Certified Product Trainer
INFORMATION 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 2
Teaching and Learning Principles
ASSESSING EDUCATIONAL NEEDS AND READINESS
TO LEARN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
TRAINING FORMATS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
TRAINING TECHNIQUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The Cone of Learning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Section 3
Insulin Pump T herapy
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
Ta b l e o f C o n t e n t s
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
Ta b l e o f C o n t e n t s
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 4
Continuous Glucose Monitoring (CGM)
GLUCOSE MONITORING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Basics of CGM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Benefits of CGM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
TRAINING GUIDELINES FOR CONTINUOUS
GLUCOSE 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
Ta b l e o f C o n t e n t s
Section 5
CareLink™ T herapy 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 6
Forms and Handouts
Medtronic Diabetes Certified Product Trainer Application
Certified Product Trainer Proficiency Checklist
Insulin Pump Initiation Settings
Pre-Pump Training Checklist
Pump Start Training Checklist
Pump Follow Up Training Checklist
Continuous Glucose Monitoring Initial Settings
Continuous Glucose Monitoring Training Checklist
Continuous Glucose Monitoring System Follow Up
Training Checklist
Glucose Sensor Calibration Worksheet
Continuation of Care
Ta b l e o f C o n t e n t s
Section 7
Universal Precautions
GENERAL PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
BLOODBORNE PATHOGENS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
PREVENTION AND TREATMENT OF NEEDLESTICKS
AND CUTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
ADDITIONAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Section 8
References
Section 1
CPT Requirements and Responsibilities
CPT Requirements and Responsibilities
In order to become a Medtronic Diabetes CPT, there are requirements that must be met and
responsibilities that must be agreed to. These are outlined in this section. These requirements
and responsibilities help to ensure that:
•
•
•
All patients receive consistent training.
All training meets Medtronic training guidelines.
All patients receive a quality training experience.
Medtronic reserves the right to consider ineligible any person who has been excluded or otherwise
limited by the Medicare Program, or any other authority, from providing services to Medicare
patients or other federal beneficiaries.
ELIGIBILITY REQUIREMENTS
To be eligible to become a Medtronic Diabetes CPT, you must meet either of the following
requirements:
❑
Hold (and provide a copy of) an active, unrestricted license from the United States or its
territories as one of the following:
•
•
Registered nurse
Registered dietitian by the
Commission of Dietetic Registration
•
•
Pharmacist
Physician (such as Doctor of
•
•
•
•
•
Physical therapist
Licensed occupational therapist
Podiatrist
Optometrist
Licensed vocational or practical nurse
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
•
•
•
Social work
Clinical psychology
Exercise physiology
health, such as health education,
health promotion, health and social
behavior, or health communication
1
CPT Requirements and Responsibilities
THE ROLE OF THE MEDTRONIC CPT
Training Focus
Your most important responsibility as a CPT is to provide patients with proper instruction
on the safe use of Medtronic products. We want patients to feel comfortable and confident
wearing and using our products.
New users are relying on you to start them on their journey of better control. Some patients
find the products easy to understand and use; others will rely on you for additional guidance
and help. Occasionally, you may need to reassure patients or address concerns about some
aspect of the therapy. Therefore, establishing trust with these new patients is important to the
training process and to the patient’s success.
You may find that some patients need basic diabetes education to help them learn how to
understand our therapies and use our products. Please consult with your Medtronic clinical
representative to discuss what is expected of you in these cases.
Communication and Documentation
Communication with your Medtronic clinical representative and the patient’s HCP regarding
training sessions is necessary.
•
Always discuss your training responsibilities with your Medtronic clinical representative
before training patients.
•
Make your Medtronic clinical representative aware of any additional time that may be
required to meet special training needs uncovered during your assessment of the patient.
•
If any concerns arise during the initial phone call or during a training session, contact
your Medtronic clinical representative so that any necessary follow-up with the HCP or
the patient can be arranged.
Carefully document each patient’s progress to ensure continuity of care and accurate,
complete training records. Training documentation forms will be provided by your Medtronic
clinical representative upon assignment of the patient training. A copy of these records must
be provided to both the HCP and the Certified Product Training department. These provide
continuity of care with the provider as well as a legal training record.
Scope of Practice
It is important that you conduct patient education within the guidelines for your scope
of practice, as defined by your professional licensing and governing body. Contact your
state licensing board for the specific guidelines for your individual licensure in your state of
residence and your scope of practice.
2
CPT Requirements and Responsibilities
Training Evaluation
At Medtronic we strive to provide an excellent overall patient experience. We work to exceed
each patient’s training expectations through professionalism, thorough product knowledge,
and an exceptional training experience. We look for you to provide patients with the
knowledge and understanding to be successful using our therapies.
To help ensure we are meeting our goals, patients are randomly selected to offer feedback
on their training, and their continued use of our therapies is evaluated on an ongoing basis.
Positive patient experiences and outcomes will be recognized. If any less than favorable
feedback is provided, your Medtronic clinical representative will work with you to ensure a
positive experience for every patient. Repeated occurrences of unsatisfactory feedback may
result in the retraction of CPT status.
PRODUCT TRAINER CERTIFICATION REQUIREMENTS
To obtain certification, you must take the following steps. These steps must be completed for
each Medtronic product for which you become certified:
1. Review this manual in its entirety to ensure that you thoroughly understand Medtronic
Diabetes’ product training and support program.
2. Read the following resources:
•
•
Insulin Patient Training Workbook
•
•
Instructional CD-ROM
Product user guide located at:
www.medtronicdiabetes.com/help/insulinpumps/index.html#manual
Additional e-learning and written references that you will be directed to by your
Medtronic clinical representative
3. Meet with your Medtronic clinical representative for hands-on training and observation
of one or more patient education and training sessions.
4. Demonstrate your patient training skills by performing one or more patient education
and training sessions with your Medtronic clinical representative observing.
5. Complete the certification exam and achieve a score >90%.
3
CPT Requirements and Responsibilities
6. Provide the following to your Medtronic clinical representative:
•
•
•
A CPT application (initial product certification only)
A copy of your current Professional Licensure with expiration date
A signed copy of the CPT expectations
7. Review and sign the CPT Proficiency Checklist provided to you by your Medtronic
clinical representative
Note: CGM and additional product certifications are reserved for more experienced
Medtronic CPTs—those who have active insulin pump training certification and have
demonstrated satisfactory skills in teaching both basic and advanced insulin pump
operation.
4
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
An effective training program must consider patients’ educational needs and readiness to
learn. As a CPT, you should be prepared to adjust product training sessions according to
patient age, educational level, individual needs, abilities, and cultural background. Use the
appropriate training formats and techniques for your particular audience.
