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.

 

#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)

#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.

#DexCom files for Smartphone Patent | #CGM

DexCom PatentDexcom Share, that little cradle that will allow the transmission of sensor data to mobile devices, is still under review by the FDA. More news from Dexcom on mobile device integration: they have filed for a patent for CGM monitoring connected to smartphones. Here’s a snippet from the announcement:

The system could contact a doctor, caretaker, or parent by text or email in the event of a blood sugar drop. It could also trigger a push notification to the patient, either telling them to eat a meal, or just setting off a specialized alarm (an illustration in the patent shows a patient setting their low blood sugar alarm to “Low” by Flo Rida.) The system could also tie into the phone’s GPS and respond to low blood sugar by recommending nearby restaurants.

For more, read the entire announcement here.

I Spy | Caleb Pitching

There are several difference between the photo of Caleb from Fall Ball (blue) and Spring Ball (green). One stood out to me more than the others. What stands out to you? (mine has nothing to do with baseball)

Pitching Fall 2012Pitching Spring 2013Yes, it’s the missing SpiBelt, and thus missing DexCom receiver. It’s around Coach Dave’s (dad’s) neck. Yet another example of the amazing range of DexCom G4!!!

“Like, you really like it, you want more.” | #DexCom Share G4

Caleb Blue WDDI do REALLY like it, and I want more, and there are hints more may be coming!

Do you follow diaTribe®? If you do not, I highly recommend it. I read about DexCom Share from diaTribe® today.

Caleb has been using DexCom G4 for over five months. He used the Seven Plus system for three years prior to the G4. The G4 is a remarkable improvement.

  • The accuracy is significantly better. There are times that we confirm a DexCom reading with a fingerstick hoping that DexCom will be wrong, as it often was with the Seven Plus, but it never is. Okay, maybe once since Caleb’s been using it, it was off. True story. No joke.
  • The range – OH THE RANGE! It is unbelievable. Everything is different with the range. As the caregiver, the controls are now in my hands, where they should be. This allows Caleb a little freedom not to have to think about his BG constantly or have me constantly asking him what DexCom says, (as used to be the case, evidenced by this video).
  • Although not at the top of the list, the color screen makes the whole experience more pleasant.

So here is the news from diaTribe® on DexCom Share, read the full post here:

Dexcom is also working on a new remote monitoring product, Dexcom Share. The product is a cradle that holds the G4 Platinum receiver and plugs into a power outlet at a user’s bedside. Data from the G4 Platinum are then sent via the cradle (using Bluetooth) to a nearby smartphone. That phone then uploads the data to a web-based platform, where it can be monitored by parents or caregivers on their own cellphones.

Why I am excited about this:

  • I’m the main caregiver to Caleb (aside from himself, of course). I’m on overnight duty. Traveling stresses me out. This will change that – completely!
  • Sleepovers. Need I say more?
  • Progress – we are moving in the right direction. In January, DexCom’s CEO spoke of DexCom’s Gen 5 which he was using at the time - the transmitter speaks with mobile devices (without the cradle) and texts alerts to caregivers. Are you drooling like I am? DexCom Share seems like a fantastic intermediary step which makes me feel like the Gen 5 is within our reach.

Speaking of DexCom’s CEO, Terry Gregg, he will be on TuDiabetes Live chat this Thursday (tomorrow).

#Dexcom #G4 Range

This was a-ma-zing! Rather than be on the edge of my seat about whether the dinner underbolus was too conservative or if the fact that he started sweating three minutes into the game would make him plummet, I sat smiling at the pretty dotted line that kept updating me during the game no matter where he was on the court. He could play and I could monitor. Bliss!

I was CERTAIN I had no chance of the range reaching my bedroom from his. We are on opposite ends of the house, and unlike the basketball court, there are several walls in between. But it reached. Just over 50 feet. It didn’t consistently read from my nightstand, but within arm’s reach on top of my covers it got a signal ALL NIGHT LONG. Sa-weeet!

Then I thought I’d go hog wild and see what happened when he was in bed upstairs and I was two floors down in the basement watching Modern Family with Dave. Consistent signal. No more running up and down two flights to check and see what the extra songs of Just Dance did to his blood sugar. Holla!

