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

Exuding Coolness | Adam Lasher from American Idol

Hanging his “robotic pancreas” from his guitar strap, Adam Lasher auditions for American Idol. I haven’t watched in years. This is an incentive to start again.

FDA Approves #Dexcom Software with Artificial Pancreas Algorithm

Screen Shot 2014-11-06 at 2.01.00 PMDexcom announced today the availability of updated software that will improve the accuracy of the system.

We are Nightscout users and use two receivers. One is approved only for adult use and the other is approved for pediatric use. Because this software update is approved for users 18 years and older, the pediatric receiver can not be updated with this new software.

We will therefore be using both receivers, each with a different algorithm. We should be in a good position to compare and assess the improvement in accuracy, even though we’d prefer just to update both with the new software.

If you are planning to update, please note that the update will require a restart of the sensor and will clear out all historical data. So download your data first if you want to keep it. Also, the update cannot be done from a Mac.

Visit Dexcom to access the software update.

Here’s the press release:

New Dexcom software achieves critical milestone in measured accuracy for continuous glucose monitoring

SAN DIEGO, Nov 06, 2014 (BUSINESS WIRE) — Dexcom, Inc., DXCM, +0.45% a leader in continuous glucose monitoring (CGM), announced today that the U.S. Food and Drug Administration (FDA) has approved new software for the Dexcom G4® PLATINUM CGM. The new Software 505 features the same advanced algorithm as used in artificial pancreas research around the world. The software will impact the performance of the Dexcom G4 PLATINUM, already considered the most accurate CGM system on the market today. The software will be made available free of charge to adult patients using the Dexcom G4 PLATINUM.

“Patients will be able to go online and download the software, or they will receive the software preloaded onto their Dexcom receiver with new orders,” said Terrence Gregg, CEO, Dexcom. “This latest software enhancement to the Dexcom G4 Platinum will make the performance level comparable to episodic blood glucose finger sticks; this is a significant step in the evolution of CGM becoming the standard-of-care over blood glucose meters for people with diabetes.”

Now, Dexcom G4 PLATINUM is the first and only CGM system on the market with a single-digit MARD (Mean Absolute Relative Difference) measurement, below 10 percent. MARD is the standard industry measurement of accuracy, where a lower MARD reflects higher accuracy. With the new software, healthcare providers, patients and caregivers will now have glucose readings from a sensor that are closest yet to lab accuracy. The combination of the new software with the CGM advantages of real-time trends, speed and direction provides a complete picture of the patient’s glucose activity.

Diabetes affects 29.1 million Americans and is the 7th leading cause of death in the United States.3 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 79 million Americans over the age of 20 are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.

 

#FDA Approves #DexCom #Share | DexCom Share

Shipments will begin October 22nd and price is $299. Prescription is not needed.

Screen Shot 2014-10-20 at 10.07.07 AMFrom CNBC:

SAN DIEGO–(BUSINESS WIRE)– Dexcom, Inc. (NASDAQ:DXCM), 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 CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE, an accessory to the Dexcom G4® PLATINUM Continuous Glucose Monitoring System, uses a secure wireless connection to transmit the glucose levels of a person with diabetes to the smartphones of up to five designated recipients, or “followers.” These followers can remotely monitor a patient’s glucose information and receive alert notifications from almost anywhere via their Apple® iPhone® or iPod® touch. With Dexcom SHARE, parents and personal caregivers can monitor a child’s or loved one’s glucose data from a remote location, giving them peace of mind and reassurance when they are apart. “Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” said Terrance H. Gregg, Chief Executive Office of Dexcom. “With Dexcom SHARE, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes.”

See full article here Prior Post DexCom Share

From the DexCom Store:

Screen Shot 2014-10-20 at 10.39.34 AM

#Nightscout | The New Rig #WeAreNotWaiting #CGMinTheCloud

IMG_7213The Grid-It works well for the “rig” (the dexcom and uploader combination that feeds the data to the cloud). It fits precisely in Cal’s CMC Urban Day pack. There is some vulnerability to the DexCom receiver’s usb port. To avoid damage, it’s important to keep the connection of the cable to the receiver immobile and intact. The Grid-It does that well.

There is a 3D printable case developed by two men who are members of the CGM in the Cloud Facebook group. The case holds the Moto G, the DexCom receiver and a special cable very snugly to limit any movement. You can either buy the case from them or download the file for free to print a case yourself, if you prefer. They also offer a DexCom only case which keeps the cable secure if you are using a different uploader but still want added strength to the DexCom usb connection.

