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Certified Product TrainerINFORMATION MANUAL

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 1983. 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:

www.medtronicdiabetes.com/products/

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

Ta b l e o f C o n t e n t s

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 2Teaching and Learning Principles

ASSESSING EDUCATIONAL NEEDS AND READINESS TO LEARN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

TRAINING FORMATS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

TRAINING TECHNIQUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

The Cone of Learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Section 3Insulin Pump Therapy

INSULIN PUMP THERAPY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Basics of Insulin Pump Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Benefits of Insulin Pump Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

TRAINING GUIDELINES FOR INSULIN PUMP THERAPY . . . . . . . . . . . . . . . . . . . 12

Insulin Pump Training Pathway . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Prior to Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13


Starting Patients on Insulin Pump Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Session 1: Pre-Pump Start Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Understanding Insulin Pump Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

BG Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Diabetic Ketoacidosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Sick Day Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Nutrition Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Exercise Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Insulin Pump Therapy Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Calling The HCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Calling the Medtronic Diabetes 24-Hour HelpLine: 800-646-4633 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Session 2: Pump Start Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Session 3: Follow-up Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

CareLink™ Personal Therapy Management Software for Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Additional Topics Reviewed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Continuing Education (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

ADDITIONAL TRAINING AND SAFETY INFORMATION . . . . . . . . . . . . . . . . . . . . . 31

Bolusing for Carbohydrates and Corrections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

The Bolus Wizard Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Benefits of the Bolus Wizard Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

How the Bolus Wizard Calculator Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Meal Bolus Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36


INFUSION SETS AND SITE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Infusion Set Choices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Infusion Set Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Site Selection and Rotation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Infusion Set and Site Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

PREVENTING ACUTE PROBLEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Diabetic Ketoacidosis (DKA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Section 4Continuous Glucose Monitoring (CGM)

GLUCOSE MONITORING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Basics of CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Benefits of CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

TRAINING GUIDELINES FOR CONTINUOUSGLUCOSE MONITORING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Overview of Continuous Glucose Monitoring Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Prior to Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Starting Patients on CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Follow-up Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Continuing Education (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62


Section 5CareLink™ Therapy Management Software for Diabetes

CARELINK PERSONAL SOFTWARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Daily Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Sensor Daily Overlay Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Sensor Daily Overlay by Meal Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Important points regarding CareLink Personal Software . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Section 6Forms 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


Section 7Universal Precautions

GENERAL PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

BLOODBORNE PATHOGENS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

PREVENTION AND TREATMENT OF NEEDLESTICKS AND CUTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

ADDITIONAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Section 8References

Section 1 CPT Requirements and Responsibilities

C P T R e q u i re m e n t s a n d R e s p o n s i b i l i t i e s

1

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)

• 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

• Physical therapist

• Licensed occupational therapist

• Podiatrist

• Optometrist

• Licensed vocational or practical nurse

• Social work

• Clinical psychology

• Exercise physiology


2

THE ROLE OF THE MEDTRONIC CPT

Training FocusYour 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 DocumentationCommunication 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 PracticeIt 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.


3

Training EvaluationAt 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 REQUIREMENTSTo 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:www.medtronicdiabetes.com/help/insulinpumps/index.html#manual

• 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%.


44

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.

Section 2 Teaching and Learning Principles

Te a c h i n g a n d L e a r n i n g P r i n c i p l e s

5

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


6

TRAINING FORMATSUsing 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 (www.medtronicdiabetes.com/learning) 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.


7

TRAINING TECHNIQUESTraining 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 effectively18:

• 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.


8

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.

After 2 weeks, we tend to remember…

I see and I forget.I hear and I remember.I do and I understand.– Confucius

Doing a Dramatic PresentationSimulating the Real Experience

Doing the Real Thing

The Cone of Learning

• 10% of what we READ

• 20% of what we HEAR

• 30% of what we SEE

• 50% of what we SEE & HEAR

• 70% of what we SAY

• 90% of what we SAY & DO

Reading

Hearing Words

Seeing

Watching a MovieLooking at an Exhibit

Watching a DemonstrationSeeing it Done on Location

Participating in a DiscussionGiving a Talk

ACTIVE

PASSIVE

Source: Edgar Dale (1969)

Section 3Insulin Pump Therapy

I n s u l i n P u m p T h e ra p y

9

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 THERAPYThe 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.


10

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 A1C6-8

• Reduction in diabetic ketoacidosis (DKA)7,9

• Fewer episodes of severe hypoglycemia7,10

• Prevention or delay of the onset and progression of diabetic nephropathy, retinopathy,

and neuropathy11

• Improved quality of life in adults6,7,9 and children12 and coping skills in adolescents9


11

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 injection2.

- 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 0.025 unit increments.

- The basal rate can be adjusted in 0.025 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 longer-acting insulin, or take injections at mealtimes.

- Meal/snack timing and size are determined by the user.


12

PHASE 1 Self-Study • Insulin Pump Therapy Workbook Patient RequiredPrerequisite • 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 OptionalPre-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 RequiredPump 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 RequiredFollow-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 OptionalFollow-Up training on information covered (if needed) in Pump Start

PHASE 5 Group Offered by local Medtronic Medtronic HighlyContinuing Training Representatives; for schedule Clinical recommendedEducation visit: www.medtronicdiabetes. Representative for all patients com/events/

Phase Format Course Facilitator Requirement

Insulin Pump Training Pathway

TRAINING GUIDELINES FOR INSULIN PUMP THERAPYThere 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.

*Group classes are recommended†Prior approval required if exceeds 2 hours


13

Prior to TrainingYour 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 www.medtronicdiabetes.com/myhome or the instructional DVD: Ask the patient to follow along and complete the button-pushing 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


14

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.


15

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

- http://www.medtronicdiabetes.com/myhome

• 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.


16

• 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 (800-646-4633) 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.


17

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 (800-646-4633, 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.


18

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.


19

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


20

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.


• Practice programming insulin sensitivity.

BG Target Ranges

• Review with each patient the target BG ranges that have been determined by the HCP.


• 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.


21

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 long-term 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.


22

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.


23

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.


24

Insulin Pump Therapy Resources • Remind patients about all the resources available to them:

- Insulin Pump Therapy Workbook

- Insulin Pump User Guide

- The Learning Center (www.medtronicdiabetes.com/learning) 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: 800-646-4633• 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

www.medtronicdiabetes.com/help as a troubleshooting resource.


25

Session 2: Pump Start TrainingAs 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 www.medtronicdiabetes.com.

• Disconnecting the pump (shower, swimming, intimacy)

• Using CareLink Personal (see Therapy Management System section of this manual)


26

• Ordering supplies

- An order should be placed when last box of infusion sets and reservoirs is opened. There are four reorder options:■ Supply reorder card ■ Phone call to Medtronic Diabetes (800-646-4633, option 2)■ mySupplyConnection™ (automatic service)■ Online Store at http://store.medtronicdiabetes.com

• Review available resources

Before you conclude this session:

• Reassure your patients and ensure their confidence

• Set the expectation that they may not have perfect BG control immediately and that

fine-tuning individual insulin pump parameters does take time

• Emphasize that the maximum benefit of insulin pump therapy can be achieved only

with appropriate follow-up with their HCP.

At the conclusion of Pump Start Training, you must document each patient’s progress on the

associated checklist, which you will forward to Medtronic and to the prescribing HCP, along

with progress notes, as a record of training.


27

Session 3: Follow-up TrainingDuring their first few days on therapy, patients may have questions or need additional

reassurance that they are using the pump correctly. They may also have concerns about

changing their infusion set. Therefore, each patient should be called at 24 hours and then again

48 to 72 hours following his or her insulin pump start to address any questions or concerns.

Your Medtronic clinical representative may request that you conduct an in-person Follow-up

Training session for a patient who would benefit from additional training. If you observe during

a Pump Start Training session that a patient will need extra time for follow-up, please schedule

with the patient at that time. Topics that you may need to cover are discussed below.

Basal Rates

• Review the basal rates recommended by the HCP.

• Explain the rationale for different basal rates at different times of the day.

• Review criteria for adjustments found on the Physician Orders to Patient and assist with

necessary changes.

• Instruct the patient on changing and adding basal rates and then observe him or her

doing so.

• Discuss use and programming of temporary basal rates.

• Have Patient confirm changes in the Basal Review.

• Explain possible use and programming of additional basal patterns.

The Bolus Wizard® Calculator

• Review Bolus Wizard calculator programming, instructing the patient as necessary on

specific aspects of it.

• Review the patient’s individual settings that were provided by the HCP.

• Review criteria for adjustments found on the Physician Orders to Patient and assist with

necessary changes.

• Discuss use and programming of Square Wave® bolus.

• Discuss use and programming of Dual Wave® bolus.

Infusion Set Site Problems

• Evaluate the appropriateness of the current infusion set.

• Discuss alternative infusion sets and instruct the patient on their use.

• Review and demonstrate site change technique (i.e., “M” or “W,” clock)


28

• Stress the importance of and rationale for changing the infusion set and reservoir every

2 to 3 days.

• Review and demonstrate skin preparation and site rotation techniques.

• Provide the Tape Tips and Other Infusion Site Information brochure and direct patients

to www.medtronicdiabetes.com/infusionsets/.

• Review measures to prevent site infections.

• In the Notes section of the checklist, list any problems the patient is having with infusion

sets and what instruction and assistance you provided to correct the problem. If the

type of infusion set was changed or if a different product was used, please include this

information.

Reservoir and Infusion Set Changes

• Review the procedure for filling a reservoir for 2- to 3-day use only, and have the patient

perform a “return demonstration.”

• Review the process of purging trapped air bubbles by tapping the side of the reservoir

and then pushing the plunger forward to expel the air that has collected at the top

of the reservoir. Have the patient demonstrate the procedure until the technique is

mastered.

• Remind the patient that insulin should be at room temperature before use and that

insulin degrades after 48 to 72 hours.

DKA Prevention and Hyperglycemia

• Remind the patient of the increased risk of DKA when a patient is on insulin pump

therapy and of the protocols for DKA prevention and hyperglycemia (see Additional

Training and Safety Information section).

• Confirm that the patient has urine ketone test strips and a glucagon emergency kit at

home and knows how to use them.


29

CareLink™ Personal Therapy Management Software for Diabetes• Let patients know that CareLink Personal Therapy Management Software for Diabetes

simplifies insulin pump therapy, CGM, and blood glucose meter information.

• Explain how web-based CareLink Personal Software generates reports and graphs that

can help patients and HCPs identify patterns, trends, and behavioral use of the pump.

• A recent study has shown that patients who use CareLink Software experience improved

control of their blood glucose levels (A1C).26

• Remind patients with internet access that this tool is located at

www.carelink.medtronicdiabetes.com.

• Explain how to affix the CareLink USB Connector to a personal computer in order to use

CareLink Personal Therapy Management Software.

• Refer patients to local Continuing Education classes to learn more about CareLink

Software or direct them to www.medtronicdiabetes.com for general information.

