U.S Teen Is First Pediatric Patient In The World To Use Breakthrough Smart Insulin Pump That Personalizes Treatment For Type 1 Diabetes

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Smart Insulin Pump That Personalizes Treatment For Type 1 Diabetes New MiniMed 670G Insulin Pump System Can Automatically Monitor AndStabilize Blood Sugar Levels So People Can Spend Less Time Managing Their Diabetes (NAPSA)—Just days shy of Claire Bickel’s fifth birthday, her mother, Francesca, noticed Claire was experiencing some unusual symptoms; she was growing increasingly thirsty, hungry, and she was constantly urinating. At first, Fran- cesca chalked Claire's symptoms up to a virusorallergies and kept her home from schoolto rest. But when her symptoms persisted, Francesca knew it was some- thing more serious and took her daughter to the doctor, where results from a blood test showed higher-than-normal blood glucose levels. After a three-day stay at Yale New Haven Hospital, and much to her family’s disbelief, Claire was diagnosed with Type 1 diabetes. Stories like Claire's are not unusual. An estimated 1.25 million Americans are living with Type 1 diabetes, and an estimated 200,000 people under the age of 20 are affected. Formerly referred to as “juvenile diabetes,’ Type 1 diabetesis an autoimmune disorder in which the body attacks cells in the pancreas that makethe insulin needed to extract energy from food. While people living with Type 1 diabetescan live normal, healthy lives, they need to continuously monitor their glucose levels andrely on daily injectionsof insulin to keep their blood sugarlevels in check. “So much goes through your mind when your child is diagnosed with a chronic, potentially life-threateningillness. It was a constant source of worry, particularly at night when blood sugar levels can dip dangerously low to the point that they may not wake up,” said Francesca. “I was waking up several times a night to check her sugar levels to make sure everything was OK.It’s a scary thought, and it can be exhausting” A new breakthrough called the MiniMed 670G system featuring SmartGuard™ HCL Technology is easing the daily burden of diabetes management for people like Claire by making the delivery of insulin more automated and personalized, giving people with Type 1 diabetes and their caregivers morefreedom to focus on their day-to-day lives. A newinsulin pump system stabilizes blood sugarlevels with less input from patients. New Breakthrough for Patients Fewer than one-third of people with Type 1 diabetes in the U.S. achieve target blood glucose controllevels, but new advancements promise to simplify and improve diabetes management.’ In September 2016,the U.S. Food and Drug Ad- ministration approved Medtronic’s new MiniMed 670G insulin pumpsystem, the world’first hybrid closed-loop system that continuously monitors glucose levels and automatically sendsthat information to an insulin pumpevery five minutes. Based on this data, a personalized amountof insulin is delivered to keep blood sugar levels withina target range, helping to relieve the burdenof diabetes managementand reducing the occurrence of high and low spikes in blood glucoselevels. As the system's algorithm learns more about a person’s body, people using the system have more freedom and can enjoy greater peace of mind throughoutthe day and night. WhentheBickels first learned about the technology, they immediately signed up for Medtronic’s MiniMed 670G Priority Access program so they could be first in line to receive the new pump once it became commercially available. Little did they know that Claire would soon becomethe world’s first pediatric patient to use this new breakthrough technology. “Tt gives me more freedom to focus on thingslike field hockey and track without having to constantly think about diabetes management,” said Claire about her new pump. “I’m excited about all the things thatwill be easier to do now,like overnight trips and even going away to college—it’s less stressful to think about now.” After seeing Claire’s diagnosis and the ups and downsassociated with diabetes management, Claire's mother is confident the new pump will simplify Claire's lifestyle and allow herto just focus on being a teenager. “I would encourage parents to seek out information about new technologies and choose the ones that are the bestfit for their child and family,’ Francesca advises people who maybehesitant to try new treatments. “This system is amazing for my daughter and our family because it allows me to worryless and be assured of a full night’s sleep?” How to Get the MiniMed 670G Insulin Pump System To learn more about the MiniMed 670G or sign up for the Priority Access program while it’s still available, visit www.medtronicdiabetes.com/products/ minimed-670g-insulin-pump-system. MiniMed 670G is approvedfor type 1 ages 14 and over. May not be safe < 7 or using < 8 units insulin/day. See bit.ly/670grisks. ‘Medtronic Fact Sheet. www.medtronic.com/content/dam/medtronic-com/us-en/newsroom/media-resources/media-kits/diabetes-management/documents/minimed-670g-fact-sheet-final.pdf Important Safety Information: MiniMed’ 670G System The Medtronic MiniMed 670Gsystem is intendedfor continuous delivery ofbasal insulin (at user selectable rates) and administration ofinsulin boluses (in userselectable amounts)for the managementoftype 1 diabetes mellitus in persons, fourteen years ofage and older, requiring insulin as well asfor the continuous monitoring and trendingofglucose levels in thefluid under the skin. The MiniMed 670Gsyste includes SmartGuard technology, which can be programmed to automatically adjust delivery ofbasal insulin based on continuous glucose monitor sensor glucose values, and can suspend delivery ofinsulin when the sensor glucose valuefalls beloworis predicted tofall belowpredefined threshold values. The system requires a prescription. The Guardian Sensor (3) glucose values are not intendedto be useddirectlyfor making therapy adjustments, butrather to provide an indication ofwhenafingerstick may be required. A confirmatoryfingerstick test via the CONTOUR'NEXTLINK2.4 bloodglucose meter is requiredprior to makingadjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR'NEXT LINK24blood glucose meter and not on values provided by the Guardian Sensor(3). Always check the pumpdisplayto ensure the glucose result shown agrees with the glucoseresults shown on the CONTOUR'NEXTLINK2.4 bloodglucose meter. Do notcalibrate your CGM deviceorcalculate a bolus using a bloodglucose meter result takenfrom an alternative site (palm) orfrom a controlsolutiontest. Do notcalibrate your CGM device when sensoror blood glucose values are changing rapidly, e.g, following a meal orphysical exercise. Ifa controlsolutiontestis out ofrange, please note thatthe result may be transmitted to yourpump whenin the “Always”send mode. WARNING: Medtronic performed an evaluationofthe MiniMed 670G system and determinedthatit may not be sajefor use in children under the age of7 because ofthe way thatthe system is designed andthe daily insulin requirements. Therefore this device should notbe used in anyone under the age of7years old. This device should also notbe used in patients who require less than a total daily insulin doseof8 units per day because the device requires a minimum of8 units per day to operatesafely. Only use rapid acting U100 insulin with this system. Pump therapy is not recommendedforpeople whose vision or hearingdoes notallow recognition ofpump signals and alarms. Pump therapy is not recommendedforpeople who are unwillingor unable to maintain contact with their healthcare professional. Thesafety ofthe MiniMed 670G system hasnotbeen studied in pregnant women. For complete details, includingproduct and importantsafety information concerningthe system andits components, please consult http://www.medtronicdiabetes.com/impor! afety-informatio d-670g and the appropriate userguide at http://www.medtronicdiabetes.com/download-library. MiniMedis a registered trademark and SmartGuardis a trademark ofMedtronic, MiniMed Inc.