Download Continuous Subcutaneous Insulin Infusion Therapy

An Overview of
Continuous Subcutaneous Insulin
Infusion Therapy
A Continuing Education Monograph for
Physicians, Pharmacists, and Nurses
CSII
This continuing education activity can also be completed online at
www.MedEdToday.com.
This activity is supported by an educational grant from Novo Nordisk Inc.
It has been accredited by Postgraduate Institute for Medicine for
physicians, pharmacists, and nurses.
An Overview of
Continuous Subcutaneous Insulin
Infusion Therapy
A Continuing Education Monograph for
Physicians, Pharmacists, and Nurses
CSII
This continuing education activity can also be completed
online at www.MedEdToday.com.
Release date: August 15, 2005
Expiration date: August 30, 2007
Estimated time to complete activity: 1.75 hours
Sponsored by Postgraduate Institute for Medicine
This activity is supported by an educational grant from Novo Nordisk Inc.
i
Program Goal
This continuing education (CE) monograph is designed to introduce the reader to the concepts
of optimal glycemic control in patients with diabetes using continuous subcutaneous insulin
infusion (CSII). The principles of CSII therapy and the skills and knowledge needed to fulfill
the important role of counseling patients about the benefits and use of CSII are also reviewed.
Target Audience
This CE monograph is designed for physicians, pharmacists, and registered nurses who treat
patients with diabetes and wish to expand their knowledge of insulin therapy and CSII.
Purpose
Provide clinicians treating diabetic patients with the latest information about Continuous
Subcutaneous Insulin Infusion (CSII) including indications, benefits and risks, patient
selection and training, types of insulin, basic mechanism of the devices and the signs and
symptoms of hypoglycemia and diabetic ketoacidosis.
Statement of Need/Program Overview
This continuing education (CE) monograph is designed to introduce the reader to the concepts
of optimal glycemic control in patients with diabetes using continuous subcutaneous insulin
infusion (CSII). The principles of CSII therapy and the skills and knowledge needed to fulfill
the important role of counseling patients about the benefits and use of CSII are also reviewed.
Educational Objectives
After completing this activity, the participant should be better able to:
• Describe the basic mechanism of CSII therapy
• Review the intent and indications for CSII therapy
• Evaluate the benefits and risks associated with CSII therapy
• Describe the process for selecting, training, and initiating patients to CSII therapy
• Identify the types of insulin used in CSII therapy
• Identify the signs and symptoms of hypoglycemia and diabetic ketoacidosis
ii
Editorial Review Board
William V. Tamborlane, MD
Professor of Pediatrics and Chief of Pediatric Endocrinology
Department of Pediatrics and the General Clinical Research Center
Yale University School of Medicine
New Haven, CT
Thomas S. Sisca, PharmD, FCCP, BCPS
Clinical Pharmacist, Antithrombosis Specialist
Anticoagulation Clinic/Antithrombosis Services
Shore Health System
Memorial Hospital
Easton, MD
Jane Young, RN, BSN, CDE, CPT
Diabetes Care Center
Genesis Medical Center
Davenport, IA
Physician Continuing Medical Education
Accreditation Statement
This activity has been planned and implemented in accordance with the Essential Areas and
Policies of the Accreditation Council for Continuing Medical Education (ACCME) through
the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Scherer Clinical
Communications. PIM is accredited by the ACCME to provide continuing medical education
for physicians.
Credit Designation
Postgraduate Institute for Medicine (PIM) designates this educational activity for a maximum
of 1.75 category 1 credits towards the AMA Physician’s Recognition Award. Each physician
should claim only those credits that he/she actually spent in the activity.
Pharmacist Continuing Education
Accreditation Statement
Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy
Education as a provider of continuing pharmacy education.
Credit Designation
Postgraduate Institute for Medicine designates this continuing education activity for 1.8
contact hour(s) (0.18 CEUs) of the Accreditation Council for Pharmacy Education. (Universal
Program Number - 809-999-05-048-H01)
iii
Nursing Continuing Education
CNA/ANCC
This educational activity for 2.2 contact hours is provided by Postgraduate Institute for
Medicine (PIM). PIM is an approved provider of continuing education by the Colorado Nurses
Association, an accredited approver by the American Nurses Credentialing Center’s
Commission on Accreditation.
California Board of Registered Nursing
Postgraduate Institute for Medicine is approved by the California Board of Registered
Nursing, Provider Number 13485 for 2.2 contact hours.
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) assesses conflict of interest with its instructors,
planners, managers, and other individuals who are in a position to control the content of CME
activities. All relevant conflicts of interest that are identified are thoroughly vetted by PIM
for fair balance, scientific objectivity of studies utilized in this activity, and patient care
recommendations. PIM is committed to providing its learners with high-quality CME activities
and related materials that promote improvements or quality in healthcare and not a specific
proprietary business interest of a commercial interest.
The following faculty reported a real or apparent conflict of interest:
Name of Faculty or Presenter
Reported Areas of Conflict
William V. Tamborlane, MD
Consulting Fees: Novo Nordisk
Speakers’ Bureau: Novo Nordisk
Thomas S. Sisca,
Consulting Fees: Aventis
PharmD, FCCP, BCPS
Pharmaceuticals,
Bristol Myers Squibb Co., UPA
Jane Young, RN, BSN, CDE, CPT
No financial relationships
related to this activity
The following planners and managers reported a real or apparent conflict
of interest:
Name of Planner or Manager
Reported Areas of Conflict
Peter Macholdt
No financial relationships
related to this activity
iv
Method of Participation
There are no fees for participating and receiving CME credit for this activity. During the
period August 2005 through August 31, 2007, participants must 1) read the learning objectives
and faculty disclosures; 2) study the educational activity; 3) complete the posttest by recording
the best answer to each question in the answer key on the evaluation form; 4) complete the
evaluation form; and 5) mail or fax the evaluation form with answer key to the Postgraduate
Institute for Medicine.
A statement of credit will be issued only upon receipt of a completed activity evaluation form
and a completed posttest with a score of 70% or better. Your statement of credit will be mailed
to you within three weeks.
Media
Monograph
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of
agents that are not indicated by the FDA. Postgraduate Institute for Medicine (PIM), Scherer
Clinical Communications, and Novo Nordisk, Inc do not recommend the use of any agent
outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not
necessarily represent the views of PIM, Scherer Clinical Communications, and Novo Nordisk,
Inc. Please refer to the official prescribing information for each product for discussion of
approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance
patient outcomes and their own professional development. The information presented in this
activity is not meant to serve as a guideline for patient management. Any procedures,
medications, or other courses of diagnosis or treatment discussed or suggested in this activity
should not be used by clinicians without evaluation of their patient’s conditions and possible
contraindications on dangers in use, review of any applicable manufacturer’s product
information, and comparison with recommendations of other authorities.
Trademarks
Amigo is a trademark of Nipro Diabetes Systems. Animas IR-1000 and Animas IR-1200
are registered trademarks of Animas Corporation. Apidra is a registered trademark of
Sanofi-Aventis. Deltec Cozmo is a trademark of Smiths Medical, Inc. ACCU-CHEK,
D-TRON, and Dahedi are trademarks of Disetronic Medical Systems. H-TRON plus is a
registered trademark of Disetronic Medical Systems. Humulin and Humalog are registered
trademarks of Eli Lilly and Company. Novolin and NovoLog are registered trademarks
of Novo Nordisk A/S. MiniMed, MiniMed 508, MiniMed Paradigm 512/712, MiniMed
Paradigm 515/715, Sof-set, Square Wave, and Dual Wave are registered trademarks of
Medtronic MiniMed. DANA Diabecare II is a registered trademark of DanaDiabecare USA.
Copyright © 2005, Scherer Clinical Communications. All rights reserved.
Published by Scherer Clinical Communications
117 West Prospect Street, Hopewell, NJ 08525
Printed in USA.
v
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Basics of CSII Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
The Insulin Infusion Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Rationale for CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Potential Advantages of CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Types of Insulin Used in CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Selection of Candidates for CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Clinical Experience with CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Type 1 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Type 2 Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Children and Adolescents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Pregnancy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
The Healthcare Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Initiating CSII Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Prepump Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Starting to Use the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Establishing and Adjusting Initial Insulin Doses . . . . . . . . . . . . . . . . . .12
Determining the Initial Basal Rate and Bolus Doses . . . . . . . . . . . .12
Individualizing Insulin Dosing . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Sick Day Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Meal Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Various Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Pump Vacations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Risks and Complications Associated with CSII . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Mechanical Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Hyperglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Diabetic Ketoacidosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Skin Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Weight Gain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Long-term Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Other Resources for Healthcare Providers and Patients . . . . . . . . . . . .21
Cost/Reimbursement Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Case Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Case Study 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Case Study 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Case Study 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Post-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Evaluation Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
vi
Introduction
This monograph reviews the use of continuous subcutaneous insulin infusion (CSII) therapy
for achieving and maintaining glycemic control in patients with diabetes. The basics of insulin
pump therapy and patient education, including pump initiation and follow-up care, are
covered. The skills and knowledge needed to fulfill the important role of counseling patients
about the benefits and use of CSII are also reviewed. Finally, the use of patient and
professional support groups and materials as additional resources for counseling patients and
helping them to integrate CSII into their daily lives are discussed.
Optimal glycemic control is the management of a patient’s blood glucose level toward
near-normal glycemia.1 The results of 2 landmark clinical studies, the Diabetes Control and
Complications Trial (DCCT)2 in type 1 diabetes and the United Kingdom Prospective
Diabetes Study (UKPDS)3 in type 2 diabetes have clearly demonstrated the benefits of
optimal glycemic control.
Basics of CSII Therapy
The Insulin Infusion Pump
CSII utilizes a small external mechanical pump into which an insulin syringe or reservoir is
placed. A computer chip enables the user to program how much insulin is delivered at any
time of the day. Pump components are housed in a small plastic case no larger than a beeper.
The pump has a lever that pushes down the plunger of the syringe to administer insulin. Thin
24- or 42-inch long plastic tubing known as an infusion set is used to connect the insulin
pump to a cannula which is inserted into subcutaneous tissue, usually the abdomen (Figure 1).
Connecting the pump to the cannula creates an open-loop insulin delivery system.1
Figure 1. Example of insulin pump and infusion set.
The pump can be worn on the belt or discreetly under clothing. Software is available to
download information from pumps to personal computers and other handheld devices such as
a wireless personal digital assistant (PDA). Although several newer models can be interfaced
with blood glucose monitors, the user must program the pump to deliver the appropriate
amount of insulin to cover basal and prandial needs as well as correct high or low blood
glucose levels. Since the pump delivers insulin immediately to the user, only rapid-acting
insulin formulations are used.
