Dexcom on Android

From press release: 

Dexcom® Announces Follow App is Now Available for Android Devices

Caregivers and Loved Ones of People with Diabetes Now Have Access to Life-Saving Glucose Data on their Android Devices

June 02, 2015 08:00 AM Eastern Daylight Time

SAN DIEGO--(BUSINESS WIRE)--Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Dexcom Follow app is now compatible with Android devices. The app is a component of the Dexcom G4® PLATINUM Continuous Glucose Monitor System with Share™, the industry’s first mobile-connected CGM system. Already available to iOS-enabled devices, the Follow app allows family members, friends and caregivers (“Followers”) to remotely view a loved one’s glucose data and trends on their smart device, giving them peace of mind and reassurance when they are apart. CGM users (“Sharers”) can invite up to five Followers to view their glucose information via the Follow app. The Followers can view the Sharer’s glucose data and trends, as well as choose to receive alerts and notifications when the Sharer’s glucose levels are outside specified ranges.

More

This is the Follow app, not the Share tool, it is still on iOS. But it is a step in the right direction. 

Dexcom - At least 5 as many as 10 product launches in 2015.

From: http://seekingalpha.com/article/2951636-dexcoms-dxcm-ceo-kevin-sayer-on-q4-2014-results-earnings-call-transcript

Kevin Sayer - President, Chief Executive Officer

Thank you, Steve. For our business update today I would like to discuss several major initiatives for 2015. Let’s start with innovation. On a worldwide basis we launched a total of five new products in 2014, compared to a total of three worldwide product launches in the previous two years combined. We are currently planning at least five more launches in 2015 and depending upon execution and regulatory time frames we can see that number go up to as many as ten product launches in 2015.

Our nearest term innovation is the DexCom SHARE Receiver. Work on the receiver of this nature commenced more than two years ago, when we received the research grant from the Juvenile Diabetes Research Foundation to develop better Juveniles to support artificial pancreas research. We want to take the opportunity to recognize JDRF support of this project. This is a great example of how industry and research collaborations can greatly benefit both parties.

Animas offers rebate on Dexcom G4

Got this email form Animas, haven't found a web version to link:

We've partnered with Dexcom to integrate glucose sensing with our insulin pumps. Find out how we can help you make a smooth transition to next generation technology as soon as it becomes available. Animas pumpers are eligible for a $200 rebate on Dexcom G4™ PLATINUM CGM today. Get the latest, greatest pump technology for just $99 when it becomes available with the ezAccess Upgrade Program.† Call 1-877-YES-PUMP to learn more, and to get all the perks that come with pump therapy from Animas and CGM from Dexcom.   *To receive the $200 rebate, Animas patients must be within their warranty period and must purchase the Dexcom G4™ PLATINUM CGM System by 04/30/2013. †The ezAccess Upgrade Program is effective 6/1/2011 to 4/30/2013. The ezAccess Upgrade Program excludes individuals with Medicare or Medicaid, or any other federal or state healthcare plans. It is not valid for patients who reside in MA. Offer not available to participants of the Animas Access Program or prior ezAccess Upgrade Program participants who have not purchased a full revenue pump since last upgrade. Other exclusions may apply.

Dexcom, Magic Radars and Connectivity: Q4 Earnings Call

Dexcom’s Q4 / Full Year 2012 earnings call is up on their site. As usual it makes for interesting listening for those interested in sensor supported diabetes care. I may get stuff wrong so first hand (ear?) listening is available: Click here to listen to the webcast. (1 hour, 4 minutes.) 

Artist's Depiction
(OK not much of an artist)

The most interesting part of the call for me was Terry Gregg talking about Dexcom Share. Share was described as a docking station for a Dexcom receiver that could send information to “designated recipients.” Share would send that information to smart phones. Naturally I assume magic and 50's style radar stations are involved. At one point Dexcom suggest that Share may be the first class III device approved by the FDA to work with a smart phone. I wouldn't know. I do know the FDA mobile guidance is not light reading.

For parents this sounds something like mySentry. I perviously likened mySenty to the BatSignal. Share seem like it may be similar but with connections to more phones than the red BatPhone in commissioner Gordon's office. By that I mean cell phones not just the dedicated mySentry receiver.

The device springs from market research with parents and Dexcom said they hope to submit a filing for Share to the FDA in Q3 2013. In part, Terry said that Share is not getting up at 3:00 am to do a finger stick.  Share then would need pediatric approval of Dexcom sensing to thrive.