Additional Topics Reviewed Please list other topics discussed with the patient in the Notes section of the checklist. Overall,

this section is the place to include any comments that you believe will be helpful to the patient

and the HCP.

DocumentationPlease document the patient’s progress and the specific areas in which additional training was

needed on the Insulin Pump Follow-up Training Checklist. Forward this document to Medtronic

Diabetes as a record of training and to the prescribing HCP, along with progress notes. You may

also use the Continuation of Care form (Forms and Handouts section) to provide the prescriber

of current status.


30

Continuing Education (optional)For patients who want additional training, Medtronic offers continuing education classes

that will further enhance insulin pump knowledge and skills. You can direct patients to these

classes or contact your Medtronic clinical representative, who can provide a list of classes

offered in your area. Local classes can also be found at www.medtronicdiabetes.com/events/

intro.do. Classes are offered on a variety of topics, including:

• Advanced features — Temporary Basal Rate, Dual Wave® Bolus, Square Wave® Bolus,

Personal Basal Patterns, etc.

• Fine-tuning insulin pump settings

• CareLink™ Therapy Management Software for Diabetes

Please encourage patients to take part in these additional learning opportunities.


31

ADDITIONAL TRAINING AND SAFETY INFORMATIONThis section provides more in-depth information on some of the most critical topics you will

address during training: the Bolus Wizard® calculator; infusion sets and site management; acute

problems such as hypoglycemia, hyperglycemia, DKA, and illness; and exercise. Please review

this information before you begin training patients and refer to it as needed as you move

forward.

Bolusing for Carbohydrates and CorrectionsOne of the major advantages of insulin pump therapy is the increased flexibility it offers

relative to food choice and meal timing. Unlike some insulin regimens in which longer-acting

insulins work slowly and “peak” throughout the day requiring food intake at certain times,

insulin pumps only deliver rapid-acting insulin. Therefore, whenever a person chooses to eat

a meal or snack, a bolus will be given. Insulin amounts are calculated based on the amount

of carbohydrate to be consumed. In addition, a correction bolus can be given if BG values

are above or below the patient’s target values. This is all done quite simply through the Bolus

Wizard Calculator.

The Bolus Wizard CalculatorThe Bolus Wizard calculator is designed to simplify meal and correction bolus dosing by

alleviating the guesswork in determining the appropriate bolus amount. Using the patient’s

personal settings (insulin sensitivity, insulin-to-carbohydrate ratio, BG target range, and active

insulin amount), the Bolus Wizard calculator determines a suggested bolus dose of insulin.

This calculation makes it easier for patients to estimate an actual bolus dose to help achieve

optimal glycemic control.29

The Bolus Wizard calculator can accommodate up to 8 meal bolus ratios, insulin sensitivity

factors, and BG target ranges throughout the day or night. It calculates a bolus dose estimation

using this pre-set information, along with the current BG value and carbohydrate amount

that is entered by the user, to make a bolus recommendation. This information is considered

anytime a bolus is delivered. The Bolus Wizard calculator can use manually entered BG values

or linked BG values that can be automatically transferred to the pump.


32

Benefits of the Bolus Wizard® CalculatorThe Bolus Wizard calculator provides several advantages over traditional ways of using and

setting a bolus:

Clinical Benefit

Evidence supports the position that using a bolus estimator to calculate a bolus decreases

the number of correction boluses required, resulting in better matching of insulin delivery to

patient needs throughout the day.29

One of the most common bolusing errors is to overcorrect for a post-meal rise in blood

glucose. Overcorrection may occur when the amount of insulin still active in the body is not

properly taken into consideration. The Bolus Wizard calculator avoids this problem by using the

adjustable active insulin curve to assess the amount of insulin from previous boluses that is still

lowering blood glucose. Better dosing accuracy helps prevent hypoglycemia secondary to the

“stacking of insulin” that can occur from frequent boluses.29, 30

Also, because the Bolus Wizard calculator factors in a patient’s preset BG target, it helps

patients “treat to target,” thereby reducing the number of glucose excursions.29, 30

Elimination of User Errors

By calculating bolus amounts automatically, the Bolus Wizard calculator helps eliminate the

mathematical errors that can occur when patients calculate food or correction boluses using

a traditional calculator or manually. Manual calculations may not be difficult if a patient’s BG

is 100 mg/dL, insulin-to carbohydrate ratio is 1:10, and insulin sensitivity is 50 (1 unit lowers

BG by 50 mg/dL). But if a patient needs to determine a bolus based on, for instance, a target

BG of 115 mg/dL, an insulin-to-carbohydrate ratio of 1:7, and insulin sensitivity of 46, the task

becomes much more challenging.

In addition, when the meter-linked capability is used and BG is automatically transferred to the

pump, user error in data entry is potentially eliminated.

Better Data Management

When CareLink™ Therapy Management Software for Diabetes is incorporated, the Bolus Wizard

calculator has recorded and provides more thorough information on meal and correction

boluses, and allows a systemic approach to data management for patients and HCPs.


33

How the Bolus Wizard® Calculator WorksWhen a bolus is given, the insulin is absorbed and begins to work quite quickly (rapid-acting).

Even though the insulin’s activity peaks in about an hour, it continues to lower glucose

levels for a few hours. This continued blood glucose lowering effect is what we refer to as

Active Insulin. The Bolus Wizard calculator automatically accounts for this and subtracts the

appropriate amount, based on the Active Insulin Time setting. Active Insulin Time can be set

from 2 to 8 hours and is determined by the HCP based on the time setting that best represents

the insulin type and the patient’s physiological insulin absorption rate.

When the Bolus Wizard calculator estimates a bolus amount:

• Active insulin only reduces the correction portion of the estimate, not the food portion.

• If the current BG is above the high target, and the active insulin is more than the

correction estimate, the correction portion of the estimate is changed to zero units (0u).

• If the current BG is below the low target and the active insulin is more than the

correction estimate, the active insulin is not considered and the correction estimate is

subtracted from the food bolus amount.


34

The following scenarios illustrate how the dose adjustment works.

In the examples below, these settings are used:

• Carb ratio: 10 grams/unit

• Insulin sensitivity: 25 mg/dL/unit

• Target BG Range: 90-120 mg/dL

• Active Insulin Time: 4 hours

No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter BG:

Food Estimate: 60 grams

= 6 units

10 grams/unit

No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 200:


= 6 units

10 grams/unit

Correction: 200 mg/dL -120 mg/dL

= 3.2 units

25 mg/dL/u

Estimate Total: 6 units + 3.2 units = 9.2 units

Current BG is Grams of Carb +

(Current BG - High BG Target) - active insulin

> high BG target Carb Ratio Insulin Sensitivity

Current BG is Grams of Carb +

(Current BG - Low BG Target)

< low BG target Carb Ratio Insulin Sensitivity

Current BG Grams of Carb

is within Carb Ratio

+ No correction needed

low-high limit

Carb ratio: the number of grams of carbohydrate that are covered by 1 unit of insulin

Insulin sensitivity factor: the number of mg/dl that blood glucose will decrease with one

unit of insulin

BG Target Range: the range the Bolus Wizard® will use to calculate correction boluses

BG within target: no correction

BG below target: BG corrected up to low target range value

BG above target: BG corrected down to high target range value

Food Estimate Correction Estimate


35



= 4.5 units

10 grams/unit

Correction: 70 mg/dL - 90 mg/dL

= -0.8 units

25 mg/dL/u

(Negative correction is deducted from food bolus)

Estimate Total: 4.5 units + (-0.8) units = 3.7 units



= 4.5 units

10 grams/unit

Correction: 0 units because the current BG is within the BG high/low target range)

Estimate Total: 4.5 units + 0 units = 4.5 units

Previous bolus activity results in a calculation of 1.5 units of active insulin. User inputs 60 grams of carb and a BG of 200:


= 6.0 units

10 grams/unit

Correction: 200 mg/dL -120 mg/dL

= 3.2 u (-1.5 mg/dL active insulin) = 1.7 units 25 mg/dL/u

Estimate Total: 6 units + 1.7 = 7.7 units



= 3.0 units

10 grams/unit

Correction:

200 mg/dL -120 mg/dL = 3.2 u (-3.5 mg/dL active insulin) = 0 units correction bolus

25 mg/dL/u

(Active insulin of 3.5 mg/dL exceeds correction. Therefore correction becomes 0 units.

Remaining active insulin is not deducted from the food bolus.)

Estimate Total: 3 units + 0 = 3 units


36



= 3.0 units

10 grams/unit

Correction: 70 mg/dL - 90 mg/dL

= -0.8 units

25 mg/dL/u

(Negative correction is deducted from food bolus)

Estimate Total: 3 units + (-0.8) = 2.2 units

Meal Bolus OptionsMedtronic insulin pumps have three bolus delivery options, which allow patients to match

insulin absorption to food absorption: Normal Bolus, Square Wave® Bolus, and Dual Wave® Bolus.

Both the Square Wave and Dual Wave Bolus features allow insulin pump users to deliver

the bolus over an extended period of time and help to decrease the risk of postprandial

hypoglycemia. There is no exact science to using the bolus options. It takes experimentation

to determine what type of bolus in what proportions works best for specific foods and meals,

individualized to each user. Be sure to have patients discuss the best bolus option for them

with their HCP.

Normal Bolus for Everyday Needs

A Normal Bolus is a meal bolus that is delivered at one time as soon as the bolus is activated.

This bolus is used for low-fat meals that are eaten over a short period of time. A Normal Bolus

is also used to lower BG using a specific amount of insulin based on sensitivity and target

glucose. This bolus type is the most commonly used option for everyday meals, snacks, and

blood glucose corrections.

Time

Am

ount

of I

nsul

in

Normal bolus


37

Square Wave® Bolus for More Time

A Square Wave Bolus is a meal bolus that is delivered evenly over a 30-minute to 8-hour

period of time. People with gastroparesis frequently use this bolus to match their slow gastric

emptying. Gastroparesis is the unpredictable absorption of food associated with digestion

that makes glucose regulation difficult. Since gastric emptying is oftentimes delayed, a normal

bolus taken before a meal may lead to low blood glucose immediately after eating and high

blood glucose several hours later.

A Square Wave® is also used for meals that contain a significant fat content. Foods high in fat

or protein may take a few hours to digest, thereby delaying absorption of the carbohydrates.

It can also be used for meals eaten over a long period of time, or when “grazing” on foods that

have carbohydrate but not a significant amount.