1
Since insulin pumps were first introduced in the 1970s there have been advances in dose
adjustment capability, infusion catheters, display screens, programming modes and
capabilities, and size.4 Newer models can monitor and record insulin usage and some even
interface with blood glucose monitors to receive blood glucose data, thereby alleviating the
need to enter it manually. Insulin to carbohydrate ratios and correction factors can also be
programmed into the new models of insulin pumps. Patients can then use the pump software
to calculate and adjust the meal bolus or deliver a correction bolus. Square Wave® and Dual
Wave® options allow the bolus dose to be given over a long time period; these features are
useful when eating drawn out meals.4 Implantable insulin pumps are available in Europe
and continuous glucose sensors that interface with the pump are currently in development.
However, development of a closed-loop system (the artificial pancreas), where an insulin
pump can automatically adjust insulin delivery in response to data received from an attached
glucose sensor, remains an elusive goal.
All changes in insulin delivery via the pump must be programmed by the user. The concepts
that are vital for controlling diabetes when using other insulin delivery systems are just as
important when using a pump. CSII is simply a different way to deliver insulin. To use a
pump, the patient must be willing to check blood glucose frequently and learn how to make
adjustments in insulin, food, and physical activity in response to those test results.
Five manufacturers marketed or serviced insulin pumps in the United States in 2005. Some
examples of currently available pumps and their specifications are listed in Figure 2: Animas
(Animas IR-1000®, IR-1200®), Disetronic Medical Systems (D-TRONTM, DahediTM, and
H-TRON®plus), Medtronic MiniMed (Paradigm® 512/712 and 515/715 insulin pumps; 508
was discontinued but continues to be serviced), DanaDiabecare USA (DANA Diabecare II),
and Deltec (CozmoTM). Due to manufacturing problems identified by the FDA in June 2003,
new pumps manufactured by Disetronic are not currently available in the United States but
existing pumps, with the exception of the recalled Dahedi, continue to be serviced. Disetronic
is currently developing the ACCU-CHEKTM Spirit insulin pump system. In May 2004, Nipro
Diabetes Systems issued a voluntary recall of the AmigoTM insulin pump due to deficiencies
related to documentation in their quality systems as identified by the FDA; the pump is
scheduled to be available again in September 2005.
Most insulin pumps are lightweight (2.8 – 4.2 ounces) and small (2.6 –4.2 inches long).
Current models vary according to the number of programmable basal rates of infusion
(12 – 48 profiles), range of infusion rate (0–99 units/hour), and smallest bolus dose
(0.025 –0.1 unit). Today’s pumps all have alarms to alert the user to catheter occlusion or high
pressure, and when the insulin reservoir is low. Pump runaway is prevented by built-in safeguard systems. Most hold up to 300 units (3 mL) of a rapid-acting insulin analog or
short-acting insulin; enough insulin for several days for most patients. Although insulin pumps
can last many years, the infusion set and cannula must be changed every 2 to 3 days. The user
can disconnect the tube from the set for sports, showering, or any other short-time activity.5
2
The Medtronic MiniMed Paradigm® 515 contains an insulin-filled 176-unit plastic
reservoir, a battery-operated pump, and computer chip that controls insulin delivery.
It is 4.62 cubic inches, smaller than the MiniMed 508®, and weighs 3.52 ounces. The
Paradigm is programmed to deliver insulin in 0.05-unit increments and programmed
bolus delivery from 0.1 to 35.0 units in 0.1-unit increments in normal, Square Wave®,
and Dual Wave® modes. These models contain alarms for occlusion, near-empty, and
overdelivery of insulin. The Medtronic MiniMed Paradigm® 515 and the Paradigm
Link Blood Glucose Meter are available as a set. The pump can receive wireless
radio transmissions from the meter which are used in combination with food
(carbohydrate) entries to estimate food and correction bolus doses. The Medtronic
MiniMed Paradigm® 712 has the same features as the 515 model but holds a larger
300-unit reservoir. New Innovations include the Web-based Medtronic CareLink®
Therapy Management System for Diabetes, which charts A1C, blood glucose, carbohydrates, and other trends. Reprinted with permission from Medtronic MiniMed.
The DANA Diabecare® II features a 300-unit plastic reservoir, dual microprocessors,
and a 24 setting basal profile. The basal delivery interval is 4 minutes with
increments adjustable from 0.01 to 16.0 units/hour. Bolus increments are selectable
0.1 unit (up to 10 units) and 1.0 unit (up to 87 units). It is powered by one 3.6
volt DC battery. Its net weight (empty) is 1.8 ounces, and safety settings include
maximum bolus, maximum basal, maximum daily total, low reservoir, occlusion,
and low battery. Used with permission from DanaDiabecare USA.
The features of Deltec CozmoTM insulin pump from Smith’s Medical, Inc., include
power by one AAA battery and a large display. The unit features a program lockout
that prevents menu entry, a delivery limit alarm to limit insulin delivery within a
60-minute period, a blood glucose test alert, change infusion set reminder, and a
missed bolus alarm that alerts users if a meal-bolus dose is not given. The unit utilizes
4 basal patterns with 48 rates in each. The basal range is 0.05 to 35 units/hour whereas the bolus range is 0.05 to 75 units. Insulin doses based on meal carbohydrate as
well as correction boluses can be calculated. The CoZmonitor blood glucose module
can be attached to the back of the pump. This photo was provided courtesy of
Deltec, Inc., St. Paul, Minnesota.
The Animas IR-1000® insulin pump from Animas Corporation contains an
insulin-filled cartridge and a battery-operated pump motor that delivers insulin
every 3 minutes. The pump has four different basal programs and can deliver up to
12 rates per basal program. The basal rates range from 0.05 to 9.9 units/hour in
0.05-unit/hour increments and the bolus ranges from 0.1 to 25 units in increments
of 0.1 unit. Safety alarms include low battery, dead battery, occlusion, near-empty
cartridge, pump malfunction, and pump delivery error. The IR-1200 pump features a
0.025 to 25 unit/hour basal rate range and an easy to debubble insulin cartridge. The
smallest bolus is 0.05 unit. The programming functions of this unit are menu-driven
and it is compatible with any infusion set using Luer™ lock connections. Functions
to calculate insulin to carbohydrate ratios and a correction bolus dose based on the
blood glucose reading are included. The new IR-1250 model includes additional
software to count calories and carbohydrate content of various foods and make
adjustments in insulin dose. Reprinted with permission from Animas Corporation.
Figure 2. Examples of insulin pumps.
3
Rationale for CSII
The programming capabilities of the pump and the flexibility CSII provides allows insulin
delivery to more closely mimic the activity of the normal pancreas. Plasma concentrations of
glucose and insulin in a nondiabetic individual with normal glycemic control are represented
in Figure 3.6 In individuals without diabetes, the pancreas secretes sufficient insulin during
the fasting state and between meals to maintain blood glucose levels in the range of 60 to
120 mg/dL (3–7 mmol/L), allowing the body’s tissues to have sufficient glucose available for
fuel. After a meal, blood glucose levels rise and the pancreas responds by rapidly increasing
the release of insulin to maintain blood glucose levels within the normal range. Basal insulin
secretion is the amount of insulin secreted by the pancreas independently of meals; it regulates
hepatic glucose output. The rate of basal secretion is not constant and has a natural biorhythm
in that it is higher in the morning, somewhat lower in the late afternoon, lower at night during
sleep, and begins to rise again in the early morning.6 Exercise and stress may also cause
metabolic changes that affect the rate of basal insulin secretion. In CSII, the patient can
administer a variable basal level of insulin throughout the day and night as well as bolus doses
of insulin at mealtimes, in an attempt to simulate the responsiveness of the pancreas in an
individual without diabetes to the body’s insulin requirements. CSII therapy is therefore
intended to help patients achieve normal or near-normal blood glucose levels.
Figure 3. Plasma concentrations of glucose and insulin in the
nondiabetic individual.
Adapted from: Pickup J, Williams G, eds. Normal metabolism: The physiology of fuel
homeostasis. In: Textbook of Diabetes. London: Blackwell Science Ltd; 1998:11.3.
Serum insulin profiles for individuals receiving insulin via CSII over a 24-hour period are
illustrated in Figure 4. Basal insulin is delivered at a programmable rate set by the patient.
The appropriate bolus dose is administered by pressing a button on the pump. The patient can
program incremental changes in basal insulin rate at either 30-minute or 1- or 2-hour intervals,
depending on the manufacturer, to simulate a natural biorhythm. The preset basal rate can
also be adjusted to accommodate exercise, illness (eg, fever), or other changes to the patient’s
routine as they occur. At mealtime, the patient is able to deliver a bolus insulin dose to
accommodate the increased insulin need after a meal.
4
Figure 4. The insulin delivery under continuous subcutaneous
insulin infusion.
Reprinted with permission from Disetronic Medical Systems, Inc.
Potential Advantages of CSII
In comparison with other currently available modes of insulin delivery, CSII therapy provides
the closest approximation of normal physiological insulin delivery to the patient with diabetes.
Therefore, CSII can be a very effective means to improve diabetes control and attain nearnormal blood glucose levels, which has psychological as well as metabolic, macrovascular,
and microvascular benefits.7,8
CSII therapy may improve or stabilize glycemic control for some patients especially if
multiple daily injection (MDI) therapy is not effective because of wide glycemic excursions
or nocturnal hypoglycemia, or due to the effects of the “dawn phenomenon” (hyperglycemia
due to increasing basal insulin requirements during the early morning hours).1,9 Optimal
glycemic control is often associated with an increased incidence of hypoglycemia and weight
gain; however, the results of some studies suggest that compared with MDI in patients who
receive proper training and education, CSII may be associated with a decreased risk of
hypoglycemia, dawn phenomenon, glycemic variability, and weight gain.8,10,11
CSII therapy may be able to help certain patients achieve a greater degree of lifestyle
flexibility and improved quality of life. Patients undergoing CSII therapy, when properly
trained and educated, may experience more freedom and flexibility in eating as well as more
freedom to engage in athletic activities.5,12 The lifestyle demands of some patients may result
in ineffective MDI therapy and lack of adherence. Some patients may not have privacy at the
workplace to inject insulin using a traditional vial and syringe. These patients may view the
pump as a more convenient and discreet way to administer insulin. Insulin pumps allow
patients to more easily adjust insulin delivery to accommodate physical strain and changes
in working conditions.
