Medical Device Professional Living With Diabetes Now Uses The Insulin Pump He Helped Get Approved In The U.S.

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He Helped Get Approved In The U.S. fortable getting in the car not worrying about experiencing a severe low.” Chip says what’s incredible about the system is that he can just roll out of (NAPS)—Chip Zimliki, 47, had been living with type 1 diabetes for over 33 years and was managinghis blood sugar levels with multiple daily injections (MDI). This meant Chip had to give himself a shot of long acting insulin once a day, as well as injectionsof rapid acting insulin at each mealtime. Having worked at the Food and Drug Administration (FDA)for eight years, Chip was very familiar with insulin pump therapy and the advancements madeto increase automation and create what's called “hybrid closed loop technology.” “[ hadn't seriously considered getting on an insulin pump. I was comfortable with MDIandfelt in control of my sugar levels. Quite frankly, I wasn’t excited aboutthe thoughtof wearing a deviceall the time,” said Chip. The next phasein his career took him to Medtronic where he joined the regulatory team five years agoto help get the first hybrid closed loop system approved in the U.S.—the first and only system that constantly self-adjusts to automatically keep sugar levels within a healthy range more often throughout the day and night.* “The career move was a no brainer for me. It was the most groundbreaking technology to have been introduced in decades—so muchso the FDA waswilling to fast-track it to ensure patients had quick access to thisfirst-of-its kind system,’ said Chip. Once at the company, he had early access to try the latest technologies—including the Guardian Sensor 3 continuous glucose monitor (CGM)that’s part of the MiniMed™ 670G system. He was able to get real-time insights into his sugar levels including how they reacted when he ate a meal, how they trended when he woke up in the morning, exer- cised or experiencedstress. “It was really eye opening to see how my bodyre- bed, see the blue shield on the screen indicating that SmartGuard™ technologyis activated, and knowit’s allowing him moretimein range. In other words, Chip Zimliki and his family found increased peace of mind after he started managing his diabetes with the latest insulin pump system. acted to things throughout the day and it made merealize I wasmt in the best control of my sugarlevels.” ‘Then one day, Chip had a scare that motivated him to get in better control of his diabetes. He was driving himself in the car when his blood sugar suddenly dropped really low. He experienced what doctors call severe hypoglycemia. Hefelt dizzy and hadto pull overto the side of the road so he wouldrttlose control of the car. That experience left him thinking about his wife Lindsay and two young children Lyla, 4, and Leo, 5. As a parent, hefelt a tremendousresponsibility to keep his children safe and that was enoughfor him to transition to insulin pumptherapy. “It was the tipping point for me—there’s nothing more important than keeping your family safe.” In October 2017, Chip started on the MiniMed™ 670G insulin pump system featuring SmartGuard™ technology, which was inspired by patients like Chip and mimics some of the functions of a healthy pancreas by taking action to adjust insulin delivery based on your sugar levels. He hasn't experienced singlesignificant low since. Now Chip can’t imagine his life without a pump andsensor. “Thebestfeeling in the world is knowing I’m driving my two precious cargos in the back and I’m safe. I feel more com- he knowsthat the system worksall the time to make automatic insulin delivery adjustments that help keep him healthy and take on most ofthe diabetes management he would’ve had to do himself. “It only took me 2 hoursto learn the pump andget used toit. It was easy to understand and to manage the screens. I was surprised at how simple it was. The blue shield on the screen is such an easily identifiable visual that immediately lets me know the system is working to help keep me in control. I just look for the blue shield and I know I’m ok.I personally love it? Chip is honored to have played an integral role in bringing this innovation to people living with diabetes. “This is the reason why I devote mylife to this stuff. It was completely rewarding to be part of this initiative. For me, it was a traumatic event to be diagnosed with diabetes. The first day I was diagnosed it took five nurses and my mother to hold me downfor a shot. If something like this can ease someone else’s diabetes challenges in life... find that extremely rewarding.” Chip isn’t done working on improving the technology. The next goalis to make the technology even better. “Its very promising for someone with type 1 diabetes to knowit’s notjust a one and done. We're going to continue to advance SmartGuard™technology so that it’s even more personalized and automated in the future—that’s beyond exciting for someonelike me living with this burdensomedisease.” *Some user interaction required. IMPORTANT SAFETY INFORMATION: The Medtronic MiniMed™ 670G system requires a prescription andis intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen years ofage and older, requiring insulin as well asfor the continuous monitoring and trending ofglucoselevels in the fluid under the skin. The MiniMed™ 670G System includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspenddelivery of insulin when the sensor glucose value falls below oris predicted to fall below predefined threshold values. The Guardian Sensor (3) is not intendedto be useddirectlyfor making therapy adjustments, but rather to provide an indication ofwhena finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor(3). WARNING:Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed andthe daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of8 units per day to operate safely.