#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:

#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

Tip for Documenting Pump Settings

This is probably a very obvious thing to do, but I want to share anyway…

Caleb and I maintain a chart of his bgs and a schedule of all his settings in a spreadsheet using “Numbers”. I have this application on all our iOS devices and any updates made to one device automatically update to all the other devices.

I love the graph I can make of his bg history. I showed Caleb’s school nurse his stats one day. Her response was, “Wow! You should get him a shirt with a picture of that saying, “This is how my week went, how about you?”

A recent three week period of Caleb’s bgs. Legends intentionally left blank.

Occasionally, I find myself wanting to record his settings but can’t take the time to update the spreadsheet. An example was this weekend when I made a few adjustments to his IC ratios while sitting in church waiting for mass to start, or the night before ROI camp when I wanted to be sure I had all his settings up to date before he hit the slopes the next day with his PDM is his chest pocket.

I’m often tempted to press the home and on/off buttons of the PDM simultaneously to take a screen shot. But since that’s an iOS device function not a PDM function, I do the next best thing – take photos of the screens on my phone.

Now I’ve got a permanent record of the settings that are most important to us. I can either just keep these photos in my gallery or use them to update his spreadsheet when I get the chance.

Caleb’s OmniPod® PDM & DexCom™ Carrying Cases

When Caleb is at school, he keeps him PDM with him wherever he goes. Over the years the way he transports it from place to placed has changed. When he was younger it was the sole responsibility of the teachers to make sure that it was with him at all times they carried it. During this past year that organically changed to him being responsible for it – not officially, but practically speaking, he’s the one with it. The exceptions are gym, recess or any other event that requires him to be active. The teacher is still responsible for it in these cases

When he was in preschool, we used a hard-drive case to keep his PDM and essentials safe. When he started elementary school, his regular OmniPod® case was carried around in a cinch sack. That was kind of big, although not bulky. His school nurse suggested one with an NYY symbol, so that made it “cool”.

Then last year when we were in Florida I found a little bag in the golf supply section of the ESPN store of Downtown Disney. I liked it because it seemed cool and a little more mature. It’s like a mini back-pack. The fact that it opened from the top instead of like a notebook seemed a little awkward. I kneeled in the store and assembled all of Caleb’s necessities in it to give it a test drive. It seemed do-able, so we gave it a shot.

It’s the only bag he’s used since and we currently have no intention of switching. It’s just the right size to hold everything he needs. It’s sporty and somewhat “hip”. We’re on our second iteration since the first was getting worn out.

So here’s what it looks like with his Dexcom™ receiver in his SPIBelt™:

DexCom in SPIbelt™ with Caleb’s OmniPod PDM carrying case

Here is everything that is kept inside the PDM case:

All the necessities that must be with Caleb at all times including his bg/dosing chart

View of the case from the top when it’s packed:

Caleb’s PDM case with main compartment open – chart, PDM, strips and poker at the ready

Separately I carry his insulin, extra Pods, glucagon and his EpiPen (peanut allergy), wipes, syringes in a different case. The school nurse also keeps a glucagon and EpiPen in her office. As Caleb has grown, he carries the Dexcom™ receiver in his pocket about as much as he uses the SPIbelt™.

The case is the CMC Mini Day Pack™ and it comes it lots of colors and also a few patterns.

#TwoBits Tuesday – An Auction and A Contest

Online Auction to benefit Diabetes Research: BrendaNovakForTheCure.org

BIT Number 1:

New York Times Best Selling author, Brenda Novak, has just opened up this year’s auction to benefit diabetes research. To date this event has raised over $1.3 million. There are LOTS of nifty things that I will be watching and I invite you to bid away!

BIT Number 2:

Today DiabetesMine.com announced The DiabetesMine™ PATIENT VOICES CONTEST.

This is your chance as get your voice heard about what you want to see in diabetes devices. You just need to create a short video about the challenges of living with diabetes and what technology you want to address those challenges. All the details and great prize info is available at DiabetesMine.com