Here is their video which shows how you put the DexCom/Moto rig together:

I got our case that you see pictured here through a local printer I found on 3D Hubs. The case was $24 and the cable was $26. IMG_7218Everything is snug. Very snug. I’m not sure I’ll ever be taking the receiver out of this case. I am getting used to taking the phone in and out of it to charge. It’s a tighter fit than what is shown on the video. Could be due to the printer, speed of printing or some other 3D print variable I’m not familiar with that results in variability in the product. It’s not l light. So although it can be worn as a lanyard with a case, it might be a little uncomfortable, but people are doing it.

The people contributing to this project are simply amazing. Such heart and soul are being given freely to make the lives of people with diabetes better. An update to the NightScout website, called Brownie, was rolled out yesterday. It allows for a Care Portal where care decisions can be documented and shared easily. We started using it this morning. I’ll post more about it soon!

#Nightscout | The first two weeks #CGMinTheCloud #WeAreNotWaiting

I bought a Boost Mobile Moto G, a cable and a Grid it. With a good sale at Target, total cost was about $73. I spent a few hours following the Nightscout Project instructions, and we were up and running.

IMG_7040Initially, it’s like the first time you get CGM data. You can’t believe it’s right in front of your face and you keep looking at it (as if to confirm its reality) and soaking up the perpetual stream of easily accessed information. That novelty does wear off. We quickly got to an as-needed access basis.

With the rig packed in Caleb’s bag, I could watch his BG while at school using the school’s wifi. Then, Caleb had a Gymnastics lesson and with their free wifi, I could run my errands and keep mindful of his BG. It became clear that having access to this information when he’s at baseball practice and dance class (places without wifi) would certainly be beneficial. I added a data plan via Ting for about $9 a month and gained continuous access to Nightscout.

We aren’t really doing anything differently, but Nightscout has enhanced our ability to manage diabetes in some subtle, yet meaningful ways:

– Caleb’s middle school schedule is jam-packed. Clearcut breaks for daily BG checks don’t exist like they did in elementary school. He and I being connected during the day via Nightscout allows flexibility for him to check his blood sugar when it’s convenient for him. If I haven’t heard from him by 9:15 – when he changes periods – rather than strum my fingers in anticipation and wonder, I just take a peek at Nightscout and stop wondering. Caleb can focus a little more on school and a little less about when exactly he needs to check his bg.

IMG_7197- Caleb is active. Gymnastics, baseball, tap, jazz, ballet, swimming, trampoline – they all have different levels of intensity and each activity can vary in intensity from one day to the next. It’s often just a guess about how to compensate carbs or insulin to mitigate.. We don’t always (if ever) guess correctly, so there are adjustments along the way. By watching remotely, I can be prepared to help him. I know if I can take my time with my errands/chores/shuttle service. I know if I should come back prepared with a cupcake for the impending low that 45 minutes of intense tapping just caused, or whip out his PDM to nonchalantly infuse some insulin because they decided to sit and review the baseball rulebook rather than run bases at practice.

– When he checks in with me, I am more prepared and he doesn’t have to spend time giving me information. We are already on the same page and get right to business, so he’s spending less time away from whatever he’s doing.

Overall, there is an added peace. Caleb is less distracted because he knows someone else it watching. Rather than wondering if that light-headedness is because of playing flute for an hour or if his BG is dropping, he is more likely to just keep playing. He does not seem as preoccupied about what his blood sugar might be. Even though he has DexCom in his pocket with him to alert him, there’s something comforting about knowing the responsibility isn’t all on him. Knowing that there is a safety net lets us all relax our shoulders a bit and focus more on life and less on diabetes.

Pictured above : Nightscout on my phone’s home screen. I see Caleb’s numbers as easily as accessing any app. 

Related posts: Nightscout | Getting Started

More to come on Nightscout including: Impact on Self-Care Development, Nightscout at School, Bumps Along the Way, The New Rig, Pebble Watch.

The New Dia Bag – CMC Urban Pack | PDM Carrying Case

For the past few years, Caleb’s been able to effectively carry his OmniPod PDM and other essentials in this: Photo Jul 17, 3 16 47 PMContents and full post about this nifty little case can be found here. Contents of his updated bag mentioned below can be found here.