Only short- and rapid-acting insulin preparations (regular human insulin, rapid-acting insulin
analogs) (see Types of Insulin Used in CSII) are currently being used in CSII. The abdomen
is the preferred site for CSII, although some patients may use the thigh. Abdominal
administration allows for relatively rapid and consistent insulin absorption.13
5
Types of Insulin Used in CSII
As discussed above, regular human insulin (Humulin®, Novolin®) and rapid-acting insulin
analogs are used in CSII therapy.14,15 The analogs are stable, effective, and safe in the
management of patients with diabetes using CSII therapy.16–18 Insulin aspart (NovoLog®),
insulin lispro (Humalog®), and insulin glulisine (Apidra®) are approved by the US Food
and Drug Administration (FDA) for use in external infusion pumps.19–21
Rapid-acting insulin analogs have become the standard formulation to use in insulin pumps.22
The use of rapid-acting analogs in CSII has increased because these agents have less
variability in onset, peak, and duration of action compared with regular human insulin. The
B chain of the insulin molecule has been modified in the rapid-acting analogs to allow for
more rapid absorption of the insulin after subcutaneous injection.19, 21, 23, 24 For example, insulin
aspart differs from human insulin at position B28, where proline has been replaced by aspartic
acid. The modification allows the analog to dissociate more quickly and be more rapidly
absorbed from subcutaneous tissue than regular human insulin.19
With regular human insulin, the onset of glucose-lowering action occurs about 30 minutes
after subcutaneous injection, peaks in 3 to 4 hours, and, in high doses, continues to lower
blood glucose for 6 to 8 hours after injection. It is important that the patient knows how to
administer bolus doses as instructed. Because of the absorption kinetics of regular human
insulin, taking the bolus dose too close to a meal may result in postprandial hyperglycemia,
followed by hyperinsulinemia and the risk of hypoglycemia. Administering the bolus dose
of regular insulin less than 30 minutes before a meal may also result in hypoglycemia.
In comparison, the onset of glucose-lowering action for rapid-acting analogs occurs in
approximately 10 to 20 minutes, peak activity occurs in 1 to 3 hours, and the duration of
action is less than 5 hours.19,21 Because the insulin analogs have a rapid onset of action, bolus
doses can be administered immediately before, or in some cases, immediately after, eating
a meal. This offers greater convenience and flexibility, which may improve adherence to
therapy.25 Because of their rapid action, it is important that the meal is not delayed after a
bolus dose of a rapid-acting analog is taken. A recent meta-analysis concluded that compared
with regular human insulin, the use of insulin analogs in CSII pumps produces a modest
(0.26%) reduction in glycosylated hemoglobin (A1C) and that patients have a greater
preference for rapid-acting insulin analogs.26 Furthermore, some studies report that the
incidence of hypoglycemia is lower during CSII with rapid-acting insulin analogs.26
Selection of Candidates for CSII
Successful CSII therapy includes careful patient selection and training on the use of the
pump, continuing care by skilled professionals, and a patient support program. The patient’s
commitment to meticulous self-monitoring of blood glucose (SMBG) and record-keeping
of SMBG values, hypo- and hyperglycemic experiences, and pump incidents (eg, clogs,
blockages, leaks) contribute to better results with CSII.1 The inability to achieve normal or
near-normal blood glucose levels on MDI is an important reason to consider a switch to the
insulin pump. Patients who experience recurrent episodes of hypoglycemia or hypoglycemic
unawareness may also consider switching to CSII. Some patients may be motivated to start
CSII from the time of initial diagnosis.
Good candidates for CSII therapy include those individuals who can adapt to the use and
demands of the insulin pump, those who want a higher level of participation in their diabetes
6
self-care, and those who understand the potential benefits and risks of CSII.27 These
individuals are usually highly self-motivated and are ready to take a very active role in the
management of their diabetes.28,29 The most common reason patients give in choosing CSII
over MDI therapy is the wish to increase flexibility with regard to daily activities.28,30 CSII
can make it easier for patients to occasionally skip or delay meals, sleep late on weekends,
exercise for prolonged periods, or adjust more easily to time zone changes.12 However,
candidates for CSII must understand that any increased flexibility in lifestyle associated with
CSII only comes with thorough training, knowledge of how to properly utilize CSII, and a
willingness to accept responsibility for day-to-day self-care.27 A supportive home environment
is another important consideration. A program of intensive glycemic management requires a
commitment by the patient and a sharing of responsibility with the patient’s family and
healthcare professional team. Positive characteristics for selection of CSII candidates are
listed in Table 1.
Table 1.
Positive Characteristics of Potential Continuous Subcutaneous
Insulin Infusion (CSII) Candidates
Motivation and Self-reliance
• Strongly self-motivated to improve glycemic control
• Ability to adjust insulin doses based on blood glucose levels and
carbohydrate content of meals
• Technical skills to operate the insulin infusion pump and infusion set
and troubleshoot the pump
• Willing and able to accept responsibility for daily self-care
Acceptance
• Can establish realistic goals for pump therapy, understands that CSII
is not a cure for diabetes
• Feels comfortable relying on the insulin pump and is not self-conscious
about wearing the pump
• Follows the healthcare provider’s schedule for office visits and
phone conversations
Family Support
• Has support of family members, significant others, and employers
(when applicable)
Monitoring
• Able and willing to self-monitor blood glucose at least 4 times a day
• Willing to maintain rigorous and thorough record keeping
• Willing to test blood or urine ketones when plasma glucose levels are
greater than 250 mg/dL and to follow up in the appropriate manner when
ketones are present
Adopted from Fredrickson L, ed. The Insulin Pump Therapy Book: Insights from the Experts.
Sylmar, Ca: MiniMed Technologies; 1995.
Characteristics that may prevent or adversely affect a patient’s ability to adapt successfully to
CSII therapy are listed in Table 2. Potential CSII candidates must have access to a well-trained
diabetes-care team to make an optimal transition from their previous therapy.
7
Table 2.
Undesirable Characteristics of Potential Continuous
Subcutaneous Insulin Infusion (CSII) Candidates
• Fear of needles, catheters, or pain
• Reluctance to tell others about their diabetes history or current therapy
• Continually miss healthcare appointments
• Cannot or will not follow treatment plans
• Psychiatric history, including depression, history of suicidal thoughts
or attempts, personality disorders, passive-aggressive behavior, other
psychiatric disorders, substance abuse
• Severe physical disability affecting the ability to use the pump
• Inadequate financial resources
• Lack of commitment to strict treatment goals or to frequent
self-monitoring of blood glucose
Farkas-Hirsch R, Hirsch IB. Continuous subcutaneous insulin infusion: A review of the past
and implementation for the future. Diabetes Spectrum. 1994;7:80 –138.
Gentili P, Maldonato A, Bloise D, et al. Personality variables and compliance with insulin
therapy in type 2 diabetic subjects. Diabetes Nutr Metab. 2000;13:1– 6.
Tannenberg RJ. Candidate selection. In: Fredrickson L, ed. The Insulin Pump Therapy Book:
Insights from the Experts. Sylmar, Ca: MiniMed Technologies; 1995;32– 47.
Clinical Experience with CSII
Type 1 Diabetes
The earlier trials on CSII involved the use of regular human insulin in patients with type 1
diabetes participating in mostly nonrandomized and poorly controlled studies.31 Studies
varied considerably in the outcome variables measured, number of patients, and length of the
trial.31–33 In a meta-analysis of 12 randomized controlled trials, most of which were conducted
before 1990 with low numbers of patients, CSII therapy provided a small advantage in
glycemic control (~0.5% lower A1C) compared with MDI therapy; however, blood glucose
levels were less variable in patients receiving CSII and 14% less insulin was used.32,33 These
conclusions were supported by an independent meta-analysis of 52 (randomized and
nonrandomized) studies31; the risk of developing mild or severe hypoglycemia was also lower
with CSII. In general, CSII either improved or did not change the levels of anxiety, quality of
life, and compliance.31 A recent meta-analysis comparing the use of rapid-acting insulin
analogs in CSII versus MDI showed that insulin pump therapy tended to produce better
glycemic control, particularly in patients with high A1C values at baseline.34
The number of patients using CSII has increased exponentially since 1990 in the United
States.35 In 2001, 160,000 patients were estimated to be using an insulin pump; the greatest
recent increase in use has been noted among children and adolescents. Several recent trials in
patients with long-standing uncontrolled hyperglycemia have shown that CSII does produce
greater reductions in A1C (0.35% to 0.84% lower) and improvements in general well-being
compared with MDI.36,37 The importance of postprandial hyperglycemia in overall glycemic
control is now well recognized.38 In 100 patients with type 1 diabetes who previously used an
insulin pump, CSII therapy with insulin aspart reduced the number of postprandial glucose
excursions and episodes of nocturnal hypoglycemia compared with MDI therapy with insulin
glargine and insulin aspart.39
8
Type 2 Diabetes
In contrast with type 1 diabetes, there are few published randomized trials of CSII therapy
in patients with type 2 diabetes.40 In 20 patients with poorly controlled type 2 diabetes who
were randomized to either MDI or CSII therapy with regular human insulin for 4 months,
the number of patients achieving satisfactory reductions in A1C (ie, A1C <50 mmol
hydroxymethylfurfural/mol hemoglobin) was higher in the CSII group (80% vs 30%).41 In
132 patients with type 2 diabetes, CSII with insulin aspart was equivalent to MDI therapy
with insulin aspart and neutral protamine Hagedorn (NPH) insulin for glycemic control after
42 weeks; however, the majority of patients preferred CSII and they had a significantly greater
improvement in overall treatment satisfaction.15 The incidence of nocturnal hypoglycemia
tended to be lower with CSII (16%) compared with MDI (22%), whereas the overall incidence
of hypoglycemia was similar between both groups.15
Children and Adolescents
Optimal glycemic control is critical in preventing growth and related disorders in children and
adolescents.42 Boland and colleagues7 found that adolescents could achieve optimal glycemic
control with the insulin pump and maintain their quality of life. Numerous observational
trials and several randomized studies have shown that CSII therapy is safe and effective in
pediatric populations including preschoolers and toddlers with uncontrolled type 1 diabetes.43–50
Because newer insulin pumps are smaller, safer, and easier to use, the number of patients aged
<20 years using insulin pumps has increased by 20-fold since the late 1990s.4
In general, CSII therapy can reduce A1C and hypoglycemic episodes in children and
adolescents with type 1 diabetes without causing abnormal increases in body weight.4 In 75
patients between 12 and 20 years of age who chose either CSII or MDI therapy, reductions in
A1C were 0.4% to 0.8% lower and the rates of severe hypoglycemia were 30% to 50% lower
with CSII compared with MDI therapy; patients using CSII also found it easier to cope with
insulin therapy.7 In 32 patients between 8 and 21 years of age randomized to either MDI
therapy with insulin glargine and insulin aspart, or CSII with insulin aspart, A1C decreased
by 0.9% with CSII whereas no change occurred with MDI; mean blood glucose levels were
also significantly lower at lunch, dinner, and bedtime in the CSII group.45 Reductions in A1C
and severe episodes of hypoglycemia during CSII therapy in patients who transitioned from
MDI therapy have been found in various observational trials.43,46, 48, 51,52
Parental supervision and involvement in diabetes care are key considerations for determining
whether CSII therapy is appropriate for younger patients. Children and adolescents have not
always been considered as good candidates for CSII because of the large size and technical
limitations of early insulin pump models, psychosocial issues regarding pump use, and
potential lack of commitment by patients, families, and clinicians in achieving the goals of
intensive glycemic control. Furthermore, many schools do not have trained personnel who can
help the child with diabetes management. Therefore, a child using an insulin pump and his or
her family must have sufficient knowledge, skills, and attitudes to independently manage the
essentials of CSII therapy. This includes managing potential problems including hypoglycemia
and pump failure. These skills should be determined by the diabetes-care team along with
parents. When glycemic control is suboptimal with CSII, missed boluses are the most likely
cause.53 Therefore, healthcare providers and parents need to be vigilant in monitoring children
using CSII. The bolus history function of the newer pump models allows parents and
clinicians to track compliance with administration of bolus doses by school-age and adolescent
patients. Similar methods are not available in children being treated with MDI therapy.