Time

Am

ount

of I

nsul

in

Square Wave bolus


38

Dual Wave® Bolus for Combination

A Dual Wave Bolus is a meal bolus that delivers part of the insulin as a Normal Bolus and the

rest as a Square Wave Bolus. This bolus is used for meals that contain carbohydrates and also

have a moderate to high fat content, such as pizza, or when a correction bolus is needed

for high blood sugar (Normal Bolus) along with a Square Wave Bolus. The Dual Wave Bolus

option allows patients to program a certain percentage of insulin for immediate delivery and

the remainder over a chosen period of time. The Dual Wave Bolus has proven to be the most

effective for mixed meals. In a recent study, the Dual Wave Bolus was found to be the most

effective method for high-carbohydrate and high-fat meals.28

In summary, carbohydrate counting by estimating grams or exchanges gives the insulin pump

user freedom in food choices and portion sizes. Entering current BG values, allows the Bolus

Wizard® to calculate a precise bolus dose, taking into account active insulin. By choosing a

bolus to best match the type of food being eaten, the insulin pump user has the ability have

the best blood glucose levels possible.

Time

Am

ount

of I

nsul

inDual Wave bolus


39

INFUSION SETS AND SITE MANAGEMENT Medtronic offers several types of infusion sets in different cannula and tubing lengths to

meet the individual needs of insulin pump users. A supply of the infusion set and reservoir

that the HCP has judged best for the patient is shipped with the insulin pump. If you as a CPT

feel that a different set is more appropriate for a particular patient, inform your Medtronic

Clinical Representative. The patient should use the set that he or she received initially while

arrangements are being made to try other infusion sets.

Changing the infusion set and site on a regular schedule is very important, as is prompt

attention to any problems that may occur.

Infusion Set ChoicesThe selection of infusion set type is determined by the patient’s body type, manual dexterity,

and personal preference. It is important that the distribution of body fat is considered when

assisting a patient in choosing an infusion set. A very thin or lean person may experience

hyperglycemia or NO DELIVERY alarms if the cannula is positioned on bone or muscle. He or

she may require a shorter cannula or one that is slightly angled. Conversely, a heavier person

may receive poor absorption from a short cannula and may require a longer cannula or one

that can be inserted at a wider angle.

All of the infusion sets from Medtronic can be disconnected, which is very convenient for

showering, swimming, contact sports, etc.

For more information on various infusion sets and their features and benefits go to:

www.medtronicdiabetes.com/products/infusionsets.

Infusion Set InspectionPatients should check the infusion set periodically for proper placement, considering the

following:

• Make sure the infusion set is inserted into the skin properly, so there are no visible signs

of the cannula pulling away from the skin.

• Look for signs of irritation or discomfort at the infusion site.

• Pay special attention when two consecutive unexplained high blood glucose readings

have occurred.


40

The cannula on most sets is soft and pliable, so it is very comfortable and usually not felt when

in place. If the infusion site becomes uncomfortable or painful, a new infusion set should be

inserted at another site. If the set becomes dislodged, the insulin pump will continue to pump

insulin, but the insulin will not enter the body. Because the cannula is pliable and usually not

felt, it may become dislodged without the patient being aware. If this dislodgement continues

unnoticed, it will lead to hyperglycemia and potentially DKA.

Site Selection and Rotation Patients need to change the infusion set and the infusion site every 2 to 3 days, always rotating

to a new site. Some insulin pump users may need to change the site more often if they notice

that their BG is less stable over time.

The SERTER® helps simplify site selection, insertion, and rotation. This device makes set

insertions fast and consistent, similar to the way lancing devices facilitate fingerstick tests. It

also allows patients to use harder-to-reach sites, giving them more site options.

The abdominal area is the most common site for set insertions. The abdomen allows for more

rapid and consistent insulin absorption, as absorption is more consistent from the abdomen

than from other infusion sites, especially after exercise. You can assist the patient in identifying

a variety of abdominal sites for adequate rotation by using the following directions:

• Visualize an M or a W on either side of the umbilicus.

• Rotate the site starting with one point and ending at the other, staying on one side of

the umbilicus if possible, until the rotation is complete, and then switching to the other

side. This gives one side a few weeks to “rest” before being used again.


41

• Make sure the site is convenient for insertion of the cannula.

• Areas to avoid:

- along the belt or waistline, at bikini or underwear lines

- within two inches around the umbilicus

- Where scar tissue is present or areas of hardened tissue due to repeated insulin injections

- any place where clothing rubs or constricts.

Using these areas could affect insulin absorption or risk dislodging the cannula.

• Do not overuse a site, and always look for signs of infection. Overuse or infection may

result in absorption issues, leading to hyperglycemia. Call the HCP immediately to

address the problem.

Infusion Set and Site Problems Discomfort on Insertion of Infusion Set or Glucose Sensor

A small percentage of patients experience discomfort when first inserting the infusion set and/

or sensor. If discomfort occurs, reassure the patient that there are solutions:

• Some healthcare providers recommend rubbing the area with ice to numb it slightly

before inserting the infusion set.

• Another option is the use of ELA-Max®, a nonprescription topical analgesic product.

Tell patients to discuss the exact procedure for use of such products with their HCP or

pharmacist.

Skin Irritation

Some patients may experience slight skin irritation that usually looks like small red bumps at

the infusion set insertion site. This is often related to skin exposure to the plastic material of an

infusion set.

Some patients may experience skin reactions to the infusion set tape. Let them know there are

many options that can help them. Refer these patients to:

• Tape Tips and Other Infusion Site Information brochure (available through the Medtronic

Diabetes 24-hour HelpLine

• www.medtronicdiabetes.com/help/sitemanagement

• www.medtronicdiabetes.com/infusionsets.


42

Infusion Site Infections

Patients need to be aware of the signs and symptoms of infection and the serious

consequences that can result if infections are ignored. Be sure to emphasize these things with

your patients. Also provide information on how to prevent skin infections and what to do when

infection occurs.

To prevent skin infections at insertion sites, patients should:

• Change the insertion set every 2 to 3 days, preferably after a bath or shower, as

recommended by the U.S. Centers for Disease Control and Prevention (CDC).21

• Always wash hands before a set change.

• Always cleanse the site with an appropriate antiseptic before insertion.

• Prepare the setup on a clean surface, such as a clean paper towel.

• Change the insertion site at the first sign of abnormal discomfort or infection.

At the first sign of an infection, patients should:

• Call their HCP if they see redness, warmth, heat, swelling, discharge or drainage, abscess

formation, or discomfort or tenderness.

- Apply warm soaks to the area if directed by the HCP.

- Take oral antibiotics if prescribed by the HCP

• Replace both the reservoir and the infusion set with new ones (wash hands after

removing an infusion set from an infected site and handling the new components to

prevent cross-contamination).

• Insert the new infusion set at a different area of the body.

Hypertrophy

Changing infusion sites every 2 to 3 days also helps to avoid hypertrophy (fatty tissue buildup

underneath the skin), which may be related to the length of time the infusion set is left in one

site. Hypertrophy causes poor insulin absorption and reduces the number of possible infusion

sites over time. It can also lead to tissue atrophy, which results in permanent scarring of the area.

Areas of hypertrophy should be avoided when selecting an infusion site.


43

PREVENTING ACUTE PROBLEMS All insulin delivery via an insulin pump involves a potential risk of hypoglycemia,

hyperglycemia, and DKA. These risks can be minimized with good glycemic control and

frequent BG monitoring. It is very important that you discuss these risks with your patients and

review prevention guidelines and treatment protocol.

By monitoring BG a minimum of 4 to 6 times a day and modifying treatment accordingly,

serious problems can be avoided. Use of CGM can also help patients avoid serious problems

associated with uncontrolled glucose levels. It is important to make sure patients understand

their individual BG targets, set by their HCP, and take appropriate action when BG is not within

the suggested target range.

Hypoglycemia Hypoglycemia is present when BG drops below approximately 70 mg/dL (3.9 mmol/L).

Hypoglycemia occurs with a lack of food, too much insulin, stress hormone release, or an

increase in the usual level of activity. The goal of treating hypoglycemia is to prevent loss of

consciousness and potential shock.

Hypoglycemia awareness is an important part of diabetes self-management. However, some

patients are not able to easily recognize symptoms of hypoglycemia because of physiological

or psychological factors. Symptoms can differ between patients, between individual episodes,

and even over time (changes may occur as often as every 2 years).31

Although most patients experience a reduction in hypoglycemic episodes after insulin pump

initiation, hypoglycemia can still occur. It Is important that patients are able to recognize

hypoglycemia and treat accordingly.

For more information go to: www.medtronicdiabetes.com/help/lifestyle.

Recognizing Hypoglycemia Symptoms

Below are some tips from A CORE Curriculum for Diabetes Education, 5th edition, published

by the AADE, to help patients interpret their own current and reliable symptoms of

hypoglycemia.32

• Be aware of changes in the ability to do routine tasks, which can be a sign that BG levels

are too low.


44

• Treat neuroglycopenic symptoms (e.g., slow thinking, blurred vision, slurred speech,

being uncoordinated, numbness, difficulty concentrating, dizziness, or fatigue/

sleepiness) as soon as possible.

- Neuroglycopenic symptoms may impair the patient’s ability to recognize additional symptoms of hypoglycemia, decision-making, and self-treatment behavior, so it is important for the patient to address any neuroglycopenic symptom as soon as possible.

- A neuroglycopenic symptom may be the first sign of hypoglycemia in patients with reduced autonomic symptoms. In fact, patients who tend to become neuroglycopenic do not seem to develop early warning autonomic symptoms (e.g., trembling/shaking, sweating, pounding heart, fast pulse, changes in body temperature, tingling in extremities, or heavy breathing). These patients should be told how to monitor themselves more carefully and frequently, in order to detect mild low blood glucose that may progress to severe hypoglycemia if left untreated.

• Be aware that certain medications, such as propranolol, may mask early warning

autonomic symptoms. Also, alcohol consumption may diminish a patient’s awareness

of hypoglycemic symptoms and impede glycemic recovery.

• Use a symptom diary to record symptoms at the time of each fingerstick, and then

review the data to identify symptoms that consistently occur with hypoglycemia. The

symptom diary may also help patients with reduced hypoglycemia awareness increase

their attention to certain signs of hypoglycemia, such as neuroglycopenic symptoms.

• Watch for reduced hypoglycemia awareness, particularly patients with the following:

- Intensive insulin therapy

- Close to normal A1C levels (6.5% or less)

- History of frequent or recurrent severe hypoglycemia

- Autonomic neuropathy

Hypoglycemia Prevention Suggestions for Insulin Pump Patients

These suggestions will help patients prevent hypoglycemia:

• Monitor BG levels a minimum of 4 to 6 times a day.

• Always test BG before bedtime; BG of >110 mg/dL (6.1 mmol/L) is the recommended BG

level. If BG is <110 mg/dL, patients may need to eat a snack containing carbohydrates. If

BG is consistently <110 mg/dL, patients may need to consult with their HCP regarding

their treatment plan.33

• Always test BG before driving; if BG is <80 mg/dL (4.4 mmol/L), do not drive.32


45

• If consuming alcohol, monitor BG often; never drink alcohol without consuming

carbohydrate-containing food.

• Set appropriate BG target goals.

• Become familiar with the use of glucose tablets.

