Guardian Technologies Glucose Monitor User's Manual
Contents
1. B a l 3 00 AM 6 00 AM 9 00AM 12 00PM 3 00PM 6 00PM 9 00PM Time of day Measures glucose levels continuously Just as 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 to help guide therapy decisions HbAlc testing and fingersticks alone provide less meaningful insights because they do not monitor glucose levels continuously HbA Ic 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 Better detects hypoglycemia and hyperglycemia for more proactive patient self management Identifies hidden variability Continuous glucose monitoring helps reveal dangerous glucose variability that may not be tracked by fingersticks alone and HbAIc testing 60 of lows may not be revealed when using fingersticks alone HbAIc testing provides a 2 to 3 month average of glucose levels and isn t intended to track highs and lows Continuous glucose monitoring identifies up to 4 times more glucose excursions requiring therapy adjustment versus fi2. 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 Fingersticks are required prior to adjusting insulin delivery and when calibrating the glucose sensor The Guardian RT monitor shows REAL Time information around the clock Innovations include on screen REAL Time glucose readings and alarms to give patients meaningful insights into their glucose levels enabling them to take control and improve their diabetes management ardiari CONTINUOUS GLUCOSE MONITORING SYSTEM Reduce glycemic variability and HbAIc levels using continuous glucose 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 More meaningful insights than fingersticks alone Fingersticks taken 4 times only give you part of the picture Fingersticks alone Glucose mmol L AM 12 00PM 3 00PM 6 00PM 9 00PM Time of day Continuous glucose monitoring completes the picture Continuous glucose monitoring pee Highs missed by these fingersticks E E I v N fo U Oo Pe Maamaa LOWS missed by these fingersticks B a
3. ardiarn CONTINUOUS GLUCOSE MONITORING SYSTEM 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 a The Guardian RT system is designed to be easy for patients to use Plus when you partner with Medtronic e Life changing impact Continuous glucose monitoring insights can help educate and Diabetes you ll get the support you need before during and after patients get started motivate diabetes patients which can have a profound effect on a patient s attitude self management and way of living Simplify new patient starts This means that you can focus more on helping patients to optimize their therapy and s step CGM interpretation methiadaloaymakes a To learn more about the 3 step CGM interpretation less on managing basic therapy adherence can easy for you to analyze continuous glucose monitoring e For Type l and Type 2 diabetic patients The Guardian RT mien methodology contact system is indicated for use in Type 1 and Type 2 diabetes Learn how
4. case study of an 18 year old diabetes patient motivated by continuous glucose monitoring to transform his poor self management 75 adjusted their insulin delivery based on the REAL Time readings 63 changed their diet based on the REAL Time readings THE 31 made lifestyle changes based on the Uar ial REAL Time readings CONTINUOUS GLUCOSE MONITORING SYSTEM These study results are preliminary A randomized controlled multi center study has recently concluded and a study analysis is currently underway
5. REAL benefits for your patients and your practice REAL protection for your patenis from high and low serie excursions REAL for your patients with REAL Time readings of glucose values updated every five minutes so they can intervene sooner for improved therapy management REAL security for your patients with REAL Time alarms to warn against hypo and hyperglycemia t 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 Solutions Software for Guardian makes downloading the data easy di S for you to focus more on optimizing therapy and lees on managing basic therapy adherence by enhancing patient understanding and self management 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 b
6. itoring system with REAL Time 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 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 Guardian RT system includes a continuous glucose sensor radiofrequency transmitter and the Guardian RT monitor to give your patients REAL Time glucose information around the clock 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 hour
7. lood glucose information obtained using standard home glucose monitoring devices The information collected by the Guardian RT 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 Guardian RT 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 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 Fai