9
Pregnancy
In pregnant women with diabetes, fetal abnormalities associated with hyperglycemia and other
metabolic anomalies are most likely to occur in the first trimester of pregnancy.54, 55 The
attainment of intensive glycemic control is therefore very important for all pregnant women
with diabetes. Diabetes care before conception and early in pregnancy has been shown to
reduce the risk of congenital abnormalities.55
CSII may be an alternative to MDI for women who intend to become pregnant but have not
been able to achieve appropriate blood glucose control with a regimen of 2, 3, or 4 daily
insulin injections. CSII may also be appropriate for pregnant women with a history of
hypoglycemia or problems with the dawn phenomenon (increased insulin need in the early
morning).12 One study compared the level of glycemic control and safety experienced by
3 groups of pregnant women: those initially using MDI therapy who were switched to CSII
therapy at 6 to 8 weeks of gestation; those on MDI throughout their pregnancy; and those on
CSII prior to and throughout their pregnancy.56 Postpartum A1C levels were ~7% for women
in both CSII groups compared with ~9% for those in the MDI group. Overall, congenital
malformations (eg, polydactyly, cleft hand, ventricular septal defects) were observed in 10%
of the neonates in this study. There were, however, no significant differences in maternal or
perinatal outcomes between the groups. Hypoglycemic rates were also similar for all 3 groups.
In pregnant patients with type 1 diabetes, CSII was effective and safe for those individuals not
achieving acceptable glycemic control with MDI.57 CSII is also effective and safe in pregnant
patients with either type 2 diabetes or gestational diabetes needing high doses of insulin.58
The Healthcare Team
To achieve optimal glycemic control, the patient with diabetes requires not only the care of
a physician but also that of other healthcare professionals. Many diabetes centers routinely
include the services of nurse educators, dietitians, pharmacists, psychologists, and podiatrists
in the management of diabetes and its related problems.59 Managing diabetes with CSII
therapy requires considerable resources, substantial expertise, and a long-term commitment
by the patient and their healthcare providers. The patient must have the necessary knowledge,
training, support, and resources to be successful with CSII therapy. If the physician, physician
assistant, or nurse practitioner does not have the resources for delivering this level of care,
the patient should be referred to an endocrinologist or diabetes center that has the required
resources. Unfortunately, some patients receive insulin pumps without adequate plans for
proper follow-up, resulting in limited effectiveness of the therapy as well as an increased risk
for adverse consequences.
A qualified pump trainer is the most appropriate person to train and help patients begin CSII
therapy. The training is a multifaceted endeavor, and pump trainers include physicians, nurses,
pharmacists, dietitians, and lay trainers. Some trainers may only be responsible for technical
aspects of pump therapy whereas others troubleshoot elevated plasma glucose, pump alarm
systems, and skin infection problems. The trainer should be well educated on the topic and
possess a wide range of educational and communication skills to be able to instruct patients on
the pump. Trainers should also be able to determine if the patient is capable of using the pump
after adequate education and should follow up after the initiation of therapy. Table 3 lists the
knowledge and skills required of the insulin pump trainer.
10
The trainer, as well as the other members of the healthcare team, should know when and to
whom to refer a patient if the need arises.60 There should be general agreement among the
team members about blood glucose goals, initial basal and bolus doses, procedures for
adjusting insulin doses, plasma glucose testing schedule, treatment of hyperglycemia and
hypoglycemia, and a variety of other issues. Team members should be supportive of each
other and provide backup support for the pump trainer.
Table 3.
Knowledge and Skills Necessary for Pump Trainers
• Understanding and knowledge of diabetes and its complications
• Knowledge of how to correctly respond to and treat hypoglycemia and
hyperglycemia
• Understanding the advantages and disadvantages of various diabetes
treatment options
• Ability to individualize therapy based on patient needs
• Knowledge of the use of insulin infusion pumps and infusion sets
– Programming
– Troubleshooting
– Installing batteries, cleaning and maintaining the pump
– Filling the reservoir and establishing infusion lines
• Calculation of basal rates and bolus doses
• Calculation of multiple basal rates
• Calculation of insulin to carbohydrate ratios
• Ability to understand and explain teaching materials
• Effective communication skills
• Familiarity with local patient support programs
Reprinted from Brackenridge B, D’Almeida B, Fredrickson L, et al. The Pump Trainer
Manual. Sylmar, Ca: MiniMed Technologies; 1994.
Initiating CSII Therapy
Prepump Training
The patient should receive comprehensive training on the principles of diabetes selfmanagement and CSII as the first step in beginning CSII therapy.12 The goal of this phase
is that the patient understands and is able to explain the following:
– The benefits and risks of CSII.
– Prevention of diabetic ketoacidosis (DKA) is feasible and dependent upon the following factors:
(1) the patient’s ability to recognize an insulin delivery problem; (2) development of
medical conditions that trigger adverse metabolic changes (eg, infection, inflammation,
emotional stress, myocardial infarction, trauma, surgery, and pregnancy); (3) medications
(eg, glucocorticoids, diuretics, and sympathomimetics); and (4) substance abuse.
– A potential change in hypoglycemia awareness.
Most patients, their family members, or significant others benefit from having 3 separate
preparatory visits. It is recommended that the pump trainer, along with the patient, family
members, and significant others discuss the following at each visit.12
11
Visit 1: At this visit, the pump trainer should accomplish the following with the patient:
(1) collect the patient’s diabetes history; (2) give a detailed overview of pump therapy,
including advantages and disadvantages; (3) set realistic goals and expectations of CSII therapy;
(4) discuss precautions associated with CSII; (5) identify support groups, dietitians, or
counselors; (6) select the insulin pump model to be used; and (7) begin the process of
obtaining insurance coverage and discussion of financial issues.
Visit 2: This visit is usually scheduled after the patient receives the insulin pump. Before the
visit, the patient should read the pump instruction manual, use an accompanying CD-ROM for
home computers, watch an educational videotape, experiment with the pump and tubing, and
perform minor pump operations. At this visit, the trainer will instruct the patient on all aspects
of the pump programming and operation. The patient will learn how to wear the pump,
practice using the pump (with saline), prime the tubing, insert the needle using proper hygiene,
and how to change the insertion site in the home setting. The patient may also learn that the
catheter is not as noticeable or intrusive as initially feared.
The patient should also meet with a dietitian (unless the trainer performs this function) prior to
the initiation of CSII to obtain a personalized meal plan and to learn carbohydrate counting.
Visit 3: Actual CSII therapy may be initiated at this visit or within the next few days.12 The
objectives of this visit are to review the patient’s technique, answer questions, and assess the
patient’s skills and understanding of pump use and his or her readiness to begin pump therapy.
Starting to Use the Pump
Except for the pregnant women who need rapid normalization of glucose levels,5 few, if any,
patients need to be admitted to the hospital to initiate pump therapy.
It is important to commit the necessary time and resources to get the patient off to a good
start. Blood glucose levels should be closely monitored during the first week of therapy, and
the insulin regimen should be changed as necessary (see Establishing and Adjusting Initial
Insulin Doses). Patients should have 24-hour access to information, which can be provided
by the pump manufacturer hotline, healthcare team, and the patient’s pump trainer. Patients
should be provided with detailed instructions about their treatment plan and how to keep a
daily diary that will provide the physician (or other healthcare team member acting under
physician supervision) with sufficient data for making precise adjustments in insulin dose
and timing.61
Establishing and Adjusting Initial Insulin Doses
Determining the Initial Basal Rate and Bolus Doses
In general, patients beginning therapy with an insulin pump are started on a lower total daily
dose (eg, 10%–25% less) than their total prepump daily insulin dose.62 In adults, basal insulin
usually accounts for ~50% of the pump dose and the remaining 50% of the total daily insulin
requirement is comprised of the bolus insulin doses administered at mealtimes.62 The basal
dose in children is usually >50%.
If an adult patient was receiving 42 units/day of insulin prior to initiating CSII, the starting
pump total insulin dose would be 32 units/day (0.75 * 42). The initial basal rate would
therefore be 0.7 unit/hour (0.50 * 32/24 hours) and the starting bolus doses would be 5.3
12
U/bolus (0.50 * 32/3). Sample guidelines for establishing a patient’s initial basal and bolus
insulin doses provided by one of the insulin pump manufacturers are shown in Table 4.
Table 4.
Sample Guidelines for Calculating Basal and Bolus Insulin Doses
for Adults Using Continuous Subcutaneous Insulin Infusion
Basal and Bolus Dose Calculation Based on the Total Prepump Insulin Dose:
• Identify the total prepump daily insulin amount
• Reduce the total prepump dose by 10% to 25% = the starting pump total
daily insulin amount
• Basal insulin dose (units/hour) = 50% of the starting pump total
dose/24 hours
• Bolus* insulin dose = 50% of the starting pump total dose/3
Reprinted from Fredrickson L, ed. The Insulin Pump Therapy Book: Insights from the
Experts. Sylmar, Ca: MiniMed Technologies; 1995.
*Calculate as carbohydrate to insulin ratio with injection therapy or as total daily
carbohydrate intake/50% of total daily dose.