ASSESSING EDUCATIONAL NEEDS AND READINESS
TO LEARN
As you prepare for a product training session, assess your patients with respect to the
following:18
•
•
Attitude toward diabetes and toward participation in the training process
Family and friends support structure, including social, cultural, or religious factors that
may influence a patient’s educational experience; encourage patients to bring a family
member or friend with them to training
•
Preferred style of learning (e.g., through demonstration, printed materials, lecture, or
computer)
•
•
Psychological status
Physical or emotional stress level (Note: Severe stress can impair a patient’s ability to
learn. Patients undergoing stressful situations, such as acute illness, should consider
postponing training until circumstances are more conducive to active learning.)
•
•
•
•
Readiness for change
Literacy level
Physical factors (e.g., age, mobility, visual acuity, hearing loss, and dexterity)
Current level of self-care, which can provide insight into a patient’s tolerance for
complexity in treatment
Diabetes requires effort, and patients are often asked to make major lifestyle changes. Patients
may need your assistance in learning the following important self-care behaviors as they relate
to using insulin pump therapy:19
•
•
•
•
Self-monitoring of BG levels
Understanding nutritional composition of meals
Engaging in physical activity and understanding its effect on insulin needs
Managing hypoglycemia and hyperglycemia
5
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
TRAINING FORMATS
Using effective training formats is just as important as the content of your training sessions.
The design of an educational program can affect patients’ learning experience, as well as their
attitude and motivation to learn.
Training formats presented in Diabetes Education and Program Management: A CORE
Curriculum for Diabetes Educators are described below.18
•
Lectures: Brief lectures may be useful for presenting information, but keep in mind that
this is a passive learning experience. Facilitate the learning process by balancing lectures
with patient interaction and more active training methods.
•
Discussions: Having a discussion with a group of patients provides an active learning
experience. Patients can gain knowledge, ask questions, and share personal experiences
through discussion. However, discussions can be unpredictable, and the trainer must be
able to effectively guide and manage the discussion so that all topics and participants
receive adequate attention.
•
Demonstrations: Demonstrations are a very useful method for teaching psychomotor
or social skills. A trainer may demonstrate a technique and then ask patients to perform
the technique themselves. This method gives patients hands-on practice, with the added
benefit of immediate feedback from the trainer.
•
Printed materials: Printed materials reinforce previously learned information, and
patients can later refer to them for reference or review. Patients should be shown how
to use the Medtronic product user guides and other printed materials that are available
to them as resources. For example, it may be helpful to point out materials that feature
pictures or step-by-step instructions. However, printed materials are not a replacement
for training with a CPT.
•
Audiovisual materials: Audiovisual materials (e.g., slides, flash animation, videos, or
food models) help diversify the presentation format, which can help reinforce learning.
•
Computers: Computerized lessons, clinical problems, and simulations can be useful
for testing increasing patient knowledge and improving problem-solving skills. The
Learning Center (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.
6
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
TRAINING TECHNIQUES
Training techniques that may enhance learning appear below:
•
Determine patient expectations for the training session and set expectations of what will
be taught during the session.
•
•
Relate the material being taught to patients’ own experiences and frames of reference.
Assess each patient’s knowledge and understanding of the concepts you are presenting
by asking questions to gain feedback and gauge understanding.
•
Give patients the opportunity to practice and successfully demonstrate the skills that
they have learned to help improve knowledge and skill retention and build confidence.
•
Provide feedback to make patients aware of their incremental progress and encourage
their continued learning.
•
Plan your training session for a time when the patient can actually start insulin pump or
CGM therapy.
When you are training adults, take into account several general observations about adult
learners to help you train them more 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.
7
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
The Cone of Learning
After 2 weeks, we tend to remember…
I see and I forget.
I hear and I remember.
I do and I understand.
– Confucius
Reading
Hearing
Words
• 10% of what we READ
P
A
S
S
I
V
E
• 20% of what we HEAR
Seeing
Watching a Movie
Looking at an Exhibit
Watching a Demonstration
Seeing it Done on Location
Participating in a Discussion
Giving a Talk
Doing a Dramatic Presentation
Simulating the Real Experience
Doing the Real Thing
• 30% of what we SEE
• 50% of what
we SEE & HEAR
• 70% of what
we SAY
• 90% of what
we SAY & DO
A
C
T
I
V
E
Source: Edgar Dale (1969)
Edgar Dale’s ‘Cone of Learning’ diagrams effectiveness of learning according to the media
involved in learning experiences. As you can see, the more active the learning experience
becomes, the more likely we will remember. Having the patient HEAR us talking and SEE us
doing is less effective than having them more actively involved. Giving them opportunities to
SAY and DO during the training increase the likelihood that they will remember what we are
teaching.20
As we work through the training process in the next chapter, and you begin to observe and
perform education and training sessions, please continue to refer to this chapter to ensure a
successful learning experience for your patients.
8
Section 3
Insulin Pump T herapy
Insulin Pump Therapy
In your role as a Medtronic CPT, you will have the opportunity to train patients on insulin pump
therapy. Below is an introduction to this therapy, which can enable patients to improve their
diabetes control.
INSULIN PUMP THERAPY
The goal of insulin delivery in diabetes is to regulate glucose levels and achieve euglycemia.
In a person without diabetes, pancreatic beta cells continuously deliver insulin into the
bloodstream. Insulin pump therapy closely mimics this natural pancreatic function by
delivering rapid-acting (or short-acting) insulin to the body both continuously, and as needed
to accommodate meals and make glucose corrections.
Before the advent of insulin pump therapy, the only option for people with diabetes
who required insulin was giving injections. Insulin injection regimens consist of various
combinations of long, intermediate, and rapid-acting insulin. These various regimens are
limited by two major considerations.
•
Injections cannot accommodate for normal variations in basal insulin needs throughout
each 24 hour period. Basal insulin requirements typically vary throughout the day and
night based on endogenous glucose output and peripheral insulin sensitivity.1 The
inability to adjust for these changing needs limits the ability to reach euglycemia when
using insulin injection therapy.
•
The absorption of intermediate- and longer-acting insulin delivered by injection can
vary by up to 46%, resulting in a day-to-day variation in blood glucose (BG) levels despite
administration of the same amount of insulin. Rapid-acting (U100) insulin has the lowest
variability (16%).2,3 Thus, rapid-acting insulin administered by an insulin pump provides
better day-to-day reproducibility, more reliable insulin availability, and fewer unexpected
fluctuations in glycemic control.4
Basics of Insulin Pump Therapy
Insulin pumps simulate normal pancreatic function by delivering rapid-acting insulin in two ways:
•
Basal rate: Background insulin delivered continuously by the insulin pump throughout
the day and night to cover metabolic need for insulin
•
Bolus: A calculated amount of insulin given when carbohydrate is eaten or to correct
high BG values
Because the basal rate is programmed to meet the individual’s metabolic needs, highs and
lows can be avoided. For example, the insulin pump can be set to deliver more insulin in the
early morning hours to correct for an increase in BG caused by hormonal activity known as
dawn phenomenon. The basal rate can also be adjusted temporarily — while exercising, for
example — to accommodate the temporary change of insulin needs.