Dexcom reported they received an extension of their CE mark giving pediatric approval of the G4 system in Europe last week. Further they said they have filed a PMA supplement with the FDA for pediatric approval in the USA. That is a 180 day regulatory process. Optimist will note that the FDA has seen the G4, the adult G4 approval was less than 180 days, the FDA on pervious calls was reportedly is very interested in pediatric use. Pessimist will make comments about the FDA.

Regarding pump integration Dexcom expects that a PMA for the Animas integrated pump to be filed first quarter of 2013. In another part of the call they noted JnJ reports that in the parts of Europe where the CGM pump is on sale the demand is 30% than where it is not available. There is some detailed conversation about PMA, 510k and who files what is in the Q and A around 35:00 (+/-) mark. There was detailed conversation about pediatric integrated pump approvals in the last few minutes of the call which is another can of worms.

Tandem was reported to have agreed to move forward with G4 integration with their pump. Previously the G5 was reported to be the path for integration for Tandem and that the G4 was being studied. So apparently the study showed that integration was a good fit.

My editorializing here is the Animas sales and the Tandem study indicate what I think many people living with diabetes hold to be self evident; that an integrated CGM / pump product is more desirable and two separate devices.

Regarding the OmniPod, Dexcom cited Insulet releases that the OmniPod is moving to a relationship with an undisclosed CGM vendor to explore a single site combination Pod/CGM sensor. Dexcom’s G5 platform with mobile connectivity was cited as part of the reason that the OmniPod chose to go in a different direction with CGM. Also Dexcom is hoping to extend the time sensors can be worn. This would create a significant difference between pod like and sensor life span.

In Q and A approval for a ten day sensor approval was to said not to be a 2013 priority.

Dexcom also reported that Roche will not be moving forward with G4 integration with their pump. Costa and time to market were cited as reasons as was the G5 and mobile.


As I have written before I own shares in Dexcom, I still do and I have an obligation to disclose that.

Dexcom G4 Approved in USA aka Dexcom Platinum

From the press release today:

October 8, 2012
U.S. FDA Approves the Dexcom G4™ PLATINUM Continuous Glucose Monitor (CGM)

New Device for Diabetes Management is Most-Advanced CGM Available with up to 30% Improvement in Hypoglycemic AccuracySAN DIEGO--(BUSINESS WIRE)-- Dexcom (NASDAQ: DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administration has approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.
Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

Fulll press release:
http://investor.shareholder.com/dexcom/releases.cfm

Kind Words for the FDA / Dexcom Earning Call

Dexcom’s earning call has become my goto source for a glimpse behind the curtain of diabetes devices. Yesterday's call was no different. I will share what I found interesting here. I may have missed some key stuff so I encourage you not to take my word for it and listen for yourself.  Unless you find earnings calls boring which I guess is understandable.

Shout-outs for the FDA
Maybe the most interesting part of the call is near exuberance with which Dexcom executives spoke of their relationship with the FDA in the Gen 4 review. They certainly were leaning that was last quarter and this time around they were practically fanboys.

The Dexcom Gen 4 was submitted at the end of the first quarter. In the last earnings call the noted that the FDA was very responsive in the review process. That seems to continue to be the case. At one point in the call (around 9:40) Dexcom says, “We couldn’t be more pleased with the progress we are seeing out of FDA on our Gen 4 submission.”

I am confident that the FDA is in no way rolling over. We all know that is not in the FDA’s DNA. That they are being responsive and communicative while filling their regulatory responsibility is what we all expect and hope for. I have been know to question the alacrity of the FDA. Based on the comments made on this call I may need to change my tune.

On the call Dexcom reported that in July, as part of the Gen 4 PMA, the FDA preformed an audit of Dexcom’s production facilities. Dexcom reports no findings or formal observations resulted from that audit. I think maybe you need to hear the intonation on the call to make “no findings or formal observations” sound like it is exciting and not the results of proctological exam (2:30.)

In Q and A Terry Gregg comments that this has been the fastest review his team have seen their decades of experience with the FDA process. That the agency has been very interactive in the execution of their responsibilities. It is still both a clinical and manufacturing process running 17 thousand pages. Towards the end of the call (41:30) Dexcom says that nothing the FDA is doing can be considered delaying, “quite the contrary.”

Of course I need to not get my hopes too high, this is not assurance of anything being approved - the product is still under review and Your Diabetes May Vary. It is however great to hear positive things about a process that so often we have only heard negative impressions.

Dexcom Gen 4 Photo care of
my friends at DiabetesMine.
Is it just me or is that an unrealistically flat 'curve?'