• Have and understand an individual plan for episodes of hypoglycemia.

• Instruct family members and friends on the use of a glucagon emergency kit and have

them write the instructions in their own words. Use a rubber band to secure written

instructions around the kit.

• Wear medical identification.

• Notify members of the healthcare team regarding any hypoglycemic events that require

assistance or occur often.

• Discuss raising target BG goals with the HCP if there is a history of severe hypoglycemia

or hypoglycemia unawareness.

• Monitor BG before, during, and after exercise and make appropriate adjustments in food

and insulin as needed.

• Minimize boluses administered at bedtime and after exercise.

• Confirm the accuracy of basal rate, insulin-to-carbohydrate ratio, and insulin sensitivity

factor (ISF). If hypoglycemia persists, contact the HCP.

• Make sure that the insulin pump settings are entered correctly. (Including time of day,

basal rates and Bolus Wizard® settings)

• Always set the AUTO OFF safety alarm on the insulin pump to sound an alarm and

stop insulin delivery if a button on the insulin pump has not been pushed in a set

number of hours.

• Consider use of Personal Continuous Glucose Monitoring.

Hypoglycemia Treatment Suggestions for Insulin Pump Patients

Each patient has individual needs, and the HCP should ensure that each patient has an

appropriate individual treatment plan. The following is a summary of the hypoglycemia

treatment recommendations from the AADE:32

• If BG is <72 mg/dL (4.0 mmol/L):

- Treat with 10 to 15 grams of glucose or any form of carbohydrate that contains glucose.

- Check BG in 15 minutes. If not >70 mg/dL (3.9 mmol/L), repeat treatment and check BG in another 15 minutes.


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• If BG levels are <50 mg/dL (2.8 mmol/L):

- Treat with 20 to 30 grams of carbohydrates.

- Check BG in 15 minutes.

- If the BG level is still low, repeat treatment even if symptoms have disappeared, and check BG in another 15 minutes.

• Eat food within the first hour after a hypoglycemia episode to avoid additional episodes

of hypoglycemia.

• Contact the HCP if hypoglycemia persists.

• Keep food high in carbohydrates handy at all times:

- At bedside to treat nocturnal hypoglycemia

- In the car to treat episodes of hypoglycemia that occur while driving

• For treatment, select from these food options, which have 15 to 20 grams of

carbohydrates:

- 3 to 4 glucose tablets

- 4 to 6 ounces of non-diet fruit juice or soda

- 8 to 10 hard candies or Lifesavers®

- 2 tablespoons of raisins

- 8 ounces of no-fat or low-fat milk

• Avoid high-fat foods (eg, ice cream, candy bars, or pizza) for treatment.

Hyperglycemia A BG higher than target, especially >250 mg/dL (13.9 mmol/L), constitutes hyperglycemia.

BG can rise as a result of illness, too much food, not enough insulin, stress hormone release,

a decrease in the usual level of activity, and non-delivery of insulin from the insulin pump.

The goal of treatment for hyperglycemia is to prevent DKA and delay or prevent diabetes

complications.

One of the greatest benefits of insulin pump therapy is that it allows patients to easily correct

high BG levels. By testing BG and taking a correction bolus as prescribed, the BG level can be

brought back into target range promptly.

For more information go to: www.medtronicdiabetes.com/help/pumptips


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Hyperglycemia Prevention Suggestions for Insulin Pump Patients

These suggestions may help patients prevent hyperglycemia:

• Monitor BG a minimum of 4 to 6 times a day and correct high BG.

• Whether eating a meal or a snack, always take a bolus to cover the carbohydrate content

of the food being eaten.

• Confirm the accuracy of basal rate, insulin-to-carbohydrate ratio, and ISF, If

hyperglycemia persists, contact the HCP.

• Make sure that the insulin pump settings are entered correctly. (Including time of day,

basal rates and Bolus Wizard settings)

• Change the infusion set and reservoir every 2 to 3 days.

Hyperglycemia Treatment Suggestions for Insulin Pump Patients

These suggestions can be followed to treat hyperglycemia:

If BG is >250 mg/dL (13.9 mmol/L):

• Take a correction bolus via the insulin pump and check for urine ketones

• Recheck BG in 60 minutes:

- If BG has not decreased, take a correction injection via syringe, check for urine ketones, and then change the reservoir, infusion set, and site.

- Also troubleshoot the insulin pump. Call the Medtronic Diabetes 24-Hour HelpLine (800-646-4633, found on the back of the insulin pump) for assistance with troubleshooting.

• Recheck BG in another 60 minutes. If BG is still not coming down, check for urine ketones

and call the HCP.

• Treat hyperglycemia aggressively to prevent DKA.

Diabetic Ketoacidosis (DKA)DKA is a complication that results from an absolute or relative deficiency in insulin.34 Since

insulin pump therapy uses only rapid-acting insulin, DKA can occur rapidly if insulin is unable

to be delivered. By taking the appropriate steps outlined below, it is possible to prevent DKA

from occurring.


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Preventing DKA

When hyperglycemia is present, these suggestions can be followed to prevent DKA:

• Always change the reservoir and infusion set. There may be a partial occlusion in the

tubing that is preventing the correct amount of insulin from being delivered. The

infusion set may be crimped or have become dislodged from the subcutaneous tissue.

• Use a different site according to the recommended site rotation guidelines. Consider

that a site may have been overused and is not absorbing insulin efficiently. Look for signs

of infection at the old site.

• Check the infusion set tubing for bubbles.

• Check the infusion set connection to make sure it has not become loose and resulted in

an insulin leak.

• Consider using a new bottle of insulin if hyperglycemia persists. There may be a loss of

insulin potency from degradation over time.

- Generally, insulin should be refrigerated at 36ºF to 46ºF (2ºC to 8ºC).

- Open or unopened vials of insulin may be stored at controlled room temperature between 59ºF and 86ºF (15ºC and 30ºC) for 1 month; unused insulin should be discarded after that time.

- Insulin should not be stored in areas of uncontrolled temperature (e.g., in a car or checked in airline baggage).31

Treating DKA

Suggestions for identifying and treating DKA are the following:

• If nausea or vomiting is present, immediately check BG and urine ketones.

• If BG is >250 mg/dL (13.9 mmol/L) or if urine ketones are present:

- Take a correction insulin injection via a syringe; contact the HCP for the insulin dose.

- Change the reservoir, infusion set, and site. Call the Medtronic Diabetes 24-Hour HelpLine (800-646-4633, found on the back of the insulin pump) for assistance with troubleshooting.

- Drink 8 ounces of liquid with no calories every 30 minutes (e.g., diet ginger ale, broth, water). If unable to drink, call the HCP.

- Check BG and urine ketones every hour and continue to take correction insulin with a syringe as directed by the HCP. If urine ketones are not decreasing, call the HCP again.

• If BG is <200 mg/dL (11.1 mmol/L) and urine ketones are still present, correction insulin

may still be indicated. Call the HCP for proper instruction.

These are general guidelines. Impress on your patients the seriousness of DKA and tell them

they must call their HCP for specific instructions if DKA is suspected.


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Illness During illness and infection, the body releases stress hormones that oppose the action of

insulin and contribute to hyperglycemia and the formation and accumulation of ketones.35

Hyperglycemia during illness can be prevented with ingestion of fluids, adjustments to insulin

pump doses, and more frequent BG monitoring. Diabetes is manageable during illness if

patients understand treatment guidelines and keep necessary supplies available at all times.

If high BG persists during illness, the HCP may recommend setting a temporary basal rate on

the insulin pump to deliver more insulin per hour. Setting an increased basal rate requires extra

BG monitoring to be alert to the potential of hypoglycemia. Increased or frequent bolus doses

can also be given to maintain BG control.

During illness, the goal of management is to meet the increased demands for insulin caused by

the effects of illness on blood sugar levels and to prevent dehydration and DKA.

Sick Day Supplies

To be prepared for sick days, insulin pump patients should have the following supplies:

• Liquids that contain sugar to replace solid foods (Popsicles®, juice, Jell-O®)

• Sugar-free liquids for replacement of lost fluids (water or broth)

• Thermometer

• Medications for fever, cough, congestion, nausea, vomiting, and diarrhea

• Extra BG and ketone testing supplies

• Glucagon emergency kit in case of severe hypoglycemia

Suggestions for Insulin Pump Patients During Illness

The following is a summary of the guidelines for sick day management issued by the AADE:35

• Maintain adequate hydration because of the risk of dehydration:

- Drink at least 8 ounces of calorie-free liquids every hour while awake.

- Drink 8 ounces of bouillon, consommé, or canned clear soup every third hour to provide sodium, electrolytes, and fluids.

- Contact your healthcare provider in the event of nausea or vomiting.

• Increase the frequency of BG monitoring and initiate ketone monitoring during illness or

if illness is suspected. BG and ketone levels should be checked when making a decision

about an insulin dose.

- Check BG every 2 to 4 hours while glucose levels are elevated or until symptoms resolve.

- Check urine ketone levels every 4 hours until a negative result is obtained.

• Keep accurate records of BG, urine ketones, medications, temperature, and all symptoms.

• Adjust medication during illness.


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• Continue basal insulin delivery using the insulin pump.

• Change the infusion site in response to any unexpected metabolic decompensation,

even if the site has been changed recently.

• Take correction boluses for elevated BG levels and for large or persistently elevated

ketone levels, as directed by the HCP.

• Substitute liquids or soft foods if unable to tolerate usual foods at meal times because of

nausea or anorexia.

Section 4Continuous Glucose Monitoring (CGM)

C o n t i n u o u s G l u c o s e M o n i t o r i n g

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In your role as a Medtronic Diabetes 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.

GLUCOSE MONITORINGBefore self-monitoring of blood glucose (BG) via fingerstick became standard practice, patients

relied on indirect and imprecise methods to gauge their glucose levels. Urine tests were the

first test that patients were able to use. However, these tests reflected only high BG levels

from the previous several hours. In the 1970s, the first fingerstick-based BG tests became

available and transformed the nature of glucose self-monitoring. Since then, this technology

has become the standard for patients with diabetes. However, BG measurements via

fingerstick provide relatively limited information. As the illustration below shows, conventional

fingersticks (indicated by blue dots) do not represent the full spectrum of actual glucose

activity, nor do they reveal the true level of a patient’s glucose control.

Basics of CGMCGM technology uses a glucose sensor inserted into the interstitial fluid. Glucose in the

interstitial fluid penetrates the semi-permeable membrane of the sensor and reacts with the

glucose oxidase found within the sensor. This reaction produces electrons, which are measured

as what we call the iSig. This iSig is then converted into the sensor glucose value by using

calibration BG values. Illustrated below is a model of plasma (G1) and interstitial fluid (G2)

glucose kinetics. Subcutaneous interstitial fluid glucose sensing accurately reflects plasma

glucose values across a wide range of glucose profiles, regardless of changes in plasma insulin.


