In Depth with Medtronic’s Chief Patient Officer
Editor’s Note: As of October 10, 2018, the Medtronic 670G Pump is approved for use by Canadians by Health Canada.
Hi! I’m Louis Dias, the chief patient officer for Medtronic Diabetes. My job starts with listening to your needs and putting patient voices at the center of everything we do, including gathering insights to guide product development, designing better experiences, creating simpler products and services, engaging with you online and offline and everything in between. Mine is a role you don’t always see in other healthcare companies, so I think it speaks to the value we place on putting our patients’ lives, aspirations and needs first.
The MiniMed 670G system…how does it work? What makes it unique?
The MiniMed 670G system is the world’s first hybrid closed loop system that automatically adjusts to your life. It consists of an advanced, waterproof insulin pump with a color screen, a continuous glucose monitor (CGM) and the advanced algorithms in our SmartGuard™ HCL technology. It helps you spend more time with your blood glucose levels in range by automatically determining your basal or “background” insulin needs based on the readings from your CGM. You still have to bolus for meals and calibrate the sensor, but our patients tell us that they are feeling better, sleeping better and spending less time concerned about diabetes. This has made a positive impact on their lives, the lives of their families and even their friends.
What is different about the new Guardian Sensor 3? How is it different than other CGM devices available?
The GuardianTM Sensor 3 is our latest, most advanced sensor to date. It’s the next generation of Medtronic sensor science. The feedback on it is amazing. I can’t tell you how many people have told us how pleasantly surprised they are at the accuracy and reliability. What makes it different from other CGMs is that it’s the only one approved to power a hybrid closed loop system. One of the reasons for that is our special diagnostic technology that continuously monitors the sensor and sends feedback to the system, which monitors the performance of the sensor and provides an extra layer of trust.
What is the difference between closed loop, open loop and hybrid closed loop?
In diabetes, closed loop is the ultimate dream and refers to a fully automated system, meaning the person would just have to do some basic tasks like inputting some settings and refilling the reservoir, and then the system would automatically control the rest of the insulin delivery. Many people call this an artificial pancreas. To be clear, the MiniMed 670G system is not a closed loop, but it’s a huge advancement.
The MiniMed 670G system is the world’s first and only hybrid closed loop. It does quite a bit automatically, but there are still some activities you need to do, like carb count and bolus for meals. This is a big leap forward and patients tell us it’s a dramatic improvement over anything that’s come before.
Open loop refers to using an insulin pump and a CGM sensor that communicate to each other, but the pump can’t take action based on the sensor. So you can see your sensor value on your pump, but the system can’t start, stop or adjust insulin delivery. Medtronic introduced the first open loop back in 2006. There’s a lot of benefit to your health by using closed loop over injections, but the decision-making still lies on the person with diabetes.
What is Auto Mode on the MiniMed 670G?
Auto Mode is the key feature of our SmartGuard technology and what has everyone so excited. This is when the system is automatically deciding how much basal insulin you’re getting based on the sensor. Auto Mode gives you hundreds of background insulin adjustments throughout the day, every five minutes. People who use Auto Mode as much as possible are typically the ones who see the highest percent of time spent in range, which of course translates to feeling better and spending more time doing the things you love.
What is the “Suspend before low” feature?
There are times when you might not want to use Auto Mode, or the system will exit from Auto Mode because it needs more information. In these cases, “suspend before low” is also a great advancement offered with our SmartGuard Technology. It’s the first and only system that stops the delivery of insulin when the system predicts you’re about to go low, helping to prevent hypoglycemia. It resumes the insulin delivery once the sensor blood glucose level recovers. This first-of-its-kind technology is not found with any other system, and the MiniMed 640G system has been available outside the US for the last couple years. We have also received incredibly positive feedback on this feature, especially for nighttime routines. Its ability to automatically resume significantly reduces the amount of alarms from previous versions of pumps.
Two key words surround the MiniMed 670G system: trust and patience. We’ve found it best to let the system gather information from you for at least a week before starting Auto Mode. Even after that it might take several more weeks for it to be able to adjust to your body. Some people are thrilled with it right away. For others, it takes a few more weeks to adjust to managing their diabetes in a completely very different way: to “let go” a bit and trust the system. But after that, the stories we hear are all love stories.
Will Auto Mode ever be fully knowledgeable and able to predict everything, given all that affects diabetes: stress, hormones, etc.?
The system is always adjusting to what happened in the last six days. People are different and have different habits during the week and on the weekend. The best way to help the system is to work with your healthcare team on key settings like insulin-to-carb ratios. Then, adjust again until the system is able to meet your needs.
Your insulin sensitivity is the most important thing, but the system needs more information, including sensor glucose values, “rate of change” (how fast those blood glucose levels go up or down), and how much insulin has been given and how much is active in your body. The system needs this critical information to help you spend more time in range.
How does the MiniMed 670G work with exercise?