R and D
Dexcom talked about their research and development priorities for the rest of the year. Naturally commercialization of Gen 4 is on the list. Interestingly for many parents is a pediatric study. Dexcom and the FDA have worked out protocols. Dexcom says the FDA “encouraged” them to get a pediatric process started for Gen 4 “as soon as possible.” Dexcom reports (9:40) that the FDA protocols are more comprehensive than Dexcom initially expected in terms of number of patients and days in clinic.  The expectation non the less remains that these trials will be completed in 2012. There is a little more “color” (analyst speak for comments on) the pediatric process (26:20) including that the trial has been through institutional review boards at pediatric centers and that patients have already started being enrolled in the pediatric trials.

Pediatric approval has an impact on pediatric use and in some cases how insurance views reimbursement. So as a parent of a pediatric PWD I see this a s good news.

Also on the R and D front is a new algorithm that is hoped to go into trials in 2013 that will support an claim for extended wear. Also under consideration but didn't sound foreseen going into trials yet is a reduced calibration study. Again on this call Dexcom stated the long term goal is eliminating finger sticks.

My editorial comments on no finger sticks is that it would be super cool and I am not holding my breath.

Partnerships
This is always my favorite part because Dexcom sometimes (often) says stuff their partners don’t. I think the world knows that the Animas Dexcom Vibe is approved and in the market in Europe. (Somewhere in the financial stuff they mentioned that CE mark triggered a four million dollar payment from Animas.) A US filing for Vibe is a function of the Gen 4 sensor. The hope is to have the Gen 4 approved and the Vibe device into the FDA this year.

Animas Vibe More at SixUntilMe

That will make for some interesting upgrade decisions. Hopefully there will be clear viable paths to get Gen 4 and then the integrated pump without buying the Dexcom twice.

Dexcom mentioned that the Tandem and Roche integration was behind the Animas product. This is constant with what has been said before. In fact last time they were saying Gen 5 form both but they didn't repeat that this call. Sadly there was not a lot more “color” on these two products.

Notable absent was any mention of Insulet. In Q and A there is specific question about that. Pod people may want to listen for themselves (28:00.) Dexcom does not currently have any development work ongoing with Insulet. Dexcom knows that Insulet is very focused on the next generation of the Ominipod and thinks that development work will resume after that effort is complete.

All very diplomatic. Given the colorful way Dexcom calls typically go I don’t have any idea what to think of diplomatic - so I’ll take it at face value and maybe try to find an Insulet earning call.


There was more interesting stuff but I am a finance geek and what I find interesting the rest of the world call stupefyingly boring. They may be onto something.

As I have written before I own shares in Dexcom, I still do and I have an obligation to disclose that.

Dexcom Earnings Call: Diabetes CGM Crystal Ball

Dexcom management provided a quarterly update as part of their earrings call last week. It contained forward looking statements so take it with that caveat. As far as I am concerned, as the parent of two T1D teens, that is the interesting stuff.

You can play it here: Listen to webcast

• They filed a PMA for the Gen 4 sensor at the end of Q1. Terry Gregg called the product “Truly Remarkable.” They will be presenting details at ADA on June 8. Boy would I like to be there. 
• The Gen 4 sensor was said to be better in all respects than the Seven +. He said it would be 20% more accurate in general and 25% more accurate better in hypo range. 
• The Gen 4 is said to have better range up to 30 feet than the Seven +. This was reflected in the high number of data captures in the trials.
• The FDA has responded with a “Rapid Responce.” He said that the FDA is doing everything in their power to get the thing through their process. The agency has reached out and Dexcom was clear to give the FDA credit for their efforts in the approval process.
• The Gen 4 is believed to be able to function with reduced calibration needs. Dexcom is  exploring how to submit later for lower calibration requirements possibly for Gen 4 or 5. Ultimately the goal of Dexcom is to eliminate the need for calibration but lets be clear that goal not a current expectation of the Gen 4 product.
• The stand alone Gen 4 product is expected to get a CE mark and enter the market in the summer.  
• The Gen 4 membrane will be used for the Gen 5 product. 
• They may explore trials for approval for a longer life of the Gen 4 sensor. There was extensive conversation around that around the 38 minute mark.  I found it fascinating but I’m a little geeky. 
• Gen 5 is a connectivity platform; to smart phones, remote monitors and the Tandem and Roche pumps. At about 45 minutes there was more on that, data integrity and conversations with the FDA. Again good geek stuff, actual humans may find it less exciting.
• They are spending R&D to an automated inserter.
• Terry Gregg mentioned and agreement with Qualcomm to integrate GDM into the hub for transmission to the SweetSpot Cloud. Understanding that is probably worth digging around Google from more information. 

In full disclosure, I own Dexcom shares. 

Anyone have a Dummies Guide to @ANTPlus

Or maybe a not so dumb but new to it patients guide to how ANT+ may impact the diabetes space?

