FDA Approves #Dexcom G4 Platinum #CGM System with #Share

Fantastic news announced by Dexcom today. Cloud information has been approved for the G4 system. New receivers will be available soon – see below for details.

As posted at MarketWatch

SAN DIEGO, Jan 26, 2015 (BUSINESS WIRE) — DexCom, Inc., DXCM, -0.29% a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The “Share” and “Follower” apps will be available on the Apple App Store at no charge.

“The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day,” said Kevin Sayer, President and Chief Executive Officer of Dexcom. “The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation.”

About Dexcom G4 Platinum with Share:

The Share receiver is anticipated to ship to new patients in early March 2015.

All patients who purchased a Share cradle will receive a free upgrade to the Share receiver.

All purchasers of a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver.

There will be a low cost cash upgrade to the Share receiver for those patients who are still under warranty with their existing receiver.

The Share receiver will be compatible with future generation Dexcom sensor systems.

About the De Novo Classification Process:

The FDA reviewed the mobile app software used with the Dexcom Share receiver (both the “Share” app on the patient’s phone and the “Follow” app on the caregiver’s phone) through its de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. The FDA has specifically classified the apps which communicate with the Share receiver as a secondary display device and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display. This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring. The Share receiver was still evaluated as a Class III medical device.

Management will hold a conference call to review this approval starting at 9:00 a.m. (Eastern Time) on Monday, January 26, 2015. The conference call will be concurrently webcast. The link to the webcast will be available on the Dexcom website at http://www.dexcom.com by navigating to “Our Company,” then “Investor Relations,” and then “Events and Webcasts,” and will be archived there for future reference.

#Nightscout | Harboring Autonomy #WeAreNotWaiting #CGMintheCloud

IMG_8890My number one reservation about starting Nightscout was the size and weight of the rig. It’s a definite price to pay. It’s not ideal, but Caleb’s been able to manage, and the benefits are currently worth the price.

My next concern was taking a step backward in the progress we had made in Caleb’s self-care.

Since he was in preschool, Caleb has always had some level of responsibility in his care, and it has advanced both organically and with careful planning each year. In third grade, we (his school nurse at the time, Caleb and I) started to take steps to prepare him for middle school. We targeted specific milestones for each of the next three years. Caleb was caring for himself as I expected a middle schooler would by the beginning of his last year in elementary school.

Given this success in autonomy, and on the verge of starting middle school, I didn’t want to compromise his progress. If I started watching his bgs, would the torch come back to me? That was absolutely not the goal. Why would we need remote access to his CGM data if he was now running the show? I didn’t have the answers to these questions, but I started seeing successes with the Nightscout Project, got over the hurdle of the rig size,  and figured with a limited financial investment, why not give it a try.

The role Nighscout played in Caleb’s autonomy was not one I anticipated. Knowing that he was no longer “alone” when I dropped him off somewhere, gave him security. This increased the opportunities to be places by himself because he was comfortable. The more he did this and saw that he could care for himself by himself, the more confidence he gained. Increased confidence added more security, which led to more confidence, and before we knew it, things had changed dramatically.

We had gone from discussing a careful plan of “what ifs” each time he was dropped somewhere, to no longer even thinking about it. This was a change in Caleb. Where he was once anxious, he was now assured. School days became easier as well. A middle school schedule is pretty hectic; he never seems to have a spare moment. He has greater flexibility to go throughout his day as he pleases, without being a slave to a diabetes care schedule. We probably would have gotten to that point because of Dexcom alone, but Nightscout got us there immediately upon starting school.

Does Caleb care for himself entirely independently? I’d say he does 90% of the work when he and I are apart. When he’s home, we’re definitely a team. He makes decisions, I make decisions, we make decisions together. When he’s at school or elsewhere, he’s in the driver’s seat. We consult throughout the day if needed. There are times when I see something on Nightscout that he hasn’t noticed yet and I will prompt him. I don’t feel like I’ve taken back control though. I feel like I’m helping him at a level that is appropriate for someone his age. He’s continued to move forward in his level of self-care. He hasn’t taken any steps back, which was my concern.

The biggest issue we were having when we starting using Nightscout, was Caleb’s self-confidence in his diabetes care. I knew he was capable, he wasn’t as sure. Nightscout propelled his confidence forward, the exact opposite outcome I had anticipated.

Related Posts:

Nightscout | Getting Started

Nightscout | The First Two Weeks

Nightscout | The New Rig

Nightscout | Getting Started #wearenotwaiting #cgminthecloud

This is a picture of Caleb’s real-time pre and post lunch CGM data as I write this post. He is at school. I am at home.

IMG_7186In April of 2013 (oh my goodness, I cannot believe it was that long ago) I mentioned DexCom Share with much enthusiasm. There’s a rumor going around that DexCom Share may be nearing FDA approval, but that is just a rumor with no substantiation. I hope we’ll hear something soon.

It seems awkward to have a cradle and to connect to this cradle wherever you go and presumably carry this cradle around. But the idea of being able to access the CGM data of a person who is nowhere near you made me giddy.

Getting this information in this way has become a reality for hundreds (is it thousands?) of people. It’s not through DexCom Share. It’s though Nightscout, created by a grassroots group of people who realized they had the ability to make this happen themselves. It is not FDA approved or regulated in any way. It is a DIY-at-your-own-risk-open-source situation. Many are making it work and enjoying the benefits despite the risks associated with it being non-regulated.

When I first heard of it, I was skeptical, and it had nothing to do with it not being FDA approved:

1. Adding anything additional to Caleb – who I’m sure already feels like a pack mule despite the nifty bags I find – is not appealing in any way. (That whole cradle issue I mention above with regard to DexCom Share). 

2. More devices/programs/databases means more opportunity for things to go wrong. We have so many variables and troubleshooting already. The thought of more is less than appealing.

3. Our goal is to encourage Caleb’s diabetes autonomy. Getting this nonstop flow of data seems like taking the reigns back into my hands, which is in direct opposition to our current goal.

4. This seems COMPLICATED! I don’t have time for complicated right now. No time at all.

The Nightscout RigThis remained on my todo list though. I wanted to learn more and when the summer and many of its activities started coming to a close, I had the opportunity to investigate. By then, people had come up with some clever ways to carry the rig – not as cumbersome as I originally thought. (Ours pictured here on the left). I was seeing people I personally knew putting it into action which made it seem more attainable. When I finally sat down and looked at it, the setup instructions were very well written and although I would still consider it complicated, is was not difficult to get set up, just required a lot of attention to detail.

It’s been less than two weeks and we are off to a good start. We got started with the bare essentials for $73 for the whole rig using wifi access. We’ve worked out several kinks, added a data plan for about $9 a month, and are getting this integrated into our regular routine.

If you are interested in getting started or just learning more, here is where you should start:

The Nightscout Project

CGM in the Cloud Facebook page