Practical CGM Improving Patient Outcomes through

Continuous Glucose Monitoring

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Jane Chiang, MD, conducted the internal review of this book to ensure
that it meets American Diabetes Association guidelines.

The paper in this publication meets the requirements of the ANSI

Standard Z39.48-1992 (permanence of paper).

ADA titles may be purchased for business or promotional use or for

special sales. To purchase more than 50 copies of this book at a discount,
or for custom editions of this book with your logo, contact the American
Diabetes Association at the address below or at [email protected].

American Diabetes Association

1701 North Beauregard Street
Alexandria, Virginia 22311

DOI: 10.2337/9781580406031
For more information or assistance with CGM or intensive diabetes
management, Gary Scheiner may be reached at (877) 735-3648 (outside
North America, +1-610-642-6055) or [email protected].
Library of Congress Cataloging-in-Publication Data
Scheiner, Gary.
Practical continuous glucose monitoring / Gary Scheiner.
pages cm
Summary: “This book will help readers understand the benefits of
Continuous Glucose Monitoring Systems, and how to use them properly
to manage diabetes and manage it right”-- Provided by publisher.
Includes bibliographical references and index.
ISBN 978-1-58040-603-1 (paperback)
1. Insulin pumps. 2. Insulin--Therapeutic use. 3. Blood sugar monitoring.
I. Title.
RC661.I63S34 2015
616.4’62061--dc23
2015011945
eISBN: 978-1-58040-626-0
Contents
Foreword by Donna Tomky
Foreword by Bruce Buckingham
Introduction
1 Essentials of Continuous Glucose Monitoring
2 Maximizing the Benefits in Real Time
3 Improving Control with CGM Data Analysis
4 Defeating the Downsides
Appendix: Helpful Products for Sensor Site Management
References
Foreword
by Donna Tomky

Everyone needs a practical guide to help them decipher the complex data
they receive from a technological source, especially when that source is
powerful continuous glucose monitoring (CGM) technology. Gary Scheiner
has put together this informative and helpful guide to aid both novices and
experienced practitioners in getting the best results out of CGM devices.

Practical CGM discusses who might consider using CGM devices and
breaks down the particular benefits for each individual, including patients,
professionals, caregivers, and significant others. Individual considerations
for each device help identify which devices may be better suited for some
and not for others; after all, not all devices will fit everyone perfectly! His
unbiased review of the currently available CGM equipment is necessary
and essential. Gary helps shed light on the performance aspects of each
device and what we can expect from them. He demystifies the data that
come from CGM and shows us what to do with all those numbers!
Knowing what those numbers mean and how to interpret trends leads to
tighter and safer glucose control. After all, isn’t that what CGM is all about?

Gary is not afraid to use his own life with diabetes to illuminate the ups
and downs of using a CGM device. For example, he recommends practical
high-alert settings to prevent users from bolusing while insulin is on board.
He appropriately calls this a “rage bolus” or an “angry bolus” when it is
done in response to an apparently slow response to insulin administration.
These practical and real-life examples from his life and from his practice
help show that the frustration and anger many of us have experienced while
using insulin are normal and understandable. What we must do is learn to
work around those feelings.

CGM wearers and clinicians alike will appreciate Gary’s practical

guidelines for selecting useful reports and getting the best results from
device software. The discussion about how to determine whether data are
inaccurate or reliable is timely and important. Gary shows how statistical
analysis of CGM data can guide translation of CGM data into real-life
results. Through numerous examples and case studies, we see how putting
information into practice can help us better interpret the complexities of
CGM data. As a health-care provider, these case studies reminded me of
past patients and situations that fit these patterns and made me really
appreciate his brilliant insight.

Be sure to read his “Ingredients for Success,” starting on page 89, which
is “a series of concise best practices for CGM success.” This section is a
worthwhile read and perhaps should be read first to summarize how to
avoid and troubleshoot problems.

Practical CGM is a practical guide for anyone using or interpreting

CGM data, and I think anyone who uses CGM or helps those who use it
should find this book insightful, helpful, and essential.

Donna Tomky, MSN, RN, ANP-BC, CDE, FAADE, is the 2011 Past
President of the American Association of Diabetes Educators and works in
the Department of Endocrinology at ABQ Health Partners in Albuquerque,
NM.
Foreword
by Bruce Buckingham

For anyone considering using CGM—and for health-care providers who are
new to or experienced with CGM use—Practical CGM provides a wealth
of facts and tips. The principles of CGM are clearly explained and will
remain valid for many years to come, even as the technology progressively
improves. The current systems are explained in great detail, with many
practical tips for the new or experienced user or health-care professional.
This book is essential for anyone considering or currently using CGM.

One of the keys to CGM use is setting appropriate expectations. This

means providing clear guidelines on how to achieve the most with a CGM
and how to balance the wealth of information, which Gary appropriately
calls “datus overwhelmus.” Gary has done an excellent job in setting those
expectations so that people using a CGM will not be overwhelmed and will
be able to take full advantage of what CGM has to offer.

CGM has been available since 2000, initially for retrospective review of
glucose data and then for real-time monitoring. The ability to continuously
monitor glucose values was considered a game changer for diabetes
management, and there were initially very high expectations about how this
information would improve glycemic control and the lives of people with
diabetes. These expectations are now just beginning to be realized 15 years
later. The early devices were not very accurate, were bigger, and had many
issues with insertion and skin reactions to adhesives. Over the last several
years, there have been significant improvements in both the accuracy and
the “wearability” of these devices, and they are now being integrated into
consumer electronics, such as smartphones. With improved sensor accuracy,
people are beginning to rely on them more and more to make diabetes-
management decisions, often depending on sensor values to make insulin
dose decisions “off label.” Practical CGM acknowledges this practice and
provides many helpful guidelines on how to do this safely as well as when
to get an essential meter reading. Using glucose trend information in real
time is critical to maximizing the benefits of a CGM. CGM users will find
many examples of how to adjust their insulin boluses and manage exercise
using rate-of-change information.

In the future, there will be factory-calibrated sensors that will only

require the use of a meter reading when the sensor value is inconsistent with
how a person is feeling. Until then, this book provides very useful
guidelines for integrating meter readings with CGM devices, e.g., when to
calibrate and adjust for other issues with subcutaneous sensor lag times.
One of the real advantages a real-time sensor provides is the ability to
generate an alarm when glucose is at a critical value or predicted to reach a
critical value. This, however, is a double-edged sword since one of the
major complaints with real-time sensors is the frequency of false alarms,
alarm burnout, and sleep disruption for the person with diabetes and/or
significant others. Gary provides helpful guidelines for getting the best
results out of alarms while minimizing alarm fatigue and burnout.

Data analysis is a huge benefit for CGM users, and yet very few CGM
users actually take advantage of this powerful information. I have found the
information provided by CGM data analysis to be invaluable in helping
people navigate the daily barriers to glycemic stability. As with daily meter
glucose readings, data analysis should not be done only every three to four
months at a medical appointment. This is a skill that every person with
diabetes can quickly learn, and it should be practiced on a regular basis.
Practical CGM illustrates how to use and interpret the multiple graphs and
data packages provided by the CGM software. Multiple “case reports” use
both the professional and personal software, and the reports cover a wide
range of CGM users, including people with both type 1 and type 2 diabetes,
pump and MDI (multiple daily injection) users, and people using real-time
or “blinded” CGM. Even the most experienced CGM user or health-care
professional can learn from these examples and begin taking full advantage
of CGM data analysis.

The future vision is the integration of CGM data with insulin delivery so
that the daily tasks of treatment decisions and diabetes management are
reduced. Overnight glycemic control with a closed-loop system is much
easier to achieve than daytime control because it does not have to deal with
rapid glucose excursions due to meals and exercise. Removing the fear of
prolonged nocturnal hypoglycemia and allowing a person to wake each
morning with a near-normal glucose value is currently a reality that is being
achieved in multiple in-home outpatient trials. Within a few years these
systems may be commercially available. Hybrid closed-loop systems that
rely on some user input during the day, such as meal announcement, will
also be available in the next several years. These systems may give
correction doses automatically based on CGM data, and the need for
carbohydrate counting and diabetes “numeracy” may be removed, with only
the need to announce that a meal or exercise session has been initiated. A
fully closed-loop system that does not require any user input may require
additional advances, such as a more rapid-acting insulin and a stable
glucagon. The commercialization of these systems will be a gradually
evolving process. But because these systems are all based on using CGM,
the information Gary has provided here will continue to be useful for many
years to come, even when systems that begin to “close the loop” become
available.