The headline reads:

ANT+ Expands Established ULP Wireless Ecosystem to Further Support Mobile Platforms and Augment Unique Use Cases in Sport, Fitness and Health

and down in the text it has this bullet: 

• Dexcom Continuous Glucose Monitoring (CGM): showing real-time glucose information at a glance. ANT+ technology will be incorporated into future products to enable connectivity with personal electronic devices.

Anyone up on this? 'Cause I aint and I would like to be. Here's why in case you forgot:

http://www.ydmv.net/2012/02/dexcom-acquires-sweet-spot-is-dewy-on.html

Dexcom Acquires Sweet Spot. Is Dewy on the way?

Dexcom released their earnings call online today. (Listen here for your self to see how off I am in my reporting.)


These calls are like a crystal ball. Fun but future looking. I looked for a picture of a Dexcom and a crystal ball ad found Kerri's Dexcom isn a glass with a super cute cutest Birdie picture. Close enough.

Right off the bat I found it interesting. Terry Gregg announced the acquisition of SweetSpot http://www.sweetspotdiabetes.com/.

Even the most casual reader of YDMV knows I have a particular interest in diabetes data. SweetSpot was identified on the call as adding sophisticated diabetes data management to the Dexcom portfolio. Terry Gregg identified two shortcoming in the Dexcom offerings; CGM pump integration and universal data integration. Ultimately they hope to see seamless data flow from the CGM to a mobile device and into the cloud.

Dexcom also mentioned the recent Tandem and Roche agreements. Interestingly the used the term “open architecture” repeatedly on the call in the CGM pump context.

Generation 4 sensors were said to be expected to be submitted to the the FDA end of Q1 early Q2 2012 and it sounds like CGM/Pump about a quarter days after Gen 4. YDMV.

Gen 5 was briefly mentioned and in the context of connecting out to open architecture devices including mobile and the cloud. Also accuracy was said to be at therapeutic levels.

The business model for sweet spot was covered in a question. At times it sounded a little big brother like with the VA, clinics and possibly insurers being customers of the data service. Naturally I would love to hear more about patients and later in the call they noted that the current product is approved for clinics.  Patients can see see what the clinic sees gets, so i guess (key word guess) patients aren't approved recipients of SweetSpot. A desire for a more patient centric data model was shared by one of the Dexcom C suite dudes. Anything is ways off in the future. There was also mention of criticism from the physician community of Dexcom for not having a means of connecting Dexcom information to the clinic. The future is digital and the acquisition of SweetSpot look like good positioning of the future.

At about 36 minutes into the call there was an interesting exchange on the Gen 5 product and the FDA. Specifically comments about the FDA concern that the health data being primary in on the mobile device. There were some interesting real world comments about os upgrades and aps running on devices. It was brief but good to know someone is having the conversations with the FDA and helping move the ball forward. I am sure the conversations are happening elsewhere but still it comforting to hear about the exchanges. Also interesting comments at about 56 min about their relationship with FDA. I'm "happy" with the FDA, industry has to make an effort.

On a personal note my kids don’t like carrying another thing so getting the CGM into the pump and ultimately the cloud is a step that may help them choose to wear sensor more.

Full disclosure, I own Dexcom shares.

http://www.ydmv.net/2012/01/of-fantasy-diabetes-devices-sheldon.html

Dexcom and Tandem Announce CGM Development.

From the News Wire:

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM - News), a leader in continuous glucose monitoring systems, announced today that it has entered into a Development and Commercialization Agreement with Tandem Diabetes Care, Inc. to integrate a future generation of DexCom’s continuous glucose monitoring (CGM) technology with Tandem’s t:slim™ Insulin Delivery System, the first ever touch-screen insulin pump.

Under the terms of the Agreement, Tandem will pay DexCom a technology license fee of $3 million, reimburse DexCom’s development, clinical and regulatory expenses, and upon commercialization of the combined system, Tandem will pay DexCom a royalty of $100 for each CGM-enabled insulin pump sold. 

more here

So that is Animas, Omni Pod, Roche and Tandem all working with Dexcom to integrate DGM into their pumps. I think the Animas agreement is exclusive outside the US (see this post). So all the agreements are nice and all, I hope that we see some products in the marketplace.

#TwoBits on People and Devices

Two great recommendations from around the DOC in case you missed them over the weekend (or maybe 3 from 4). While they are not intended to be variations on a theme I can't help but eeing them that way. Yes they talk about Dexcoms but I see the theme as commentary on supporting the people with diabetes in our lives without being a pain in the ass about it. Not the easiest thing to do, particularly for a parent, but equally true of a partner or co-worker (or even a waiter* but then going there would make this three bits.)

