#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.

OmniPod® Insulin Management System UST400 | User Review

OmniPod® UST400Please see our comprehensive review of the OmniPod UST200 system which still applies to the UST400 system.

Executive summary of our review of the UST400 system: lighter, more discreet, better performance, improved range, minor annoyances of new ID screen and multiple confirm screens. Negligible failure rate.

Digging Deeper:

The smaller Pod is the most noticeable change for us, as users for over six years. Caleb’s reaction was immediate and dramatic. It is lighter and more comfortable. For days he continued to comment about it – less noticeable under his clothes, could barely feel it, and it’s so light. Caleb never ever complained about the former Pod. He doesn’t complain about much when it comes to diabetes, and he’s also not easily impressed by diabetes developments. So for him to go on and on about how awesome the new Pod is, is noteworthy.

Other improvements I like:

  • The range. It is nothing like the increased range that the Dexcom G4 provides, but it is improved. I have found that at times I can be in the hallway while Caleb is in his room sleeping and change a basal rate. In a vehicle, I can deliver a bolus without having to reach back or pass the PDM. Little things like that are a nice plus. It’s not completely reliable though. Particularly if the Pod is on Caleb’s back and he’s facing me thereby creating a barrier between Pod and PDM, connection can be difficult.
  • IOB on the home screen. Easy peasy, always at the ready. I no longer need to continuously do math to figure out what’s left of delivered bolus’. Caleb is also much more aware of IOB since it’s in his face all the time.

That’s pretty much it. Other than that it’s business as usual for us.

Other Observations:

  • I was really looking forward to the new IOB calculation. I thought this would be a significant improvement for us. It’s not. After so many years of dealing with IOB, we’re so aware of it, that the calculation is nothing more than a verification for us.
  • Although the improvements from our perspective are few, the smaller Pod size is a substantial enhancement – much more than I expected. Not only does Caleb find it more comfortable, but we’re getting improved insulin delivery. Caleb is back to changing his Pods every three days rather than every other day. His blood sugars have also been much more consistent – this may or may not be to the new Pod. He’s on a new schedule at school which may have something to do with it, but I think the Pod is a contributing factor.
  • As far as error rate, for several months this was not an issue for us. Over about five months we maybe had two errors.This has changed since the temperature dropped and coats went back on. We seem to be having a static issue. We had this during the first winter of using Omnipod, but not since. After years of going into school for maybe one Pod error a year, I’ve been into school several times in just the past few weeks to change an errored Pod. It seems to be coincident with putting on or taking off a coat. I hope Insulet will figure this out soon like they did with the older Pods.
  • The ID screen is fun – I can change the name to something funny like “Foxy” after Caleb spent a week singing, “What Does The Fox Say”, to give him a chuckle the next time he turns it on. He can do the same – leave me little messages to make me smile. It’s also annoying – especially for night checks. I suppose the increased range increases the risk that the wrong person can get bolused when there are multiple Podders is the room. Since there are none in our proximity, it would be nice to turn it off.
  • The extra confirm screens are also a minor nuisance and even less so than the ID screen, so it’s really not even worth mentioning.

We are very happy with the system. We’ve spoken to Caleb about trying out other pumps. He is not interested. He values the tubelessness of OmniPod over anything else that is available for insulin pumpers today.

Abbott Freestyle and Freestyle Lite Strips Recall

Several weeks ago we went through this:

Screen Shot 2013-11-22 at 10.11.31 AM

Screen Shot 2013-11-22 at 10.35.00 AM

This was after a few other lows – like 30s lows – that we didn’t verify. We just treated, only to see something like 300 pop up a couple hours later.

Three was not our lucky number for a few days.

Caleb has used Freestyle strips since he was diagnosed. We have never had an issue like this with false lows. There is the occasional, unusually high number that warrants a double check before infusing significant doses of insulin, which brings a different result. But we haven’t experienced this false low issue.

We stopped using that particular vial of strips, started testing strips with control solution and haven’t had an issue since. It seems like we might not have been the only ones experiencing this:

Important Urgent Product Recall FreeStyle® andFreeStyle Lite® Test Strips

Please click the above link for full details. Only certain meters are affected.

Lots being recalled are as follows:

Screen Shot 2013-11-22 at 10.21.02 AM

photoI checked all our strips this morning.

The release also states: “A test strip insert is included with every carton of test strips, and provides very important product information. Please read your test strip insert carefully to ensure that you are using the correct Blood Glucose Meter for your test strip type.” 

Freestyle Lite strips are technically not approved for use with the OmniPod controller.