I would recommend this book to anyone considering CGM, to

experienced CGM users and to any health-care provider who is taking care
of people with diabetes (whether type 1 or type 2). CGM systems are
getting better and better and are becoming an integral part of managing
diabetes, and Practical CGM offers many insights to make the best out of
all that CGM offers.

Bruce Buckingham, MD, is a Professor of Pediatric Endocrinology at the

Stanford School of Medicine and Stanford Children’s Health.
Introduction
If New Technology Falls in Our Laps, Does It
Make a Sound?
It was a hot, muggy day down in southern Florida. My wife and I decided to
bring the kids to visit their grandparents (aka Mom-Mom and Pop-Pop)
from our home just outside of Philly. The last time we visited, we bought
my parents a computer and set them up with high-speed Internet so that
they could follow our blogs and video-chat with their grandkids in real
time. It wasn’t the best computer in the world, but it was more than good
enough to surf the net and maybe even help them keep their checkbook
balanced.

What we found when we arrived at their condo was not to be believed.

They were using the computer, but not as we originally intended. The clock
at the bottom right corner of the screen served as their bedroom clock. And
they kept the screen on all the time, with a plain white background, to serve
as a nightlight. Said my mom, “You think I want your father breaking a toe
on his way to the bathroom in the middle of the night? The man has a
prostate!”

Speaking of Mom, she also found that the edges of the display were the
perfect place to leave sticky note messages for my dad. Important stuff, like
“Buy eggs” and “Pick up my medication.” Mom did figure out how to play
solitaire on the computer, but that’s the extent of their use of any actual
programs. My dad found a creative use for the hardware . . . specifically, the
cooling fan. They don’t like running the air conditioner until the
temperature reaches a thousand degrees, but that fan on the CPU, when
positioned just right, could keep his legs cool while he watched TV.

I’m sharing all this unsettling information about my parents and their
computer to prove a point: There is a big difference between having
technology and using it to one’s advantage. Continuous glucose monitoring
systems (hereafter referred to as CGMs) are a perfect example. Tens of
thousands of people with diabetes use CGMs, but how many are really
benefiting from them? For those who are benefiting in some way, how
many are taking full advantage of everything CGM has to offer? And how
much are their health-care providers really able to glean from the dizzying
array of data that CGMs and their accompanying software produce?

Having lived with type 1 diabetes for 30-plus years and having treated
and managed clients with diabetes for more than 20 years, I’ve never been
one to take a “woe is me” approach. We’ve got this disease; we’d might as
well manage it right.

The purpose of this book is not to sell you on the merits of CGM.
Whether you treat patients who use CGM or have diabetes (type 1 or type
2) and wear a monitor yourself, this book is all about making diabetes
easier to manage. We’re past the point of being in awe of CGM’s cool-
looking graphics. It’s time to start reaping the benefits of this innovative
technology. Technology to benefit us all.

To communicate effectively with CGM users and clinicians worldwide,

glucose data throughout this book will be expressed in both mg/dL and
mmol/L. The mmol/L values will be placed in square brackets. For
example, 180 [10] means 180 mg/dL or 10 mmol/L.
Chapter 1

Essentials of Continuous Glucose Monitoring

There’s a reason so many major companies have invested heavily in
fingerstick glucose monitoring. Point-in-time glucose readings are valuable,
and not just for those who are pricking their fingers. They rake in billions
for medical device manufacturers because they allow us to titrate (fine-
tune) insulin and medication doses, see cause-and-effect relationships
within our daily lives, conduct cutting-edge research on new treatments,
and fix elements of diabetes management programs that just aren’t working.
Like a photograph or a painting, fingerstick blood glucose (BG) readings
depict what is happening at a particular moment in time, but they also leave
a lot to the imagination. Take any 10 people and show them a portrait of da
Vinci’s Mona Lisa, and you’ll hear 10 different interpretations about who
she was, what she was like, and what she was thinking about.