Abby has a piece on SixUntilMe about her first day on the job as an RN, a low during orientation and a new coworkers calmly asking “Are you OK.” A spectacular piece. I particularly love the way she speaks of those three words.

“If you have diabetes, you know why this made me feel so comfortable. There was no stress from her side conveyed to me. She didn't freak out and ask someone for juice. At no point did she have a worried look on her face. She just knew.”

I highly recomend that we parents out here diabetes land read this and think about ways of talking with our kids about diabetes in ways that are: comfortable, not stressed, no freak out, skip the worried look and simply let them know we are there for them.

It ain’t easy. It is a great goal. I'll try. I'll slip up. I'll try again.

Christopher and Dayle write at A Consequence of Hypoglycemia writes about how they would improve the Dexcom CGM. Since I am out there advocating that people talk about what they want from gadgets you may think I like this because Christopher and Dayle write about what they want from their respective gadgets in this post.

OK I do like that, what makes this great is that the gadget are put info the context of how those devices effect the people they care about. They speak of time sensitive alarm volumes and custom alarms, kinda like selecting a ring tone on your phone. What is magic is they do that in consideration of the person next to them. Towards the end Dayle offers up the great idea of the Dexcom having a buddy system with other devices. Devices that play nice, what a concept. It is even more impressive when it is in the context of the devices supporting their loved ones as well as themselves. The idea that customizing devises so that people interact more comfortably, with less stress, fewer freak outs and simply dealing with the diabetes on the 'Are you OK' level seams so simple. In that it is revolutionary.

Great stuff.



*We can leave the waiter out of the equation but Kerri piece is so reminiscent of most of our dinners out with diabetes that I have to smile. Somehow dinner out is a particularly hard time to just ask "Are you OK?"

Peeping in on Dexcom and the FDA

Dexcom released an earnings call yesterday.

Here is my voyeur's disclaimer: I listen to Dexcom’s earning calls more as Peeping Tom looking in a window into what seems to me to be strange courtship of of industry and the FDA around integrating of sensor and pumps. That is more interesting to me than the perspective of a Dexcom shareholder. I think my bias as a parent of diabetic kids is more pronounced than my vested interest in a few Dexcom shares. That said, as you read this, know I write from personal interests and make no bones about them.

This peep and tell used to be a lot easier when the call was available transcribed on Seeking Alpha. I recommend to anyone foolish enough to take my interpretation of the call as fair and balanced to re-think that and listen to the call themselves. They can find it here:
http://investor.shareholder.com/dexcom/events.cfm
While many, if not most folks may find earnings calls only slightly less dull than watching paint dry, listening for yourself will free you from my slant.

The call starts with new board members and a new president as symbols of plans to grow, whoopee. Wait I own shares that should be: Whoopee!

Somewhere in the call was a mention, in passing, of a type 2 CGM study. I opened another window to peep through and found a link and have posed an abstract of that study.

Dexcom talked about working with the FDA collaboratively to define what they need to do to get trials done for the gen 4 sensor. It sounds like Dexcom is hoping to get clarity from the FDA and have trials and the PMA for the 4th generation product started this year. This is significant because gen 4 is this product that will be paired up with pumps from Animas and Omni Pod. As I understood the call the gen 4 product studies are expected to take 60 to 90, under the heroic assumption that Dexcom has a clue about what the FDA wants. (Sorry, was that too sarcastic about FDA intent?) Dexcom is hoping to have a PMA supplement to the FDA by late summer.

Dexcom said on the call, they continue to expect the Animas / Dex integrated product to be introduced in Europe before it comes to market in the USA. In fact they said they expect the combo product to be marketed before the end of this quarter in Europe.

The Pod product is expected to be the new Pod and the gen 4 sensor. Neither of which as far as I can tell FDA blessed. So while both apparently are in works that sounds a bit further down the road. (Insert you favorite piece of FDA timing skepticism here.)

Dexcom seem to think that US products are in the time frame of end of this year or beginning of next year. If I am not mistaken that has been the expected time frame on each call back over a number of years. (Insert you favorite piece of product timing skepticism here. Which is why parents shouldn’t speculate on this stuff - but hey these tools are possibly a means to better lives for our kids - I mentioned we’re parents right?)

Hold not thy breath, lest ye die.


In the ‘interesting conversation’ side bar realm one of the issues the FDA may worry about is the risk of dosing insulin based on a device that isn’t indicated for that use and may not be sufficiently accurate. {Cough: meters} Far be it from me to point out that meter accuracy has been something that advocates have been calling for an improvement in since the late 80s.  Before the DCCT - the bench mark study on tight control taht got the world chasing tight control with meters that were not designed for that.

