REAL benefits for your patients
and your practice
The Guardian®RT System delivers:
• REAL protection for your patients from high and
1
low glycemic excursions.
-4
• REAL insight for your patients with REAL-Time
readings of glucose values updated every five minutes,
so they can intervene sooner for improved therapy
management.
2-4
• REAL security for your patients with REAL-Time
alarms to warn against hypo- and hyperglycemia.
• REAL empowerment for your patients by enabling
them to use their Guardian RT System as a diary
showing how diet, exercise, medication, and lifestyle
1
affect glycemic control.
-3
Solutions®Software for
Guardian makes downloading the data easy.
• REAL advantages for you to focus more on optimizing
ther
apy an
ss on mana
d le
ging basic therapy adherence
by enhancing patient understanding and selfmanagement of glycemic control.
Safety Information
Continuous Glucose Monitoring
Medtronic MiniMed Guardian RT Continuous Glucose Monitoring System
Patients should always discuss potential risks and benefits with a physician. Please review the
product manual prior to use for detailed instructions and disclosure.
Prescription Device Warning
Caution: U.S. law restricts this device to sale by, or on the order of, a licensed physician.
Indications for Use
The Guardian RT Continuous Glucose Monitoring System is intended to continuously record
interstitial glucose levels in persons 18 years and older who have Type 1 or Type 2 diabetes.
This information is intended to supplement, not replace, blood glucose information obtained
using standard home glucose-monitoring devices. The information collected by the GuardianRT
Continuous Glucose Monitoring System may be downloaded and displayed on a computer and
reviewed by healthcare professionals. This information may allow identification of patterns of
vel excursions above or below the desired range, facilitating therapy adjustments that
e-le
os
gluc
ay minimize these excursions.
m
Contraindications
Successful operation of the GuardianRT Continuous Glucose Monitoring System requires
adequate vision and hearing. Use of the GuardianRT Continuous Glucose Monitoring System is
not recommended for patients whose impaired vision or hearing does not allow full recognition
nitor signals and alarms, or who do not have a caregiver that can perform this function
f the mo
o
for them.
Warnings/Precautions
dianRT Continuous Glucose Monitoring System users should be educated to program
r
The Gua
and operate the monitor and respond to alarm conditions prior to attempted use of the system.
The current and voltage signals shown in the monitor are to be used only for finding potential
problems with the GuardianRT Continuous Glucose Monitoring System and do not indicate the
current glucose value. Infection and/or site irritation may result from improper insertion and
maintenance of insertion site.
Read Chapter 2, “Inserting the Sensor,” in your product manual, for proper preparation of site
prior to insertion. Failure to follow instructions may result in pain or injury.
dquarters
a
s He
e
t
abe
Di
o
dtr
Me
18000 D
thridg
Nor
www.minimed.com
1-800-MINIMED (1-800-646-4633)
CGMS and Guardian are registered trademarks of Medtronic MiniMed.
System Gold is a trademark of Medtronic MiniMed.
©2005 Medtronic MiniMed. All rights reserved. 9197565-011 091305
nic Diab
nshir
o
v
e
e, CA 91325
e
es
t
e Str
eet
13
Leading the way to the
first artificial pancreas
As the pioneer of both insulin pump therapy
and continuous glucose monitoring,
onic Diabetes is the only company with
Medtr
the resources, advances and technological
building blocks necessary to achieve an
artificial pancreas. This has been our vision
since the inception of the company more
than 20 years ago.
d.c
Call 1-888-206-REAL or visit www.minim
additional information.
References:
tents. Sensor technologies.
a
US P
1.
Data on File Medtronic Diabetes, 2005.
2. Bode BW, et al.
Clin Practice.
3. Kaufman FR, et al.
2001;24(12):2030.
4. Ludvigsson J, et al.
2003;111(5 Pt 1):933-8.
5. Bode B, et al.
2004;6(2):105-13.
6. Derr R, et al.
2003;26(10):2728-33.
7. DCCT.
1997;277(5):374-5.
Diabetes Research and
1999;46:183-90.
Diabetes Care.
Pediatrics.
DiabetesTechnol Ther.
Diabetes Care.
JAMA.
e
il GM, et al.
e
St
8.
2000;49(Suppl 1):510.
9. Gross TM, et al.
2000;2(Suppl 1):S19-26.
10. Caplin NJ, et al.
2003;20:238-41.
11. Skyler JS, et al.
2000;2(Suppl 1):S7-12.
Diabetes Care.
12. ADA
2002;25(1):S33-49.
13. Ludvigsson J, et al.
2003;20(1):7-12.
14. Pilot Study. Guardian RT. Data on File
Medtronic Diabetes 2005.
dianr
r
om/gua
s.
e
t
Diabe
DiabetesTechnol Ther.
Diabet Med.
Diabetes Technol Ther.
