Dexcom CEO Kevin Sayer Explains G6

WRITTEN BY: Michelle Boise

Editor’s Note: Beyond Type 1 had the chance to sit down with Dexcom CEO Kevin Sayer days after the FDA approval of the Dexcom G6. Read his interview below, and get full coverage of launch and G6 details here.

The Dexcom G6 has just gotten FDA approval with a targeted ship date of June 4, 2018. The Type 1 community is buzzing with excitement. We all want to know, what new features will the next-generation continuous glucose monitor offer? What new business partnerships are in the works that could link Dexcom CGM technology with other software platforms? Beyond Type 1 got to sit down with Dexcom CEO Kevin Sayer to find out how the launch of G6 might change the face of diabetes care as we know it.

G4 was launched soon after you started at Dexcom in 2012. How is the G6 launch a part of the vision you’ve had for CGM technology since then?

I was at Minimed when the very first sensor was approved in 1999, so my vision for CGM has always been a device you can put on your body that would replace fingersticks. I think what G6 with no calibrations enables us to do is develop trust with patients and make the device less intrusive to people living their lives. The CGM data stream in addition to automated insulin delivery systems that we are working with mean all kinds of software possibilities going forward. We have an API open interface platform we were developing with G5 but will apply to G6, allowing software developers to work with us to grab data through a portal and incorporate CGM data into their apps. There are companies like Glooko and OneDrop that could give patients an experience that could be different from Dexcom. We are also working with Apple, Fitbit, and other nutrition companies.

G6 gives us the ability to make a product that is accurate enough that patients can adopt it to these other software platforms. It really opens up the world to a future where you can stream data to these apps without any calibration.

What have you brought from your experience at previous device companies to Dexcom?

What I’ve learned is that you’ve got to make a product that meets everyone’s needs and solves a problem. We did that at Minimed, Biosensors International and I think we solve fabulous problems here at Dexcom. We do a great job with that.

Some people are uneasy about the no-calibration option of the G6. What can you tell them in terms of accuracy and safety with this new feature?

No calibration is something everybody has asked for forever. I can tell you that the clinical data on this sensor with no calibration very much supports the accuracy and performance of the no calibration system. I do not believe patients will experience difficulty with that over time. I understand the concerns and so did everyone at Dexcom – for that reason we have within the system the opportunity to enter a calibration if you like. The algorithm is designed to accept that calibration as another data point.

We have not seen anything that would indicate a problem. We are comfortable with it and so is the FDA. Patients will have the opportunity to decide, though.

What feature are you most excited about in the G6 and how do you think it will change the way people manage diabetes?

At the top of the list, we are excited about no calibration, but also the physical characteristics of the system. We have used the same insertion technology since we launched in 2006; that device while effective and safe, it’s kind of scary looking for patients. Our new insertion system has been years in the making. You don’t ever see a needle and it’s inserted in milliseconds. I haven’t seen a single patient that didn’t say, “wow” when comparing to the one before. The transmitter is also much thinner; we have significantly reduced the profile so it’s less likely to get caught on your clothes or peeled off.

The third piece – I am just really excited about the technology. When we launched G4 system in 2012, it was an entire platform change for us with a new algorithm and new sensor. That performance and platform was really the engine that enabled our company to grow and do the great things that we have done. The G6 launch is reminiscent of that – we have a new sensor, algorithm, physical interaction with patients. It goes to the phone and is connected, we haven’t given a penny of the great features of G5. I really think it’s going to be another turning point for our company and a wonderful product.

How will the G6 pave the way for integrated closed loop systems?

We have been involved with closed loop systems for a very long time. The G6 will be incorporated into closed-loop systems going forward. We have three formal business relationships that we’ve announced with Insulet, Tandem, and Lilly. Each of these three has insulin delivery devices in the pipeline that will have the G6 system integrated. Our device is labeled interoperable, so over time, we are going to develop software kits and integration kits to make it more interoperable by taking data from the CGM and insulin delivery systems to enhance the life of patients.

What alterations did you make in the G6 from customer feedback on previous CGM generations?

Certainly the size we took from customer feedback.

we took from customer feedback. We’ve also added a new alert, a predictive low alert , approximately 20 minutes before you hit a low of 55, you’ll get an alert regardless of your threshold settings.

, approximately 20 minutes before you hit a low of 55, you’ll get an alert regardless of your threshold settings. We have maintained all the share functionality in G5.

Now, Tylenol is no longer a problem . We blocked the acetaminophen within the membrane structure of the sensor, so in the past we had a counter indication that if you took acetaminophen, your readings could be higher than your actual glucose values.

