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)

#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.

Insulet Investor Call Q1 2013 | New OmniPod

Insulet released Q1 earnings today and held a related investor call. There were statements made that give me the impression there may be a light at the end of the waiting-for-the-new-system tunnel.

The explanation for the delay of deployment for new customers was provided by Duane DeSisto, President, Chief Executive Officer and Director, beginning with the discussion of greater than anticipated interest from new customers resulting in greater demand than original expectations:

“With this significant uptick in demand we did make the decision to delay the transition of existing customers for approximately ninety days in order to build additional OmniPod supply. While the manufacturing process continues to improve we had an unexpected component issue that resulted in lower than planned production in the latter part of Q1. While this component issue was quickly identified and remedied…we determined it most prudent to build inventory to ensure that both manufacturing lines were operating efficiently before we commenced the transition of over 45,000 customers to the new OmniPod. At this point we expect that conversion to start in the next few weeks and we remain confident that nearly all customers will be transitioned by the end of the third quarter.”

Later on in the call when asked: “Do you have inventory levels today to support that transition, or do you think you will have that by the end of the month?” Answer was: “We will have inventory levels here in the next few weeks that we will start converting people.”

Other news:

Lilly Partnership to develop a new OmniPod targeted toward highly insulin resistant people with type 2 diabetes to deliver Humilin U500 insulin. 

As previously disclosed, Insulet has signed a development agreement with an unnamed CGM partner for the development of a sensor to be included in the OmniPod. Human trials are hoped to begin in early 2014. This would be make Insulet the only provider of a system with one product on the body and one handheld device for both insulin pump and CGM.

Listen to the entire call here.

Information is helpful. Thank you for sharing, Insulet. Keep it coming, please.

Read it here.

“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).

Six Years of Waiting | #OmniPod®

Caleb with his first Pod.

Caleb with his first Pod.

It was at this time of year six years ago when David attended an informational session for the OmniPod system, just a few weeks before Caleb started pumping. At that session – six years ago – the sales rep spoke about a new, smaller Pod that would be available “soon”.

Six. Years. Ago.

This past December, Insulet announced that FDA approval had been obtained for these new Pods. Wahoo! They were careful to set expectations clearly – they are not available yet, but distribution would begin at the end of February and when it’s time to reorder, you’ll get the new system. I thought that was great – be upfront with your customers and don’t over-promise.

It’s the end of March and there is no sign of us getting the new system. When we ask Insulet representatives, there is no clear response and we get some mumbo-jumbo about needing to set up training for the new system.

It’s been over three months since the announcement. When Insulet made the announcement, they stated they had planned for this transition for over a year. We’ve waited patiently since December. We are ready to reorder, which we were told was the basis for the transition and would be seamless. But we are now told we can only have the older generation Pods, and there is no clear expectation of when Caleb can begin using the new system.

Six years, Insulet. Does that count for nothing? We have been loyal and supportive. We don’t expect a red carpet, but we don’t think it’s unreasonable to expect you to acknowledge your long-standing customers in some way. We’ve stood by you for six years. We haven’t complained. But now, I have to be honest, I’m irked.

I see new customers with their new systems. They have been loyal to other pump companies, even critical of OmniPod in some cases, but they are getting priority. This isn’t sitting well with me.

I get the business end of this – I do. But part of good business is setting reasonable expectations for your customers. In my mind, Insulet has over-promised and under-delivered.

We will remain loyal, Insulet. We believe in your product. I can’t say I don’t feel a little taken advantage of by being put at the end of the line after all this time, perhaps because you know we are so loyal.

It’s been six years.

Looking back over the years and some of Caleb’s activity with OmniPod: