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Continuous Glucose Monitoring and Indications for Use 1 Doyle EA, Weinzimer, Steffen AT, Ahern JAH, Vincent M, Tamborlane WV

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Continuous Glucose Monitoring and Indications for Use 1 Doyle EA, Weinzimer, Steffen AT, Ahern JAH, Vincent M, Tamborlane WV The Peace of Mind Try on the Paradigm® Revel™ System for size (actual size) You Want. The Freedom You Deserve. Call 1.800.646.4633 for more information or visit www.MedtronicDiabetes.com References Continuous Glucose Monitoring and Indications for Use 1 Doyle EA, Weinzimer, Steffen AT, Ahern JAH, Vincent M, Tamborlane WV. The REAL-Time Continuous Glucose Monitoring System is indicated to record A randomized prospective trial comparing the efficacy of insulin pump interstitial glucose levels in persons 7 years of age or older who have Type 1 or therapy with multiple daily injections using insulin glargine. Diabetes Care. Type 2 diabetes. This information is intended to supplement, not replace, blood 2004;27(7):1554-1558 glucose information obtained using standard home blood glucose monitoring 2 Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with devices. A confirmatory fingerstick is required prior to treatment. Continuous long-term continuous subcutaneous insulin infusion in Type 1 diabetes. Glucose Monitoring information may be downloaded and displayed on a Diabetes Care. 1996;19:324-327 computer and reviewed by healthcare professionals. This information may 3 Lauritzen T., Pramming S., Deckert T., Binder C. Pharmacokinetics of allow identification of patterns of glucose-level excursions above or below continuous subcutaneous insulin infusion. Diabetologia. 1983;24(5):326-329 the desired range, facilitating therapy adjustments that may minimize these 4 The Diabetes Control and Complications Trial Research Group. The effect excursions. A version of the product specially designed for children is indicated of intensive treatment of diabetes on the development and progression for patients age 7-17. of long-term complications in insulin-dependent diabetes mellitus. NEJM. 1993;329:977-986 Warnings/Precautions/Adverse Reactions 5 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Insulin pump therapy uses only fast-acting insulin. Therefore, any interruption Study Group. Continuous glucose monitoring and intensive treatment of in insulin delivery (due to infusion set clogs, leaks, loss of insulin potency, or Type 1 diabetes. N Engl JMed. 2008;359:1464-1476 insulin pump malfunction) may result in hyperglycemia (high blood glucose) 6 Keenan, B., Cartaya, R., Mastrototaro, J. Accuracy of a New within two to four hours and, subsequently, the rapid onset of diabetic Real-Time Continuous Glucose Monitoring Algorithm. J Diabetes Sci Technol. ketoacidosis (DKA) within 4 to 10 hours. The onset of stress or illness (caused 2010;4(1):111-118 by infection or an emotional event) can also result in a rise of blood glucose 7 Mastrototaro, J., Shin, J., Marcus, A., Sulur, G. The Accuracy and Efficacy of levels and the development of DKA. The intensive management of diabetes Real-Time Continuous Glucose Monitoring Sensor in Patients with Type 1 has also been associated with increased incidence of hypoglycemia (low blood Diabetes. J Diabetes Sci Technol. 2007;1(3):400-404 glucose). Never go to bed with a blood glucose value below your target level. 8 Corriveau EA, Durso PJ, Kaufman ED, Skipper BJ, Laskaratos LA, Heintzman Blood glucose tests should be performed before driving a vehicle or operating KB. Effect of Carelink, an Internet-based insulin pump monitoring system, machinery, because hypoglycemia can have serious consequences. on glycemic control in rural and urban children with Type 1 diabetes mellitus. www.MedtronicDiabetes.com Pediatric Diabetes. 2008;9(Part II):360–366 Paradigm, Bolus Wizard and MiniLink are registered trademarks and Revel and CareLink are trademarks of Medtronic MiniMed, Inc. OneTouch® UltraLink® is a Footnotes trademark of LifeScan, Inc. Medtronic Diabetes * “Insulet Corporation”; JMP Securities; January 21, 2010. 18000 Devonshire Street ** Does not apply to upgrade patients who previously received a USB. 9403429-011 020910 ©2010 Medtronic MiniMed, Inc. All rights reserved. Northridge, CA 91325 + Data on file, Medtronic MiniMed, Inc., Northridge, CA. 1.800.646.4633 ‡ Visit www.MedtronicDiabetes.com for full program terms, eligibility, and conditions. ¥ In this internal home-use study, the predictive alert was set at 30 minutes and the low threshold alert was set at 70 mg/dL. The performance is calculated using a +/- 30 minute event analysis on 90,472 meter readings paired with sensor readings. § For a list of compatible computer operating systems, please visit www.MedtronicDiabetes.com. Empow Ering you Insulin pump therapy puts to stay hEalthy you in control long tErm i nsulin pump therapy delivers precise doses of insulin day and night like a pancreas, giving you optimal control that’s personalized to your lifestyle. Tighter