Guardian Technologies Glucose Monitor Users Manual

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Leading the way to the

first artificial pancreas

REAL-Time glucose readings and alarms

for reduced glucose variability1-4

DiabetesHeadquarters

Medtronic Diabetes

18000 DevonshireStreet

Northridge, CA 91325

www.minimed.com

1-800-MINIMED (1-800-646-4633)

CGMS andGuardian are registered trademarks of Medtronic MiniMed.

System Gold is a trademark of Medtronic MiniMed.

©2005 Medtronic MiniMed. All rights reserved. 9197565-011 091305

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.

6. Derr R, et al. Diabetes Care.

2003;26(10):2728-33.

7. DCCT. JAMA.

1997;277(5):374-5.

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.

12. ADA Diabetes Care.

2002;25(1):S33-49.

13. Ludvigsson J, et al. Pract Diab Int.

2003;20(1):7-12.

14. Pilot Study. Guardian RT. Data on File

Medtronic Diabetes 2005.

References:

Call 1-888-206-REAL or visit www.minimed.com/guardianrt for

additional information.

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.

• REAL advantages for you to focus more on optimizing

therapyandless on managing basic therapy adherence

by enhancing patient understanding and self-

management of glycemic control.13

Safety Information

Continuous Glucose Monitoring

Medtronic MiniMedGuardian 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.

PrescriptionDevice 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.

Contraindications

Successful operation of the Guardian RT 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

ofthe monitor signals and alarms, or who do not have a caregiver that can perform this function

for them.

Warnings/Precautions

The Guardian RT 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.

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.

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.

The Guardian RT monitor shows REAL-Time

informationaround the clock —Innovations

include on-screen REAL-Time glucose readings

and alarms togive patients meaningful insights

into their glucoselevels, enabling them to take

control and improve their diabetes management.

REAL-Time system components help your patients

manage their diabetes like never before

REAL-Time Glucose Readings

REAL-Time Alarms

REAL-Time Alarms

warn patients of hypoglycemia and hyperglycemia, day or night, that may not

be revealedby fingersticks alone and HbA1c testing.5,6 Alarms can bepresetto

sound or vibrate. The sound volume of the alarms can also be adjusted to suit

your patient’s uniqueneeds. Patient response to REAL-Time alarms resulted

in a significant reduction in the duration of hypoglycemic excursions.5

REAL-Time Glucose Readings

areviewable atthe 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.

Awareness of glucose variability is important because even brief fluctuations

in glucose levels can lead to long-term diabetes complications like eye, nerve,

kidney and heart disease.6,7

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®System,

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.2-4

Now Medtronic Diabetes proudly brings the benefits of continuous glucose monitoring directly to

patients with the Guardian RT system. This newtechnology 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.2-5

Continuous glucose monitoring system

with REAL-Time glucose readings and alarms

Now available to your patients:

The Guardian RT Transmitter — Communicates wirelessly

through radio frequency (RF) to the Guardian RT monitor

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.8-10 Fingersticks are

required prior to adjusting insulin delivery and

when calibrating the glucose sensor.

Solutions®Software for Guardian — Usingaspecial docking

stationknown as the Com-Station™, you and your patients can

easily download historical information from the Guardian RT

system to a computer.

•Generates Customizable Treatment Reports — these

reports show the effect of meals, exercise and medication

on a patient’s glycemic control

•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 Guardian RT system includes

a continuous glucose sensor,

radiofrequency transmitter, and

the Guardian RT monitor to give

your patients REAL-Timeglucose

information around the clock

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

More meaningful insights than fingersticks alone

Patient response to REAL-Time alarms resulted in a

48% reductionin mean duration of hypoglycemic

excursion, from 64.4 minutes to 33.6 minutes

(P = 0.004).5Patients in the control group, without

REAL-Timealarms, experienced no significant change

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

— 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

Fingersticks taken 4 times only

give you part of the picture*

Lows missedby thesefingersticks

Highs missedby these fingersticks

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

Continuous glucose monitoring

completes the picture

Lows missedby thesefingersticks

Highs missedby these fingersticks

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

REAL-Time alarms helped reduce the

duration of hypoglycemic excursions10

P = 0.03

By helping to reduce HbA1c levels, continuous

glucose monitoringhelps to reduce the risk of long-

term complications and increase a patient’s lifespan7

Continuous glucose monitoring

reduces HbA1cs

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

Better detects hypoglycemia and hyperglycemia

for moreproactive patient self-management

• Identifies hidden variability: Continuous glucose monitoring helps

reveal dangerous glucose variability that may not be tracked by

fingersticks alone and HbA1c testing6

— 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

— Continuous glucose monitoring identifies up to 4 times more

glucose excursions requiring therapy adjustment versus

fingersticksalone, so patients can intervene more quickly3

*Chart is illustrative of a patient taking 4 fingersticks in one day, at times shown.

•Measures glucose levels continuously: Justas the systems of a human

body monitors glucose levels to guide insulin release, continuous

glucose monitoring measures glucose 24 hours a day giving patients

meaningful insights tohelp guide therapy decisions

•HbA1c testing andfingersticksalone provide less meaningful insights

because they do not monitor glucose levels continuously

— HbA1c testing is performed at a single point in time, once every

2to 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 glucosemonitoring provides updated glucose

readings every five minutes — up to 288 glucose measurements per

day — to alert patients to take action sooner2-5

The Guardian RT system provides increased

patient satisfaction and control14

In a pilot study of 16 people using

the Guardian RT*:

94% used REAL-Time glucose readings

and/or alarms to control glucose levels

81% reported greater satisfaction with

their glucose control

75% adjusted their insulin delivery based

onthe REAL-Timereadings

63% changedtheir diet based on the

REAL-Time readings

31% made lifestyle changes based on the

REAL-Time readings

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 living13

— This means that you can focus more on helping patients to optimize their therapy and

less on managing basic therapy adherence

More life-changing insights for your patients

More meaningful support for you

Medtronic Diabetes helps you and your patients get started on the

Guardian RT system

The Guardian RT system is designed to be easy for patients to use. Plus, when you partner with Medtronic

Diabetes you’ll get the support you need before, during and after patients get started.

Simplify new patient starts

•3-step CGM interpretation methodology makes it

easy for you to analyze continuous glucose monitoring

information

— 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

• 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.

We’rethe only company toprovide highly trained technicians who answer your call personally,

unlike other companies that need to page professionals first

•Moresupport professionals and services than any other diabetes technology company

To learn more about the

3-step CGM interpretation

methodology contact

your local Medtronic

Diabetes representative

“When he sawhis 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-management13

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.

• For Type 1 and Type 2 diabetic patients: The Guardian RT

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

*These study results are preliminary. A randomized, controlled, multi-center

study has recently concluded and a study analysis is currently underway.