According to the American Diabetes Association (ADA), blood glucose targets should range
between 90 to 130 mg/dL for average preprandial plasma values and be <180 mg/dL for peak
postprandial plasma glucose levels in adults with diabetes.63 The American Association of
Clinical Endocrinologists recommends that fasting plasma glucose be <110 mg/dL and 2-hour
postprandial blood glucose <140 mg/dL.64 Blood glucose target values should be carefully
selected to reduce the risk of serious hypoglycemia. Target averages are somewhat lower for
pregnant patients, generally not exceeding 105 mg/dL before meals or 130 mg/dL 2 hours
after a meal.5,65 These goals are somewhat higher for patients with a history of hypoglycemic
unawareness, at least at the start of therapy.9,63
Most adult patients require basal doses ranging from 0.4 to 2.0 units/hour; toddlers and
younger children will require less. Patients begin CSII therapy with 1 basal rate but may add
1 or 2 additional rates during the day and/or night as their daily insulin requirements are
further established.62 For example, a patient may have a certain basal rate programmed for
9 PM to 3 AM to cover nocturnal insulin needs, a second rate to deliver slightly more insulin
from 3 AM to 9 AM to address increased insulin need in the dawn hours, and a third rate to
cover the daytime hours from 9 AM to 9 PM. If a patient’s basal rate(s) results in persistent
hypoglycemia or hyperglycemia, then a new basal rate should be calculated.62 In adults, once
the patient’s individual basal rates are established, they often do not need to be adjusted unless
changes in lifestyle, body weight, or health status occur. In children, basal and bolus doses are
constantly changing due to growth and pubertal development.66
The basal insulin rate is correctly established if blood glucose levels remain in the target range
under fasting conditions. Blood glucose levels should be checked before and after meals (or
more frequently if needed) during initiation of CSII. The initial basal rate should also be
verified based on overnight blood glucose levels obtained at bedtime, nighttime (midnight
and/or 3 AM), and breakfast (7 AM). This is helpful for the early recognition of nocturnal
hypoglycemia. The actual test schedules may vary for a specific patient based on varied life
schedules and mealtimes.
It is important that the patient is instructed in the proper timing of the bolus dose, depending
on the type of insulin used. Bolus doses of regular human insulin should be administered 30
minutes prior to eating a meal whereas bolus doses of a rapid-acting insulin analog should be
13
injected within 15 minutes of commencing a meal. Bolus doses are based on premeal blood
glucose readings and estimated food intake. With normal bolus dosing, the patient receives an
immediate bolus, programmable in 0.025-unit increments of insulin or higher, depending on
the pump manufacturer. Some insulin pumps can deliver a normal bolus as well as perform
Square Wave and Dual Wave delivery. The Square Wave and Dual Wave boluses are designed
to help people better match insulin action to insulin need, such as during periods of extended
eating or to compensate for delayed digestion (eg, gastroparesis). Square Wave delivery allows
for programming a bolus for delivery over a period of 30 minutes to 8 hours. The Dual Wave
bolus combines an immediate bolus with an extended Square Wave bolus in one easy step.
The Medtronic pumps offer these insulin bolus delivery options. Other available pumps also
offer similar delivery options.
Individualizing Insulin Dosing
Determining the patient’s individual insulin need is a key step for helping to correct high
blood glucose values observed after pump therapy has begun. The amount varies considerably
from patient to patient, depending on the degree of insulin resistance, and an estimate should
be calculated for each patient. Based on data from the patient’s diary, the physician can
estimate how much 1 unit of insulin will lower plasma glucose for that specific patient
and then adjust the insulin dose.62, 67
Insulin responsiveness can also be estimated for patients with type 1 diabetes by the “1500
rule” when using regular human insulin or the “1800 rule” when using a rapid-acting insulin
analog.67,68 The rule is used to estimate how much 1 unit of regular human insulin or a rapidacting insulin analog lowers plasma glucose when the patient’s total amount of daily regular
insulin or analog dose is divided into 1500 or 1800, respectively. For example, if the patient
is using 50 units of regular insulin per day, 1500 divided by 50 equals 30, which means that
1 unit of regular insulin lowers plasma glucose 30 mg/dL over a 4- to 6-hour interval. The
rule of 1800 is used for a rapid-acting analog because 1 unit tends to lower blood glucose
somewhat more over a 2- to 4-hour interval.68
Sick Day Management
As with patients using MDI therapy, general principles of sick day management also apply to
CSII patients. Plasma glucose as well as blood and urine ketone levels may increase during
times of stress or illness. It is important for patients to frequently test for blood or urine
ketones during illness (as instructed), or when blood glucose levels are elevated, and adjust
their insulin dose accordingly.69 The first step is to make sure that elevated blood glucose
levels are not due to an infusion site or other pump problem. This can be accomplished by
taking a correction dose and then remeasuring the glucose level in 30 to 60 minutes to make
sure that blood glucose values are falling. If not, the infusion set and site should be changed
and a correction bolus given by injection. Sites should almost always be changed if the
patient is symptomatic and has positive ketones. The patient should contact a diabetes team
member if these steps are unable to lower glucose and ketone values or when persistent
nausea or vomiting occurs.69 Patients should also plan ahead for sick days. They should have
adequate supplies of insulin, infusion sets, extra supplies for glucose and ketone testing,
sugar-containing clear fluids, glucagon kit, thermometer, and antiemetic and antidiarrheal
medications, which should be used with the guidance of their healthcare team.
14
Record Keeping
Rigorous monitoring of blood glucose levels helps to ensure the safety and effectiveness of
intensive insulin therapy. The trainer should review the patient’s record-keeping techniques
and show the patient how record keeping may differ during pump therapy. The SMBG logs
should have notations for diet and activity, bolus dose adjustments, and changes in basal rates
to assist the healthcare team in optimizing therapy.
Meal Planning
Proper nutrition is essential to successful diabetes management.70 Carbohydrate content is used
to determine premeal bolus insulin doses in most cases because carbohydrates are the main
determinant of meal-related insulin demand. When patients are comfortable with CSII therapy,
they should be introduced to the concept of counting carbohydrates and the I:C ratio to allow
for more flexible meal planning. Carbohydrate counting allows the patient to determine the
premeal bolus of insulin based upon the actual grams of carbohydrate in that meal.
This ratio is the number of grams of carbohydrate covered by 1 unit of short- or rapid-acting
insulin. This value is calculated by dividing the total grams of carbohydrate consumed in a
day by the total bolus insulin administered in a day. A dietitian may assist the pump user in
calculating an accurate I:C ratio, which is typically in the range of 10 to 20 grams of
carbohydrate per unit of insulin. The labeling of most packaged food contains information on
the carbohydrate content in the metric system (ie, grams). Adjustments in dose and the timing
of insulin delivery can be made as their diet changes, with guidance from a dietitian or
certified diabetes educator working under the supervision of a physician.70 Some patients with
diabetes may need to increase their insulin dose when excessive protein is included in a meal.
In this situation, enough protein may be converted to glucose to produce a noticeable effect
on postprandial hyperglycemia. In addition, excessive dietary fat intake may affect glucose
absorption and accentuate and sustain postprandial hyperglycemia.70 For children, the I:C
ratio is based on age. Children <5 years start with 0.3 unit/15 g of carbohydrate, 5 to 7 years
(0.5 unit/15 g), 8 to 11 (0.7 unit/15 g), 12 to 14 (1.0 unit/15 g), and 15 to 18 years (1.5
units/15 g).4
Various Activities
Patients using CSII are encouraged to participate in recreational sports, including contact or
water sports. However, it is important for patients to understand that the timing and intensity
of a workout can cause hypoglycemia, and patients should be taught how to prevent or treat
hypoglycemia during times of mild to intense physical exertion. Patients can compensate
for exercise with appropriate adjustments of basal and bolus insulin doses or increased
carbohydrate intake. They should also be aware that the risk for nocturnal hypoglycemia is
also greater after a day of increased physical activity.
Currently or potentially sexually active pump users should be counseled about pump use
during sexual activity. They do not have to remove the pump during sexual activity, but if
the pump is taken off, it should not be removed for a prolonged period or significant
hyperglycemia or DKA may occur.
15
Pump Vacations
Patients may need to remove the pump for certain activities such as swimming and showering.
If no food is consumed or blood glucose is not elevated, no additional insulin is usually
required if the pump is removed for 2 or 3 hours.4 The “quick release” feature of current
infusion sets makes such temporary disconnections very easy. The healthcare team and
patient should develop strategies for dealing with pump failure or removing the pump for
longer periods and for taking pump vacations. These procedures should be reviewed
periodically. A randomized crossover trial with 100 individuals showed that patients can
temporarily switch from CSII with insulin aspart to basal-bolus therapy with insulin glargine
(basal) and insulin aspart.39 The quantity of insulin given in the basal mode should be
determined and replaced by a similar amount of NPH or a long-acting insulin analog. Bolus
doses can be calculated and given by injection at mealtime.71 The exact requirements should
be determined by blood glucose monitoring, expected activity levels, and carbohydrate
counting. If the pump vacation is longer than 3 days, a return to a basal-bolus regimen with
MDI will be required. Overlap with previous insulin doses via injection should be considered
when returning to CSII therapy.71
Risks and Complications Associated with CSII
Patient education and the use of specific troubleshooting techniques can prevent, reduce, and
help manage complications associated with pump use, thus avoiding a crisis (Table 5). The
patient must clearly understand that the insulin pump is not a “closed-loop” system and does
not automatically deliver insulin in response to blood glucose levels. It is therefore critical for
the patient to understand how to adequately monitor blood glucose levels, correctly program
the pump, and perform everyday management techniques to prevent serious metabolic
disturbances. The syringe, reservoir, tubing, and injection site should be changed at the same
time every 48 to 72 hours. Using good hygiene measures and changing the injection site
regularly, as directed, helps to reduce injection-site reactions, infection, and interruptions of
insulin delivery.12
16
Table 5.
Suggestions for Troubleshooting Continuous Subcutaneous
Insulin Infusion Therapy
• Review the alarm card
• Differentiate between alarm and error messages
• Review maximum values for overinfusion alarm
• Review possible causes for high blood glucose levels
– Loss of insulin potency?
– Precipitation or crusting
– Bolus dose too small?
in tubing or cannula?
– Recent illness?
– Catheter dislodged?
– Leaks or air in tubing?
– Pump malfunction?
– Crimps in the cannula?
– Reservoir out of insulin?
– Poor absorption from infusion site?
• Change the infusion set if elevated blood glucose values fail to respond
to an appropriate correction dose or when a high blood glucose value is
accompanied by a positive ketone test
• Always be prepared to give insulin by subcutaneous injection with
another insulin delivery system and have appropriate supplies available
• Check for ketones in the urine or blood
• Review possible causes of low blood glucose levels
– Basal insulin rate too high?
– Bolus insulin dose too large?
– Low carbohydrate meal? Miscalculation of meal’s
carbohydrate content?
– Increased exercise?
