REAL benefits for your patients
and your practice
The Guardian® RT System delivers:
•
•
REAL protection for your patients from high and
low glycemic excursions.1-4
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
affect glycemic control.1-3 Solutions® Software for
Guardian makes downloading the data easy.
Leading the way to the
first artificial pancreas
As the pioneer of both insulin pump therapy
and continuous glucose monitoring,
Medtronic Diabetes is the only company with
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.
•
REAL advantages for you to focus more on optimizing
therapy and less on managing basic therapy adherence
by enhancing patient understanding and self-
management of glycemic control.13
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
glucose-level excursions above or below the desired range, facilitating therapy adjustments that
may minimize these excursions.
REAL-Time glucose readings and alarms
for reduced glucose variabi l ity1-4
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
of the monitor signals and alarms, or who do not have a caregiver that can perform this function
for them.
additional information.
Warnings/Precautions
The GuardianRT Continuous Glucose Monitoring System users should be educated to program
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.
References:
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.
1. US Patents. Sensor technologies.
Data on File Medtronic Diabetes, 2005.
2. Bode BW, et al. Diabetes Research and
Clin Practice. 1999;46:183-90.
3. Kaufman FR, et al. Diabetes Care.
2001;24(12):2030.
4. Ludvigsson J, et al. Pediatrics.
2003;111(5 Pt 1):933-8.
5. Bode B, et al. DiabetesTechnol Ther.
2004;6(2):105-13.
8. Steil GM, et al. Diabetes.
2000;49(Suppl 1):510.
9. Gross TM, et al. DiabetesTechnol Ther.
2000;2(Suppl 1):S19-26.
10. Caplin NJ, et al. Diabet Med.
2003;20:238-41.
11. Skyler JS, et al. Diabetes Technol Ther.
2000;2(Suppl 1):S7-12.
Diabetes Headquarters
Medtronic Diabetes
18000 Devonshire Street
Northridge, CA 91325
12. ADA Diabetes Care.
2002;25(1):S33-49.
1-800-MINIMED (1-800-646-4633)
6. Derr R, et al. Diabetes Care.
2003;26(10):2728-33.
7. DCCT. JAMA.
13. Ludvigsson J, et al. Pract Diab Int.
2003;20(1):7-12.
14. Pilot Study. Guardian RT. Data on File
Medtronic Diabetes 2005.
CGMS and Guardian are registered trademarks of Medtronic MiniMed.
System Gold is a trademark of Medtronic MiniMed.
1997;277(5):374-5.
©2005 Medtronic MiniMed. All rights reserved. 9197565-011 091305
Download from Www.Somanuals.com. All Manuals Search And Download.
Reduce glycemic variability and HbA1c levels
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
patient outcomes versus fingersticks alone by reducing glycemic variability and HbA1c levels.2-5
Reduces HbA1cs and related complications
•
Reduces long-term diabetes complications: Continuous glucose monitoring has been shown to help guide
therapy adjustment leading to reductions in HbA1c levels versus the use of fingersticks alone2-4
More meaningful insights than fingersticks alone
•
•
Measures glucose levels continuously: Just as the systems of a human
— Each 1% reduction in HbA1c reduces the risk of long-term complications like eye, nerve, kidney and heart
disease by 15% to 30%7,12
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
Fingersticks taken 4 times only
give you part of the picture*
HbA1c testing and fingersticks alone provide less meaningful insights
because they do not monitor glucose levels continuously
Fingersticks alone
REAL-Time alarms helped reduce the
duration of hypoglycemic excursions10
Continuous glucose monitoring
reduces HbA1cs
16.7
11.1
5.6
0
— HbA1c testing is performed at a single point in time, once every
2 to 3 months and produces an average blood glucose level
Target zone
— Fingersticks also measure glucose levels at a single point in time —
patients test on average 4 to 5 times per day
Continuous glucose monitoring vs. fingersticks4
3:00 AM 6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM
9.0
8.5
8.0
7.5
Time of 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 sooner2-5
Fingersticks alone
CGM
Continuous glucose monitoring
completes the picture
7.0
P = n.s.
P = .011
6.5
6.0
Continuous glucose monitoring
Better detects hypoglycemia and hyperglycemia
for more proactive patient self-management
16.7
11.1
5.6
0
Start
6 weeks
12 weeks
Highs missed by these fingersticks
P = 0.03
•
Identifies hidden variability: Continuous glucose monitoring helps
reveal dangerous glucose variability that may not be tracked by
fingersticks alone and HbA1c testing6
Patient response to REAL-Time alarms resulted in a
48% reduction in mean duration of hypoglycemic
excursion, from 64.4 minutes to 33.6 minutes
By helping to reduce HbA1c levels, continuous
Target zone
glucose monitoring helps to reduce the risk of long-
Lows missed by these fingersticks
term complications and increase a patient’s lifespan7
(P = 0.004).5 Patients in the control group, without
REAL-Time alarms, experienced no significant change
— 60% of lows may not be revealed when using fingersticks alone.9,11
HbA1c testing provides a 2 to 3 month average of glucose levels
and isn’t intended to track highs and lows6
3:00 AM 6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM
Time of day
— Continuous glucose monitoring identifies up to 4 times more
glucose excursions requiring therapy adjustment versus
fingersticks alone, so patients can intervene more quickly3
* Chart is illustrative of a patient taking 4 fingersticks in one day, at times shown.
Download from Www.Somanuals.com. All Manuals Search And Download.
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.
Medtronic Diabetes helps you and your patients get started on the
Guardian RT system
Motivates patients to improve self-management
The GuardianRT system is designed to be easy for patients to use. Plus, when you partner with Medtronic
•
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 living13
Diabetes you’ll get the support you need before, during and after patients get started.
Simplify new patient starts
— This means that you can focus more on helping patients to optimize their therapy and
less on managing basic therapy adherence
•
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
your local Medtronic
•
For Type 1 and Type 2 diabetic patients: 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
— 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
Diabetes representative
•
•
Helpful training and educational tools familiarize you and
your patients with the system and its use
Certified specialists train your staff, which helps you
“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%.”
to train your patients
The Guardian RT system provides increased
patient satisfaction and control14
Rely on trusted customer support
•
24-hour Helpline — available 24 hours a day, 365 days a year at absolutely no cost to patients.
In a pilot study of 16 people using
the Guardian RT*:
We’re the only company to provide highly trained technicians who answer your call personally,
unlike other companies that need to page professionals first
94% used REAL-Time glucose readings
•
More support professionals and services than any other diabetes technology company
and/or alarms to control glucose levels
81% reported greater satisfaction with
– Excerpt from a case study of an 18-year old diabetes patient motivated by
continuous glucose monitoring to transform his poor self-management13
their glucose control
75% adjusted their insulin delivery based
on the REAL-Time readings
63% changed their diet based on the
REAL-Time readings
31% made lifestyle changes based on the
REAL-Time readings
*These study results are preliminary. A randomized, controlled, multi-center
study has recently concluded and a study analysis is currently underway.
Download from Www.Somanuals.com. All Manuals Search And Download.
|