9
Insulin Pump Therapy
Boluses are delivered when extra insulin is needed. The insulin pump user controls the timing
and the amount of the bolus. A meal bolus is given after the user determines the carbohydrate
content of the meal and the insulin amount needed is calculated. This bolus delivery
adaptability enables flexible meal timing and meal size. Boluses are also used to correct high
BG levels measured by fingerstick/meter value.
Use of the Bolus Wizard® calculator is the preferred method of calculating bolus doses. The
Bolus Wizard calculator computes personalized bolus doses using predetermined values
(carbohydrate ratios, insulin sensitivity factors and BG targets) and values entered by the
patient (BG readings and amounts of carbohydrate). The Bolus Wizard calculator also takes into
account the amount of active insulin from previous bolus’ that is still lowering blood glucose.
This helps to prevent hypoglycemic episodes that can result from “stacking” insulin.
Benefits of Insulin Pump Therapy
Insulin pump therapy is considered the “gold standard” in diabetes management. In fact,
the majority of diabetes specialists who themselves have diabetes and require multiple
daily injections use this therapy to manage their diabetes.4
Insulin pump therapy offers both clinical and lifestyle benefits. Several studies in adults and
children have shown that when compared with insulin injections, insulin pump therapy leads
to several significant improvements in health and well-being:
•
•
•
•
Decrease in hemoglobin 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
•
10
Improved quality of life in adults6,7,9 and children12 and coping skills in adolescents9
Insulin Pump Therapy
These benefits are the result of three distinct advantages of insulin pump therapy:
•
Decreased variability of insulin absorption
- The insulin pump uses only rapid-acting insulin, reducing absorption variability by
30% compared with intermediate- and longer-acting insulin given by 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 longeracting insulin, or take injections at mealtimes.
- Meal/snack timing and size are determined by the user.
11
Insulin Pump Therapy
TRAINING GUIDELINES FOR INSULIN PUMP THERAPY
There are several steps included in the Insulin Pump Training Program. The table below
outlines the phases of training with a high level overview of what occurs during each phase.
This section provides guidelines to follow throughout each step to help ensure a successful
patient training experience.
Insulin Pump Training Pathway
Phase
Format
Course
Facilitator
Requirement
PHASE 1
Prerequisite
Self-Study
•
•
Patient
Required
before
attending
initial training
session
CPT
Optional
(if needed)
•
•
PHASE 2
Pre-Pump
Start
Group
Training
Class or 1:1
training*
Insulin Pump Therapy Workbook
e-learning module at
The Learning Center
Instructional video
Review of product user guide
Pre-Pump Training
Review and Practice of:
• Insulin pump therapy basics
• 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
Pump Start
Group
Training
Class or 1:1
training*
Pump Start Training
Return Demonstration and show of:
• Basic competency in pump
programming
• Infusion set/reservoir change
• Understanding of safety
guidelines
• Troubleshooting
CPT
Required
PHASE 4A
Follow-Up
Phone calls
24 and 72
hours
following
Pump Start
Follow-Up Training
Discuss BG control
Review use of bolus wizard
Infusion Set /change
Using advanced features
CPT
Required
PHASE 4B
Follow-Up
1:1 Training†
Reinforcement and additional
training on information covered
in Pump Start
CPT
Optional
(if needed)
PHASE 5
Continuing
Education
Group
Training
Offered by local Medtronic
Representatives; for schedule
visit: www.medtronicdiabetes.
com/events/
Medtronic
Highly
Clinical
recommended
Representative for all patients
•
•
•
•
*Group classes are recommended
†Prior approval required if exceeds 2 hours
12
Insulin Pump Therapy
Prior to Training
Your Medtronic clinical representative will notify you and provide demographic information
for the patient you are asked to train. If for any reason you are unable to conduct the training,
please contact your Medtronic clinical representative immediately. We strive to train every
patient within a 30-day window after the pump is received. You may be asked to train two to
three patients in a group training session. Your Medtronic clinical representative will work with
you to set up the necessary accommodations.
Once you have accepted a training assignment, please contact the patient promptly, contact
the patient (and possibly the HCP) again just prior to training, and ensure that you are clear on
the training objectives and the required training documentation, as discussed below.
Initial Contact With the Patient
Please contact each patient within 48 hours after receiving his or her demographic
information. Welcome the patient to Medtronic and insulin pump therapy, answer any
questions the patient has, reassure the patient about any concerns, and schedule the training.
During your initial phone call, you will need to do the following:
1. Assess the patient’s educational level and knowledge of diabetes management and
determine whether group or one-on-one training is the best option. Group training
is recommended for most patients. Interactive and engaging, group sessions provide
facilitator-directed, hands-on, step-by-step training as well as the opportunity to learn
from peers. However, the individual option may be better for a patient who needs more
intensive one-on-one instruction.
Please communicate with your Medtronic clinical representative if the patient has
special circumstances that require additional training.
2. Stress the importance of preparing for the training session and ask the patient to open
the pump box and check the packing slip. Instruct the patient to review and complete
all the self-study materials including:
•
Insulin Pump Therapy Workbook: Encourage the patient to read the workbook, review
key learning points, and complete the practice exercises.
•
Learning Modules: The Learning Center at www.medtronicdiabetes.com/myhome
or the instructional DVD: Ask the patient to follow along and complete the buttonpushing exercises. Assure the patient that practicing with the pump and pushing
buttons will not damage the pump.
•
Insulin Pump User Guide and A Step-By-Step Guide to the Minimed Paradigm® REAL-Time
Revel™ Insulin Pump
13
Insulin Pump Therapy
3. Notify the patient that instructions on starting insulin pump therapy from the HCP are
needed at the training session. The instructions must include:
•
Initial pump settings (basal rates, insulin-to-carbohydrate ratios, insulin sensitivity
factors, target range, active insulin time).
•
Directions for insulin on the day or evening before pump therapy starts.
These instructions must be signed and dated by the HCP. (See Insulin Pump Initial
Settings form in the Forms and Handouts section.)
4. Ask the patient to bring the following to training:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Insulin pump and supplies boxed with it
3 reservoirs
3 infusion sets
Infusion set insertion device
3 IV Prep™ wipes (or 3 alcohol wipes)
Transparent dressing (IV3000™), if shipped with insulin pump
A vial of rapid-acting insulin (patient will need to obtain prescription prior to class)
Blood glucose meter, test strips, and lancets
Insulin Pump Therapy Workbook
Insulin Pump User Guide
Glucose tablets or some form of fast-acting carbohydrate
A snack
Family member or friend for support, if desired
Blood glucose logbook (with at least the previous week’s readings)
5. Review the date, time, and location of training. Be sure to provide your contact
information.
14
Insulin Pump Therapy
Additional Contact With the Patient and HCP Prior to Training
1. Call the patient the day prior to training. Ask if self-study has been completed and if
he or she feels ready to begin. It is okay to re-schedule the training if the patient needs
more time to complete. If the patient seems nervous or apprehensive, offer reassurance.
Let the patient know that you will be covering details and answering questions about
operating the insulin pump during the training session.