• Ensure that the patient understands how to prevent low blood
glucose levels
– Perform self-monitored blood glucose (SMBG) as instructed,
especially before a meal or driving
– Perform SMBG at bedtime and during the night if necessary
– Have a supply of quick-acting carbohydrates available
– Review glucagon administration with family members
– Always have appropriate supplies available (and not expired)
– Contact healthcare team for frequent or asymptomatic hypoglycemia
Mechanical Problems
Although the new pump models are mechanically very reliable, problems may occur that can
result in interrupted or excessive insulin flow. Because only rapid-acting insulin is used in
CSII therapy, any disruption in the flow of insulin for whatever reason—from an empty
reservoir to a kinked line or loose set to low batteries—can cause blood glucose to quickly
become dangerously elevated. Insulin pumps are equipped with sophisticated alarm systems
and other safety features, including maximum basal and bolus dose limits. However, patients
should be instructed to use SMBG and not to rely solely on alarm systems. Patients should be
instructed to monitor blood glucose levels at least before each meal and at bedtime, and once a
week at 3 AM.60 Patients should also be instructed to always keep an insulin syringe or insulin
pen available (and occasionally practice using it) as a “backup” in the event of mechanical
failure of the pump.
17
Hyperglycemia
The most common causes of hyperglycemia are the administration of inadequate bolus or
basal doses and underestimation of carbohydrate intake. A trend to higher blood glucose
levels is the sign that children and adolescents have “outgrown” their current insulin doses.
Hyperglycemia can also occur when the insulin is not absorbed properly from the infusion site
or because of infusion set crimping, occlusion or leak, empty reservoir, or dislodging of the
needle or cannula. CSII patients should be taught to inspect the pump, syringe, and infusion
set at least 2 times a day.60 Inspections should also be done whenever a high blood glucose
level occurs. Unexplained elevated blood glucose levels should be treated with insulin using
appropriate troubleshooting techniques. Patients must adhere to a regular schedule, including
changing the infusion set, filling and changing the insulin in the reservoir, and checking for
leaks when changing the reservoir and infusion sets. Clogging of the infusion line may also
occur. Some infusion sets (eg, Sof-set®) are lined with insulin-compatible material that reduces
the incidence of clogging.
Hypoglycemia
An increased risk of hypoglycemia is associated with intensive glycemic control. Patients
and their families should be taught how to recognize, prevent, and treat hypoglycemia. To
minimize the risk for hypoglycemia, patients should be educated to perform SMBG and to
recognize the symptoms of hypoglycemia (Table 6). Hypoglycemia can be more quickly
reversed in patients using CSII because the subcutaneous insulin depot is not as large as with
MDI therapy.4 To minimize the risk of severe hypoglycemia, patients must be able to respond
to hypoglycemic signs and symptoms by having a fast-acting carbohydrate such as orange or
apple juice (1/2 cup), brown sugar (1 tablespoon), or 2 to 3 glucose tablets readily available.
A more specific recommendation for children is 8 grams of carbohydrate if blood glucose is
<51 to 70 mg/dL, 15 g if it is 41 to 50 mg/dL, and 30 g if it is <40 mg/dL.4 If the patient is
unable to orally ingest a carbohydrate, a glucagon injection may be needed. All patients should
have a glucagon injection kit available. Glucagon is a counterregulatory hormone that causes
the release of glucose from liver glycogen stores. Parenteral administration of glucagon results
in prompt mobilization of liver glycogen, thereby raising blood glucose levels. Patients, family
members, or significant others should be taught when and how to give a glucagon injection.72
A glucagon injection kit should always be accessible for hypoglycemic emergencies. It
should be remembered that a carbohydrate snack may still be needed after the glucagon is
administered and that vomiting occurs in some people after the administration of glucagon.
Therefore, patients should be positioned on their side or stomach. A glucagon injection will
not work if liver glycogen has been depleted by fasting for >24 hours. Therefore, intravenous
glucose may need to be administered by emergency personnel.
Hypoglycemia can occur when basal insulin rates are calculated incorrectly or because of
improperly timed or calculated bolus doses. Carefully programmed insulin delivery can
potentially reduce the incidence of hypoglycemic episodes. As discussed earlier, the results
of some studies indicate that CSII can be significantly better than MDI in reducing the risks
of hypoglycemia in patients who receive proper training and education in the use of the
insulin pump.10, 11 Some patients have hypoglycemic unawareness or recurrent episodes of
hypoglycemia and require assistance. These patients need to have their target blood glucose
ranges carefully established and adjustments made in insulin dosage, food intake, and
exercise.72 Bedtime insulin boluses should only be administered with extra caution to
minimize the risk of nocturnal hypoglycemia.67
18
Table 6.
Common Signs and Symptoms of Hypoglycemia
Central Nervous
Warning Symptoms
System Impairment
Miscellaneous
Sweating
Drowsiness
Hunger
Tremors
Confusion
Blurred vision
Headache
Anxiety
Dizziness
Nausea
Speech impairment
Weakness
Palpitations
Loss of consciousness
Shivering
Diabetic Ketoacidosis
CSII patients use only rapid-acting insulin and therefore do not have the “cushion” of an
intermediate-acting insulin to help prevent metabolic decompensation caused by insulin
deficiency and associated counterregulatory hormone responses. This results in elevated
gluconeogenesis, glycogenolysis, lipolysis, and ketogenesis as well as inhibition of peripheral
glucose utilization. During CSII, only relatively small amounts of insulin are continuously
infused, resulting in a small subcutaneous depot. Therefore, any interruption in insulin delivery
lasting for several hours or more can result in DKA. The risk of DKA can be minimized by
frequent SMBG and appropriately responding to elevated blood glucose readings.73
In the presence of severe insulin deficiency, glucose cannot be utilized. Blood glucose levels
rise precipitously and a metabolic chain of events is triggered that results in the breakdown of
fat for energy and the production of ketones. The signs and symptoms associated with ketone
production include the urinary excretion of glucose, dehydration, electrolyte imbalances, and
acid-base derangements (Table 7). Severe ketosis may result in vomiting, difficulty breathing,
and a fruity breath odor. Patients must be taught the importance of SMBG and of monitoring
for blood or urinary ketones. Patients should also be instructed in how to anticipate and
recognize the signs and symptoms of DKA.73
Patients should establish a routine of systematically checking the pump, infusion set, and
infusion site. Patients with type 1 diabetes, whose blood glucose level is >250 mg/dL by
SMBG, should perform a blood ketone check.74 If ketones are positive and the patient cannot
find any problem with the insulin pump, they should administer a supplemental bolus dose
and recheck plasma glucose, as directed by a healthcare provider. The patient should consider
changing the infusion set if blood glucose remains higher than 250 mg/dL because the infusion
set may be occluded, and consult with their healthcare provider for further instruction.73
19
Table 7.
Signs and Symptoms of Diabetic Ketoacidosis
Signs
Symptoms
Nausea and vomiting
Polydipsia and polyuria
Tachycardia
Hypotension or shock
Weakness or anorexia
Dehydration
Abdominal pain
Warm, dry skin
Visual disturbances
Hyperpnea or Kussmaul respiration
Somnolence
Impaired consciousness or coma
Weight loss
Fruity breath
Copyright © 2004 American Diabetes Association
From: Medical Management of Type 1 Diabetes. Adapted and reprinted with permission from
The American Diabetes Association.
To order this book, please call 1-800-232-6733 or order online at http://store.diabetes.org.
Skin Infections
Skin infections are a potential, although preventable, risk of insulin pump therapy. They are
associated with prolonged use of a single injection site or poor hygiene. In addition, some
patients with a history of Staphylococcus aureus infections or who are nasal carriers of the
organism may be at a higher risk of infection. Patient education can help minimize the number
of infections a patient may experience.12
Patients can reduce the risk for skin infections by changing the infusion sets every 48
to 72 hours, which can vary depending upon the type of infusion used, adhering to
recommendations for skin hygiene, and keeping the infusion site clean and dry.12 If patients
develop infections at the needle site, they should clean the skin with an antibacterial soap
and consider the use of an infusion set with an antibacterial dressing. They should also
visually examine the injection site for signs of inflammation and irritation, change the site
if there is a problem with the current site, and seek medical attention if they suspect that
infection has occurred. Patients should never reuse an infusion set because this can increase
the risk for infection.12
Weight Gain
Patients may gain weight when starting CSII therapy as more intensive therapy and
improvement in glycemic control makes more calories available from meals because glucose
is not excreted in urine. Some clinical data, however, suggest that less weight gain occurs
with CSII compared with MDI therapy.8,11
Long-term Follow-up
Patient education is an ongoing process. Patients can continue their CSII education by
discussing such topics as multiple basal rates, advanced programming, small adjustments of
bolus doses, adjusting to exercise and travel, and calculating the I:C ratio. During the first
2 months of CSII therapy, intensive follow-up with the healthcare provider should be conducted
to reassure the patient and the healthcare provider. Once the healthcare provider is confident
that the patient has mastered the pump and can handle it on his/her own, follow-up visits can
be adjusted to adhere to the patient’s needs. It is critically important for the physician and
20
other healthcare professionals to periodically reassess the patient’s knowledge and skills
regarding CSII therapy on an ongoing basis.
Other Resources for Healthcare Providers and Patients
Many health support materials and services are available to the patient and healthcare
professional, including instruction manuals, educational brochures, videotapes, newsletters,
Websites, and toll-free hotlines. Useful Websites include www.diabetesincontrol.com and
www.cdc.gov/diabetes. Many other support materials are produced and available from pump
manufacturers, and their Internet sites answer basic questions about diabetic topics and insulin
pump therapy, and discuss specific products.
Patients, institutions, pump manufacturers, ADA affiliates, and others have formed pump
support groups that allow CSII patients to exchange information and provide emotional
support. Healthcare professionals should know about CSII support groups in their region
and encourage their patients to join. If local groups do not exist, patients and healthcare
professionals may consider starting a support group.
The American Association of Diabetes Educators (AADE; Website www.aadenet.org) and
the American Diabetes Association (Website www.diabetes.org) offer a variety of educational
programs for health professionals interested in continuing their education in pump therapy.
The insulin pump manufacturers also support educational programs for physicians, diabetes
educators, pump trainers and pump users, and provide information and technical support
services to patients and diabetes educators on their respective Websites (www.animascorp.com,
www.disetronic.com, www.minimed.com, www.danapumps.com, www.delteccozmo.com,
www.nipro-diabetes.com). Other online sources that provide direction to patients and
healthcare professionals include www.insulin-pumpers.org and www.diabetesnet.com.
