribing HCP, along with progress notes. Practical Tips Below are some practical tips to follow before a training session: Have pump initiation orders signed by each patient s HCP including long-acting insulin prior to the insulin pump start. Be sure that starting the basal rate on the insulin pump does not overlap with long-acting insulin present in each patient s system. Have each patient check his or her blood sugar when beginning the session. Low BG levels can interfere with a patient s ability to learn. Make sure that the learning environment is comfortable. Distractions in the environment must be limited to ensure effective learning. Training sessions in the provider s office is often ideal if possible. Have all necessary materials available Alert your Medtronic clinical representative of any difficulties or problems you encounter during the patient training process. Always document and report medical issues that arise to the prescribing HCP and your Medtronic clinical representative. Above all, remember that learning anything new takes time and practice. 17

28 Insulin Pump Therapy Session 1: Pre-Pump Start Training You may be asked to conduct Pre-Pump Start Training with a group of patients or an individual patient. In either case, you will cover the same topics. Before attending this session, patients should have a basic understanding of insulin pump therapy and self-management skills. They are expected to have completed the Insulin Pump Therapy Workbook, and either the e-learning module or the instructional video,. Although patients are required to complete the self-study work before they come to Pre-Pump-Start Training, it is important for you to determine each patient s level of understanding of these basics and teach accordingly. The purpose of Pre-Pump Start Training is to allow patients to become comfortable with the insulin pump and to practice essential skills that will prepare them for the actual pump start and safe use of the therapy. This session includes training on the theory and science of pump therapy, self management, available resources, button pushing, programming, and practice changing the reservoir and the infusion set. Patients should demonstrate competency performing the basic skills before starting on insulin. Product-specific information on button pushing, programming, and infusion set and reservoir changes will be provided to you by your Medtronic clinical representative. Important topics that apply to all patients regardless of the product they are using, such as the theory and science of insulin pump therapy, self management, and resources, are discussed below. At the conclusion of Pre-Pump Start Training, you must document each patient s progress on the associated checklist, which you will forward to Medtronic Diabetes and to the prescribing HCP, along with progress notes, as a record of training. It is critical that you assess each patient s readiness to move forward with starting insulin in the pump in Pump Start Training. The following topics should be reviewed. Patients should be engaged in discussion and their understanding evaluated. 18

29 Insulin Pump Therapy Understanding Insulin Pump Therapy Point out the benefits of insulin pump therapy. Discuss how the insulin delivery most closely mimics the way the human pancreas delivers insulin. Explain that insulin delivery must provide for: - A background amount to cover normal body functions (basal rate) - An extra amount when food is eaten (meal bolus) - An extra amount when glucose is high (correction bolus) Explain the type of insulin that has been prescribed to use in the pump. Basal Rate Have patient explain the purpose of basal insulin. Describe how insulin pump delivers small amounts of basal insulin consistently throughout each hour. Explain that patients may start with one or two basal rates in the beginning and that the HCP may add rates as they fine-tune their diabetes control. Review with each patient the basal rate or rates that have been prescribed by the HCP. Have patients record this information for future reference. Have patients program single basal rate. Have patients program multiple basal rates. Meal Bolus Explain that a bolus is needed to cover the carbohydrate contained in a meal or snack. Discuss the benefits of using the Bolus Wizard calculator when delivering a bolus. Review with each patient the insulin-to-carbohydrate ratio or exchange factor that the HCP has recommended. Have patients write down this information for future reference. Have patients practice giving meal boluses. Grams or Exchanges Carbohydrates can be entered into the pump as grams or exchanges Have patients program carbohydrate amounts into the Bolus Wizard 19