2. Ask the patient if the HCP has provided him or her with signed insulin pump start
instructions.
a. Be sure that the instructions have not expired; if they have, you must request a new
copy before starting the patient on insulin in the pump.
b. Ensure directions for current insulin prior to pump start are included.
If the patient has not received, contact the patient’s HCP to obtain these instructions.
You CANNOT start any patient on insulin pump therapy without signed orders from the
patient’s prescriber.
3. Make sure patient has a vial of rapid acting insulin. Instruct them to contact HCP to
obtain if necessary.
Some providers may not change the patient’s insulin dose prior to training and instead will
use the temporary basal rate option to complete the duration of long- or intermediate-acting
insulin. If so, you will need to assist the patient with setting a temporary basal rate when starting
insulin in the pump.
Understanding the Training Objectives
It is important that training provides each patient with a sound foundation and the basic
knowledge to begin insulin pump therapy. After the training is complete, patients should:
•
Show competency in programming and operating the insulin pump and be able to set
initial insulin pump settings.
•
Be able to fill a reservoir and change an infusion set. Performing a site change can be one
of the more challenging steps for patients. We want to ensure patients are comfortable
and confident with this process. They should know what tools are available to help them:
- Insulin Pump User Guide
- Instructional CD-ROM
- 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.
15
Insulin Pump Therapy
•
Understand the need to regularly check BG levels and individual BG monitoring
schedule.
•
•
Know their BG target ranges and how to manage highs and lows.
Know when to ask for help with diabetes management issues and how to contact the
appropriate source of assistance (HCP, CPT, or Medtronic HelpLine).
•
•
Have a plan for follow-up with the HCP.
Know how to call the Medtronic Diabetes 24-Hour HelpLine (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.
•
•
16
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.
Insulin Pump Therapy
Starting Patients on Insulin Pump Therapy
Your training sessions provide the foundation for insulin pump therapy and set the stage
for long-term therapy success. You can help ensure your patient’s success by setting
clear expectations up-front. Before you begin the actual training, the following steps are
recommended:
•
•
Describe your role and responsibilities.
Remind patients that the written HCP’s orders to the patient should be strictly followed
and that any changes are to be made only with the express written approval of the HCP.
•
Tell patients that they can call the Medtronic 24-Hour HelpLine (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.
17
Insulin Pump Therapy
Session 1: Pre-Pump Start Training
You may be asked to conduct Pre-Pump Start Training with a group of patients or an individual
patient. In either case, you will cover the same topics. Before attending this session, patients
should have a basic understanding of insulin pump therapy and self-management skills.
They are expected to have completed the Insulin Pump Therapy Workbook, and either the
e-learning module or the instructional video,. Although patients are required to complete
the self-study work before they come to Pre-Pump-Start Training, it is important for you to
determine each patient’s level of understanding of these basics and teach accordingly.
The purpose of Pre-Pump Start Training is to allow patients to become comfortable with
the insulin pump and to practice essential skills that will prepare them for the actual pump
start and safe use of the therapy. This session includes training on the theory and science of
pump therapy, self management, available resources, button pushing, programming, and
practice changing the reservoir and the infusion set. Patients should demonstrate competency
performing the basic skills before starting on insulin.
Product-specific information on button pushing, programming, and infusion set and reservoir
changes will be provided to you by your Medtronic clinical representative. Important topics
that apply to all patients regardless of the product they are using, such as the theory and
science of insulin pump therapy, self management, and resources, are discussed below.
At the conclusion of Pre-Pump Start Training, you must document each patient’s progress on
the associated checklist, which you will forward to Medtronic Diabetes and to the prescribing
HCP, along with progress notes, as a record of training. It is critical that you assess each patient’s
readiness to move forward with starting insulin in the pump in Pump Start Training.
The following topics should be reviewed. Patients should be engaged in discussion and their
understanding evaluated.
18
Insulin Pump Therapy
Understanding Insulin Pump Therapy
• Point out the benefits of insulin pump therapy. Discuss how the insulin delivery most
closely mimics the way the human pancreas delivers insulin.
•
Explain that insulin delivery must provide for:
- A background amount to cover normal body functions (basal rate)
- An extra amount when food is eaten (meal bolus)
- An extra amount when glucose is high (correction bolus)
•
Explain the type of insulin that has been prescribed to use in the pump.
Basal Rate
•
•
Have patient explain the purpose of basal insulin.
Describe how insulin pump delivers small amounts of basal insulin consistently
throughout each hour.
•
Explain that patients may start with one or two basal rates in the beginning and that the
HCP may add rates as they fine-tune their diabetes control.
•
Review with each patient the basal rate or rates that have been prescribed by the HCP.
Have patients record this information for future reference.
•
•
Have patients program single basal rate.
Have patients program multiple basal rates.
Meal Bolus
•
•
•
Explain that a bolus is needed to cover the carbohydrate contained in a meal or snack.
Discuss the benefits of using the Bolus Wizard® calculator when delivering a bolus.
Review with each patient the insulin-to-carbohydrate ratio or exchange factor that the
HCP has recommended. Have patients write down this information for future reference.
•
Have patients practice giving meal boluses.
Grams or Exchanges
•
•
Carbohydrates can be entered into the pump as grams or exchanges
Have patients program carbohydrate amounts into the Bolus Wizard
19
Insulin Pump Therapy
Correction Bolus
•
•
•
Explain the purpose of a correction bolus and when a correction dose will be estimated.
Discuss the benefits of using the Bolus Wizard calculator to determine a correction bolus.
Have patients practice giving correction boluses.
Insulin Sensitivity
•
•
Discuss how insulin sensitivity is used to determine a correction bolus for high BG.
Review with each patient the insulin sensitivity that has been recommended by the HCP.
Have patients record this information for future reference.
•
Practice programming insulin sensitivity.
BG Target Ranges
•
Review with each patient the target BG ranges that have been determined by the HCP.
Have patients record this information for future reference.
•
Explain when a correction dose will be estimated.
Active Insulin From Prior Boluses
•
Explain that the Bolus Wizard® calculator keeps track of active insulin from prior boluses
before determining a suggested correction bolus amount.
•
Note that the Active Insulin Time default setting is 6 hours and the HCP should select the
active insulin time most appropriate for the patient.
BG Testing
Testing Schedule
•
Ask each patient to describe his or her current BG testing schedule, as prescribed by
the HCP.
•
Discuss the BG testing schedule for insulin pump therapy, which typically includes
fasting, before and after meals, bedtime, and occasionally a 2:00 to 3:00 am check.
20
Insulin Pump Therapy
AIC Testing
•
Explain that hemoglobin A1C plays an important role in diabetes management.
- A1C is a 2- to 3-month average of overall blood glucose control. A1C testing indicates
whether patients are experiencing sustained high BG levels, which can cause longterm health problems.
•
State that A1C should be tested every 3 to 6 months to help determine whether the
current diabetes treatment plan is working.