We’ve had it just over a week. In addition to the amazing range, it’s simply slick looking and I could barely pry it out of Caleb’s hands for the first several days. He calls it “Hawkeye” after one of his favorite Avengers. He mentioned that Hawkeye’s “real” name is Clint Barton which is strangely similar to Clara Barton for which the diabetes camp where we spent a week as a family is named.

It’s probably too early to comment on accuracy, but I have to say, the experience has been very good thus far. It’s missed a couple of lows, but I think that’s due to the typical delay between interstitial fluid and blood. What we haven’t had are those riding along without a care in the world thinking everything’s wonderful until the fingerstick comes up with a 250 situations yet. I could really get used to this. I’m afraid I may already be used to this.

And did you notice my World Diabetes Day blue fingernail? ;) I didn’t think so.

Related post: DexCom Adhesive Irritation and Allergy

TriCamp with Coach Cliff | TriRidgefield

Last summer, Colin had a very exciting and fun week at TriRidgefield’s Kids Camp. For about a year before, Colin had great interest in running and that extended to triathlon training the more and more he heard about it.

He had no hesitation about signing up again this year. When I asked Caleb if he wanted to go, he said. “No, that’s Colin’s thing. My thing is baseball.” I could not influence him to change his mind.

Then his school held a Rod Dickson Kids Marathon training event and Caleb got the bug. His interest did a 180 degree turn. He was in for Kids Camp 120%.

Colin cheering on brother Caleb

I was thrilled to see Caleb excited about this discipline, pleased to see him and his brother share an interest and tickled to know that he would be under the tutelage of Coach Cliff Scherb, Ironman.

Cliff and Caleb both have type 1 diabetes, use the OmniPod and DexCom Seven Plus systems. They both have rocking buzz cuts which enhance their speediness. :)

Caleb had a fantastic week. He had so much fun. I was worried it would be a little too intense for him. He said the workouts were exhausting, but only when I asked. His consistent reference to his days at camp were “That was fun. Camp is so much fun. I can’t wait to go back because it’s so fun. Fun, fun, fun!!”

Colin finishing the bike

Since last year’s camp experience, Colin got a new bike. It is just about the only thing he got for Christmas this year. He saved up every penny that came his way and asked anyone interested in getting him a gift to contribute to his bike. After the first day of camp he felt validated in this investment. I wouldn’t describe camp as uber competitive, but there are some serious kid athletes in attendance. Colin made a great improvement this year over last and finished second in his age group.

Caleb didn’t place, but he did fabulously. I was so proud of both of them.

photobomb by Grandma Grace

When I interviewed Cliff in 2010, I asked for advice on Colin’s behalf. He emphasized swimming for the younger crowd. I saw firsthand how important this part of the race is. Colin was not the fastest swimmer, but he came out pretty strong and made up some time in the bike and run. I could see how not having any prior swim experience other than goofing around in the pool impacted Caleb’s performance. He and Lila are now in weekly swim lessons! But I have to say that the improvement in his technique in just the one week of tricamp was astounding.

I cannot say enough about what nice, professional and encouraging people Evan (the camp director) and Coach Cliff are. The kids were great, the parents were great – it was a fabulous week all around.

It’s been said over and over what a terrific guy Cliff is, but you’ll have to tolerate me saying it yet again. He really is one of the nicest people I’ve ever met. This was not a diabetes camp, but Caleb and Cliff had that connection. Just knowing that there was someone around him that understood was a great influence to Caleb, and the fact that it was Cliff, a humble, kind and skilled athlete, made the experience even sweeter.

I was lucky enough to contribute to an article in Diabetes Forecast that featured Cliff that I invite you to check out. He talks about being an Ironman and living with diabetes and balancing the two. It’s really no joke – this guy is an expert when is comes to endurance training and managing blood sugars. Every time I talk to him I get a new tip. I am so blessed to have had so much direct exposure to that brain trust. If training of this nature is at all an interest of yours, please read Cliff’s story. He is the founder and principal coach of TriStar Labs in Norwalk, CT. We’re looking forward to cheering him on this August when he races in the Ironman US Championship in New York City.