Dexcom’s G4 Platinum CGM is a management device that has not only achieved a level of success by surpassing anything on the market before it, but it has cultivated an appreciative growing base of customers and the respect of the medical provider community. Dexcom’s President and CEO Terry Gregg talks about the company’s philosophy behind its product development as well as what consumers can expect in the future.
By: John Parkinson, Clinical Content Coordinator, DiabetesCare.net
Terry Gregg had an excellent understanding of CGM technology before he came to Dexcom—having been in leadership positions at Medtronic and Minimed previously. He was friendly with the founders and executives of Dexcom, and had remained in touch with them, even after retiring from Medtronic. In 2005, Dexcom asked Gregg to join the board of directors and he spent some time getting to know the company’s technology.
While the company had been ingrained in research, Gregg (pictured, left) saw the opportunity to make the company into a commercial enterprise. As such, he came onboard as president and CEO of Dexcom in 2007.
Dexcom launched its STS CGM—their first CGM for the commercial market—in the spring of 2006. The following year, the company launched its Seven CGM. Along the way, the company went on to forge partnerships with other diabetes industry companies such as Animas and Insulet, and more recently, Tandem.
And in October 2012, the company launched its G4 Platinum. This product is long-lasting, discreet, and waterproof. While indicated for seven days, it has been widely reported that people use it for longer. Some of its unique features include: The ability of the receiver to read data up to 20 feet away from the transmitter/sensor; it can be changed to high and low tones with pre-selected melodies; and it comes in different colors.
Gregg understands it all comes down to delivering what people with diabetes (PWD) need, and not what researchers think may be helpful to PWD. His company surveys people with diabetes for their feedback, and if anecdotal stories can serve as evidence, there has been an overwhelmingly positive response and support for Dexcom’s G4.
Another sign of its popularity is the company Dexcom keeps. The G4 is being used in conjunction with insulin pumps from other companies in a majority of artificial pancreas research trials. The G4 is also being used by pharmaceutical companies to collect data and identify glucose trends while investigating oral agents and insulins according to Gregg.
The company is working on its G5 and G6 versions, and predicts they will have them fully-developed and FDA approved in 2015 and 2016/2017, respectively. Dexcom is currently awaiting word from the FDA about its Share product, which is a remote monitoring system that is going to be used with the G4 Platinum.
Gregg believes the Affordable Care Act will lead to a greater utilization of performance-based medicine, and that not only providers will be compensated on better outcomes, but says CGMs could play a greater role in this area for not only the type 1 market, but the type 2 market as well.
With so much excitement surrounding Dexcom and their technology, DiabetesCare.net spoke to Gregg about their existing products, what’s in the company’s development pipeline, the type 2 market for CGMs, and his long-term goal of a “bloodless” glucose check for people with diabetes.
DiabetesCare.net: Can you talk about how Dexcom’s technology differentiates itself in the CGM market?
Gregg: Our G4 Platinum CGM system has the most accurate, durable sensor that has been commercially introduced. You will see some future data that shows the G5 and G6 versions will have the ability to show our coefficient variability is around 7 percent. What that really means is every sensor that is produced from day 1 to day 30 of the month is going to behave similarly.
What this translates to is patient trust in our CGMs. We are seeing greater utilization by patients. They have the comfort to stop a CGM session when it’s appropriate, and reinitiate a new sensor session almost immediately. We are unobtrusive. Most patients say that by day two they don’t even know they have a sensor on. It has become, ‘this is what I do.’
Left: Here is the G4 Platinum CGM. Some of its unique features include: The ability of the receiver to read data up to 20 feet away from the transmitter/sensor; it can be changed to high or low tones with pre-selected melodies; and it comes in different colors.
DiabetesCare.net: Looking at the clinical side, can you provide some guidance in terms of how medical providers and patients can get the most out of Dexcom’s CGMs?
Gregg: Studies have demonstrated that the more you use it the better the outcomes. Patients do you use it off-label and extend use beyond 7 days and get pretty good results, but the key is that you have to utilize it every day, because it doesn’t work if it’s not body-worn.