•
•
•
Tell patients to talk with their HCP regarding their A1C target goal.
Encourage patients to know their A1C results.
Note that the American Diabetes Association (ADA) recommends a goal of < 7.0%,19 and
the American Association of Diabetes Educators (AADE) recommends a goal of < 6.5%.20
Continuous Glucose Monitoring Capacity
•
•
Explain that the insulin pump is equipped to perform CGM.
Note that CGM is not intended as a replacement for fingersticks and should be used as
an adjunct therapy.
Hypoglycemia
• Have patients define hypoglycemia and ask them to explain the signs, symptoms, and
causes, and appropriate treatment.
•
•
Have patients describe the appropriate treatment for hypoglycemia.
Ask each patient to discuss previous episodes of hypoglycemia to assess awareness of it;
then ask how they would handle a similar situation using the insulin pump.
•
Address the importance of having a glucagon emergency kit at home and instruction for
its use.
•
Ensure that patients understand the ways to prevent hypoglycemia and the importance
of wearing the MedicAlert bracelet or necklace.
•
Emphasize the importance of frequent BG monitoring if a patient has hypoglycemia
unawareness.
•
Review each patient’s individual plan for hypoglycemia if the HCP prepared one.
A complete hypoglycemia protocol can be found in the Additional Training and Safety
Information section of this manual.
21
Insulin Pump Therapy
Hyperglycemia
• Have patients define hyperglycemia
• Ask patients to discuss prior experiences with hyperglycemia to assess previous
treatment strategies.
•
Ask why hyperglycemia might occur with an insulin pump. Make sure patients
understand that once they begin insulin pump therapy, they will not have longer-acting
insulin on board. Remind them that hyperglycemia can quickly escalate to diabetic
ketoacidosis (DKA) if they are not receiving insulin from their insulin pump for any reason.
•
Make sure patients can list all the necessary steps for treatment of high blood sugars in
the following order:
1. Taking insulin by injection
2. Checking for urine ketones
3. Troubleshooting the insulin pump
4. Changing the reservoir and infusion set
5. Following up with the HCP
•
Stress that patients should have a back-up insulin plan and that insulin should always
be available in case of insulin pump failure. Tell patients to always carry a back-up insulin
vial and a syringe or an insulin pen in case of a problem with the insulin pump.
•
Review each patient’s individual plan for hyperglycemia if the HCP prepared one.
A complete hyperglycemia protocol can be found in the Additional Training and Safety
Information section of this manual.
Diabetic Ketoacidosis
• Discuss the signs, symptoms, and causes of DKA.
• Ask patients to discuss all DKA prevention strategies of which they are aware.
• Review each patient’s individual plan for DKA if the HCP prepared one.
A complete DKA protocol can be found in the Additional Training and Safety Information
section of this manual.
22
Insulin Pump Therapy
Sick Day Management
• Remind patients that illness often causes glucose levels to run high; therefore, BG and
urine ketones should be tested regularly during illness.
•
•
Explain the increased risk of DKA during illness.
Discuss the elements of a sick day protocol. Make sure patients know what supplies to
keep on hand for sick days.
A complete sick day protocol can be found in the Additional Training and Safety Information
section of this manual.
Nutrition Overview
• Discuss carbohydrate counting and how it helps to achieve optimal glucose control
• Ensure patients understand that carb counting is not an exact science and that it takes
some practice and will become easier with time.
•
Understanding label reading:
- Demonstrate how to look at the serving size and total carbohydrate information on a
food label.
•
Discuss estimating carbohydrate using the exchange system
- Foods containing carbohydrate
- Common serving sizes
Carbohydrate Counting books are available through your clinical representative to be used
when teaching these concepts.
Exercise Safety
• Discuss exercise and the effects on blood glucose values.
• Discuss how a temporary basal rate can be set to accommodate for these changes
during exercise.
•
•
Ensure understanding that different types of exercise can have different effects.
Explain that determining these rates take time and that frequent BG monitoring is
necessary for safety and to determine the correct insulin adjustment.
•
Remind patients that it is important to always carry a source of fast-acting carbohydrate,
such as glucose tablets, during exercise.
•
Remind patients that they should refrain from exercise for the first few days or weeks of
insulin pump therapy if their HCP has asked them to do so.
23
Insulin Pump Therapy
Insulin Pump Therapy Resources
• Remind patients about all the resources available to them:
-
Insulin Pump Therapy Workbook
Insulin Pump User Guide
The Learning Center (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.
24
Insulin Pump Therapy
Session 2: Pump Start Training
As in the case of Pre-Pump-Start Training, you may be asked to train a group of patients or an
individual patient. In either case, you will cover the same topics.
The purpose of Pump Start Training is to have patients acquire the basics pump skills necessary
to safely start on insulin. They will demonstrate competency to independently:
•
•
Program basal rates
Program Bolus Wizard settings and understand how boluses are calculated using these
settings (See Additional Training and Safety Information section)
- Perform bolus entering BG and carbohydrate
- Perform meal bolus without BG
- Perform correction bolus without carbohydrate
•
Confidently demonstrate reservoir fill and infusion set change (see Additional Training
and Safety Information section for important site change topics)
•
Clearly explain safety guidelines or treating lows and highs, avoiding DKA, and
managing sick days. (See Additional Training and Safety Information section)
Other topics included in this session:
•
•
CareLink™ Personal Therapy Software (See CareLink Software section of the manual)
Wearing the insulin pump:
- Can be clipped to their waistband like a pager, either in or out of a case, in a pocket,
or inside their clothing.
- Can place the insulin pump next to them in bed or clip it to their clothing or pillow
when sleeping
- The Remote Programmer or the vibrating Easy Bolus feature are options if a patient
wants to conceal the insulin pump
- Accessories available in the Medtronic Diabetes Accessory Guide that comes with the
insulin pump or at www.medtronicdiabetes.com.
•
•
Disconnecting the pump (shower, swimming, intimacy)
Using CareLink Personal (see Therapy Management System section of this manual)
25
Insulin Pump Therapy
•
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.
26
Insulin Pump Therapy
Session 3: Follow-up Training
During 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)
27
Insulin Pump Therapy
•
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.
28
Insulin Pump Therapy
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.
Documentation
Please 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.
29
Insulin Pump Therapy
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.
30
Insulin Pump Therapy
ADDITIONAL TRAINING AND SAFETY INFORMATION
This 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 Corrections
One 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 Calculator
The 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.
31
Insulin Pump Therapy
Benefits of the Bolus Wizard® Calculator
The 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.
32
Insulin Pump Therapy
How the Bolus Wizard® Calculator Works
When 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.
33
Insulin Pump Therapy
The following scenarios illustrate how the dose adjustment works.
Food Estimate
Current BG is
Grams of Carb
> high BG target
Current BG is
Carb Ratio
Grams of Carb
< low BG target
Current BG
Carb Ratio
Correction Estimate
(Current BG - High BG Target)
+
Insulin Sensitivity
+
- active insulin
(Current BG - Low BG Target)
Insulin Sensitivity
Grams of Carb
is within
Carb Ratio
low-high limit
+
No correction needed
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
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
10 grams/unit
= 6 units
No active insulin from previous bolus delivery.