We have observed many athletes having success with MiniMed 670G. One feature that’s often used is the Temp Target, which allows you to temporarily set the target to 150mg/dL (8.3mmol/L) instead of 120mg/dL (6.6mmol/L) to accommodate for exercise. This is a good topic to talk with your doctor about if this makes sense for you. I’d also recommend following several Beyond Type Run athletes on Instagram as they document their journeys with the system.
There is a reported shortage of Medtronic sensors. Can you give us some information about that?
Even when you listen to your patients and do your best to prepare for what’s coming next, unforeseeable things happen. Sensor supply is a temporary challenge right now as a result of several factors. Demand for our sensors has dramatically increased over the last several months due to CGM reimbursement wins in several countries (which is great—improved access for people with diabetes is a good thing) and excitement for the MiniMed 670G system. In addition, we have a large manufacturing facility in Puerto Rico, which was impacted by Hurricane Maria.
Fortunately, we’re back in production now. Addressing these supply issues is the first priority for our entire team right now, and all of our employees are committed to resolving this temporary challenge. We know how important this is to our customers and are committed to resolving as quickly as possible.
We are prioritizing Guardian 3 sensors for the people who have already started on the MiniMed 670G system. We realize that means some others won’t be able to start on a new CGM as soon as they’d like, but we feel strongly this is the right way to prioritize.
Can you talk a little bit about the recent infusion set recall?
This is a voluntary recall. The Medtronic mission is clear: we put our patients first. The voluntary infusion set recall is an example of how important it is to continuously monitor feedback from patients and investigate issues that arise. We take this responsibility very seriously and partnered with the FDA on a voluntary recall of the product. We communicated to patients as rapidly and clearly as possible. We have infusion sets with a new and enhanced membrane and were able to immediately ship replacement products, starting with those who only had affected product at home. Others are receiving their replacement sets as quickly as possible but typically one box at a time. Any time we discover a potential issue like this, we’re going to respond the same way: quickly, thoroughly and thoughtfully.
There’s also been a lot of talk lately about Animas closing and your arrangement with them to support their customers. Can you talk about that?
Yes, first I want to say that I get how frustrating and disappointing this is to Animas customers. Both Animas and Medtronic are working closely to make sure that patients stay on therapy. Your pump choice is very personal. And speaking of choice, I want to be clear that customers still have choices in what technology they use to manage their diabetes. When their Animas warranty expires, users can choose among several different companies.
In the meantime, we are focused on ensuring that the people using Animas pumps can stay on pump therapy and receive the supplies and support they need, while we continue to support our existing Medtronic customers. There’s a lot more information about what this means for different groups of people on our blog. I want your readers to know that whether they are a long-term Medtronic customer or just joining the Medtronic family from Animas, we’ll be here for them every step of the way.
What are you most excited about for the future of diabetes management?
We always want people in the diabetes community to be happy, to live the lives they want, and to chase the dreams they have. I’m excited for new and interesting ways for people to become more and more empowered in their diabetes care. For some people, that might be building on the MiniMed 670G system to provide even more personalized automation (because we all know that no two people with diabetes are the same). But others might not want to let go quite so much. For them it’ll be more about being in the driver’s seat of their diabetes management.
There’s so much innovative technology, new services and better education and training. It’s all going to be integrated with your life, in the car, on your body, in the house, with your family and even with your doctor. Devices will be simpler, more efficacious, and fun to use—all to help people live exciting, inspiring lives with diabetes. Whether you have diabetes or not, you have the right to be happy.
What made your team decide to sponsor the Beyond Type Run Team?
Beyond Type Run really spoke to us because we’re just so inspired by what these runners are doing: living well with diabetes and taking on a big challenge. We’re inspired by the entire diabetes community and moved when you take on any type of adventure. These runners are a great example of that character we see among people with diabetes. They encourage others to take on their own personal challenge and earn that sense of accomplishment that’s really important for emotional wellbeing.
This ties in really closely with what we’re about at Medtronic. We come to work every day because we’re inspired by the millions of people living with diabetes. You are the inspiration for new technologies like the MiniMedTM 670G system.
Important Safety Information
*WARNING: Do not use the suspend before low feature to prevent or treat low blood glucose. Always confirm your sensor blood glucose reading using your blood glucose (BG) meter, and follow the instructions of your healthcare professional to treat low blood glucose. Using suspend before low alone to prevent or treat low blood glucose may result in prolonged hypoglycemia.
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, 14 years of age and older, requiring insulin as well as for the continuous monitoring and trending of blood glucose levels in the fluid under the skin.
At the time of manufacture and when the reservoir and tubing are properly inserter, your pump is waterproof. It is protected against the effects for being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.
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 blood glucose monitor and not on values provided by the Guardian Sensor (3).
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.
Editor’s Note: As of February 26, 2018, The Guardian™ Sensor 3, Medtronic’s CGM for its hybrid closed loop system, the MiniMed™ 670G system, has received FDA approval for use on the upper arm. This expanded indication will provide more flexibility for patients as well as accuracy.