Granted meters may be more accurate than sensing but the simple fact of living with type 1 is that it is a balancing act. Part of that balance is coping with less than perfect sources of information. Sensing can ad trend to the over all mix of information. Trend can inform urgency. More importantly studies show sensing makes for better results.

So FDA repeat after me: "Perfect is not be the enemy of better."

I feel a number of my typical rants coming on and am looking around to borrow Glen Bech chalk board. If that isn’t a sign I have carried on too long I don’t know what is.

The Good, the Bad and the Ugly

I watched the Indy Car opener toady. Delaney was psyched to see Charlie Kimball’s car. We were all sad to see him leave the race early.

I think he is a roll model for her and a lot of other kids with type 1. I don’t expect many of those kids to have an interest in becoming Indy Car drivers.  That isn’t what a roll model is about. Charlie is a roll model because he is living his dream and bringing diabetes along kicking and screaming whether it likes it or not.

Diabetes is a rat bastard. It doesn't want kids with type 1 to dream. It wants to limit and define the lives it touches. Charlie shows that with hard work, character and a Dexcom screwed on the high tech steering wheel of life they can chase down their dream at a few hundred miles an hour. Chasing dreams is more than simply good.

At some commercial break during the race I saw a tweet that MTV is casting a reality bit with someone with diabetes. They are looking for a bad diabetic. Here in part is their casting call:

Does your diabetes hold you back from living the life the way you want? Do you have an extreme form of the disease which requires you to constantly inject yourself with insulin? Does it make you feel different from your peers? How is your situation more difficult than your friends' at school? Are you embarrassed by your diabetes?

It sure seems like they are looking to help that rat bastard diabetes limit and define lives. That my friends is just another case of the ugly.

In reality, we have a choice. We can tune into MTV and wallow in diabetes or what ever the find that limits and defins lives. On the other hand Indy Car has races trough the fall. We can watch Charlie strap the Dexcom to the steering wheel and take diabetes where no one has taken it before. Where fast matters and diabetes doesn't.

Charlie is a rookie in the professional big league of his sport. He is a dedicated, hard working and pleasant. Those traits are the reality of what makes him a roll model.

I am looking forward to the next race. I'll be watching. As for MTV well I will maintain my perfect record of tuning them out. Diabetes isn’t the only thing that wants to limit and define the lives it touches. Unlike being diagnosed with diabetes we have a choice as to what we get on TV.

Use the powers of your remote only for good.

Editorializing Conjecture on CGM Pump Intergration

Europe is going to see Dexcom integration into insulin pumps before those of us on the left side of the pond, or so it seems from Dexcom’s earning call. We have to deal with Zombies first. Oh and it is going to named after a Pontiac.

Dexcom’s earrings call is online. You are welcome to go give it a click. I did. It's here: http://biz.yahoo.com/cc/0/121120.html

I listened for news on the integration of CGM into insulin pumps. Dexcom is working on that with both the Pod People and Animas. (I wish I had as good a nick name for Animas as Pod People is for Insulet with visions of the classic 1956 movie Invasion of the Body Snatchers, if you think of one post it as a comment - must be a 50s B movie.)

Where was I other than Zombie Invasions?

Oh Yeah! Earnings calls, the bit on the next generation of Dexcom sensor and combination Dexcom/pump products starts at about 11 minutes into the call. The good news: Dexcom received a CE mark for the 4th generation sensor. That is the one that will be integrated into the pumps. Dexcom expects it to launch in Europe with a Animas pump in the first half of 2011. The call even mentioned the combo pump thing has a name, “The Vibe.” Well, if you are going to name something after a Pontiac, Vibe is better than Aztec but it is no GTO.

Meanwhile the zombie invasion continues within the FDA or at least as far as getting pump/sensor approvals is concerned. Oops, that was a forward looking editorial statement based on conjecture. What I mean to say is that Dexcom publicly reported actual “constructive discussions” with the FDA on what it may take to get a gen. 4 sensor approved here in these United States.

The bit that confused the heck out of me (not that it is all that difficult to confuse me) is apparently in trials the FDA now considers glucose level manipulation a significant risk.

Really?

Hello FDA - Those living with type 1 kinda hav’ta to manipulate glucose levels 24/7. The manipulating blood glucose up is called eating. Bringing, sorry, manipulating blood sugar down is the whole insulin thing. What you are calling significant risk is what families living with type 1 diabetes call daily living. While I appreciate all the carefulness, I kinda, hav’ta, wanta call BS on the FDA for acting like a bunch of zombies pretending they don’t know there is a lot of glucose manipulation going on already.  Better tools would minimize the whole diabetes varies thing and therefor risk in actual daily lives. Doh! that was editorializing conjecture too.

