Dexcom’s Kevin Sayer talks new G7 scientific trial knowledge

On the J.P. Morgan Healthcare Convention this week, Dexcom, maker of steady glucose monitoring techniques, made waves after CEO Kevin Sayers introduced new scientific trial knowledge from its but to be launched CGM, the G7. 

The 308 particular person trial demonstrated that the G7’s imply absolute relative distinction (MARD) was 8.2% for adults and eight.1% for pediatric sufferers. The G7 was submitted to the FDA within the fourth quarter of 2021 and continues to be awaiting regulatory clearance. 

On the monetary facet, Sayers revealed the corporate is predicted to make $2.448 billion in unaudited income for 2021, a 27% enhance from 2020. On this upcoming 12 months, the corporate forecasts that it’ll herald between $2.82 billion and $2.94 billion in whole income. 

MobiHealthNews sat down with Sayers to debate what’s subsequent for Dexcom and the way forward for diabetes care. 

MobiHealthNews: I would love to start out off with an summary of the information you introduced at J.P. Morgan and to listen to a bit of bit extra concerning the G7. 

Sayers: We closed the 12 months properly. We grew 27% for the 12 months, and through a pandemic time in ’20 and ’21, we hung one other billion {dollars} of income on our outcomes. And I’d problem anyone to do higher than what we have performed throughout these occasions.

Large information out of J.P. Morgan, and a number of the issues persons are speaking to me about and asking us. We talked quite a bit about our Dexcom One product that we launched in 4 European international locations, and that is a chance. [It’s] the primary time we have differentiated on software program as a product, as a special product. We have by no means performed that earlier than. And doing that we predict is a giant a part of our future. We do suppose that we will finally section this market into a few product strains after which be very profitable with it. …

The options of the G7 that I talked about essentially the most … it is 60% smaller than our G6 and a bit of bit greater than a nickel, a bit of smaller than 1 / 4. It is actually very unnoticeable to individuals who put on it. It is a half hour heat up. … It’s nonetheless related. It is going to be related to everyone. However along with being interoperable and connectable, we have additionally enhanced cybersecurity right here. 

We actually have taken new expertise. Our circuit and chip within the G6 was developed approach again within the 2016-17 timeframe, and cybersecurity and Bluetooth has superior considerably since then. So the brand new chips we have now on this will once more make folks really feel safer…

We have developed a brand new software program platform for this the place a few of your knowledge that sometimes you’d discover in our CLARITY software – that are tendencies over an extended time period – goes to be obtainable proper within the app, and other people will subsequently be capable of look and see what their timing ranges for some time period and get extra info. [It’s] simply a neater person expertise with respect to beginning up and all the things we have discovered. …

Then we get to the accuracy knowledge. Dexcom has at all times been the most effective. …Finger sticks of their exams again within the day had been like 10% off from laboratory blood instrument measurements. Our imply to common relative distinction is within the low eight with this product when in comparison with a laboratory instrumentation. So we’re getting near our finger sticks with the accuracy of this. Folks can actually depend on it to make good choices they usually’ll really feel very snug with what they’ve. [It] once more units the bar increased for everyone else.

MobiHealthNews: I do know prior to now we have talked quite a bit about perhaps increasing past simply folks with diabetes. Is that also a consideration or is that also one thing that you are looking at sooner or later?

Sayers: That may be very a lot one thing we’re sooner or later. And we have now relationships with quite a lot of early section corporations which can be attempting in a certified, accepted method. To be clear, they have the right paperwork to get folks utilizing CGM for simply well being and wellness. And the outcomes from these guys have been actually good. 

Two research I talked about in my presentation, the Onduo research, which noticed reductions – and these had been the Kind 2 sufferers – however if you take a look at the mixed set of outcomes, [you see] higher cardiovascular outcomes, weight reduction, all types of issues. After which Welldoc ran a research once more in Kind 2 sufferers, however individuals who had a median glucose above 180 on this cohort of sufferers. They used the product after 24 weeks of steady CGM, the place lowered common glucose by a median of 54 factors. So then you definitely get into different makes use of of the expertise, metabolic stuff. Any individual involved about what they’re consuming or as prediabetes approaches. How shut are you? When do you begin a compound? Possibly to cease this factor?

MobiHealthNews: I would love to speak a bit of bit extra concerning the software program. How does Dexcom One change the sport for the long run, and notably Dexcom’s huge imaginative and prescient for the long run? What sorts of capabilities are you able to foresee with including software program?

Sayers: With Dexcom One, what we did is we took options out. We made it a extra easy product that may justify a lower cost level. And we took a number of the alerts and alarm options out. We took the flexibility to share knowledge out. We took some issues out to make it a extra easy product and extra aggressive with what’s in these marketplaces. And so sooner or later, on the software program facet … I might see a day the place we have now a menu of options that both folks can get reimbursed for, or they will select to not use if they do not need to, or they will pay for in the event that they’re extremely refined. And what I would love is a platform whereby if folks develop these options, we will add tiles to our personal software program and make it so you may get out and use one other app and maintain Dexcom as your hub.

MobiHealthNews: What do you see as 2022 comes down the pipeline? What are a number of the greatest adjustments in diabetes care that you are looking out for? And what are a number of the issues that you simply foresee for Dexcom as properly?

Sayers: One factor we would prefer to see is elevated entry all around the world to our expertise. And whereas it isn’t extremely technical, it is simply actually necessary. When this product is reimbursed and coated, folks come and get it they usually use it they usually have unbelievable experiences with it. …

I feel you will have some very thrilling developments on the pharmaceutical facet as folks maintain these new Kind 2 compounds. [They] look very thrilling and really partaking. It is going to be fascinating to see how they roll out and the place that each one shakes out throughout the drug corporations. I do know they’re all working very onerous on these compounds they usually seem to supply excellent outcomes.  

I feel the opposite factor in our world, we’re very a lot anticipating the launch of Omnipod 5 with insulin this 12 months. We have labored with insulin for a few years and we had been so excited to get this built-in product lastly.