8. lure to follow instructions may result in pain or injury Diabetes Headquarters Medtronic Diabetes 18000 Devonshire Street Northridge CA 91325 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 Leading the way to the first artificial pancreas References Ww vI N US Patents Sensor technologies Data on File Medtronic Diabetes 2005 Bode BW et al Diabetes Research and Clin Practice 1999 46 183 90 Kaufman FR et al Diabetes Care 2001 24 12 2030 Ludvigsson J et al Pediatrics 2003 111 5 Pt 1 933 8 Bode B et al DiabetesTechnol Ther 2004 6 2 105 13 Derr R et al Diabetes Care 2003 26 10 2728 33 DCCT JAMA 1997 277 5 374 5 Steil GM et al Diabetes 2000 49 Suppl 1 510 Gross TM et al DiabetesTechnol Ther 2000 2 Suppl 1 S19 26 Caplin NJ et al Diabet Med 2003 20 238 41 Skyler JS et al Diabetes Technol Ther 2000 2 Suppl 1 S7 12 ADA Diabetes Care 2002 25 1 S33 49 Ludvigsson J et al Pract Diab Int 2003 20 1 7 12 Pilot Study Guardian RT Data on File Medtronic Diabetes 2005 REAL Time glucose readings and alarms for reduced glucose variability Now available to your patients Continuous glucose mon
9. ngersticks alone so patients can intervene more quickly Chart is illustrative of a patient taking 4 fingersticks in one day at times shown monitoring vs fingersticks alone Reduces HbAlcs and related complications e Reduces long term diabetes complications Continuous glucose monitoring has been shown to help guide therapy adjustment leading to reductions in HbAIc levels versus the use of fingersticks alone Each 1 reduction in HbAlc reduces the risk of long term complications like eye nerve kidney and heart disease by 15 to 30 REAL Time alarms helped reduce the duration of hypoglycemic excursions Continuous glucose monitoring reduces HbAlcs Duration of Hypoglycemic Excursions minutes per event Period Period 2 Continuous glucose monitoring vs fingersticks E Fingersticks alone CGM 69 6 D9 ro oe in Alerts Off Alerts Off Alerts Off oo ro HbAIc SE x in Alerts On on in oY ro Alert Group Control Group 6 weeks 12 weeks lt 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 P 0 004 Patients in the control group without REAL Time alarms experienced no significant change By helping to reduce HbAIc levels continuous glucose monitoring helps to reduce the risk of long term complications and increase a patient s lifespan G
10. s 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 REAL Time Alarms warn patients of hypoglycemia and hyperglycemia day or night that may not be revealed by fingersticks alone and HbAIc testing Alarms can be preset to sound or vibrate The sound volume of the alarms can also be adjusted to suit your patient s unique needs Patient response to REAL Time alarms resulted in a significant reduction in the duration of hypoglycemic excursions glucose readings and alarms 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 Solutions Software for Guardian Using a special docking station known as the Com Station you and your patients can easily download historical information from the Guardian RT system to a computer e Generates Customizable Treatment Reports these reports show the effect of meals exercise and medication on a patient s glycemic control e 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 Continuous Glucose Sensor provides REAL insights
11. to quickly review reports of the overnight 8Y i patients who desire better glucose control to improve their pre prandial and post prandial periods to assess your Ha local Medtronic health and quality of life patient s glucose control for optimal diabetes Diabetes representative management e Helpful training and educational tools familiarize you and your patients with the system and its use e Certified specialists train your staff which helps you When he saw his own fluctuating blood glucose on the to train your patients The Guardian RT system provides increased patient satisfaction and control computer after having used the glucose sensor for three Rely on trusted customer support days he suddenly seemed to understand Insulin doses e 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 were adjusted and he became more motivated to eat We re the only company to provide highly trained technicians who answer your call personally unlike other companies that need to page professionals first regular meals with better content HbAIc decreased 94 used REAL Time glucose readings e More support professionals and services than any other diabetes technology company and or alarms to control glucose levels within a few months from 9 4 to 7 6 81 reported greater satisfaction with their glucose control Excerpt from a
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