This year, he’s upgraded to something a little bigger. Things were a little cramped in the other bag. But the proportions of the bag to his body were good so we made it work. Now that he has a bigger body, he can handle a little bigger bag without being too clumsy. I wasn’t looking for a new bag; I just happened upon this. It’s by the make maker of the smaller one, and I figured it was worth a shot.

Screen Shot 2014-08-29 at 8.59.04 AM

 

PDM Carrying Case | CMC Urban PackHe carries about the same stuff in it. He uses his iPod to keep me updated throughout the day, and this case has ample room for that. He typically carries his DexCom receiver with his Tallygear cover in a pocket, but there’s enough room to stash it in this bag if he’s going to active and doesn’t want to carry it.

An unplanned advantage of this new bag is that it holds his new Nightscout rig perfectly in a separate, safe compartment!

More on our CGM in the Cloud experience coming next. (Click here)

In the Middle #backtoschool


Screen Shot 2014-08-27 at 12.20.15 PM
My kids went back to school on Monday. They are each starting a new school – one in high school, one in middle school and one moving up to her intermediate elementary school. New schools mean new schedules and lots of adjusting. We are on day number three and I’m happy to report, so far, so good. We’re all learning and adapting. 

Entering a middle school means having lots of teachers. Lots of teachers means lots of emergency supply bins. I’ve seen many people posting pictures of their school supplies and I did the same. Each of Caleb’s ten classroom will have an emergency set of carbs – juice, glucose School Suppliestabs and gels. Caleb carries a stash of carbs with him and rarely needs to go into the reserves, but you never know when a stubborn low day will come your way. 

We’re still trying to figure things out from what to leave in your locker to insulin to carb ratios. I will report back with our routine once we get it settled. In the meantime, if you are heading back to school soon and are looking for tools to prepare your child’s teachers, I recommended checking out the ADA’s Safe at School series of videos. We used the Hypoglycemia one specifically for an all-staff orientation. 

 

#Dexcom Investor Call #CGM Q4 2013

DexCom G4Here are some excerpts from Dexcom’s most recent earnings call as posted on SeekingAlpha.com that I found interesting. These are specific to Dexcom’s cloud based platforms and the elimination of regular fingersticking, both areas of focus in development for G5 and G6 and having pending applications to the FDA. There was also reference to studies showing the accuracy of G4 as superior to Enlite, particularly in hypoglycemia. There was much more to the call including discussion of the financial impact of pediatric approval as well as Terry Gregg’s future with Dexcom, and I invite you to read the transcript in full at SeekingAlpha.com.

Terry Gregg, CEO

…our G4 PLATINUM sensor is significantly more accurate than Medtronic’s Enlite sensor. At this time most investors are aware of the work by Boston University where Dr. Steven Russell shared comparative data from patients simultaneously wearing the G4 PLATINUM and Medtronic’s Enlite with reported MARD of 10.8% for the G4 PLATINUM and 17.9% for the Enlite.

From the question and answer section:

…And then last question is you mentioned that on the progress with G5 and G6 anything in particular on the timing of those or when we might see a regulatory submission or studies? Thanks.

Kevin Sayer – President and Chief Operating Officer

We run early phase studies on our technologies before we go to publication we are running early phase studies on several different versions of these products in the pipeline now. But as far as timing when I need to get share approved first and that is really our first foray into the Gen5 market that will be our first cloud-based mobile application where you can share your data with others.

I think once we get that approval that will trigger a lot of efforts and a lot of thoughts on our partners to how we think accelerate things and how fast we can go. So now those product lines are both in pretty heavy development right now.

And another, 

…can you separate out the specifics of G5 like what exactly will be the benefit G5 over G4 and then the same for G6?

Kevin Sayer, President and COO

G5 is going to be focused largely on connectivity, mobility and convenience. And it will come out more than likely as a series of launches rather than one big launch with the end goal of G5 being a simplified application system at the end, combined with connectivity to a phone in addition to be in connected to your receiver and cloud-based data. We’ll go there in a series of steps.

That system will use the Gen4 sensors currently configure but with new algorithms that we’ve developed over the course of the past few years that will improve accuracy and reliability.

With respect to the Gen6 system that’s our first step towards doing a couple of three things, culminating some of the calibrations, getting the replacement claim or dosing claim so you can dose insulin and then ultimately eliminating finger sticks altogether.