Many of us jumped for joy at the recent news regarding the Dexcom Share systems approval for use. I just received mine, and I’m thrilled with it! I recently had the chance to talk with Dexcom CEO Kevin Sayer to ask him a few questions about it.

Who would you say would be the target audience for this product?

I would think the primary audience is kids and parents within the pediatric population. The ability for remote viewing of this kind of data could be huge for them. I can also see those who travel a lot and those with hypoglycemia unawareness to be early adopters. We all tend to quickly respond to a notification on our phones, so we hope with this capability we will see better outcomes with fewer hypoglycemic incidents. We’re excited to see how this will work across the entire disease state.

Does it have the same updated algorithm as the former system?

For adults over the age of 18, the new receiver will be updated with the latest algorithm approved for this population. For pediatrics, the advanced algorithm is not yet approved, so the pediatric population will be using a receiver with the same algorithm currently approved for children ages 2-18. The new algorithm for use by pediatric patients is currently being reviewed by the FDA and will be available to pediatric patients in the future.

What do you hope this product will achieve?

First and foremost we believe we’re paving the way for the ability to share data instantly and enable those affected by type 1 to have better outcomes. What this can also do is broaden CGM acceptance as connectivity will draw in more users. For right now, the thing that is most difficult for us to tackle is why more people don’t have CGM. It’s so much better and different from previous diabetes management tools. Our biggest road-blocks right now are old-school thinking and a general lack of awareness. Clinicians and many patients are used to a certain way of handling data. We believe moving data to mobile platforms will change the perception of CGM and increase awareness. The demand for this product once it’s out there and understood will be very telling as to how we move towards the next steps.

To get this message out, Dexcom has increased our field team from 40 sales people to 110 in just three years. We see the need and we just have to get more and more people convinced of continuous glucose monitoring in general. This product will also change the CGM experience. We have tried to create an experience similar to when you buy a Fitbit or something that someone relates to in their everyday life to help with that.

In terms of Bluetooth, what kind of technology must in place for this to “work?” (a.k.a. do you need a smartphone)?

The device itself will be compatible with Apple products with Bluetooth LE and wifi capability including the iPhone and iPod Touch devices. The receiver connects to the Apple device through Bluetooth LE and the Apple device needs to be connected to either a cellular network or wifi in order to transmit data through the free “Share” application found in the “app store.” We have configured “loss of data” alarms in the event that connectivity is lost.

People who follow a patient will download the free “Follow” app for the “app store.” With this app, followers will be able to set their own alarms, potentially different for the person they are following. For example, a patient may set their low alarm at 70, but a follower may want the low alert at 80 or some other number and may not want to be alerted until the patient has been below that threshold for some period of time. Additionally, followers can turn off all of the alarms if they wish or Dexcom patients using the Share app can disable all followers for periods of time. The apps have very rich features sets. A Dexcom user can choose to have up to 5 “followers” at any given time.

What if any, is your relationship with the Nightscout group, and did their #wearenotwaiting campaign have anything to do with the acceleration of this product?We are very aware of what they are doing, and don’t have a relationship with them because they are not using an FDA-approved product.

Engineering efforts on the Dexcom G4 receiver with Share started more than 18 months ago. We filed with the FDA for this system approximately 4 months ago and were approved by the FDA in a very short time period. It was a relatively quick approval for a number of reasons. We used the same apps that are used by the recently approved Dexcom Share Cradle system, the apps were not new to the FDA. The major thing for the FDA to approve for this product was the addition of Bluetooth LE capability to the G4 platinum receiver. We believe our strategy of having a narrow focus and isolating small incremental improvements helps accelerate innovation and we plan to use this strategy moving forward.

I believe what Nightscout and others have done is validate the need for what we’ve been trying to achieve for years. They have certainly created more awareness for the need for connectivity in the diabetes community. With our recent approvals, the FDA has created a path for groups like Nightscout to continue to do what they are doing as long as they comply with the recently issued FDA guidance. Dexcom is already very aware of the controls, documentation and testing necessary to develop software that meets FDA standards.

What are the costs for this product?

Here is how it’s broken down:

Those who have purchased a Dexcom receiver after 1/1/15 will be eligible for the new receiver at no charge. Patients will be required to contact Dexcom prior to April 30, 2015, to take advantage of this offer.

For those current Dexcom users with a receiver less than a year old, an upgrade to the new system is available for $199. This offer also expires on April 30, 2015.

If you have a Dexcom receiver more than a year old out of warranty you can get a receiver through our normal sales operations at current pricing. We have not increased the price of the G4 Platinum receiver because of the Bluetooth LE capability

What we can expect from Dexcom in terms of product advancement?

We’re constantly evaluating possible next steps in improvements in technology for those affected by type 1 diabetes. Our next FDA filing will be for our Gen5 system, where the transmitter can communicate directly with a mobile phone and the receiver will no longer be necessary. All sensor data can then go seamlessly from the mobile phone to the cloud and be shared with others. We will eliminate the need for the receiver. We will continue to offer the patients a receiver for backup and the Dexcom G4 Platinum receiver with Share will be compatible with the Gen5 system. After that, we are working on several advancements to improve sensor performance, more connectivity with other devices such as Android apps and Smart Watches, and patient convenience.

—Anna Floreen–GluAnna