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Interstitial glucose reflects plasma glucose13

Benefits of CGM CGM shows the complete picture of glucose activity, not just snapshots of glucose levels. It

allows users and clinicians to gain more insight by providing real-time information about

glucose levels and showing glucose trends between fingersticks, leading to improved glucose

control. CGM also provides additional information beyond the “average” of overall glucose

levels that is represented by hemoglobin A1C (A1C). A recent study has shown that patients

who use CGM at least six days a week substantially lower their A1C levels without an increase

in hypoglycemia, compared with patients who use it less frequently.14

Continuous glucose readings allow patients to better manage their diabetes by intervening

on a real-time basis to reduce the frequency and severity of hypoglycemic or hyperglycemic

episodes. Patients can learn how diet, exercise, medication, lifestyle, and episodes of illness

affect their glucose levels. Furthermore, historical analysis provides insights for both patients

and HCPs that can be translated into treatment adjustments and optimization. Several studies

have demonstrated a significant difference in A1C outcomes on the basis of adjustments in

insulin regimens in response to CGM.15-17

k 21

k 01

Glucose

Insulin

Interstitial fluid glucose (G2) isalmost alwayscomparable withBG (G1)

G2G1

k 12

Plasma (G1)Interstitial fluid (G2)

Glucose sensor

Cells

Capillary


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TRAINING GUIDELINES FOR CONTINUOUS GLUCOSE MONITORINGThe table below outlines the phases of training involved in CGM training and provides a high

level overview of what occurs during each phase. This section provides guidelines to follow

and tools to use throughout each step to help ensure a successful patient training experience.

Many of the tools that are referred to are included in the CGM Training Kit that your Medtronic

clinical representative will provide to you.

Overview of Continuous Glucose Monitoring Training

Throughout this CGM patient training process, you will be referred to tools found in the

CGM Foundations Training Kit (training kit is provided to you by your Medtronic Clinical

Representative). These tools were developed to create a positive, simplified training process

that incorporates adult learning principles to ensure memory of concepts imperative to CGM

success. We expect that you will use these tools throughout the training process to ensure a

positive and effective training experience.

PHASE 1 Self-Study • Getting Started With CGM Patient RequiredPrerequisite • e-learning module at before The Learning Center attending • Instructional video initial training • Review of product user guide session

PHASE 2 Group CGM Training CPT RequiredCGM Start Training • Understanding CGM Class or 1:1 • Sensor site selection, insertion, training* settings and start • “8 Keys to Success”

PHASE 3A Phone calls Follow-Up Training CPT RequiredFollow-Up 1–3 days and • Reinforce “8 Keys to Success” 3–7 days • Identify any patient issues following • Use of CareLink™ Therapy CGM Start Management Software for Diabetes

PHASE 3B Group Reinforcement and additional CPT OptionalFollow-Up Training training on information covered (if needed) Class or 1:1 in CGM Start Training†

PHASE 4 Group Offered by local Medtronic Medtronic HighlyContinuing Training Representatives; for schedule Clinical recommendedEducation visit: www.medtronicdiabetes. Representative for all patients com/events/

*Group classes are recommended†Prior approval required if exceeds 2 hours

Phase Format Course Facilitator Requirement


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Prior to TrainingYour 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. 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) 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. The CGM Pre-Training Call Guide (see CGM Training Kit) walks you through the

points to cover on the call.

1. Review expectations with the patient. Knowing the patient, their reasons for using CGM

and what they expect the therapy to provide for them are all important to know in order

to provide a positive training experience. Clarifying any misconceptions is key to the

patient’s success on the therapy.

2. Assess if a 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.

3. Discuss the information the patient will need to review prior to the training session.

Ensure the patient knows what to bring to the training session. This Information is

outlined in the Pre-Training and Training Materials Checklists which are provided to the

patient with the CGM starter kit.

4. Notify the patient that instructions on starting CGM therapy from the HCP are needed at

the training session. These instructions include the alert settings and must be signed and dated by the HCP. (See the sample Insulin Pump Initiation Settings and CGM Initial Settings forms in the Forms and Handouts section.)

5. Review the date, time, and location of training. Be sure to provide your contact

information. If possible, send the patient a reminder email using the email template

found on the CGM Training CD/DVD in the CGM Training Kit provided to you by your

Medtronic clinical representative.


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Understanding the Training Objectives

It is important that training provides each patient with a sound foundation and the basic

knowledge to begin CGM therapy. After the training is complete, patients should:

• Understand the value of trends and the information that CGM provides.

• Understand how and when to calibrate.

• Know that all treatment decisions must be determined based on fingerstick BG results.

• Be able to insert a sensor and start a sensor properly.

• Understand their alert settings and that they can be personalized to meet their needs.

• Understand the value of using CareLink™ Personal to assess their diabetes control.

• Have a plan for follow-up with the HCP.

• Know when to ask for help with diabetes management issues and how to contact the

appropriate source of assistance.

• Know how to call the Medtronic Diabetes 24-Hour HelpLine (800-646-4633) for technical

assistance. This information is also found on the back of the insulin pump.

• Know how and when to reorder sensors. Typically, an order should be placed when the last

box of infusion sets and reservoirs is opened. Also, be aware of the four options for ordering:

- Supply reorder card

- Phone call to Medtronic Diabetes (800-646-4633, option 2)

- mySupplyConnection™ (automatic service)

- Online Store at http://store.medtronicdiabetes.com

Understanding Documentation Requirements

Whether training is conducted in a group or an individual setting, it must follow the Medtronic

Diabetes training guidelines. Upon your acceptance of each patient’s training, the training

checklists will be provided. The checklists are your record of the training, and serve as the legal

documentation for the training that was provided. It is expected that each patient will be able to

demonstrate proficiency in the core concepts of CGM therapy when training is complete.

The completed checklists and/or progress notes confirm that you have reviewed and explained

the checklist topic. The checklists are your documentation of the training.

• 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.


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Starting Patients on CGM Your training sessions provide the foundational understanding of CGM, and set the stage for

the patient’s long-term success.

Face to Face Training

Suggested training flow for the face to face training is as follows:

• Review expectations and clarify any misconceptions patient may have

• Teach and have patient return demonstration and insert sensor

• Use Prescribers CGM Orders to Patient to enter settings in the Sensor Set-up menu

• Connect transmitter (after 10-15 minutes have passed) and Start Sensor

• Facilitate the “8 Keys to Success” using the Getting Started Guide for CGM and

Learning Guide (See CGM Training Kit)

• Review key points and schedule follow-up

This training process is outlined and the facilitation of “8 Keys to Success” is demonstrated

on the “Continuous Glucose Monitoring (CGM) Patient Training Video” (see CGM Training Kit).

Please watch this video prior to observing and demonstrating patient training session with

your Medtronic clinical representative.

The following topics should be reviewed during the training. Patients should be engaged in

discussion and their understanding evaluated.

Understanding CGM

Differences between sensor glucose and meter glucose values

• The accuracy of CGM glucose sensor values versus BG meter values is comparable to

the accuracy of self-monitoring of blood glucose readings versus standard laboratory

measurements. At any one time point, glucose sensor values are rarely the same as

BG meter values. A greater difference may be noted especially when glucose values

are changing rapidly (after meals, a correction bolus, exercise, treatment of lows, etc.).

Patients may notice these differences when they compare fingerstick glucose results

with sensor glucose readings. Most of the time, the difference will be small (<20%),

but if rapidly changing conditions exist, the difference may be >20%.

Setting realistic expectations about the differences between glucose levels obtained

from the glucose sensor and a fingerstick is crucial. It is important to manage patients’

expectations regarding the sensor glucose values displayed by a CGM system. Patients

must understand that differences are normal and in most cases do not have any clinical

implications. Although it is not always necessary for patients to fully understand why the

differences exist, the reasons are described below:


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- Physiological lag time: Glucose is transported from the small intestine to the cells, passing first into the blood and then through the interstitial space immediately before entering the cell. Hence, there may be a difference in the glucose measured in each of these areas, especially when glucose levels are changing.

- Technology: A CGM system updates the displayed glucose value every 5 minutes. Changes between updates are represented only in the value that is displayed after the change. Combined with physiological lag time, patients may observe a delay of approximately 10 minutes between BG values and interstitial glucose level reported by the glucose sensor.

- Use of BG meter: Variability in BG meter readings, hands not properly washed and inaccurately coded meters cause greater differences between meter and sensor values. Minimizing these as much as possible helps to minimize the difference.

Calibration process and frequency

• Calibrations give the information that the sensor provides a value that means

something to us.

- The glucose reaction that occurs in the sensor provides a measurement of glucose levels that we refer to as iSig

- Calibrating converts this iSig into a sensor glucose value (displayed on the pump) which is comparable to blood glucose values

• Calibrations should be performed when glucose levels are least likely to be changing

rapidly. This ensures better accuracy.

• Meters that automatically transmit BG values to the pump may be used, as the patient is

asked whether they would like to use the BG value for calibration.

• Calibrations schedule

- On day one of a new sensor, a calibration is needed:■ Approximately 2 hours after sensor is started■ Again within 6 hours■ Again within 12 hours

- Early on, more frequent calibrations may improve sensor performance

- After day one, calibrations should be done 3-4 times a day for optimal sensor accuracy

- A minimum of 1 calibration every 12 hours is required to receive sensor readings

It is important that you walk through a typical day for each patient and ensure they understand

when they will be performing calibrations.

Fingerstick confirmations are required to calibrate the system and to confirm glucose sensor

readings prior to treatment changes

• All treatment decisions must be made based on fingerstick BG results.


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Inserting the Sensor

• Site selection and rotation

- Help the patient select a site with an adequate fatty layer for glucose sensor insertion within the shaded areas of the figure below.

- Avoid:■ 2 inches from your navel■ 2 inches from you pump infusion site■ 3 inches from a manual injection site■ Sites where clothing may rub or constrict (e.g. beltline)■ Sites where body naturally bends a great deal■ Sites that are scarred or have hardened tissue or stretch marks

- Instruct the patient to rotate the glucose sensor sites so that sites do not become overused

• Site Preparation

- Instruct to clean site with alcohol, waiting until the site is dry before inserting the glucose sensor.■ skin preparation solutions such as I.V. Prep® should NOT be used prior to glucose

sensor insertion ■ can be used after insertion and before applying a sterile dressing

• Glucose sensor insertion

- Demonstrate the correct way of inserting the glucose sensor.

- Available resources■ User Guide■ Instructional CD ROM

• Ensure the patient understands the importance of waiting 10-15 minutes before

connecting the glucose sensor.

• Connecting glucose sensor to transmitter

• Performing the Sensor Start

• Tape transmitter to skin


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Programming Glucose Sensor Information

The following settings will be programmed into the Sensor Settings. You must have the signed

Prescriber’s CGM Instructions to Patient prior to the training and assist the patient to set

according to the orders.