Pract Diab Int.
t f
REAL-Time glucose readings and alarms
for reduced glucose variability
or
1-4
Now available to your patients:
Continuous glucose monitoring system
with REAL-Time glucose readings and alarms
The Guardian®RT Continuous Glucose Monitoring System is the latest advance in diabetes
management by Medtronic Diabetes, the 20-year pioneer of continuous glucose monitoring and
insulin pump therapy. Medtronic Diabetes is the sensor expert and pioneered CGMS
the first FDA-approved continuous glucose monitoring system for physician use. Insights from
the 3-day diagnostic system have been used by physicians in more than 150,000 patients
worldwide to gain valuable insights into their glycemic control.
Now Medtronic Diabetes proudly brings the benefits of continuous glucose monitoring directly to
patients with the Guardian RT system. This new technology gives patients access to REAL-Time
glucose readings and alarms, around the clock, so they can intervene in ways never before
possible, reducing their glucose variability and achieving improved diabetes management.
The Guar
a continuous glucose sensor,
radiofrequency transmitter, and
the Guardian RT monitor to give
y
information around the clock
dian RT system includes
atients R
our p
EAL-Time gluc
ose
®
System,
-4
2
2-5
REAL-Time Glucose Readings
are viewable at the push of a button. An updated glucose value is available
every five minutes — 288 times per day — at work, during mealtime, when
exercising and overnight, to help patients take action before they experience
a problem. You can also view previous glucose values during the last 8 hours.
wareness of glucose variability is important because even brief fluctuations
A
in glucose levels can lead to long-term diabetes complications like eye, nerve,
kidney and heart disease.
6,7
REAL-Time Alarms
warn patients of hypoglycemia and hyperglycemia, day or night, that may not
d by fingersticks alone and HbA1c testing.
ale
e
v
e
e r
b
5,6
Ala
rms c
an b
sound or vibrate. The sound volume of the alarms can also be adjusted to suit
tient’s unique needs. Patient response to REAL-Time alarms resulted
a
our p
y
in a significant re
duction in the duration of hypoglycemic excursions.
e pr
5
t to
e
s
e
REAL-Time system components help your patients
manage their diabetes like never before
The Guardian RT Transmitter — Communicates wirelessly
through radio frequency (RF) to the Guardian RT monitor
REAL-Time Glucose Readings
REAL-Time Alarms
®
tware for Guardian —
ns
Solutio
n kn
tio
a
t
s
easily download historical information from the Guardian RT
tem to a computer.
sys
f
So
wn as the Com-Station™, you and your patients can
o
g a special docking
Usin
Continuous Glucose Sensor provides
REAL insights — This tiny REAL-Time sensor
inserts easily under the skin in a virtually
painless process. It measures current glucose
levels in interstitial fluid. The accuracy of
continuous glucose monitoring is proven in
numerous published studies.
required prior to adjusting insulin delivery and
when calibrating the glucose sensor.
an RT mo
The Guar
inf
include on-screen REAL-Time glucose readings
an
into the
control and improve their diabetes management.
di
atio
orm
d alarms t
ir gluc
ound the clock
n ar
o give patients meaningful insights
v
e le
os
nitor
els, enabl
-10
8
Fingersticks are
EAL-Time
ws R
o
sh
v
— Inno
ing them to take
ns
tio
a
•
reports show the effect of meals, exercise and medication
tient’s glycemic control
a
n a p
o
• Includes Historical Trend Graphs — Up to 21 days of
information are available for downloading glucose trends to
make it easier for you to optimize your patient’s therapy
the
omizable Treatment Reports —
t
s Cus
e
t
a
Gener
e
s
Reduce glycemic variability and HbA1c levels
3:00 AM
0
5.6
11.1
16.7
6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM
Time of day
Fingersticks alone
Glucose - mmol/L
Target zone
Lows missed by these fingersticks
Highs missed by these finger sticks
Continuous glucose monitoring
3:00 AM
0
5.6
11.1
16.7
6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM
Time of day
3:00 AM 6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM
Time of day
Fingersticks alone
Glucose - mmol/L
0
5.6
11.1
16.7
Glucose - mmol/L
Target zone
Target zone
P = 0.03
9.0
8.5
8.0
7.5
7.0
P = n.s. P = .011
6.5
6.0
Start 6 weeks
Continuous glucose monitoring vs. fingersticks
4
HbA1c, % ± SE
12 weeks
Fingersticks alone
CGM
using continuous glucose monitoring vs. fingersticks alone
The revolutionary Guardian®RT system gives patients the benefits of continuous glucose
monitoring in REAL-Time, around the clock. Continuous glucose monitoring is proven to improve
-5
patient outcomes versus fingersticks alone by reducing glycemic variability and HbA1c levels.