User inputs 60 grams of carbs and a BG of 200:
Food Estimate:
Correction:
60 grams
10 grams/unit
= 6 units
200 mg/dL -120 mg/dL
25 mg/dL/u
= 3.2 units
Estimate Total: 6 units + 3.2 units = 9.2 units
34
Insulin Pump Therapy
No active insulin from previous bolus delivery.
User inputs 45 grams of carbs and a BG of 70:
Food Estimate:
Correction:
45 grams
10 grams/unit
= 4.5 units
70 mg/dL - 90 mg/dL
25 mg/dL/u
= -0.8 units
(Negative correction is deducted from food bolus)
Estimate Total: 4.5 units + (-0.8) units = 3.7 units
No active insulin from previous bolus delivery.
User inputs 45 grams of carbs and a BG of 100:
Food Estimate:
45 grams
10 grams/unit
= 4.5 units
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:
Food Estimate:
Correction:
60 grams
10 grams/unit
= 6.0 units
200 mg/dL -120 mg/dL
25 mg/dL/u
= 3.2 u (-1.5 mg/dL active insulin) = 1.7 units
Estimate Total: 6 units + 1.7 = 7.7 units
Previous bolus activity results in a calculation of 3.5 units of active insulin.
User inputs 30 grams of carb and a BG of 200:
Food Estimate:
30 grams
10 grams/unit
= 3.0 units
Correction:
200 mg/dL -120 mg/dL
25 mg/dL/u
= 3.2 u (-3.5 mg/dL active insulin) = 0 units correction bolus
(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
35
Insulin Pump Therapy
Previous bolus activity results in a calculation of 0.5 units of active insulin.
User inputs 30 grams of carb and a BG of 70:
Food Estimate:
Correction:
30 grams
10 grams/unit
= 3.0 units
70 mg/dL - 90 mg/dL
25 mg/dL/u
= -0.8 units
(Negative correction is deducted from food bolus)
Estimate Total: 3 units + (-0.8) = 2.2 units
Meal Bolus Options
Medtronic 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.
Amount of Insulin
Normal Bolus for Everyday Needs
Normal bolus
Time
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.
36
Insulin Pump Therapy
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
Amount of Insulin
blood glucose several hours later.
Square Wave bolus
Time
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.
37
Insulin Pump Therapy
Amount of Insulin
Dual Wave® Bolus for Combination
Dual Wave bolus
Time
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.
38
Insulin Pump Therapy
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 Choices
The 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 Inspection
Patients 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.
39
Insulin Pump Therapy
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.
40
Insulin Pump Therapy
•
•
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.
41
Insulin Pump Therapy
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.
42
Insulin Pump Therapy
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.
43
Insulin Pump Therapy
•
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
•
44
Always test BG before driving; if BG is <80 mg/dL (4.4 mmol/L), do not drive.32
Insulin Pump Therapy
•
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.
45
Insulin Pump Therapy
•
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
46
Insulin Pump Therapy
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.
47
Insulin Pump Therapy
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.
48
Insulin Pump Therapy
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.
49
Insulin Pump Therapy
•
•
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.
50
Section 4
Continuous Glucose Monitoring (CGM)
Continuous Glucose Monitoring
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 MONITORING
Before 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 CGM
CGM 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.
51
Continuous Glucose Monitoring
Glucose
Insulin
Interstitial fluid
glucose (G2) is
almost always
comparable with
BG (G1)
Glucose sensor
k 01
Capillary
k 21
G1
G2
Cells
k 12
Plasma (G1)
Interstitial fluid (G2)
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
52
Continuous Glucose Monitoring
TRAINING GUIDELINES FOR CONTINUOUS GLUCOSE
MONITORING
The 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
Phase
Format
Course
Facilitator
Requirement
PHASE 1
Prerequisite
Self-Study
•
•
Patient
Required
before
attending
initial training
session
CPT
Required
•
•
Getting Started With CGM
e-learning module at
The Learning Center
Instructional video
Review of product user guide
PHASE 2
CGM Start
Group
Training
Class or 1:1
training*
CGM Training
• Understanding CGM
• Sensor site selection, insertion,
settings and start
• “8 Keys to Success”
PHASE 3A
Follow-Up
Phone calls
Follow-Up Training
1–3 days and • Reinforce “8 Keys to Success”
• Identify any patient issues
3–7 days
• Use of CareLink™ Therapy
following
Management Software for
CGM Start
Diabetes
CPT
Required
PHASE 3B
Follow-Up
Group
Training
Class or 1:1
Training†
Reinforcement and additional
training on information covered
in CGM Start
CPT
Optional
(if needed)
PHASE 4
Continuing
Education
Group
Training
Offered by local Medtronic
Representatives; for schedule
visit: www.medtronicdiabetes.
com/events/
Medtronic
Highly
Clinical
recommended
Representative for all patients
*Group classes are recommended
†Prior approval required if exceeds 2 hours
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.
53
Continuous Glucose Monitoring
Prior to Training
Your Medtronic clinical representative will notify you and provide demographic information
for the patient you are asked to train. If for any reason you are unable to conduct the training,
please contact your Medtronic clinical representative immediately. 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.
54
Continuous Glucose Monitoring
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.
55
Continuous Glucose Monitoring
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:
56
Continuous Glucose Monitoring
- 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.
57
Continuous Glucose Monitoring
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.
•
•
•
58
Connecting glucose sensor to transmitter
Performing the Sensor Start
Tape transmitter to skin
Continuous Glucose Monitoring
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.
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.
•
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
59
Continuous Glucose Monitoring
•
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
60
Continuous Glucose Monitoring
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.
61
Continuous Glucose Monitoring
Follow-up Training
Follow-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.
62
Section 5
CareLink ™ Therapy Management
Software for Diabetes
C a r e L i n k™ T h e r a p y M a n a g e m e n t S o f t w a r e f o r D i a b e t e s
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.
63
C a r e L i n k™ T h e r a p y M a n a g e m e n t S o f t w a r e f o r D i a b e t e s
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.
64
Section 6
Forms and Handouts
Medtronic Diabetes Certified
Product Trainer (CPT) Application
Name:
Date:
Title/Credentials:
CDE: ❑ Yes ❑ No
BC-ADM: ❑ Yes ❑ No
Years of experience in the field of diabetes education:
Professional License #:
State:
Diabetes Program Affiliation:
Mailing Address:
(Home preferred)
Contact Information:
Home:
Cell:
E-mail:
Business:
Fax:
Times available for training:
❑ Weekdays
❑ Weekends
❑ Mornings
❑ Afternoons
❑ Evenings
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.