Our long-term goal is to remove the burden of having to do finger-stick measurements in order for people to gauge their glucose to measure their insulin. We have spent a good chunk of our R&D dollars on the pursuit of additional iterations and new membrane systems to work towards that goal.
DiabetesCare.net: Dexcom recently received FDA approval for expanded use of the company’s G4 Platinum CGM for patients with diabetes who are ages 2 to 17. What were some of the considerations in going for the pediatric population and are there differences in the technology for pediatric use versus for adults?
Gregg: The real basis for it was that we knew that around 8 to 10 percent of our customers were under 17 years of age. And they were being prescribed the product off-label, so there was a need to pursue that pediatric indication. Secondly, we looked at the size of that market and said there is approximately 150,000 people who are 17 and younger who have type 1, so we have a moral responsibility to pursue it.
We worked with FDA to design a unique clinical trial that was specific to the pediatric population. There is a FDA mandate now that all biological agents and medical devices must have a specifically designed clinical trial for pediatrics.
In terms of the technology, the sensors are the same, but the glycemic variability in the pediatric patient is different than in an adult—it is much more rapid changing. We had to change our labeling to reflect that.
DiabetesCare.net: While the majority of Dexcom customers are type 1 patients, can you make the case for why CGMs can be important for type 2s to incorporate into their lives?
Gregg: The minute type 2 patients begin taking insulin, they have the same challenges as type 1s in terms of avoiding hypoglycemia. We just got back some data in the last couple of weeks that there are 5 million patients in the U.S. who use insulin, and there are over 400,000 new patients starting insulin every year. Obviously we have to build a slightly different product, and the reason I say that is less than 5 percent of pump users are type 2, but it is growing, particularly as younger patients begin insulin regimens earlier in their diabetes.
Using a CGM might be something that they want to migrate to. Our goal is to be convenient for type 2 patients, and they are at the center of our focus. What do they want? Well, they tell us they want the discreetness, so they want something small to use. And that is something we are going to accomplish with our next transmitter introduction, we are going to go down in transmitter size. We are transitioning all that information to a phone, rather than pointing it to a receiver so that they have an ease-of-use experience.
On the insurance payer side, it’s about expanding their coverage of type 2 patients using insulin. We are actually getting coverage by the third-party system. We continue to see that grow, similar to what we saw back in 2008 when we saw the first policy coverage by an insurance carrier for type 1s. And today, 98 percent of commercially insured type 1 patients have coverage for CGM.
Insurance companies understand that if you reduce the glycemic variability, you reduce the costs associated with diabetes. If you just look at one important component, hypoglycemia, insurance payers are extremely astute of the reduction of cost associated with keeping patients out of the ER as the result of a hypoglycemic event.
I think where we need to go with the payer system—but we are not there yet—is that we need to be part of that fabric of cost-savings on a more global basis. You hear with the Affordable Care Act that physicians are going to get paid for better outcomes. I would suggest to you that the device industry is going to get paid for technology that drives better outcomes.
We are already engaged in that discussion with payers. We are willing to go at a shared risk here. We will put our CGMs up and we’ll look at it at whatever timeframe the payers designate as being appropriate for coverage, especially if they only want it to be for those people who have had hypoglycemic events in a designated period of time. We are so confident in our technology that we are willing to risk some of the costs upfront because we believe in the cost savings our CGMs can ensure. And that, I believe, is what the future landscape is going to look like for reimbursement.
DiabetesCare.net: In your conversations and from what you have heard from people, do you find medical providers are receptive to type 2s using CGMS and can benefit, especially those on insulin?
Gregg: I would say it’s still challenging to many providers. There are only two national insurers today that provide coverage for insulin-using type 2 patients. And you will see that grow. I think in the next 2-3 years, it will become part of the reimbursement landscape as well.
It’s a terrible game we have to play in. The more there are medical claims, the more it moves up the level of sensitivity. If insurers get enough claims they will take another look at it. They will go back and take a look at their payer history associated with that and begin to say wait a minute maybe there is a patient with a 9 A1c, and I know patients with 9s who have gotten down to a 7. I’m not paying for them on this; we should go back and look at this and consider coverage for type 2s. Obviously, the number of type 2s on insulin far exceed the number of type 1s. It will be a slow-moving progression to coverage, but it has already started.
DiabetesCare.net: Your company is working with Tandem and Animas on developing compatible technology to work in concert in the artificial pancreas. Do you see these collaborations as the first phase towards integration and eventually the development of artificial pancreas systems?
Gregg: Yes. We are in about 80 percent of the artificial pancreas research projects today. In those, are Tandem, Animas, but there is also Insulet and Roche. I expect Asante will also migrate their pump into some of these trials.
A lot of work has to be done in order to achieve it. Right now, we can get to overnight control from a standpoint where you are not eating and you are just sleeping. We can keep people within range in that setting. The challenge comes during the day because people are doing different activities from work to dealing with stress factors to eating.
In addition, all these artificial pancreas systems must work together. They have infusion sets, glucose sensors, insulins, and algorithms. You need to have four components working without any issues. I haven’t seen any trials that have worked perfectly yet—even in highly controlled conditions.
DiabetesCare.net: While there is still much to be done, it is amazing how much has been accomplished and an exciting time to be interested in the diabetes industry right now. The artificial pancreas will really make a difference in peoples’ management once these various version and next generational systems come onboard.
Gregg: The achievement in the last three to four years compared to the last 10 years before that is like working at warp speed. That is the good news; things are happening very quickly.
DiabetesCare.net: Do you believe the CGM technology will eventually have two separate markets: those who use it for the artificial pancreas systems and those who use it as a standalone product?
Gregg: Absolutely. I believe CGMs will become part of the diabetes landscape, no matter what the methodology of insulin delivery is—whether it be the artificial pancreas, sensor-augmented pumps, or multiple daily injections.
I always question how many patients will ultimately migrate to artificial pancreas. Will it be everybody? I’m not sure. When we query patients about it, there is a good number of people who say they won’t because they still want that degree of control over their diabetes. Time will tell. As the artificial pancreas systems get better, patients will trust them more.
And you add to that people who are non-insulin- using type 2s. There’s been some studies that have been done with CGMs without the use of prandial insulin that show benefits, so I do think there is a role for CGMs in that patient market as well.
DiabetesCare.net: Do you have anything to report or any news about what is in the pipeline or exciting news about your existing product lines?
Gregg: We are anxiously awaiting word from the FDA about our Share [remote monitoring] product and its approval. It has radio chips in it so the Gen 4 [G4 Platinum] receiver will be placed in it and it will communicate with either an i-Phone or i-Pod touch. Then under notification, it will send information to our servers and we can actually send it to followers.
The next in line behind that is the G4 for diagnostic use, which we have applied to the FDA for that indication. The G5 will be a product with eventually four or five different iterations to it, which we will release as we develop them. The final product will combine all of these versions and goes directly to the phone. At this point, the FDA is going to be cautious about what private information migrates to the phone. Obviously, cyber security is in the minds of everyone with every wireless tool.
As these products become part of the diabetes landscape, with glucose data you always have got to have a primary end-user. The protocol between transmitter and receiver is a phone, so you have to ensure upgrading your system on the phone doesn’t corrupt the signal between the transmitter and the receiver.
After finalizing the various features and components for G5 we will move onto developing the G6. If you think of G5 as a lot of hardware changes and a new algorithm, then G6 is going to have some new proprietary membranes. And with this version, it will get us into single digit accuracy.
Left: Dexcom's G4 Platinum is plugged into the cradle of the Share Remote Monitoring System. The Share cradle can charge the receiver and still transmit CGM data every five minutes to a nearby i-Phone or i-Pod touch. With the use of the Dexcom Share app, the i-Phone will receive the CGM data and that data can be shared with up to five people remotely.
DiabetesCare.net: Do you have any sense of a timeline for these products?
Gregg: We have set out the G5 being a late 2015 release, and G6 for late 2016 or first part of 2017. We are hoping that Share will be approved in the second quarter of this year, and that the diagnostic use indication for the G4 is in the same time frame, possibly the third quarter of this year. In terms of artificial pancreas partnerships, we are expecting Animas to have its Vibe product out later this year, and Tandem’s sometime in 2015.