Cost/Reimbursement Considerations
The cost of therapy is an important issue to consider when selecting candidates for CSII
therapy. The initial cost for the insulin pump device and the ongoing monthly cost are higher
than those for MDI therapy. The approximate cost for a commercially available insulin pump
is about $6,000 and infusion sets and dressings can cost $150 to $400 per month; insurance
may cover up to 100% of the cost. Many insurers provide coverage for the cost of the pump,
medical services associated with training the patient, and the cost of disposable supplies, but
the exact coverage usually includes outpatient initiation of pump therapy. Some insurers
will not pay for the initial cost or maintenance of the pump whereas others limit coverage on
the amount of supplies used within a specified time period. Most insurance plans require
documentation of the medical necessity of the pump, according to the insurer’s guidelines,
before coverage can begin.
Conclusions
The findings of landmark trials such as the DCCT and UKPDS provide clear evidence
that optimal glycemic control can prevent or delay the development or progression of
microvascular complications of diabetes in patients with type 1 or type 2 diabetes.
Appropriately selected patients of all ages with type 1 and type 2 diabetes can benefit from
intensive glycemic therapy with an insulin pump. As with other modalities, the benefits of
treatment with CSII must be weighed against the risks. Intensive glycemic control and the
potential for improved quality of life can outweigh the potential complications of CSII for
many people. Furthermore, patients with gestational diabetes can also utilize CSII. Insulin
pump training is a multifaceted endeavor. Education and intensive pump training by qualified
pump trainers and certified diabetes educators working in concert with a healthcare team
21
are critical to the successful implementation and long-term success of pump therapy. It is
important that pump trainers and educators have the knowledge and communication skills
needed to help the CSII patient achieve the goals of intensive glycemic control.
Case Studies
The following case studies and questions are presented to challenge and increase your
knowledge of insulin pump therapy.
Case Study 1
CP is a 56-year-old woman who has had type 1 diabetes for more than 30 years. She indicated
that she monitors her blood glucose levels 4 times a day, denies alcohol use, and does not
engage in vigorous exercise. Her blood glucose levels can range from 35 to 350 mg/dL, on
any given day, and her A1C level was 6.5%. CP has been experiencing 2 to 3 hypoglycemic
episodes per week, often requiring paramedic visits several times a year. She does not feel
any symptoms of hypoglycemia unless her plasma glucose levels fall well below 50 mg/dL.
Her insulin regimen was changed from split NPH and regular insulin to 4 injections per day
(3 injections of a rapid-acting insulin analog and 1 basal insulin injection at bedtime), and she
received blood glucose awareness training. Her I:C ratio was set at 1 unit of insulin for 15 to
20 grams of carbohydrate. Her plasma glucose levels ranged from 70 to 250 mg/dL within
2 weeks of changing therapy and stabilized at 60 to 210 mg/dL, but she still experienced
episodes of hypoglycemia.
Questions
What is happening to CP?
Why would you consider CSII therapy for CP?
What should be done immediately?
Answers
This patient is experiencing hypoglycemic unawareness. Possible causes of hypoglycemia
include inappropriate target glucose levels, inappropriate I:C ratio, variable insulin absorption,
excessive boluses to correct hyperglycemia, and insufficient or irregular SMBG. Because
of the frequency and severity of her hypoglycemic episodes, this patient may benefit from
CSII. By frequently monitoring her plasma glucose levels, CP may be able to prevent many
hypoglycemic episodes. As an immediate step, CP’s blood glucose target range was raised
to 100 to 200 mg/dL. She received specific, individualized guidelines for meal-related bolus
doses and was advised to keep fast-acting carbohydrates on hand at all times.
Clinical Course
CP was concerned about her ability to control her disease without recurring episodes of
serious hypoglycemia and elected to discuss pump therapy with her insurer. The insurer was
proactive in disease management and willing to pay for the pump. CP received CSII training
and began therapy with a rapid-acting insulin analog. Two weeks after initiation, her daily
range of plasma glucose excursions improved. At 4 months after the initiation of CSII therapy,
her A1C level was 6.7%, and she has not experienced episodes of severe hypoglycemia since
beginning CSII. CP is now aware of signs and symptoms of hypoglycemia with plasma
glucose readings of ≤70 mg/dL. She is motivated and conscientious in her day-to-day diabetes
management. For the first time, she believes that she is in control of her disease and is
confident in her ability to manage her diabetes.
22
Case Study 2
PC is a 12-year-old girl who was diagnosed with type 1 diabetes 18 months ago. Two
injections per day of a mixture of Lente and insulin lispro were initiated and both PC and her
parents received standard diabetes education. PC initially required a total daily dose (TDD) of
1.8 units/kg per day. Although her glucose levels were stable, she experienced hypoglycemia
during sports and competitive ice skating. After 1 year, her TDD had been decreased to 1.3
units/kg per day, and she was switched to insulin glargine therapy. She administered insulin
glargine once a day (at bedtime), and insulin aspart with 3 meals, using an I:C ratio of 1 unit
per 10 g for a TDD of 1.2 units/kg per day. After 1 month, a 3 PM bolus of insulin aspart was
added to cover her snack. This regimen worked well, although PC continued to experience
hypoglycemia during intense physical activity.
Pump Treatment
PC and her parents were counseled about the option of CSII therapy. They were informed that
CSII offered more convenience and flexibility compared with MDI therapy. The diabetes-care
team also described studies in children and discussed how patients with active lifestyles prefer
insulin pumps. PC began pump treatment with insulin aspart when she was just over 13 years
old. PC did quite well on the pump with programmed basal rates of 1.1 units (12 AM), 0.8 unit
(3 AM), 1.0 unit (9 AM), and 1.1 units (9 PM). Her initial I:C ratio was 1 unit per 10 g (TDD of
1.1 units/kg per day).
Sports
Through trial and error, PC and her parents—with consultation from the diabetes-care team—
have learned how to adjust her pump to accommodate the very intense demands of competitive
ice skating and avoid either hypo- or hyperglycemia during or after an event or practice.
PC learned that she needed to set a temporary lower basal rate for evenings after an intense
practice session, as well as during practice sessions to avoid hypoglycemia. She measures her
glucose level before, after, and sometimes during practice. For a competition, PC tests before
and after the event, but leaves the pump off during the event to prevent hypoglycemia as well
as for cosmetic purposes.
Metabolic Control
PC’s A1C levels rose during the first year of CSII, during which time she reached menarche.
Insulin doses were increased (TDD over the next year ranged from 1.3–1.4 units/kg per day),
and metabolic control improved shortly thereafter. Because PC seemed to be very sensitive to
insulin for the 24-hour period prior to each menses, she learned to reduce her insulin basal
doses by more than 50% the day before menses began. If a practice session took place during
that day, she decreased the dose even further. PC is now 15 years old and continues to be quite
successful with her diabetes care, which she manages with complete independence. She is
currently on a TDD of 1 unit/kg per day, with a 1 unit per 7 g carbohydrate bolus dose. She
has achieved the ADA’s treatment guideline of an A1C <7%; her last 2 measurements were
5.7% and 6.9%. She has reported many times in her follow-up visits that she is pleased with
her decision to begin pump treatment.
23
Case Study 3
JD is a 55-year-old female with a body mass index of 28.2. She was diagnosed as having type
2 diabetes 12 years ago and has been using human insulin formulations for nearly 5 years.
JD’s blood pressure is 140/85 mm Hg and she also has signs of neuropathy. Although JD’s
A1C level has been reduced to 8.1% with a basal-bolus regimen, she has also experienced
wide glucose excursions and nocturnal hypoglycemia. These problems may be related to
irregular mealtimes caused by her busy work and travel schedule as a sales rep, and by small
peaks of basal insulin or different requirements for basal insulin at different times of the day.
Questions
Is this patient a candidate for CSII?
How should insulin pump therapy be initiated for this patient?
Answers
Insulin pump therapy is now a viable option for patients with type 2 diabetes. Insulin pumps
have increased flexibility and freedom but pump use requires a willingness to monitor blood
glucose at least 4 times a day and consistent record keeping. The patient also needs to develop
technical skills to operate the pump and adjust insulin doses based on meal carbohydrate
intake and blood glucose readings. Because patients generally require less insulin when using
CSII, JD’s total insulin administered is reduced by 25% when changing to CSII from MDI.
A rapid-acting insulin analog is used with bolus doses administered just before meals. Since
the basal dose is usually 50% of the daily CSII dose, the hourly rate is calculated by dividing
the daily basal dose by 24. The bolus doses are calculated by dividing by the number of meals
with adjustment for carbohydrate content. Discrete adjustments in dosing can be done at
any time.
Clinical Course
After attending some pump pretraining workshops and working with a diabetes educator,
JD decides to try the insulin pump. Following early problems adapting to the pump and
fine-tuning the dosing by blood glucose monitoring, JD has become very comfortable
with CSII therapy after 8 months. Her A1C is down to 7.0% and glucose excursions and
nocturnal hypoglycemic episodes have also been reduced. JD attributes the improvements
to the convenience and flexibility the CSII regimen offers. The basal infusion rate may be
decreased at times when she is physically active and requires less insulin.
24
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with multiple daily injections using insulin glargine. Diabetes Care.
2004;27:1554-1558.
64.
American Association of Clinical Endocrinologists. Medical guidelines
for the management of diabetes mellitus: The AACE system of
intensive diabetes self-management—2002 update. Endocr Pract.
2002;1(Suppl 8):40-82.
46.
Litton J, Rice A, Friedman N, et al. Insulin pump therapy in toddlers
and preschool children with type 1 diabetes mellitus. J Pediatr.
2002;141:490-495.
65.
American Diabetes Association. Gestational diabetes mellitus. Diabetes
Care. 2004;27(Suppl 1):S88-S90.
66.
47.
Plotnick LP, Clark LM, Brancati FL, Erlinger T. Safety and
effectiveness of insulin pump therapy in children and adolescents
with type 1 diabetes. Diabetes Care. 2003;26:1142-1146.
Amiel SA, Sherwin RS, Simonson DC, et al. Impaired insulin action in
puberty. A contributing factor to poor glycemic control in adolescents
with diabetes. N Engl J Med. 1986;315:215-219.
67.
48.
Sulli N, Shashaj B. Continuous subcutaneous insulin infusion in
children and adolescents with diabetes mellitus: Decreased HbA1c
with low risk of hypoglycemia. J Pediatr Endocrinol Metab.
2003;16:393-399.
Davidson PC. Bolus and supplemental insulin. In: Fredrickson L, ed.
The Insulin Pump Therapy Book: Insights from the Experts. Sylmar, Ca:
MiniMed Technologies; 1995:58-71.
68.
Evert AB, Mauseth RS. The new insulin analogs: Using a team
approach to implement basal-bolus insulin therapy. Practical
Diabetology. 2004;23:28-37.
69.
Dudley WE, Dudley MJ. Everyday management. In: Fredrickson L, ed.
The Insulin Pump Therapy Book: Insights from the Experts. Sylmar, Ca:
MiniMed Technologies; 2004:94-104.