© 2006 Medtronic MiniMed, Inc. All rights reserved. 9401500-012 110106
Please list languages other than English in which you provide product training and diabetes education:
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Insulin Pump Initiation Settings
Fax to: ________________________
Prescriber’s Instructions to Patient
Patient Name: _____________________________________________________________ Date: ____________________
DOB: ___________________________________________________ Weight: ____________________________________
Current Regimen: ____________________________________________________________________________________
=
Pre-pump TDD
Basal Settings
Time
Rate (units / hour)
Basal Rate
12 a.m.
Carb Ratio
(grams / unit)
(B)
(L)
(D)
Correction
Bolus
Meal Bolus
Bolus Settings
Set Dose (units)
OR (B)
(L)
(D)
(Workspace for calculations)
ISF (mg / dL / unit)
Target Ranges (mg / dL)
12 a.m.
Active Insulin Time (hours)
Day
Night
_______ - _______
_______ - _______
______________
NEW: This setting is required
for all patients.
Insulin instructions for transition to pump:_______________________________________________________________
__________________________________________________________________________________________________
Comments:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
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 adjusting
Low BG: Consider immediate adjustment
Adjustments should be made when BGs
are outside of these ranges
Fasting/pre-meal: _______ to _______mg/dL
Post-meal:
_______ to _______mg/dL
Bedtime:
_______ to _______mg/dL
Nocturnal:
_______ to _______mg/dL
These instructions shall be valid for 6 months unless otherwise specified here: ______________months
Prescriber Name: ____________________________ Signature: __________________________ Date:________________
Call provider for severe low BG or if ketones occur. Call Medtronic for technical assistance at 800-646-4633.
9403006-011 061609 ©Medtronic MiniMed, Inc. 2009. All rights reserved.
__________________________________________________________________________________________________
CPT INFO
PATIENT
Pre-Pump Training Checklist
PH:
FX:
EMAIL:
VEND#:
IO:
INFUSION SET:
PUMP TYPE:
SAP ID:
Patient Name
Certified Product Trainer
Insulin Pump Model:
S/N:
‰ Have
Alternate Phone:
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-ByStep 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 Testing
‰ Testing Schedule
‰ A1c Testing
‰ Continuous Glucose Monitoring System
Capabilities
Hypoglycemia (low BG)
‰ Hypoglycemia protocol
‰ Glucagon
Hyperglycemia (high BG)
‰ Ketone testing
‰ Hyperglycemia protocol
DKA
‰ Preventing DKA
Sick Day Management
‰ Sick day protocol
‰ Sick day supplies
Nutrition Overview Nutrition overview
‰ Exchange system
‰ Carbohydrate counting
‰ Understanding a food label
Exercise safety
‰ Effects on Glucose Levels
‰ Use of Temporary Basal Rates
Insulin Pump Therapy Resources
‰ User’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
20100201 9501276-011 ©2010 Medtronic MiniMed All rights reserved.
Home Phone:
CPT INFO
PATIENT
Pump Start Training Checklist
PH:
FX:
EMAIL:
VEND#:
IO:
INFUSION SET:
PUMP TYPE:
SAP ID:
Patient Name
Certified Product Trainer
Insulin Pump Model:
S/N:
Home Phone:
Alternate Phone:
‰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
Have patient check BG prior to and after training session
Optimizing The Insulin Pump
Check all that apply:
‰
Introduction to Insulin Pump Therapy
Self Management Skills
‰
‰
‰
‰
Hyperglycemia
‰
‰
Basal Insulin
DKA Prevention/Back-up MDI Plan
Hypoglycemia
Insulin Pump Supplies
Understanding Insulin Pump Therapy
‰
Bolus Insulin
‰Meal Bolus
‰I:C Ratio
‰Correction Bolus
‰Sensitivity Factor
‰BG Target Ranges
‰Active Insulin
BG Testing Schedule
The Insulin Pump
Basic Features
‰
‰
‰
‰
‰
‰
‰
‰
Battery Insertion
‰
‰
‰
‰
‰
‰
Date and Time
‰
‰
‰
Setup
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
‰
Dual Wave™ and Square Wave™ Bolus
‰
‰
‰
‰
‰
‰
‰
‰
‰
Fill Reservoir and Connecting to Infusion Set
‰
‰
‰
‰
No Delivery Alarm
‰
When to Call the 24-Hour HelpLine
1-800-646-4633
Easy Bolus
Missed Bolus Reminder
BG Reminder
Personal Basal Patterns
Lock Keypad
Alert Type
Auto-Off
Daily Totals/Daily Average
Alarm Clock
Block
Self-Test
User Settings
Capture Option
CareLink™ Software/USB
The Reservoir and Infusion Sets
Infusion Set Type______________________
Button Functions
Home Screen/Modes of Operation
Alarms, Alerts and Screen Messages
Main Menu
Status Screen
Clip/Guard Placement/Removal
Continuous Glucose Monitoring System Capabilities
Basic Programming
Rewind
Insert Reservoir and Fill Tubing
Infusion Set Insertion
Fill Canula
Disconnect the Infusion Set
Tape Options and Site Prep
Site Selection and Rotation
When to Change Infusion Set
Troubleshooting: Site, Tubing, Insulin, Pump
Suspend/Resume
Manual Bolus/Express Bolus/Max Bolus
Basal/Max Basal
Basal Review
Temp Basal Rate
Bolus Wizard® Calculator
When to Order Supplies
How to Order Supplies (1-800-843-6687)
When to Call Healthcare Provider for
Assistance HCP # ________________________
Wireless Meter Options/Connecting Devices
Use
Patient Signature: _________________________________________________
Date:____________
Product Trainer’s Signature:_________________________________________
Date:____________
FAX COMPLETED FORM WITHIN 30 DAYS OF TRAINING TO: 800.849.2152
20100201 9501273-011 ©2010 Medtronic MiniMed All rights reserved.
CPT INFO
VEND#:
PATIENT
Pump Follow Up Training Checklist
PH:
FX:
EMAIL:
INFUSION SET:
PUMP TYPE:
SAP ID:
IO:
Patient Name
Certified Product Trainer
Insulin Pump Model:
S/N:
Home Phone:
Initial Training Date:
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
‰Have patient check BG prior to and after training session
Basal Rates
‰
‰
‰
Multiple Basal Rates
Temporary Basal Rate
Patterns
‰
‰
‰
‰
Instruct/review Bolus Wizard calculator programming
Program and instruct on use of wireless meter (optional)
Square Wave™
Dual Wave™
‰
‰
‰
‰
Evaluate 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
‰
‰
‰
Filling reservoir correctly
Expelling bubbles
Letting insulin rise to room temperature
‰
‰
‰
Review DKA prevention and hypoglycemia protocol
Review hypoglycemia protocol
Other:_____________________________________
‰
‰
‰
Registration and sign up
Reading and printing reports
Other:_____________________________________
Bolus Wizard® Calculator
Infusion Sets and Site Management
Preventing Acute Problems
CareLink™ Personal Therapy Management Software
Notes (optional):____________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
Patient’s Signature:__________________________________________________ Date:____________
Product Trainer’s Signature: __________________________________________ Date:____________
FAX COMPLETED FORM WITHIN 30 DAYS OF TRAINING TO: 800.849.2152
20100201 9501277-011 ©2010 Medtronic MiniMed All rights reserved.