So it seems commercialization of Dexcom / Pump combo is 6 moths off for Europe.  For us, just like it has been for the last few years, best case is a year here. Seems like the same time system as the cure - you know the one that has been ten years down the road for decades.

disclosure

I have two T1 teens, own a few shares of Dexcom and like movies more than earnings calls.

/disclosure

FTNW: FDA seeks more data from Dexcom

From the News Wire: Dexcom Share Down as FDA seeks Data:

http://www.reuters.com/article/idCNSGE6A409Z20101105?rpc=44

Nov 5 (Reuters) - Shares of DexCom Inc (DXCM.O) fell as much as 29 percent on Friday, a day after the company said the U.S. health regulator had asked for additional data related to four of its products awaiting approval.

"The regulatory delays will impact the timing of milestone payments from the company's strategic partners, which may result in DexCom needing to raise additional capital to fund the business," Wiliam Blair & Co analyst Ben Andrew said.

OK

Alfred says OK. I think this trend is more than just OK.




OK I know that it isn't really called Alfred well other than ours and I know that isn't what the green OK means but three hours in Epcot on July 4th including chocolate mousse that is still OK by me.

Oh and the Red Ninja was on the case with Alfred.

- Posted using BlogPress from my iPhone

FTNW: Dexcom Earnings Call

The Dexcom Earnings call went up on Seeking Alpha 5/5. It sounds like they will be out with pump CGM integration with OmniPod sooner than with Animas.

With regard to Pump CGM integration Terry Greg said:

Shifting to our insulin pump partnerships, we are pleased to report that we have filed a PMA supplement with the Food and Drug Administration for our first generated integrated system with Insulet Corporation. We're extremely excited about the combination of our SEVEN PLUS system with the OmniPod Insulin Management System which will merit Insulet's unique [tubeless] insulin delivery device with our best in class CGM technology.

Although we cannot predict the ultimate decision or timing for a decision by the FDA, we typically expect a PMA supplement to be subject to 180 day review cycle, give or take a few months, and we hope to be positioned to launch a first product with Insulet late this year or early next.

But as you're well aware the timing of the regulatory process is uncertain. With respect to Anima, we continue to push forward on the development of a modified transmitter capable of supporting a unified global launch by Anima*. And while the development cycle has taken slightly longer than expected, we remain committed to filing a PMA supplement with the combined DexCom Anima's* system later this year as well.

*Animas - I quote'm like they write'm

Later they said of the Animas trasmitter:

Ben Andrew - William Blair
... And then you talked about the modified transmitter for Animas to launch and filing the PMA supplement later this year. Is that kind of a year end sort of event given some of the delays you've seen Terry or can we look for it before then.

Terry Gregg
Well we're still going through the technical review of that as late as last night with their folks being here. Obviously, if we can pull that in earlier, we will since it is a brand new transmitter versus the existing transmitter with the Gen3 system. Some of those still challenge us. So I would not want to predict other than in the comments that I made by the end of the year.

On the CGM The Next Generation:

I'm pleased to report that we have successfully completed a pivotal trial for our fourth generation short-term sensor, and we expect to file a PMA supplement with the FDA before the end of the quarter. In addition to improved manufacturing ability and reduced cost, our goal with Gen4 is to bring the market a next generation sensor, which will offer an unmatched level of performance and ease of use for our patients.

I expect to give additional color on the key attributes of Gen4 during our next earnings call post PMA submission, and of course we will not stop with Gen4, and we are equally excited about the progress we've made on the development of a fifth generation sensor, which we've mentioned may have application not only as a future ambulatory sensor, but also as a subcutaneous sensor for use in the hospital outside of critical care.

Full disclosure I own shares in Dexcom. My kids use Dexcom.

From The News Wire: Artificial Pancreas Used in T1s

Hi there YDMV fans. This one sounds interesting. Dexcom & Omni Pod used in closed loop:

NEW ORLEANS, June 8 /PRNewswire/ -- UC Santa Barbara and SansumDiabetes Research Institute scientists have demonstrated for the firsttime that an automated artificial pancreas system (APS) can safely andeffectively maintain desired blood glucose levels in patients with type1 diabetes. The clinical study results will be presented today in alate-breaking poster session(1) at the American Diabetes Association's69th Scientific Sessions in New Orleans.