2
Reduces HbA1cs and related complications
More meaningful insights than fingersticks alone
Fingersticks taken 4 times only
give you part of the picture
Continuous glucose monitoring
completes the picture
*
Measures glucose levels continuously:
•
t as the systems of a human
Jus
body monitors glucose levels to guide insulin release, continuous
glucose monitoring measures glucose 24 hours a day giving patients
meaningful insights to help guide therapy decisions
• HbA1c testing and fingersticks alone provide less meaningful insights
because they do not monitor glucose levels continuously
— HbA1c testing is performed at a single point in time, once every
2 to 3 months and produces an average blood glucose level
— Fingersticks also measure glucose levels at a single point in time —
patients test on average 4 to 5 times per day
• REAL-Time continuous glucose monitoring provides updated glucose
readings every five minutes — up to 288 glucose measurements per
day — to alert patients to take action sooner
2-5
• Reduces long-term diabetes complications: Continuous glucose monitoring has been shown to help guide
-4
therapy adjustment leading to reductions in HbA1c levels versus the use of fingersticks alone
2
— Each 1% reduction in HbA1c reduces the risk of long-term complications like eye, nerve, kidney and heart
,12
disease by 15% to 30%
REAL-Time alarms helped reduce the
duration of hypoglycemic excursions
7
Continuous glucose monitoring
10
reduces HbA1cs
Better detects hypoglycemia and hyperglycemia
for more proactive patient self-management
• Identifies hidden variability: Continuous glucose monitoring helps
veal dangerous glucose variability that may not be tracked by
e
r
fingersticks alone and HbA1c testing
6
— 60% of lows may not be revealed when using fingersticks alone.
HbA1c testing provides a 2 to 3 month average of glucose levels
and isn’t intended to track highs and lows
6
— Continuous glucose monitoring identifies up to 4 times more
glucose excursions requiring therapy adjustment versus
e, so patients can intervene more quickly
n
s alo
tick
ers
g
fin
* Chart is illustrative of a patient taking 4 fingersticks in one day, at times shown.
3
atient response to REAL-Time alarms resulted in a
P
ean duration of hypoglycemic
n in m
ductio
e
48% r
excursion, from 64.4 minutes to 33.6 minutes
9,11
(P = 0.004).
EAL-Tim
R
5
Patients in the control group, without
e alarms, experienced no significant change
By helping to reduce HbA1c levels, continuous
g helps to reduce the risk of long-
in
or
nit
ose mo
gluc
term complications and increase a patient’s lifespan
7
More life-changing insights for your patients
More meaningful support for you
The knowledge and insights provided by the Guardian®RT system can dramatically improve the way your
patients manage their diabetes to help them achieve optimal glycemic control. This life-changing technology
is also easier for you to manage with the hands-on training and support provided by Medtronic Diabetes.
Motivates patients to improve self-management
Life-changing impact:Continuous glucose monitoring insights can help educate and
•
motivate diabetes patients, which can have a profound effect on a patient’s attitude,
self-management and way of living
— This means that you can focus more on helping patients to optimize their therapy and
less on managing basic therapy adherence
• For Type 1 and Type 2 diabetic patients:
13
The GuardianRT
system is indicated for use in Type 1 and Type 2 diabetes
patients who desire better glucose control to improve their
health and quality of life
Medtronic Diabetes helps you and your patients get started on the
Guardian RT system
The GuardianRT system is designed to be easy for patients to use. Plus, when you partner with Medtronic
etes you’ll get the support you need before, during and after patients get started.
Diab
Simplify new patient starts
• 3-step CGM interpretation methodology makes it
easy for you to analyze continuous glucose monitoring
information
To learn more about the
3-step CGM interpretation
methodology contact
— Learn how to quickly review reports of the overnight,
pre-prandial, and post-prandial periods to assess your
patient’s glucose control for optimal diabetes
management
your local Medtronic
Diabetes representative
The Guardian RT system provides increased
patient satisfaction and control
14
In a pilot study of 16 people using
the Guardian RT*:
94% used REAL-Time glucose readings
ontrol glucose levels
o c
d/or ala
an
81% reported greater satisfaction with
ir gluc
the
75% adjusted their insulin delivery based
n the REAL-Tim
o
63% changed their diet based on the
REAL-Time readings
31% made lifestyle changes based on the
REAL-Time readings
rms t
e control
os
e readings
“When he saw his own fluctuating blood glucose on the
computer after having used the glucose sensor for three
days, he suddenly seemed to understand. Insulin doses
were adjusted, and he became more motivated to eat
regular meals with better content. HbA1c decreased
within a few months from 9.4% to 7.6%.”
– Excerpt from a case study of an 18-year old diabetes patient motivated by
continuous glucose monitoring to transform his poor self-management
• Helpful training and educational tools familiarize you and
your patients with the system and its use
• Certified specialists train your staff, which helps you
to train your patients
Rely on trusted customer support
• 24-hour Helpline — available 24 hours a day, 365 days a year at absolutely no cost to patients.
vide highly trained technicians who answer your call personally,
o
o pr
any t
omp
nly c
e the o
e’r
W
unlike other companies that need to page professionals first
•
Mor
e support professionals and services
13
than any o
ther diab
etes technology company
*These study results are preliminary. A randomized, controlled, multi-center
study has recently concluded and a study analysis is currently underway.
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