70.
Brackenridge BP, Reed JH. Counting carbohydrates. The key to proper
bolusing. In: Fredrickson L, ed. The Insulin Pump Therapy Book:
Insights from the Experts. Sylmar, Ca: MiniMed Technologies;
1995:72-83.
71.
Beaser RS, Gallego MC. Intensifying insulin treatment program. In:
Beaser RS, ed. Joslin’s Diabetes Handbook. Boston, Ma: Joslin
Diabetes Center; 2001:273-328.
72.
Hirsch IB, Polonsky WH. Hypoglycemia and its prevention. In:
Fredrickson L, ed. The Insulin Pump Therapy Book: Insights from the
Experts. Sylmar, Ca: MiniMed Technologies; 1995:128-142.
73.
Sonnenberg GE, Fredrickson L. DKA prevention. In: Fredrickson L, ed.
The Insulin Pump Therapy Book: Insights from the Experts. Sylmar, Ca:
MiniMed Technologies; 1995:116-126.
74.
Burdick J, Harris S, Chase P. The importance of ketone testing. Pract
Diabetol. 2004;23:19-25.
49.
Weintrob N, Benzaquen H, Galatzer A, et al. Comparison of continuous
subcutaneous insulin infusion and multiple daily injection regimens in
children with type 1 diabetes: A randomized open crossover trial.
Pediatrics. 2003;112:559-564.
50.
Weinzimer SA, Ahern JH, Doyle EA, et al. Persistence of benefits of
continuous subcutaneous insulin infusion in very young children with
type 1 diabetes: A follow-up report. Pediatrics. 2004;114:1601-1605.
51.
Maniatis AK, Klingensmith GJ, Slover RH, et al. Continuous
subcutaneous insulin infusion therapy for children and adolescents:
An option for routine diabetes care. Pediatrics. 2001;107:351-356.
52.
53.
Saha ME, Huuppone T, Mikael K, et al. Continuous subcutaneous
insulin infusion in the treatment of children and adolescents with type
1 diabetes mellitus. J Pediatr Endocrinol Metab. 2002;15:1005-1010.
Burdick J, Chase HP, Slover RH, et al. Missed insulin meal boluses and
elevated hemoglobin A1c levels in children receiving insulin pump
therapy. Pediatrics. 2004;113:e221-e224.
54.
Greene MF. Prevention and diagnosis of congenital anomalies in
diabetic pregnancies. Clin Perinatol. 1993;20:533-547.
55.
Mills JL, Baker L, Goldman AS. Malformations in infants of diabetic
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treatment. Diabetes. 1979;28:292-293.
26
Post-Test
This program can also be completed online at www.MedEdToday.com. Please provide 1 answer for
each question (14 correct answers are necessary for successful completion). Place all answers on the
exam answer key provided on the evaluation form following this post-test.
1.
Which of the following are possible reasons to switch a patient from MDI to CSII therapy?
A.
B.
C.
D.
2.
Which of the following statements is NOT true about insulin pumps?
A.
B.
C.
D.
3.
D.
Less need to adjust insulin doses
Less need for SMBG
Greater flexibility to vary mealtimes and activity levels
Less need to monitor blood glucose or check ketones during illness
Prepump training goals for the patient include all of the following EXCEPT________ .
A.
B.
C.
D.
9.
True
False
CSII therapy is associated with which of the following advantages compared with MDI?
A.
B.
C.
D.
8.
Regular and long-acting insulin preparations are used in CSII therapy
Bolus doses of regular human insulin should be administered 30 minutes prior to a meal
Some studies suggest that the incidence of nocturnal hypoglycemia is lower when rapid-acting insulin
analogs are used for CSII
All of the above
Because insulin infusion pumps include an alarm system, patients do not need to monitor their
blood glucose levels as closely as with MDI.
A.
B.
7.
Self-reliant and motivated
Ability to solve problems
Willingness to adhere to frequent SMBG
All of the above
Which of the following is not true?
A.
B.
C.
6.
A small external pump connected to an infusion set and cannula
A small external pump connected to an infusion set and continuous blood glucose monitor
A small implantable pump
None of the above
Positive characteristics of a good candidate for insulin pump therapy include which of the
following characteristics?
A.
B.
C.
D.
5.
Glucose meters can be interfaced with some insulin pumps
The rate of insulin delivery automatically changes in response to readings received from the glucose
meter in all pumps
Long-acting insulins cannot be used
Pump components are housed in a plastic case no larger than a beeper
CSII therapy utilizes________ .
A.
B.
C.
D.
4.
Inability to achieve desired glycemic control with MDI
History of hypoglycemic unawareness
History of recurrent episodes of serious hypoglycemia
Any of the above
Understanding of the advantages and risks of CSII therapy
Calculating the patient’s insulin sensitivity
Procedures for minimizing the risk of DKA
Ability to use the pump, prime the tubing, and insert the needle
During therapy with CSII, hypoglycemia may occur because of all of the following EXCEPT_______ .
A.
B.
C.
D.
Basal rates that are set too high
Incorrect bolus dose
Improperly timed bolus doses
Basal rates that are set too low
27
10. CSII is NOT intended for toddlers or adolescents.
A.
B.
True
False
11. Which of the following is true for CSII therapy?
A.
B.
C.
D.
The basal rate is correctly determined if the fasting blood glucose values remain within the target range
Patients use an average of 75% less total daily insulin on CSII compared with prepump experience
Patients immediately begin CSII with 2 or 3 initial basal insulin rates
Both B and C
12. Signs and symptoms of DKA include all of the following EXCEPT________ .
A.
B.
C.
D.
Fruity breath
Hypertension
Dehydration
Somnolence
13. The risk of DKA can be reduced by________ .
A.
B.
C.
D.
Consuming a fast-acting carbohydrate
Establishing a routine for checking the pump, infusion set, and infusion site
Checking blood or urine ketones when plasma glucose levels are above 250 mg/dL
Both B and C
14. Which of the following is NOT true for patients on CSII therapy?
A.
B.
C.
D.
Adjustments in insulin dose should be considered when the patient’s diet changes
Basal doses of insulin should be based on the patient’s individualized meal plan
Patients should keep a supply of glucagon on hand
Both B and C
15. The recommended interval for changing the infusion set in CSII is________ .
A.
B.
C.
D.
24 hours
24 to 48 hours
24 to 72 hours
48 to 72 hours
16. Which of the following statements is not true about CSII therapy?
A.
B.
C.
D.
Patients using CSII therapy can participate in water sports.
CSII therapy involves the use of a “closed-loop” system.
The patient’s log recordings of SMBG values can be used by the healthcare team to help optimize therapy.
None of the above
17. CSII can be used during pregnancy.
A.
B.
True
False
18. All of the following EXCEPT ____ are undesirable characteristics of potential CSII candidates?
A.
B.
C.
D.
Fear of needles and pain
Inadequate financial resources
Presence of microvascular complications
Lack of commitment to strict treatment goals
19. Prepump training is usually conducted over 3 visits. All of the following EXCEPT ____ are covered
during visit 2.
A.
B.
C.
D.
Pump therapy is initiated
Trainer instructs patient on all aspects of pump programming and operation
Patient practices using the pump with saline
Patient learns how to change the insertion site in the home setting
20. Potential risks and complications of CSII therapy include all the following EXCEPT ________ .
A.
B.
C.
D.
28
Hypoglycemia
DKA
Retinopathy
Hyperglycemia
Evaluation Form
An Overview of Continuous Subcutaneous Insulin Infusion Therapy
Project ID: 3228 ES 13
Postgraduate Institute for Medicine (PIM) respects and appreciates your opinions. To assist us in evaluating
the effectiveness of this activity and to make recommendations for future educational offerings, please
take a few minutes to complete this evaluation form. You must complete this evaluation form to receive
acknowledgment of participation for this activity.
Please answer the following questions by circling the appropriate rating:
5 = Outstanding
4 = Good
3 = Satisfactory
2 = Fair
1 = Poor
Extent to Which Program Activities Met the Identified Purpose
• Provide clinicians treating diabetic patients with the latest information about 5
Continuous Subcutaneous Insulin Infusion (CSII) including indications,
benefits and risks, patient selection and training, types of insulin, basic
mechanism of the devices and the signs and symptoms of hypoglycemia
and diabetic ketoacidosis.
4
3
2
1
Extent to Which Program Activities Met the Identified Objectives
Upon completion of this activity, participants should be better able to:
• Describe the basic mechanism of CSII therapy
5
4
3
2
1
• Review the intent and indications for CSII therapy
5
4
3
2
1
• Evaluate the benefits and risks associated with CSII therapy
5
4
3
2
1
• Identify the types of insulin used in CSII therapy
5
4
3
2
1
• Identify the signs and symptoms of hypoglycemia and diabetic ketoacidosis 5
4
3
2
1
Overall Effectiveness of the Activity
• Was timely and will influence how I practice
5
4
3
2
1
• Will assist me in improving patient care
5
4
3
2
1
• Fulfilled my educational needs
5
4
3
2
1
• Avoided commercial bias or influence
5
4
3
2
1
Impact of the Activity
The information presented (check all that apply):
❏ Reinforced my current practice/treatment habits
❏ Provided new ideas or information I expect to use
❏ Will improve my practice/patient outcomes
❏ Enhanced my current knowledge base
❏ Yes ❏ No
Will the information presented cause you to make any changes in your practice?
If yes, please describe any change(s) you plan to make in your practice as a result of this activity:
How committed are you to making these changes?
(Very committed) 5
4
3
2
1 (Not at all committed)
Future Activities
Do you feel future activities on this subject matter are necessary and/or important to your practice?
❏ Yes ❏ No
29
Please list any other topics that would be of interest to you for future educational activities:
Follow-up
As part of our ongoing continuous quality-improvement effort, we conduct post-activity follow-up
surveys to assess the impact of our educational interventions on professional practice. Please
indicate your willingness to participate in such a survey:
❏ Yes, I would be interested in participating in a follow-up survey
❏ No, I’m not interested in participating in a follow-up survey
Additional comments about this activity:
If you wish to receive acknowledgment of participation for this activity, please complete the
post-test by selecting the best answer to each question, complete this evaluation verification of
participation and FAX to: 303-790-4876.
Post-Test Answer Key
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Request for Credit
Name
Degree
Organization
Specialty
Address
City
State
Zip
Telephone
Fax
E-Mail
For Physicians Only
I certify my actual time spent to complete this educational activity to be:
❏ I participated in the entire activity and claim 1.75 credits.
❏ I participated in only part of the activity and claim _____ credits.
Signature
30
Date Completed
© 2005 Scherer Clinical Communications
August 2005
Printed in USA