control. w ith proper insulin pump use, you’ll be six times more likely to consistently achieve your target a1C with an insulin pump than with shots of long-acting insulin.1 Fewer hypoglycemic episodes. Don’t let its small size fool you w ith precise, timely insulin doses, you can cut your episodes about the size and shape of a small cell phone, the of hypoglycemia by up to 85%.2 paradigm® revel™ insulin pump is not implanted; it’s discreetly clipped to your belt, slipped into a pocket Better predictability. or worn under your clothes. insulin is delivered t raditional, long-acting insulin can “pool” under the skin, resulting to your body through an infusion set and a tiny tube in uneven absorption rates causing unpredictable lows and highs. (a “cannula”) that’s placed just below the skin, and insulin pumps use only rapid-acting insulin, which is absorbed with replaced every 2 to 3 days. more predictability so you can deliver smaller, more precise doses of insulin when that’s all your body needs.3 Basale rat y ou can program your insulin pump to continuously More flexibility. deliver tiny and precise amounts of insulin 24 hours a an insulin pump gives you more flexibility for life’s unpredictable day. this is called the basal rate. it helps you maintain moments. Eat when you’re hungry, delay a meal if you want, even normal glucose levels between meals and overnight. broaden your food choices. Bolus Dose Fewer daily shots. you can deliver additional insulin, called a bolus dose, with multiple daily shots, you give yourself at least 120 shots every to metabolize the extra glucose from a meal or to month. with insulin pump therapy, you don’t require any insulin correct a high blood glucose reading. shots. you just change your infusion set 12 times per month and control your insulin delivery through the insulin pump. you can deliver your insulin discreetly anytime, anywhere, with the push of a few buttons. Insulin pump therapy helps to achieve better control, reducing the risk of long-term complications4 Eye damage (retinopathy): Kidney damage: may be reduced up to 76%4 may be reduced up to 56% 4 Cardiovascular damage: Nerve damage (neuropathy): may be reduced up to 42% 4 may be reduced up to 60% 4 a ssumes 4 shots per day for 30 days and one infusion set change every 2 to 3 days Everyone has a goal. What’s yours? lower a1C Achieve your goal of successful diabetes management. tighter glucose control whether the focus is on lowering your a1C to ensure a longer, healthier life, tighter control to avoid chasing your glucose levels, or preventing hypoglycemic Fewer hypoglycemic events so you don’t stress when you’re behind the wheel, it all comes down to events the three key elements of diabetes management. the paradigm® revel™ system is designed to help you reach your diabetes management goals. The 3 Key Elements of Effective Diabetes Management M G IN Y O L L R N U U E I C S V T I O O N L S I R E E I D N 1 2 G 3 THERAPY ADJUSTMENT Key Diabetes Insulin Delivery Continuous Glucose Therapy Adjustment Management Precise insulin delivery when you Monitoring (CGM) Refine your therapy Element: need it helps you achieve your REAL-Time readings and long- management by seeing and ideal A1C while reducing the risk term trend tracking let you know analyzing the effects of of dangerous lows — and long- where your glucose level is now, various factors in your life on term health risks.1,2,4 where it’s been, and where it’s your glucose control — such going, for improved control and as specific foods, exercise, peace of mind. and stress. Variety of Colors to Fit Your Personality IN Y L R U E ® S IV N L I E D 1 The MiniMed Paradigm Revel™ Insulin Pump t his small, portable device fits easily into your lifestyle, continuously delivering fast-acting insulin 24 hours a day — helping you to eliminate shots for good. Bolus Remotely Discreetly and easily deliver a bolus without going through Features That Give You Peace of Mind Features That Give You Freedom the Bolus menu with the easy bolus feature and the minimed paradigm® remote Bolus Wizard® Calculator Many Bolus Options (sold separately). the Bolus wizard Calculator does the math for you. it simplifies life changes every day. set your bolus rates to closely match insulin doses, reduces math errors, and uses an “active insulin your insulin delivery to the meal you’re going to eat (for curve” to factor in the amount of active insulin left in your body example, pizza requires a different bolus than a sugary soda). to help prevent “insulin stacking.” Customizable Basal Patterns NEW Insulin Delivery Options accommodate to your changing daily lifestyle and body needs Deliver multiple basal rates as low as 0.025 units/hr, and set up (illness, weekends, weekdays, etc). insulin-to-carbohydrate ratios as low as 1 to 1 to match your body’s insulin needs. Temporary Basal Rates increase or decrease your basal insulin delivery “on the fly” to NEW Missed Meal Bolus Reminder respond to changes in activity level, stress, illness, etc.
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