It is important that the patient demonstrates understanding of these alerts and the ability

to program and change the settings, as it is likely that they may need to be adjusted as the

patient becomes accustomed to CGM and glucose levels improve.

• High and Low Glucose Alerts

- The threshold at which a High or Low Glucose alert will sound

• High Repeat

- Sets the frequency that certain alert reminders repeat after being cleared

- Relates to High Glucose, High Predictive, Rising Rate of Change

• Low Repeat

- Sets the frequency that certain alert reminders repeat after being cleared

- Relates to Low Glucose, Low Predictive, Falling Rate of Change

• Predictive Alert

- Provides an early warning of a potential glycemic excursion so that action can be taken to prevent or reduce severity of the excursion

- Determines the amount of time estimated before High or Low Glucose Alert is reached

- Set from 5 to 30 minutes in 5 minute increments

- High and Low Predictive are set independently

• Rate of Change Alert

- Alerts patient of rapid changes in glucose levels

- Provides a notification when sensor glucose levels are changing at or faster than, the per-minute rate selected

- Set from 1.1 mg/dL/min to 5 mg/dL/min in 0.1 mg/dL/min increments

- The Rise Rate and Fall Rate are set independently

• Cal Repeat

- Sets the frequency that an Enter BG Now alert repeats after being cleared

Note: If too many alerts are set, ranges are too narrow or set too sensitive, patients can get frustrated by excessive alerts. Please assure the patient that settings can be adjusted if this occurs.


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• Cal Reminder

- Provides an alert prior to calibration BG being due

- Set from 5 minutes to 6 hours in 5 minute increments

• Transmitter ID:

- Found on the back of the transmitter

- This must be entered appropriately to ensure communication between the transmitter and the pump

• Weak Signal

- Provides an alert when the transmitter has not been able to communicate sensor information with the pump, allowing the patient to bring transmitter and pump closer together to re-establish connection

- Set from 5 to 40 minutes in 5 minute increments

- If weak signal exceeds amount of time that transmitter can store data, a Lost Signal will occur and Find Lost Sensor will need to be performed

• Graph Time-Out

- Determines the time that the sensor graph will remain on the screen

- Set from NONE to 6 minutes in 2 minute increments

Use of Product

• Enter meter BG to calibrate

- Ensure patient understands how and when to calibrate

• Trend Graphs

- 3, 6, 12 & 24 hour trend graphs are available

- Discuss the information provided

- Ensure patient knows how to access

• Trend arrows

- Discuss the trend arrows and the parameters they represent


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Other topics to be reviewed

• Review basic care of the continuous glucose monitoring system

• Use on aircraft

- Instruct patient that CGM system should not be used on an aircraft. Review how to disconnect and reconnect the transmitter for air travel.

• Remove for x-ray, MRI

- Explain that patients who are going to have an x-ray, CT scan, MRI must take off his/her insulin pump, transmitter and remove glucose sensor.

- Explain airport security systems do not require removal

• Ensure patients know how to remove glucose sensor and transmitter.

Alerts

Ensure the patient knows how to clear an alert. It is important that they know to refer to the

Getting Started with CGM Guide or User Manual when these alerts occur.

• Weak Signal

- Indicates that the insulin pump is not receiving data from the transmitter. Instruct patient to move the insulin pump closer to the transmitter

• Lost Sensor

- Indicates that the insulin pump has not received data from the transmitter for 40 minutes. Instruct patient to move insulin pump closer to glucose sensor and take steps to Find Lost Sensor

• Low Transmitter (low battery)

- Indicates the transmitter battery is low but will continue to transmit sensor data. Instruct patient to charge transmitter at next sensor change.

• Charge Transmitter

- Indicates the transmitter batter is depleted. Instruct patient to charge transmitter immediately.

• Sensor End

- Indicates the glucose sensor has reached the end of its life. Instruct patient that the sensor must be replaced.

• Meter BG Now

- Indicates a calibration is needed to update the glucose sensor and receive glucose data. Instruct patient to enter a meter BG.

• Cal Error

- Indicates sensor did not accept calibration BG. Instruct patient to wait at least 15 minutes or until BG levels stabilize. Then retest and calibrate again.


62

Follow-up TrainingFollow-up training and documentation is required for every CGM patient. This may be a

combination of telephone follow-up and face-to-face visits.

Phone calls are required 1-3 days and 3-7 days after CGM start. The CGM Follow-up Discussion

Guide (see CGM Training Kit) outlines the topics to review, assessment questions that help to

uncover patient issues, and educational tips that address these possible issues.

By this time, patients with Internet access should be using CareLink™ Personal Software. They

may need your assistance using the software and understanding the reports. Use Getting

Started with CareLink Personal Software for CGM (see CGM Training Kit) as a teaching tool.

The patient’s progress and the specific areas in which additional training was needed must

be documented on the CGM Follow-up Training Checklist (see Forms and Handouts section).

Forward this document to Medtronic Diabetes as a record of training and to the prescribing

HCP, along with progress notes.

Continuing Education (optional)For patients who want additional training, Medtronic Diabetes offers continuing education

classes that will further enhance CGM knowledge and ensure their continued success. Your

Medtronic clinical representative can provide a list of classes offered in your area. Local classes

can also be found at www.medtronicdiabetes.com/events/intro.do. Please encourage CGM

patients to take part in these additional learning opportunities.

Section 5CareLink™ Therapy Management

Software for Diabetes

C a re L i n k™ T h e ra p y M a n a g e m e n t S o f t w a re fo r D i a b e t e s

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The Medtronic CareLink Therapy Management Software for Diabetes is an online system

that patients and HCPs can use to view historical data and analyze information about patient

glucose patterns using data from blood glucose meters, insulin pumps, and CGM. The software

platform consists of CareLink Personal Software for patient use and CareLink Pro Software for

professional use.

As a CPT, you will be assisting patients using CareLink Personal. The following tools will help in

your understanding of the software:

• Setting up your own CareLink Personal account gives you experience using the software.

• Online CareLink tutorial at www.medtronicdiabetes.com/carelinktutorial will allow

you to explore such topics as understanding the software, getting started, getting

connected, entering data, and viewing reports.

• Getting Started with CareLink Personal Software for CGM will provide details on reports

and applying the information to make therapy adjustments.

You will need to be comfortable answering patient questions about CareLink Software that

arise during training sessions.

CARELINK PERSONAL SOFTWARE The patients you are training may need assistance accessing and using CareLink Personal

Software. The simple steps to take are outlined below:

1. Register to use the software by going to http://carelink.medtronicdiabetes.com and

clicking on Sign Up Now.

2. Sign in with the username and password created during the registration process.

3. Follow on-screen directions until the “Select the Link Device” screen is shown, and then

select the appropriate device and click Next.

4. When prompted, plug the link device into an available port, and then click Next. The

computer will now recognize the device.

5. Upload data by clicking on the Upload tab and following the on-screen instructions.

When reviewing the available CareLink Reports with patients, focus on just a few reports at

first, so that they will not be overwhelmed by the data. Patients can learn more about CareLink

Reports as they become more familiar with the software and how to use it.

C a re L i n k™ T h e ra p y M a n a g e m e n t S o f t w a re fo r D i a b e t e s

64

Patients may find the following three reports very helpful for reviewing glucose data recorded

by CGM.

Daily Summary Report • The Daily Summary Report provides a single-day view of carbohydrate and

insulin intake.

• It also shows the effects of carbohydrate intake and insulin dosing on glucose levels.

• Shows the sensor alerts that sounded (if CGM is used).

Sensor Daily Overlay Report • The Sensor Daily Overlay Report compares days of the week.

• Patients view several sensor tracings together and look for patterns in glucose control.

• Helps to identify where therapy changes need to be made.

Sensor Daily Overlay by Meal Report • The Sensor Daily Overlay by Meal Report reveals what happens to glucose levels as

a result of food intake.

• Patients can learn how meals affect their glucose levels.

• Can also help determine how long it takes for food to digest and for insulin to work.

Important points regarding CareLink Personal Software • Using CareLink Personal Software allows a patient’s HCP to quickly and easily access their

glucose data through our provider designed CareLink Pro Software. This ability to link

information allows:

- a more efficient and valuable office visit with provider.

- more complete information from insulin pump, CGM, and blood glucose meter.

- reports and graphs to be generated that help provider identify patient behaviors as well as patterns and trends to make therapy changes.

• A recent study has shown that patients who use CareLink Personal Software experience

improved control of their blood glucose levels (A1C).28

• With Internet access, that this tool is located at www.carelink.medtronicdiabetes.com.

• Local Continuing Education classes may be offered to learn more about CareLink

Software. General information can be found at www.medtronicdiabetes.com.

Section 6Forms and Handouts

Times available for training:

❑ Weekdays ❑ Mornings ❑ Weekends ❑ Afternoons ❑ Evenings

Please list languages other than English in which you provide product training and diabetes education:

Signature: Medtronic Diabetes CPT Applicant Date:

Signature: Medtronic Diabetes Clinical Consultant Date:

Signature on this application verifies that the applicant has properly demonstrated proficiency in the operation of Medtronic MiniMed products. This application WILL NOT be processed unless it is signed by all parties and is submitted with a CPT Proficiency Checklist.

Name: Date:

Title/Credentials:

Years of experience in the field of diabetes education:

Diabetes Program Affiliation:

Mailing Address:(Home preferred)

CDE: ❑ Yes ❑ No BC-ADM: ❑ Yes ❑ No

Professional License #: State:

Home: Cell: Business:

E-mail: Fax:

Contact Information:

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Medtronic Diabetes CertifiedProduct Trainer (CPT) Application

Basal Settings

Insulin instructions for transition to pump:_______________________________________________________________

__________________________________________________________________________________________________

Comments:

__________________________________________________________________________________________________

__________________________________________________________________________________________________

__________________________________________________________________________________________________

These instructions shall be valid for 6 months unless otherwise specifi ed here: ______________months

Prescriber Name: ____________________________ Signature: __________________________ Date:________________

Patient Name: _____________________________________________________________ Date: ____________________

DOB: ___________________________________________________ Weight: ____________________________________ Current Regimen: ____________________________________________________________________________________ Pre-pump TDD

Basa

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Time Rate (units / hour)

12 a.m.

Insulin Pump Initiation SettingsPrescriber’s Instructions to Patient Fax to: ________________________

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Instructions for adjustments• If nocturnal, fasting/pre-meal or bedtime BG > target, increase basal 10-20%• If nocturnal, fasting/pre-meal or bedtime BG < target, decrease basal 10-20%• If post-meal BG > 60 mg/dL above pre-meal BG, decrease carb ratio by 10-20%• If post-meal BG < 30 mg/dL above pre-meal BG, increase carb ratio by 10-20%

Elevated BG: Verify trends 2-3 days before adjustingLow BG: Consider immediate adjustment

Adjustments should be made when BGsare outside of these ranges

Fasting/pre-meal: _______ to _______mg/dL

Post-meal: _______ to _______mg/dL

Bedtime: _______ to _______mg/dL

Nocturnal: _______ to _______mg/dL

Bolus Settings

Mea

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Carb Ratio (grams / unit)

(B)(L)(D)

Set Dose (units)

(B)(L)(D)

OR

Corr

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ISF (mg / dL / unit)

12 a.m.Target Ranges (mg / dL)

Day Night

_______ - _______ _______ - _______

Active Insulin Time (hours)

______________

(Workspace for calculations)

=

Call provider for severe low BG or if ketones occur. Call Medtronic for technical assistance at 800-646-4633.

