I’d like to share a story about one of our employees, Chip Zimliki, senior regulatory affairs director. Chip has the unique experience of working at the FDA on insulin pump therapy and then joining our regulatory team to help get our ground-breaking technology approved in the U.S. Chip’s story highlights how his experience working with our technology helped him make the decision to switch from MDI to our MiniMed 670G system, allowing him greater freedom and peace of mind.
Chip Zimliki had been living with Type 1 diabetes for over 33 years and was managing his 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 injections of 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 made to increase automation and create what’s called “hybrid closed loop technology.”
“I hadn’t seriously considered getting on an insulin pump. I was comfortable with MDI and felt in control of my sugar levels. Quite frankly, I wasn’t excited about the thought of wearing a device all the time,” said Chip.
The next phase in his career took him to Medtronic where he joined the regulatory team five years ago to 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 much so the FDA was willing to give the product special emphasis and prioritize the review process,” 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, exercised or experienced stress. “It was really eye opening to see how my body reacted to things throughout the day and it made me realize I wasn’t in the best control of my sugar levels.”
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. He felt dizzy and had to pull over to the side of the road so he wouldn’t lose 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, he felt a tremendous responsibility to keep his children safe and that was enough for him to transition to insulin pump therapy. “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 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 a single significant low since. Now Chip can’t imagine his life without a pump and sensor.
“The best feeling in the world is knowing I’m driving my two precious cargos in the back and I’m safe. I feel more comfortable 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 bed, see the blue shield on the screen indicating that SmartGuard™ technology is activated, and know it’s helping him to spend more time in range. In other words, he knows the system works to make automatic insulin delivery adjustments* that help keep him healthy and take on most of the diabetes management he would’ve had to do himself.”
“It only took me 2 hours to learn the pump and get used to it. 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 my life 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 down for a shot. If something like this can ease someone else’s diabetes challenges in life … I find that extremely rewarding.”
Chip isn’t done working on improving the technology. The next goal is to make the technology even better.
“It’s very promising for someone with Type 1 diabetes to know it’s not just 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 someone like me living with this burdensome disease.”
*Refers to “Auto Mode” functionality. Some user interaction required. Individual results may vary.
IMPORTANT SAFETY INFORMATION
The Medtronic MiniMed 670G system requires a prescription and is 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 of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels 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 suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.
The Guardian Sensor (3) is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a 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 and the 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 of 8 units per day to operate safely.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Do not use the serter on products other than the Enlite sensor or Guardian Sensor (3). Medtronic cannot guarantee the safety or efficacy of this product if used with other products. The reservoir is contraindicated for the infusion of blood or blood products.
Infusion sets are indicated for subcutaneous use only and not for intravenous (IV) infusion or the infusion of blood or blood products. Insulin pump therapy is not recommended for those who are unwilling to perform at least four blood glucose tests per day. As insulin pumps use rapid acting insulin only, BG testing is required to help identify rapid glycemic deterioration due to insulin infusion occlusion, infusion site problems, insulin stability issues, user error, or a combination of these. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional.
The safety of the 670G system has not been studied in people with impaired kidney function. Please let your healthcare professional know if you have kidney disease so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks. The safety of the 670G system has not been studied in pregnant women, people with type 2 diabetes, or in people using other anti-hyperglycemic therapies apart from insulin. Please let your healthcare professional know if any of these conditions apply to you so you and your healthcare professional can determine if the potential benefits of using the system outweigh the risks.
For complete safety information, please consult the appropriate User Guide.