Guardian Technologies Glucose Monitor Users Manual
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2015-02-09
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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 therapy and less on managing basic therapy adherence by enhancing patient understanding and selfmanagement 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 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. 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 R E A L - T i me g l u co s e read i ng s a nd a l a r m s 1-4 fo r re d u c e d g l u co s e va r i a b i l i t y than 20 years ago. Call 1-888-206-REAL or visit www.minimed.com/guardianrt for additional information. 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 Guardian RT 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. 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 References: 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. Now available to your patients: Continuous glucose monitoring system with REAL-Time glucose readings and alarms REAL-Time system components help your patients manage their diabetes like never before 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 Guardian RT Transmitter — Communicates wirelessly the 3-day diagnostic system have been used by physicians in more than 150,000 patients through radio frequency (RF) to the Guardian RT monitor 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 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.2-5 Continuous Glucose Sensor provides REAL insights — This tiny REAL-Time sensor REAL-Time Glucose Readings REAL-Time Glucose Readings REAL-Time Alarms 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. 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 system includes REAL-Time Alarms a continuous glucose sensor, warn patients of hypoglycemia and hyperglycemia, day or night, that may not be revealed by fingersticks alone and HbA1c testing.5,6 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.5 radiofrequency transmitter, and the Guardian RT monitor to give your patients REAL-Time glucose information around the clock 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. 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. 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. • 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 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 Fingersticks taken 4 times only give you part of the picture* Fingersticks alone Glucose - mmol/L Glucose - mmol/L REAL-Time alarms helped reduce the duration of hypoglycemic excursions10 Continuous glucose monitoring reduces HbA1cs Target zone Fingersticks alone 0 16.7 — 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 Time of day 11.1 5.6 16.7 Continuous glucose monitoring Target zone 9.0 • 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 0 11.1 5.6 Continuous glucose monitoring completes picture 3:00 AM 6:00 AM 9:00 AMthe 12:00 PM 3:00 PM 6:00 PM 9:00 PM Target zone Time of day Continuous glucose monitoring Lows missed by these fingersticks 3:00 AM 6:00 AMmissed 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM Highs by these fingersticks Time of day Better detects hypoglycemia and hyperglycemia for more proactive patient self-management 11.1 5.6 0 • Identifies hidden variability: Continuous glucose monitoring helps reveal dangerous glucose variability that may not be tracked by fingersticks alone and HbA1c testing6 Target zone Lows missed by these fingersticks 3:00 AM 6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM Time of day — 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 fingersticks alone, so patients can intervene more quickly3 * Chart is illustrative of a patient taking 4 fingersticks in one day, at times shown. Fingersticks alone CGM 8.5 Highs missed by these fingersticks 0 16.7 Glucose - mmol/L — 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 — HbA1c testing is performed at a single point in time, once every 2 to 3 months and produces an average blood glucose level 11.1 5.6 • HbA1c testing and fingersticks alone provide less meaningful insights because they do not monitor glucose levels continuously • 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 HbA1c, % ± SE Glucose - mmol/L 16.7 • 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 Reduces HbA1cs and related complications 8.0 7.5 7.0 P = n.s. P = .011 6 weeks 12 weeks 6.5 6.0 Start P = 0.03 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).5 Patients in the control group, without REAL-Time alarms, experienced no significant change By helping to reduce HbA1c levels, continuous glucose monitoring helps to reduce the risk of longterm complications and increase a patient’s lifespan7 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 living13 — 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: 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 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 To learn more about the 3-step CGM interpretation methodology contact your local Medtronic Diabetes representative • Helpful training and educational tools familiarize you and your patients with the system and its use The Guardian RT system provides increased patient satisfaction and control 14 “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 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 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. 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 • 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’re the only company to provide highly trained technicians who answer your call personally, unlike other companies that need to page professionals first • More support professionals and services than any other diabetes technology company
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