World Diabetes Day 2013 | DSMA Twitter Chat #wddchat13

Original creation by Lorraine of thisiscaleb

Original creation by Lorraine of thisiscaleb.com

Two years ago, Caleb and I made this photo. I’m happy to see that is actually comes up as an image when “World Diabetes Day” is googled and that people choose to use it as a profile photo or just share in general.

I made the above this year as a cover photo size. You are welcome to use and share this also if you wish.

Today is Dr. Frederick Banting’s birthday. We honor him, the man who discovered insulin in 1921, by recognizing World Diabetes Day on this date every year. One of my favorite parts of World Diabetes Day is the lighting up of all the buildings and monuments around the world in blue (feel free to share the video linked here). They are not only beautiful, but the recognizable images with the blue hue screams unity and support, which I love.

Today DCAF is hosting an all day twitter chat. I will be moderating the 11AM EST hour and the topic will be “Letting Go Yet Still Involved”. I know it’s not all that catchy, but hopefully it at least connote’s the intent of the chat. :)

Please join in at any time and Happy World Diabetes Day to one and all!

#WDDCHAT13

Diabetes Awareness | World Diabetes Day from Lorraine Sisto on Vimeo.

“High Blood Sugar Demon” and more by @madeulookbylex

Video

I came across Lex yesterday when I was doing a little research on a curling wand.

Lemme ‘splain – since creating my own Barbie head which compensated for the one Santa never brought despite requesting one year after year (yes I’m talking about Lila) I’ve been doing various hair things which brought me to this particular investigative work.

After watching the review by Lex, and enjoying her presentation, I looked at her other YouTube videos and was surprised to see one titled “High Blood Sugar…”

Yup, Lex has type 1 diabetes. Oddly, I found this pretty cool. That’s morbid, right? But Lex seems cool, so it seemed cool to just “come upon” this tidbit about her when I actually was not looking for it, ya know?

And check out this video too – she TOTALLY nails it!

Tallygear for #DexCom #G4

Caleb’s been G4ing it since November. G4 Rocks. Period. Life will be even more exciting when DexCom Share is available. Like, soon, please, pretty please with sugar on top??

When Caleb used DexCom Seven Plus, he used a SPIbelt to carry the receiver. This served us well. Seven Plus needed to be on him to stay in range. He was young (started Dexcomming in first grade) so this was similar to taping it to his body to make sure it didn’t get lost. It was not overly intrusive on his expression of fashion at that age.

Caleb was a fourth grader when he started G4ing. The SPIbelt was becoming less appealing from a style perspective and Caleb was much more responsible with his diabetes devices. Also zipping and unzipping the belt to see the screen – less than ideal. And have I mentioned the range on this baby? The G4 receiver is often with me and sorry – but I wasn’t too keen on wearing the SPIbelt on a regular basis.

Enter Tallygear.

TallyGear G4

We started with Caleb’s favorite color, green, added blue for Blue Fridays, and got a couple others for fun – lightning blue and what we call lollipop – vibrant spirals. These are great – they provide an easy way for David and I to carry the receiver – we can use the strap, or the carabiner on a belt loop or attached to the strap of my bag. Caleb uses the carabiner to hang it from his baseball or dance bags. He otherwise will carry it in his pocket. Being able to see the screen through the clear case is molto bene.

Tallygear G4 FreedomYou see above David wearing it while coaching Caleb – Caleb can worry about stealing home while David plays coach and G4 moderator. What is notable in the middle picture is that there is NO receiver on Caleb (see the before photo) but G4 is still in use.

Tallygear Belt Clip

Donna from Tallygear also created a belt clip case. This clip is SOLID and it twists so the case can go horizontally or vertically. This is not Caleb’s preferred way to wear it – I see this as a great option for a more professional look for a more mature user. I like how it makes a nifty little stand to set at your desk. I can’t overemphasize the clip – it is really strong and secure; like I said: SOLID.

Donna has many other products including a new tote that includes a spot for G4 (or a phone) with the clear screen for visibility, and added space to carry other incidentals. If you have a need for a device case, I hope you will check it out. Donna has a great selection of patterns, her speed of delivery is second to none, and she is super accommodating. (Hey, I just noticed this bike case, which looks pretty nifty as well!)

If you have a Tallygear story or post, you are welcome to link it up in the comments. 

 

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.

Special Sunday Edition of DSMA Live ‘Rents

Bennet Dunlap and I have the pleasure of co-hosting DSMA Live Parents Talk every other Monday. This coming week, however, we have a special opportunity. We will actually physically be in the same location, so we are having a special Sunday edition. I hope you will be able to join us. Rather than have a scheduled guest, it’s going to be our first Co-Host Edition, and perhaps we’ll have some special surprise pop-in guests with us!

Live Sunday, April 28th 9PM EST on Blog Talk Radio.

BennetLorraine