. We blocked the acetaminophen within the membrane structure of the sensor, so in the past we had a counter indication that if you took acetaminophen, your readings could be higher than your actual glucose values. The transmitter, the applicator, sensor and software are all different. After the launch, we can roll out the app enhancements that we’ve gotten feedback on.

What about upgrade options?

We will take care of patients. We have always provided upgrade paths for our in-warranty patients and rest assured that will happen. We don’t want people not buying G5, waiting for G6. We’ll make sure there’s a path for people to get what they need.

Where on the body is it approved for use?

It is FDA approved on the abdomen and the backside.

What do you hope to learn about this new technology in its application and what’s on the horizon?

We will certainly learn more with the launch and particularly with the mobile app. We get all those data points on our server and we will analyze that data and make sure that things are going the way they’re supposed to be.

One of the things that excites me most about G6 is that we have two new platforms coming in the next couple years that will be developed based on our relationship with Verily (Google Life Sciences). These projects aim to miniaturize the electronics and ultimately to make it disposable. After testing, we think these two products will come out rather rapidly in 2019-2020.

At the earliest, we also think we can extend the life to 10-14 days by 2019. We think that’s important for the wear experience and to the patient.

The next generation of sensors will focus on three things that we apply to every system we make:

Performance: patients need to trust that number

patients need to trust that number Convenience: making people’s lives simpler. Feeding to phone and sharing, smaller in size, and (later) disposable

making people’s lives simpler. Feeding to phone and sharing, smaller in size, and (later) disposable Cost: we want to increase access and make this technology available to everyone who needs it

Cost and access to Dexcom CGM continues to be a concern in the community. What can individuals expect for costs associated with the G6?

We have not negotiated pricing with all the payers; we don’t anticipate the cost of G6 to be more than G5. Certainly with label use it should not be. Part of the cost concern in the community is related to the fact that the sensor does shut off in 10 days. That was part of the FDA requirement to get the labeling that we got. If you have a sensor that you don’t calibrate and restart that algorithm will assume it’s a new sensor, which is a problem. We think it is a fair trade for patients overtime and eventually we would like to extend the life to 10-14 days.

Do you think the G6 can have an impact on CGM technology awareness and increase its adoption?

I absolutely do because it so much easier to use. Users have expressed fears in the past based on the look of the insertion device or the size of the transmitter. They’ve asked why they need to calibrate with a finger stick. With this product, those fears will go away. Increasing access isn’t just with patients’ awareness of the device benefits though; it’s on the payer as well.

It’s still harder to get than we’d like it to be.

I was interviewed recently about a regret at Dexcom, and I don’t have many, but one is that it is still too hard for everybody to get this. I wish it were easier. That’s one of my personal missions. [To improve access] I think we have to continue to work to show payers that we provide great health outcomes and that they are worth it.

There’s been talk of Dexcom serving the Type 2 diabetes population. Can you let us know what the company has planned for in this corner of the diabetes market?

Certainly with respect to intensive insulin users in Type 2. Medicare approves all intensive insulin users for CGM, and that is the broadest reimbursement decision on insulin use that we’ve had to date. So if you are a Medicare patient with Type 2, have multiple daily injections, or using an insulin pump, you are now eligible for a Dexcom. In the intensive world that’s the type of coverage we have always sought and we continue to look for that. That piece of the Type 2 population we already have a product and are serving there.

With respect to the rest of the Type 2 population, there are a number of things that we are working on that are important and we think will show a benefit. When we meet with insurance companies, we talk about the cost of healthcare. While Type 1 diabetes is costly it isn’t a big percent of the patient base. But when we talk about Type 2 diabetes, we hear that they spend a fortune on it. We think we can deliver better outcomes in Type 2 with CGM use. Not CGM use 24/7, 365 days a year, but over periods of time. For example, when one goes on some of these new compounds that appear pretty effective, a CGM is a good device to see how effective these drugs really are. If you see continual highs, you see it isn’t effective. We think it is a much better way to evaluate the overall health of someone with Type 2 diabetes than the tools we have today.

We’ve run sensors on many Type 2 patients as part of our work with UnitedHealthcare. And there’s a large part of the Type 2 population who are Medicare patients.

Simple exercises, like going for a walk with a CGM, may change patients’ exercise routines. Also, the timing of their meds – if a patient takes a pill at a different time you might see dramatically different results. You start saving the system money on a acute basis, but over the long haul what happens, we can delay complications or eliminate them through better information with CGM and some coaching. We think it can have a profound effect.

It will be a different market and interaction but we think overtime it’s a wonderful opportunity.

Read more about the features and FDA approval of the Dexcom G6.

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