As we will discuss in Chapter 2, adding a continuous glucose monitor

(CGM) to one’s diabetes management is like taking all those images and
turning them into a movie, complete with “story notes.” CGM lets us see
and understand the full picture—where we came from, where we are, and to
an extent, where we’re headed. CGM’s alert features provide the user with
an early warning system to guard against severe hypoglycemia and
prolonged hyperglycemia. And the ability to analyze CGM data
retrospectively gives health-care providers and their patients an opportunity
to make decisions based on facts rather than assumptions.

These are among the reasons that CGM is growing in popularity. There
is no question that the technology still has considerable room for
improvement, and our ability to interpret CGM data is still evolving.
Nevertheless, CGM has already been shown to be an effective tool for
improving glucose control and quality of life for users.1–5

GET TO KNOW THE EQUIPMENT

Currently, Dexcom and Medtronic offer CGM systems in the United States.
Although systems by other manufacturers are available in other countries,
our discussions will focus on devices that are approved by the U.S. Food
and Drug Administration (FDA) and available for sale in the U.S. In
addition to real-time systems that allow the user to see, learn from, and
react to their own data, both Medtronic and Dexcom offer professional use
systems. Professional systems are borrowed for a fixed period of time
(typically 6–7 days). The only significant difference between systems is
whether the user is able to see their data while they wear the sensor. The
Dexcom G4 Professional system has an option that allows the user to see
their data in real time or to blind it (not showing it on the display) until the
receiver is downloaded. The Medtronic Professional system, called iPro, is
always blinded to the user. Health-care providers download the professional
system after removing the sensor from the patient and analyze the
information to make therapy adjustments.

Regardless of the manufacturer and whether the device is for real-time

or professional use, three components are common to all CGM systems: a
sensor, a transmitter, and a receiver or display.

Sensors
The sensor is a thin, flexible, metallic filament that is about a finger-
width long (Fig. 1.1). It is placed in the layer of fat below the skin using a
push-button insertion device (Fig. 1.2). The insertion device pops a small
needle (with the sensor attached) into the skin and then retracts the needle,
leaving only the sensor below the skin. The insertion process is virtually
painless when done properly; training by a device manufacturer
representative is highly recommended. Sensors are indicated for ~1 week of
use (6 days for the Medtronic Enlite; 7 days for the Dexcom G4).
Anecdotally, users have reported the ability to use sensors for longer than
their FDA-approved indication, but at present no controlled studies have
evaluated the safety and efficacy of prolonged sensor use.
Figure 1.1—Sensors.
Figure 1.2—Insertion devices.

Transmitters
Once below the skin, the sensor reacts with glucose molecules by
generating a miniscule electric current. This current travels up to the base of
the sensor on the skin surface where it connects to a transmitter (Fig. 1.3).
The transmitter is about the size of a thumbnail. It contains its own power
source and a radio transmitter. Transmitters require periodic charging or
replacement to keep the power fresh.
Figure 1.3—Transmitters. The image on the left also shows the
transmitter charger.

Receivers and Displays

The radio frequency generated by the transmitter varies based on the
magnitude of the electrical impulse coming from the sensor. Each
transmitter has a unique ID and is linked to a receiver—a device that
interprets the radio signals and displays the corresponding glucose data
(Fig. 1.4). The Dexcom CGM utilizes a handheld receiver about the size of
a small cellular phone. It also transmits to the Animas Vibe insulin pump
and soon will be able to transmit to other insulin pumps. The Medtronic
CGM display is integrated into Medtronic insulin pumps (model x22 and
higher). Medtronic also offers a stand-alone receiver (not an insulin pump)
called Guardian. The Guardian receiver has similar functionality to the
CGM component of Medtronic’s insulin pumps, although it is only
approved for use with Medtronic’s previous-generation Sof-sensor and uses
an older algorithm to interpret the signals.