Infusion Set Change
Dear _______________________________________________,
Date:______________________
Thank you for referring your patient to Medtronic for Insulin Pump Therapy: ___________________________________,
(Patient Name)
DOB: _____/_____/_____.
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 ______ / ______ / ______
Current Insulin Pump Settings:
Basal Rates
Time
Insulin Pump Model: _________________________
See Attached CareLink® Software Report
Bolus Wizard Settings
Basal Rate(s) (unit/hr)
12:00 a.m Standard
A
B
Time
Carb Ratio
(gm)
12:00 a.m.
Time
Sensitivity
(mg/dL)
12:00 a.m.
Time
Target Ranges
(mg/dL)
12:00 a.m.
-
Active Insulin Time (hours): __________
Infusion set type:
Quick-set®
Silhouette®
Average TDD (units/day): ____________
Infusion site rotation frequency: ____________
Sure-T™
_______
Carb Counting
Bolus Wizard® Use
Manual Bolus
Dual / Square Bolus
Temp Basal Rate
Basal Patterns
Infusion Set Insertion / Priming
Site Selection / Rotation
Site Adhesion / Tape Issues
Basal Testing
Ratio Testing
CareLink™ Personal Upload
SMBG
Hypoglycemia / Rule of 15
Hyperglycemia Management
Sick Day Management
Exercise
_________________________
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
9403007-011 061609 ©Medtronic MiniMed, Inc. 2009. All rights reserved.
Education Provided:
Fax to: _______
_______________
__
Continuous Glucose Monitoring Initial Settings
Prescriber’s Instructions to Patient
Date: ________________________________
Patient Name: _____________________________________________________________ DOB: ____________________
Glucose Alerts
High Alert Settings
Low Alert Settings
Time
ON 12:00am
____________
____________
Units
____________ mg/dL
____________ mg/dL
____________ mg/dL
OFF until ____________________ (date)
12:00am
____________ mg/dL
____________
____________ mg/dL
____________
____________ mg/dL
OR
Base settings on CareLink™ data
LOW REPEAT
____________ minutes (5 min - 1 hour)
Patient to determine
PREDICTIVE ALERT (LOW)
ON ____________ minutes (5 -30 min)
OFF
RATE OF CHANGE ALERT (FALL RATE)
ON ____________ mg/dL per min (1.1 - 5.0)
OFF
GLUCOSE ALERT (HIGH)
Time
ON 12:00am
____________
____________
Units
____________ mg/dL
____________ mg/dL
____________ mg/dL
OFF until ____________________ (date)
12:00am
____________ mg/dL
____________
____________ mg/dL
____________
____________ mg/dL
OR
Base settings on CareLink™ data
HIGH REPEAT
____________ minutes (5 min - 3 hours)
Patient to determine
PREDICTIVE ALERT (HIGH)
ON ____________ minutes (5 -30 min)
OFF
RATE OF CHANGE ALERT(RISE RATE)
ON ____________ mg/dL per min (1.1 - 5.0)
OFF
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):
Prescriber Name: __________________________________________________________
Prescriber Signature: _______________________________________________________Date: ____________________
20100305 9501292-011 ©Medtronic MiniMed, Inc. 2010. All rights reserved.
GLUCOSE ALERT (LOW)
CPT INFO
PATIENT
Continuous Glucose Monitoring
Training Checklist
PH:
FX:
EMAIL:
VEND#:
IO:
SAP ID:
Patient Name
Certified Product Trainer
Device Model:
S/N:
Alternate Phone:
Have patient check BG prior to and after training
session
Patient 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 CGM
Calibration:
®
‰ 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 Support
HCP # ________________________
When to Call the 24-Hour HelpLine 1-800-646-4633
Patient’s Signature:____________________________________________
Date :_____________
Product Trainer’s Signature:____________________________________
Date:_____________
FAX COMPLETED FORM WITHIN 30 DAYS OF TRAINING TO: 800.849.2152
20100201 9501275-011 ©2010 Medtronic MiniMed Inc. All rights reserved.
Home Phone:
CPT INFO
PATIENT
Continuous Glucose Monitoring System
Follow Up Training Checklist
PH:
FX:
EMAIL:
VEND#:
IO:
SAP ID:
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
Have patient check BG prior to and after training session
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
20100201 9501274-011 ©2010Medtronic MiniMed All rights reserved.
‰ Setting and Managing Alerts
‰ Sensor Insertion/Glucose Sensor Start
‰ Site/Adhesive Troubleshooting
‰ Use of Medtronic CareLinkTM System
Notes (optional):
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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Section 7
Universal Precautions
Universal Precautions
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.
77
Universal Precautions
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/
78
Section 8
References
References
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Type-1 diabetes patients using insulin pump therapy. Diabetes research and Clinical Practice.
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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.
1998;21:1910-1914.
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.
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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.
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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
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patients followed for a mean of 2 years. Diabet Med. 2002;19:746-751.
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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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plasma glucose independent of insulin: implications for continuous monitoring. Am J
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14. Tamborlane, WV, Beck RW, Bode BW, Buckingham B, et al. Continuous glucose monitoring
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17. Kaufman F, Halvorson M, Carpenter S, Cooper K, Kolopp M, Mueller J. The Medtronic
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(suppl 1):S12-S54.
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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Mortality Weekly Report, Vol. 32, No. 31.
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25. Ask the diabetes team. Children with Diabetes website. Available at http://www.
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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.
33. Redefining diabetes control. American Diabetes Association website. Available at:
http://www.diabetes.org/uedocuments/DCVDissue1.pdf. Accessed March 16, 2009.
34. Davidson MB, Schwartz S. Hyperglycemia. In: Franz MJ, ed. A CORE Curriculum for Diabetes
Education: Diabetes and Complications. 5th Ed. Chicago, Ill: American association of
Diabetes Educators; 2003 21-39.
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Education: Diabetes Management Therapies. 5th ed. Chicago, Ill: American Association of
Diabetes Educators; 2003:311-334.
36. Richard VS, Kenneth J, Ramaprabha P, Kirupakaran H, Chandy GM. Impact of introduction
of sharps containers and of education programs on the pattern of needle stick injuries in a
tertiary care centre in India. J Hosp Infect. 2001;47:163-165.
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Notes
82
Medtronic Diabetes
18000 Devonshire Street
Northridge, CA 91325
1.800.646.4633
20100302 9501293-011 ©2010 Medtronic MiniMed, Inc. All rights reserved.
IV3000 and IV PREP are trademarks of Smith & Nephew.
Paradigm, Serter, Bolus Wizard, Dual Wave and Square Wave are registered trademarks and
CareLink, Revel and mySupplyConnection are trademarks of Medtronic MiniMed, Inc.
www.medtronicdiabetes.com