#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.

Holidays and Diabetes | Guest Post Accu-Check Diabetes Link

Caleb Christmas 2012When I think of managing diabetes with the holidays, my initial reaction is that it’s just like any other day – one blood sugar at a time. But when Rob asked me to write a guest post on the subject, I realized we do handle things a little bit differently.

“Holidays: When a Kids Job is to Just Be a Kid” posted today at Accu-Chek Diabetes Link.

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).

What I Need You to Know, Caleb

Screen Shot 2013-04-06 at 4.03.56 PMDear Caleb,

Before your brother was born, your dad and I led very similar lives. We met in college and each started working with an accounting firm after we graduated. We spent years working long hours and advancing our careers.

Then Colin was born.

Dad continued to work, and I spent my days with Colin. Then you and Colin. Then you, Colin and Lila.

That’s what you’ve always known. You’ve always known me to be the anchor at home because Dad’s schedule is unpredictable. It isn’t unusual for Dad not to know where in the country he will be two days before he needs to be there.

Dad’s here helping in the house a lot. He coaches all your sports. He cooks many meals, he reads with you guys, plays games and all that other stuff. But he’s also got a demanding job that means there are lots of nights with just the four of us at dinner and many mornings where it’s just the four of us getting ready for our days.

There are many things that you, Colin and Lila do primarily with me since I’m the one who is always here. One of those things is managing your diabetes. Whether it’s just deciding on what to do with a blood sugar or prepping your gear each day or managing things at school, it’s mostly just you and me. Dad helps here and there, but you and I are the team when it comes to diabetes.

There is something that I need you to know, Caleb. Your dad has always been there for you to support you and whatever has come your way because of diabetes. Always.

IMG_2799He was the one doing most of the overnight checks in the early weeks. He gave you as many shots as I did when you were first diagnosed. It was a challenging time for all of us. So much had changed and none of us knew where we fit in this new normal we were trying to create. The distinction in our roles in your diabetes care developed over time out of necessity. I was here at home all the time and Dad was not. It’s just that simple.

What I need you to know, Caleb, is that when times became very challenging for us relative to diabetes when you were nine, your dad was there fighting for you as fiercely as I have ever seen him fight for anything. He spent countless hours working to protect you, despite the demands of his job. Nothing was more important to him. Things were hard for us, Caleb. But your dad remained steadfast in his defense of you. I could not have gotten through that time without him and his focus and determination to care for you. You, Colin and Lila mean more to him than anything else in this world. If he could move heaven and earth to protect you, he would.

When you grow up, you will likely look back on your childhood and think of me as the person who cared for your diabetes. For the most part I did. But what I need you to know, Caleb, is that Dad was always there too.

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:

Smaller Vial Equals Improved Potency

ApidraThe unofficial theory I’ve heard is: that which makes Apidra® work quicker (remember apidra is Pig Latin for rapid) also makes it more susceptible to “going bad” quicker. I think of it this way: its composition is broken down allowing it to do it’s job faster, but that broken-down state means that it’s closer to losing its potency.

I read this somewhere some time on some forum. It made sense to me so I tend to believe it. I don’t know if it’s accurate.

After using Apidra® for a while and having great success, I started to notice that toward the end of a 1000 u vial of insulin, numbers seemed to creep up a bit. To isolate this variable to be sure the higher BGs coincided with the age of the insulin vial takes data tracking and analysis. The work I did in this area was not extensive, but in general, I think the older the vial, the lesser the potency.

I did not see this with Novolog®. Once I took a vial out of the fridge I didn’t put it back. I continued this practice with Apidra®. I had heard Apidra® was more vulnerable to spoilage from heat. So at first I tried to keep the vials in the fridge between changes. That became cumbersome.

My dear friend, Cari, told me that she uses pen vials for her son’s insulin source (a fellow OmniPodder). This serves two purposes:

Apidra Pen1) It allows for flexibility if you need to give an injection. Say you have a pump delivery issue (and yes, ours are almost nonexistent at this point, but not completely eradicated) rather than needing to change a Pod or draw up a dose with a regular needle because perhaps it’s not exactly convenient to do so in the middle of a restaurant or when you’re on the pitcher’s mound, you are prepared with the ease and convenience of an insulin pen.