NEW: This setting is required for all patients.

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Patient Name Certified Product Trainer Insulin Pump Model: S/N: Home Phone: Alternate Phone:

Have patient check BG prior to and after training session

Patient Self Study. Check all that apply.Viewed CD/DVD Completed Online Course Completed exercises in Basics of Insulin

Pump Therapy Workbook and Step-By-Step Guide

Reviewed User Guide Understanding Insulin Pump Therapy

Theory Insulin for the insulin pump Basal rate Meal Bolus

Grams of Carbohydrates Exchange Counting

Correction Bolus Insulin Sensitivity Factor BG Target Ranges Active Insulin

Blood Glucose TestingTesting Schedule A1c Testing Continuous Glucose Monitoring System

CapabilitiesHypoglycemia (low BG)

Hypoglycemia protocol Glucagon

Hyperglycemia (high BG)Ketone testing Hyperglycemia protocol

DKAPreventing DKA

Sick Day ManagementSick day protocol Sick day supplies

Nutrition Overview Nutrition overviewExchange system Carbohydrate counting Understanding a food label

Exercise safetyEffects on Glucose Levels Use of Temporary Basal Rates

Insulin Pump Therapy ResourcesUser’s Guides Online Learning Center

www.medtronicdiabetes.com/myhome Medtronic Diabetes website

www.medtronicdiabetes.com/help When to call your Healthcare Provider

When to call the 24-Hour HelpLine 1-800-646-4633

Notes: _____________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

_____________________________________________

Patient’s Signature:____________________________________________ Date :_____________

Product Trainer’s Signature:_____________________________________ Date:_____________

FAX COMPLETED FORM WITHIN 30 DAYS OF TRAINING TO: 800.849.2152

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Pre-Pump Training Checklist

Have patient check BG prior to and after training sessionIntroduction to Insulin Pump TherapySelf Management Skills

Hyperglycemia DKA Prevention/Back-up MDI Plan Hypoglycemia Insulin Pump Supplies

Understanding Insulin Pump TherapyBasal Insulin Bolus Insulin

Meal Bolus I:C Ratio

Correction Bolus Sensitivity Factor BG Target Ranges Active Insulin

BG Testing Schedule The Insulin PumpBasic Features

Battery Insertion Button Functions Home Screen/Modes of Operation Alarms, Alerts and Screen MessagesMain Menu Status Screen Clip/Guard Placement/Removal Continuous Glucose Monitoring System Capabilities

Basic ProgrammingDate and Time Suspend/ResumeManual Bolus/Express Bolus/Max Bolus Basal/Max BasalBasal ReviewTemp Basal Rate

Bolus Wizard® CalculatorSetupWireless Meter Options/Connecting DevicesUse

Optimizing The Insulin PumpDual Wave™ and Square Wave™ BolusEasy Bolus Missed Bolus ReminderBG Reminder Personal Basal Patterns Lock Keypad Alert Type Auto-OffDaily Totals/Daily AverageAlarm Clock BlockSelf-TestUser Settings Capture Option CareLink™ Software/USB

The Reservoir and Infusion SetsInfusion Set Type______________________

Fill Reservoir and Connecting to Infusion Set Rewind Insert Reservoir and Fill Tubing Infusion Set Insertion Fill CanulaDisconnect the Infusion SetTape Options and Site Prep Site Selection and Rotation When to Change Infusion Set

Troubleshooting: Site, Tubing, Insulin, PumpNo Delivery Alarm When to Order Supplies How to Order Supplies (1-800-843-6687) When to Call Healthcare Provider for Assistance HCP # ________________________ When to Call the 24-Hour HelpLine 1-800-646-4633

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Patient Name Certified Product Trainer Insulin Pump Model: S/N: Home Phone: Alternate Phone: Check all that apply: Viewed CD/DVD

Completed exercises in Basics of Insulin Pump Therapy and Step-By-Step GuideReviewed User Guide Completed Online Training at www.medtronicdiabetes.com/myhome

Patient Signature: _________________________________________________ Date:____________

Product Trainer’s Signature:_________________________________________ Date:____________


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Pump Start Training Checklist

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Patient Name Certified Product Trainer Insulin Pump Model: S/N: Initial Training Date:

Home Phone: Alternate Phone:

Patient self study. Check all that apply: Viewed CD/DVD Completed exercises in Basics of Insulin Pump Therapy and Step-By-Step Guide

Reviewed User Guide Completed Online Training at www.medtronicdiabetes.com/myhome


Basal RatesMultiple Basal RatesTemporary Basal Rate Patterns

Bolus Wizard® CalculatorInstruct/review Bolus Wizard calculator programming Program and instruct on use of wireless meter (optional) Square Wave™ Dual Wave™

Infusion Sets and Site ManagementEvaluate appropriateness of current infusion set Discuss and instruct on alternate infusion sets Review and demonstrate site change technique Review and demonstrate skin preparation and site rotation

Infusion Set ChangeFilling reservoir correctly Expelling bubbles Letting insulin rise to room temperature

Preventing Acute ProblemsReview DKA prevention and hypoglycemia protocol Review hypoglycemia protocol Other:_____________________________________

CareLink™ Personal Therapy Management SoftwareRegistration and sign up Reading and printing reports Other:_____________________________________

Notes (optional):____________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________ Patient’s Signature:__________________________________________________ Date:____________

Product Trainer’s Signature: __________________________________________ Date:____________


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Pump Follow Up Training Checklist

Active Insulin Time (hours): __________ Infusion set type: Quick-set® Silhouette® Sure-T™ _______

Average TDD (units/day): ____________ Infusion site rotation frequency: ____________ Education Provided: Carb Counting Bolus Wizard® Use Manual Bolus Dual / Square Bolus Temp Basal Rate Basal Patterns

Comments:__________________________________________________________________________________________________

__________________________________________________________________________________________________

__________________________________________________________________________________________________

__________________________________________________________________________________________________

Thank you for allowing me to participate in your patient’s diabetes care. If you have any further questions regarding

the information above, you may call me at _____________________ or email to ________________________________.

___________________________________________________________ __________________________Diabetes Clinical Manager / Certified Product Trainer Date

Dear _______________________________________________, Date:______________________

Thank you for referring your patient to Medtronic for Insulin Pump Therapy: ___________________________________, DOB: _____/_____/_____. (Patient Name) Below you will find the current insulin pump settings along with a summary of the key training topics covered with your patient. I have instructed your patient to follow-up with you for continued management of insulin pump therapy and glycemic control. I have encouraged your patient to call the Medtronic 24 hour customer support group for any technical assistance.

Insulin Pump Therapy initiated on ______ / ______ / ______ Insulin Pump Model: _________________________

Current Insulin Pump Settings: See Attached CareLink® Software Report

Basal Rates Bolus Wizard Settings

Time Basal Rate(s) (unit/hr)

12:00 a.m Standard A B

Time Carb Ratio (gm)

12:00 a.m.

SMBG Hypoglycemia / Rule of 15 Hyperglycemia Management Sick Day Management Exercise _________________________

Time Sensitivity (mg/dL)

12:00 a.m.

Time Target Ranges (mg/dL)

12:00 a.m. -

-

-

-

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Infusion Set Insertion / Priming Site Selection / Rotation Site Adhesion / Tape Issues Basal Testing Ratio Testing CareLink™ Personal Upload

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GLUCOSE ALERT (LOW) GLUCOSE ALERT (HIGH)

Date: ________________________________

Patient Name: _____________________________________________________________ DOB: ____________________

Continuous Glucose Monitoring Initial SettingsPrescriber’s Instructions to Patient

Fax to: _______ _______________ __

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Glucose Alerts

Time UnitsON 12:00am ____________ mg/dL ____________ ____________ mg/dL ____________ ____________ mg/dL

OFF until ____________________ (date) 12:00am ____________ mg/dL ____________ ____________ mg/dL ____________ ____________ mg/dLORBase settings on CareLink™ data

Time UnitsON 12:00am ____________ mg/dL ____________ ____________ mg/dL ____________ ____________ mg/dL

OFF until ____________________ (date) 12:00am ____________ mg/dL ____________ ____________ mg/dL ____________ ____________ mg/dLORBase settings on CareLink™ data

LOW REPEAT ____________ minutes (5 min - 1 hour) Patient to determine

HIGH REPEAT ____________ minutes (5 min - 3 hours) Patient to determine

Low Alert Settings High Alert Settings

PREDICTIVE ALERT (LOW) ON ____________ minutes (5 -30 min) OFF

PREDICTIVE ALERT (HIGH) ON ____________ minutes (5 -30 min) OFF

RATE OF CHANGE ALERT (FALL RATE) ON ____________ mg/dL per min (1.1 - 5.0) OFF

RATE OF CHANGE ALERT(RISE RATE) ON ____________ mg/dL per min (1.1 - 5.0) OFF

Prescriber Name: __________________________________________________________

Prescriber Signature: _______________________________________________________Date: ____________________

Yes, patient may adjust settings as necessary after initial use. No, it is preferred that the patient not adjust settings without consulting prescriber

Notes (optional): ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Patient Name Certified Product Trainer Device Model: S/N: Home Phone: Alternate Phone:

Have patient check BG prior to and after training sessionPatient Pre-Training. Check all that apply.

Viewed CD/DVD Completed Online Course Reviewed Getting Started With CGM Reviewed the product user guide

Inserting the Sensor Site Selection and Rotation Site Preparation Glucose Sensor Insertion (with Sen-serter® Device)

Starting New Sensor Wetting Period Connect Glucose Sensor to Transmitter Start New Glucose Sensor Connection Icon Initialization Period Tape Transmitter to Skin

Understanding CGM Basics Difference Between Sensor Glucose Reading and Blood

Glucose Meter Reading Why Calibration is Necessary Fingerstick Confirmations Required

Programming Settings: Settings Entered Glucose Limits Low: _________ High: _________ Hi Repeat _____________ Lo Repeat _____________ Predict Alert Low: _________ High: _________ Rate Alerts Fall: _________ Rise: _________ Cal Repeat _____________ Cal Reminder _____________ Weak Signal _____________ Graph Time Out _____________ Review Settings Notes:

Using CGMCalibration:

Entering BG Through the Bolus Wizard® Calculator Manual Calibration Best Times to Calibrate Daily Calibration Routine Glucose sensor – status screen

Reading The Display: 3, 6, 12 and 24-hour Graphs Single Trend Arrow and Double Trend Arrows Glucose Sensor – Status Screen

CareLink™ Therapy Management Systems Registration/Sign up USB/Upload Reading and Printing Reports

Basic Care Charging, Storing, and Cleaning the Transmitter Tape Tips Removing Glucose Sensor and Transmitter Bleeding, Irritation, Redness and Pain Using on Aircraft Remove for X-ray, MRI Glucose Sensor Storage and Expiration

Alarms and Alerts Clear Alarm (ESC then ACT) Weak Signal Lost Sensor/Find Lost Sensor Sensor Error CAL ERROR Meter BG Now Change Sensor Low Transmitter Bad Transmitter Sensor End Reconnect Old Sensor

Assistance and Product SupportHCP # ________________________

When to Call the 24-Hour HelpLine 1-800-646-4633

Patient’s Signature:____________________________________________ Date :_____________

Product Trainer’s Signature:____________________________________ Date:_____________


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Continuous Glucose Monitoring Training Checklist

Follow-up Phone Calls Recommended

24-hour follow-up phone call: date ________________ time:________________72-hour follow-up phone call: date ________________ time:________________

Features and techniques taught to optimize use of the continuous glucose monitoring system:

Understanding CGM Data Display and Trends

Understanding Differences in SG and BG

Calibration

Setting and Managing Alerts

Sensor Insertion/Glucose Sensor Start

Site/Adhesive Troubleshooting

Use of Medtronic CareLinkTM System

Notes (optional):

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Patient Name Certified Product Trainer Device Model: S/N: Home Phone: Alternate Phone:

Check all that apply: Viewed CD/DVD Completed Online Course Attended CGM Start Face-to-Face Training


Patient’s Signature: _______________________________________________ Date:____________

Product Trainer’s Signature:________________________________________ Date:____________


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Continuous Glucose Monitoring System Follow Up Training Checklist

Section 7 Universal Precautions

U n i v e r s a l P re c a u t i o n s

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As a Medtronic Diabetes CPT, you are expected to follow universal precautions in the course

of patient training, to safeguard both the patients with whom you are working and yourself.

Universal precautions are infection control measures that reduce the risk of transmitting

bloodborne pathogens through exposure to blood or body fluids among patients and

healthcare workers. Increasing the safety of injections is an important component of universal

precautions. Be sure to follow the injection-related and other universal precautions discussed

below during patient training.

Some locations where you provide training may not have the appropriate protective supplies

needed to follow the universal precautions outlined below. If not, you will be responsible for

bringing these items with you to the training site.

GENERAL PRECAUTIONS• Use protective barriers, such as gloves, for direct contact with blood and other bodily

fluids. Barrier protection prevents skin and mucous membrane contamination.

• Immediately wash hands or other skin surfaces should contamination occur with

blood or other bodily fluids.

• Wash hands with soap and water before and after procedures.

• Take special care when performing procedures involving needles or other sharp instruments or when cleaning such items in order to avoid accidental injuries.

• Discard contaminated sharps immediately (without recapping) in puncture-resistant

containers marked with a biohazard symbol for disposal. Studies have shown that

accidental exposure to bloodborne pathogens often occurs during disposal. Up to one

third of all sharps injuries are reported to be disposal related.36 Be aware of the following

factors related to sharps injuries:

- Poor design or placement of sharps disposal container

- Overfilling sharps disposal containers

BLOODBORNE PATHOGENS• Be aware of common bloodborne pathogens, including hepatitis B virus, hepatitis C

virus, and human immunodeficiency virus (HIV).

• Be mindful that exposure to such pathogens may occur through needlesticks or cuts

from other sharp objects contaminated with an infected patient’s blood.

• Keep in mind that exposure may also occur through eye, nose, mouth, or skin contact

with a patient’s blood.

U n i v e r s a l P re c a u t i o n s

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PREVENTION AND TREATMENT OF NEEDLESTICKS AND CUTS

• Reduce exposure to needlesticks and cuts by:

- Encouraging patients to perform their own site changes

- Demonstrating site changes on fake skin models, pillows, or dolls

- Avoiding handling patients’ sharps

- Not recapping needles by hand

- Disposing of needles only in sharps disposal containers

- Using gloves

• If you are stuck by a needle or sharp object that is contaminated with an infected

patient’s blood, or if you get blood in your eyes, nose, or mouth, or on broken skin, take

immediate action by doing the following:

- Wash needlesticks and cuts with soap and water or a skin disinfectant if available.

- Flush splashes to the nose, mouth, or skin with water.

- Irrigate eyes with clean water, saline, or sterile irrigants.

- Call your HCP.

ADDITIONAL INFORMATION• For further information about universal precautions or protecting yourself and patients

from bloodborne pathogens, visit the following websites:

- www.cdc.gov/ncidod/dhqp/bp_universal_precautions.html

- www.osha.gov/index.html

- www.who.int/en/

• For additional information about needlestick prevention:

- Visit the U.S. Department of Health and Human Services National Institute for Occupational Safety and Health website: www.cdc.gov/niosh

- Call 800-35-NIOSH (800-356-4674) for a copy of the brochure Preventing Needlestick Injuries in Health Care Settings.

• For more information on sharps and waste disposal, go to:

- http://www.epa.gov/osw/nonhaz/industrial/medical/med-govt.pdf

- http://cdc.gov/needledisposal/

Section 8References

R e fe re n c e s

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1. Scheiner G, Boyer B. Characteristics of basal insulin requirements by age and gender in

Type-1 diabetes patients using insulin pump therapy. Diabetes research and Clinical Practice.

2005;69:14-21.

2. Heinemann L, Weyer C, Rauhaus M, Heinrichs S, Heise T. Variability of the metabolic

effect of soluble insulin and the rapid-acting insulin analog insulin aspart. Diabetes Care.

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3. Heise T, Nosek L, Ronn BB, et al. Lower within-subject variability of insulin detemire in

comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes.

2004;53:1614-1620.

4. Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of

subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and

ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes.

2000;49:2142-2148.

5. Graff MR, Rubin RR, Walker EA. How diabetes specialists treat their own diabetes: findings

from a study of the AADE and ADA membership. Diabetes Educ. 2000;26:460-467.

6. DeVries JH, Snoek FJ, Kostense PJ, Masurel N, Heine RJ, for the Dutch Insulin Pump Study

Group. A randomized trial of continuous subcutaneous insulin infusion and intensive

injection therapy in type 1 diabetes for patients with long-standing poor glycemic control.

Diabetes Care. 2002;25:2074-2080.

7. Linkeschova R, Raoul M, Bott U, Berger M, Spraul M. 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;19:746-751.

8. McMahon SK, Airey FL, Marangou DA, et al. Insulin pump therapy in children and

adolescents: improvements in key parameters of diabetes management including quality of

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9. Bruttomesso D, Pianta A, Crazzolara D, et al. Continuous subcutaneous insulin infusion (CSII)

in the Veneto region: efficacy, acceptability and quality of life. Diabet Med. 2002;19:628-634.

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therapy in young children with diabetes. Diabetes Spectrum. 2001;14:84-89.

11. The Diabetes Control and Complications Trial Research Group. The effect of intensive

treatment of diabetes on the development and progression of long-term complications in

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insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic

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1999;22:1779-1784.

13. Rebrin K, Steil GM, Van Antwerp WP, Mastrototaro JJ. Subcutaneous glucose predicts

plasma glucose independent of insulin: implications for continuous monitoring. Am J

Physiol Endocrinol Metab. 1999;277:E561-E571.

14. Tamborlane, WV, Beck RW, Bode BW, Buckingham B, et al. Continuous glucose monitoring

and intensive treatment of type 1 diabetes. NEJM. 2008;359:1464-1476.

15. Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic

control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics.

2003;111:933-938.

16. Tavris DR, Shoaibi A. The public health impact of the MiniMed Continuous Glucose

Monitoring System (CGMS)—an assessment of the literature. Diabetes Technol Ther.

2004;6:518-522.

17. Kaufman F, Halvorson M, Carpenter S, Cooper K, Kolopp M, Mueller J. The Medtronic

MiniMed Paradigm 522 Continuous Glucose Monitoring System for patient use: real-time

sensor glucose values and trend information. Diabetologia. 2004;47(suppl 1):A316.

18. Anderson, RM. Applied principles of teaching and learning. In: Franz MJ, ed. A CORE

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Chicago, Ill: American Association of Diabetes Educators; 2003:1-22.

19. Rubin PR, Napora JP. Behavior change. In: Franz MJ, ed. A CORE Curriculum for Diabetes

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Association of Diabetes Educators; 2003:65-69.

20. Dale E. Audio-Visual Methods in Teaching. 3rd Edition. Holt, Rinehart, and Winston (1969).

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22. Cobin RH, Davidson JA, Ganda OP, et al, and the Consensus Statement Writing Committee.

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23. Toxic-Shock Syndrome in a Patient Using a Continuous Subcutaneous Insulin Infusion

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24. Thethi K, Outland J, Kawji H, Rao A, Mallik T, Fonseca V. Loss of glycemic control over

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subcutaneous insulin infusions. Paper presented at: 89th Annual Meeting of the Endocrine

Society; June 2-5, 2007; Toronto, Canada.

25. Ask the diabetes team. Children with Diabetes website. Available at http://www.

childrenwithdiabetes.com/dteam/. Accessed October 22, 2007.

26. Chowdhury TA, Escudier V. Poor glycaemic control caused by insulin induced

lipohypertrophy. BMJ. 2003;327:383-384.

27. Rice D, Sweeney K. Choosing and using an insulin pump infusion set. Diabetes Self Manag.

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28. Corriveau EA, Durso PJ, Kaufman ED, Skipper BJ, Laskaratos LA, Heintzman KB. Effect of

Carelink, an internet-based insulin pump monitoring system, on glycemic control in rural

and urban children with type 1 diabetes mellitus. Pediatr Diabetes. 2008;9(pt II):360-366.

29. Chase HP, Saib SZ, MacKenzie T, et al. Post-prandial glucose excursions following four

methods of bolus insulin administration in subjects with type 1 diabetes. Diabet Med.

2002;19:317-321.

30. Gross T, Kayne D, King A, et al. A bolus calculator is an effective means of controlling

postprandial glycemia in patients on insulin pump therapy. Diabetes Technol Ther.

2003;5:365-369.

31. Mudaliar SR, Lindberg FA, Joyce M, et al. Insulin aspart (B28 aspinsulin): a fast-acting analog

of human insulin: absorption kinetics and action profile compared with regular human

insulin in healthy nondiabetic subjects. Diabetes Care. 1999;22:1501-1506.

32. Gonder-Frederick LA, Zrebiec J. Hypoglycemia. In: Franz MJ, ed. A CORE Curriculum

for Diabetes Education: Diabetes Management Therapies. 5th ed. Chicago, Ill: American

Association of Diabetes Educators; 2003:277-310.

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Notes

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