30 Insulin Pump Therapy Correction Bolus Explain the purpose of a correction bolus and when a correction dose will be estimated. Discuss the benefits of using the Bolus Wizard calculator to determine a correction bolus. Have patients practice giving correction boluses. Insulin Sensitivity Discuss how insulin sensitivity is used to determine a correction bolus for high BG. Review with each patient the insulin sensitivity that has been recommended by the HCP. Have patients record this information for future reference. Practice programming insulin sensitivity. BG Target Ranges Review with each patient the target BG ranges that have been determined by the HCP. Have patients record this information for future reference. Explain when a correction dose will be estimated. Active Insulin From Prior Boluses Explain that the Bolus Wizard calculator keeps track of active insulin from prior boluses before determining a suggested correction bolus amount. Note that the Active Insulin Time default setting is 6 hours and the HCP should select the active insulin time most appropriate for the patient. BG Testing Testing Schedule Ask each patient to describe his or her current BG testing schedule, as prescribed by the HCP. Discuss the BG testing schedule for insulin pump therapy, which typically includes fasting, before and after meals, bedtime, and occasionally a 2:00 to 3:00 am check. 20

31 Insulin Pump Therapy AIC Testing Explain that hemoglobin A1C plays an important role in diabetes management. - A1C is a 2- to 3-month average of overall blood glucose control. A1C testing indicates whether patients are experiencing sustained high BG levels, which can cause longterm health problems. State that A1C should be tested every 3 to 6 months to help determine whether the current diabetes treatment plan is working. Tell patients to talk with their HCP regarding their A1C target goal. Encourage patients to know their A1C results. Note that the American Diabetes Association (ADA) recommends a goal of < 7.0%, 19 and the American Association of Diabetes Educators (AADE) recommends a goal of < 6.5%. 20 Continuous Glucose Monitoring Capacity Explain that the insulin pump is equipped to perform CGM. Note that CGM is not intended as a replacement for fingersticks and should be used as an adjunct therapy. Hypoglycemia Have patients define hypoglycemia and ask them to explain the signs, symptoms, and causes, and appropriate treatment. Have patients describe the appropriate treatment for hypoglycemia. Ask each patient to discuss previous episodes of hypoglycemia to assess awareness of it; then ask how they would handle a similar situation using the insulin pump. Address the importance of having a glucagon emergency kit at home and instruction for its use. Ensure that patients understand the ways to prevent hypoglycemia and the importance of wearing the MedicAlert bracelet or necklace. Emphasize the importance of frequent BG monitoring if a patient has hypoglycemia unawareness. Review each patient s individual plan for hypoglycemia if the HCP prepared one. A complete hypoglycemia protocol can be found in the Additional Training and Safety Information section of this manual. 21

32 Insulin Pump Therapy Hyperglycemia Have patients define hyperglycemia Ask patients to discuss prior experiences with hyperglycemia to assess previous treatment strategies. Ask why hyperglycemia might occur with an insulin pump. Make sure patients understand that once they begin insulin pump therapy, they will not have longer-acting insulin on board. Remind them that hyperglycemia can quickly escalate to diabetic ketoacidosis (DKA) if they are not receiving insulin from their insulin pump for any reason. Make sure patients can list all the necessary steps for treatment of high blood sugars in the following order: 1. Taking insulin by injection 2. Checking for urine ketones 3. Troubleshooting the insulin pump 4. Changing the reservoir and infusion set 5. Following up with the HCP Stress that patients should have a back-up insulin plan and that insulin should always be available in case of insulin pump failure. Tell patients to always carry a back-up insulin vial and a syringe or an insulin pen in case of a problem with the insulin pump. Review each patient s individual plan for hyperglycemia if the HCP prepared one. A complete hyperglycemia protocol can be found in the Additional Training and Safety Information section of this manual. Diabetic Ketoacidosis Discuss the signs, symptoms, and causes of DKA. Ask patients to discuss all DKA prevention strategies of which they are aware. Review each patient s individual plan for DKA if the HCP prepared one. A complete DKA protocol can be found in the Additional Training and Safety Information section of this manual. 22

33 Insulin Pump Therapy Sick Day Management Remind patients that illness often causes glucose levels to run high; therefore, BG and urine ketones should be tested regularly during illness. Explain the increased risk of DKA during illness. Discuss the elements of a sick day protocol. Make sure patients know what supplies to keep on hand for sick days. A complete sick day protocol can be found in the Additional Training and Safety Information section of this manual. Nutrition Overview Discuss carbohydrate counting and how it helps to achieve optimal glucose control Ensure patients understand that carb counting is not an exact science and that it takes some practice and will become easier with time. Understanding label reading: - Demonstrate how to look at the serving size and total carbohydrate information on a food label. Discuss estimating carbohydrate using the exchange system - Foods containing carbohydrate - Common serving sizes Carbohydrate Counting books are available through your clinical representative to be used when teaching these concepts. Exercise Safety Discuss exercise and the effects on blood glucose values. Discuss how a temporary basal rate can be set to accommodate for these changes during exercise. Ensure understanding that different types of exercise can have different effects. Explain that determining these rates take time and that frequent BG monitoring is necessary for safety and to determine the correct insulin adjustment. Remind patients that it is important to always carry a source of fast-acting carbohydrate, such as glucose tablets, during exercise. Remind patients that they should refrain from exercise for the first few days or weeks of insulin pump therapy if their HCP has asked them to do so. 23

34 Insulin Pump Therapy Insulin Pump Therapy Resources Remind patients about all the resources available to them: - Insulin Pump Therapy Workbook - Insulin Pump User Guide - The Learning Center ( or the instructional video - Medtronic diabetes website (www. medtronicdiabetes.com) Calling the HCP Instruct patients to always treat their BG before contacting the HCP. Clarify that patients should call the HCP rather than Medtronic Diabetes regarding these clinical or health care issues: - BG or insulin adjustment questions - Management follow-up - Severe hypoglycemic or hyperglycemic episodes - Guidelines for exercise and temporary basal rates - Planning for sick days, hyperglycemia, and insulin pump failure - Positive urine ketones or symptoms of DKA Make sure patients have the HCP office number and pager number for emergencies. Calling the Medtronic 24-Hour HelpLine: Instruct patients always to treat their BG before contacting the HelpLine. Be sure to point out that the HelpLine number is located on the back of the insulin pump. Clarify that patients should call Medtronic for technical assistance with their insulin pump, not for therapy adjustments or medical issues. Encourage patients with technical questions to refer first to the Insulin Pump User Guide, Pump School Online instructional tutorials, the instructional video, or as a troubleshooting resource. 24

35 Insulin Pump Therapy Session 2: Pump Start Training As in the case of Pre-Pump-Start Training, you may be asked to train a group of patients or an individual patient. In either case, you will cover the same topics. The purpose of Pump Start Training is to have patients acquire the basics pump skills necessary to safely start on insulin. They will demonstrate competency to independently: Program basal rates Program Bolus Wizard settings and understand how boluses are calculated using these settings (See Additional Training and Safety Information section) - Perform bolus entering BG and carbohydrate - Perform meal bolus without BG - Perform correction bolus without carbohydrate Confidently demonstrate reservoir fill and infusion set change (see Additional Training and Safety Information section for important site change topics) Clearly explain safety guidelines or treating lows and highs, avoiding DKA, and managing sick days. (See Additional Training and Safety Information section) Other topics included in this session: CareLink Personal Therapy Software (See CareLink Software section of the manual) Wearing the insulin pump: - Can be clipped to their waistband like a pager, either in or out of a case, in a pocket, or inside their clothing. - Can place the insulin pump next to them in bed or clip it to their clothing or pillow when sleeping - The Remote Programmer or the vibrating Easy Bolus feature are options if a patient wants to conceal the insulin pump - Accessories available in the Medtronic Diabetes Accessory Guide that comes with the insulin pump or at Disconnecting the pump (shower, swimming, intimacy) Using CareLink Personal (see Therapy Management System section of this manual) 25

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