2) The amount of insulin you have unrefrigerated at any time is significantly less. The vials are 300 u rather than 1000 u. Instead of using one vial per month, we’re using one a week.

Poof! The monthly bg creep issue was eliminated. I no longer worry about the age of the insulin and whether it’s gone bad.

With so many variables to manage with diabetes, being able to eliminate one is a win! With two day site changes and smaller vials, we’re up to two! Win, win!!

Apidra® | Pumping 48 hours

Caleb has been pumping with Apidra® for over two years. Prior to that, he used Novolog®.

I wrote about my love of Apidra® – quick onset, short tail. We tackled 140 carbs at a restaurant with relative ease. 

Shortly after that post, things went a little sideways and I didn’t know why. He had unrelenting highs at night. I would correct mid 200s all night long to no avail and end up with a wee hour Pod change. Then two nights later it would happen all over again, just like Groundhog Day.

I’ve brought you right to the punchline, so the problem is probably crystal clear to you. It was anything but clear to me at the time. This is why:

- Caleb had been pumping with Apidra® for about two months with no issues at all. His Pods would last the full three days and even up to eighty-hours with the 8 hour grace period.

- The “sideways” path started around the holidays. The variables were greater at this time. Timing of meals, content of meals. Schedules in general were off. BG control can easily be less than optimal in these circumstances.

- The pattern of highs every other night had not quite established itself. We were still getting some Pods through the full three days without an issue.

- Not a single person I knew who was Podding and Apidraing had this problem. All sailed smoothly through their full three days.

- Then there was the night when he actually did correct and I convinced myself that it couldn’t be the insulin clogging in the pump. Remember, I was not sleeping much during this time, so my reasoning was less than optimal.

I tested EVERYTHING. Food. Activity. Basals. Site locations. Moon phases. I called EVERYONE. Users. Insulet. Sanofi. Insulet again. Sanofi again. More users.

IMG_8529I thought Caleb might have to change pumps. If you know us, you know Caleb has only pumped OmniPod®. It’s been six years. We’ve never considered anything else. But Apidra® had been so effective, I was considering a pump change rather than an insulin change.

Finally, I tested the insulins. I put Caleb back on Novolog®. He went a couple of weeks and managed through day three without a problem. I put him back on Apidra® and the second day highs came right back.

It was clear. At right around the 48 hour mark, insulin seemed to have trouble getting through.


The photos in this post are of different cannulas from problematic Pods with what seems like obstructions. I had seen many a cannula before this issue that looked much the same. These other cannulas had been delivering insulin freely according to Caleb’s BGs. So even the visual evidence found in these photos didn’t convince me right away.

So we had to decide whether pump changes every two days would be worth it. I look back now remembering how difficult a decision it was, yet today it’s no big deal. It’s a slight nuisance to change Caleb’s Pod 15 times a month instead of 10. Nothing more.

And it’s worth it.

He’s using his pump of choice and my insulin of choice.

There are some benefits to more frequent site changes:

- Caleb’s sites heal MUCH more quickly. His scarring is greatly reduced. I noticed this almost instantly.

- He almost never has a kink, failure or delivery issue in any way, shape or form. This has been HUGE. When we were changing his sites every three days, that third day could be rather suspenseful. I only realized this in retrospect, now that the suspense is gone. I used to wonder more about what might be causing an unexplained high and take a gamble on whether it was just diabetes being diabetes or if there was a delivery issue. Many a time I took the wrong bet and took off a kinked or clogged Pod. Now it’s almost always diabetes just being the PITA that diabetes is, and we can correct and move on with confidence. To me, this has really had a great impact on Caleb’s overall diabetes management: increased confidence = better decisions.

Although this doesn’t seem like a prevailing issue, I know we aren’t the only ones experiencing this. If you’re having a similar challenge and haven’t quite decided what the problem is, I hope this post may help a little.

Next up: Eliminating Another Insulin Variable.

#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