The UCSB and Sansum researchers, working with the Schneider Children'sMedical Center of Israel, tested an automated insulin delivery systemcomprising the OmniPod(R) System and the DexCom STS7(R) continuousglucose monitor, linked and controlled through UCSB's artificialpancreas software. The software's insulin delivery algorithm, optimizedfor each patient, includes a unique safety feature, based on clinicalparameters, which prevents insulin-induced low blood glucose levels(hypoglycemia).

Read the full story here:

http://www.itnewsonline.com/showprnstory.php?storyid=50113

Clearly there is a lot of work going on and lots more to come. PWD are not going to see these at there next endo visit. It does get me wondering, how would you feel about using a closed loop?

There are so many non-insulin delivery variables in the YDMV equation that I am kinda sceptical. (I know me being skeptical who would have thought it?) How does it know there is exercise coming up? How does it account for stress?

Terry's Two Bits on DexCom and Pumps

Not much has come down the information super highway about how the DexCom CGM will work with pumps. We're told it will work with pumps and to be looking next summer / fall. There were some tidbits in the DexCom presentations to wall street. So figured what the heck why not write them a letter. Here is what I wrote and their reply:

Terry Gregg
President & CEO
DexCom, Inc.
6340 Sequence Drive
San Diego, CA 92121

Hi Terry

I have a particular interest in DexCom, in a small ways as a both a little share holder on a pure CGM play and as a diabetes blogger and in a very large way as the parent of two type 1 kids who have a very real long term interest in continuously managing their glucose.

I had the pleasure of talking to some of your team at Children With Diabetes Friends for Life conference in Orlando last month. Thanks for sending them. Maybe next year you can arrange for some trials of your device like MiniMed did this year. That would be great! A two day trial of their device dramatically changed my 14 year old son’s disinterest in wearing a CGM into a tangible interest in using one.

Since then I have read over your comments on earnings calls reported on Seeking Alpha. I have some questions that you may or may not know answers to.

In the March 11 call you talked about how DexCom and the pump folks will deliver data to us, families with diabetes. You said:

“In each case, DexCom’s CGM data will be displayed on the partner’s pump. In addition to insulin dosing information, patients will have access to glucose trend information, as well as high and low alarms, all in a single display unit.”

http://seekingalpha.com/article/68139-dexcom-incorporated-q4-2007-earnings-call-transcript?page=2

That sounds like how MiniMed is doing things now. That is good except we don’t love their pump. It is an attractive approach to CGM Pump integration as it requires less belt space on my daughter’s Batgirl like utility belt of diabetes gadgets.

I have to wonder is that ‘on the pump’ approach really going to be the case? Insulet most obviously will bring the data to their PDA like controller. For their approach to pumping the PDA is the pump interface.

Animas seems to be going down a similar path with the Ping meter/remote. Given that, do you continue to see the CMG data showing up on the partner’s pump or on will it be on another device like the remote control meter? Unlike heads to solve a problem, where two is better than one, for diabetes junk for a kid to carry one device is better than two.

Further the flexibility to choose the meter that best suits the user’s lifestyle is a feature that would be limited but using a PDA Meter as an intermediary. I would hate to be required to use the Pod or Ping meter to calibrate the CGM. But then you know recognize this value by your recent effort to get approval to us any meter to ‘Open Code’ the Seven unit.

So will it be CGM data displayed on the pump, or a meter in between?

Respectfully Yours

Bennet

Terry emailed back:

Bennet,

Thank you for your letter. Insulet will indeed display our sensor readings on their PDA. With respect to Animas, our first generation combination device will display on their pump for regulatory reasons, followed by future iterations utilizing remote programming devices (i.e., Ping). It is our goal to have these remote devices utilize an "Open Choice" format for the SMBG calibration.

We are actively pursuing a pediatric claim for our device and hope to have approval sometime next year.

Regards,

Terry

From The News Wire: DexCom on Animas and Podd

From DexCom's Earnings Call as reported on Seeking Alpha - Their thoughts on CGM and Pumps and the next generations of the DexCom product.

Terry Gregg - DexCom President

..Our continued goal is to complete all development, clinical and regulatory efforts with Animas and be positioned to launch our first product during the summer of 2009. But, as you are well aware, the timing of the regulatory process is uncertain we would expect to combine product with Insulet to follow later in 2009.

We are also pleased to report that we have filed a PMA supplement for a third generation continuous glucose monitoring system with the Food and Drug Administration. Data from our approval support trial demonstrated significant improvements in system on time and improved accuracy as compared to our current product. In addition our third generation system will include twin doors to complement our turn graph and event entry capabilities such insulin intake, (inaudible) exercise as well as configurable alarms.

Keep inline with generation alliterations we continue to make progress on our fourth generation product. We expect this design to incorporate an enhanced membrane system, we have been greater accuracy and be suited for large volume production. Additionally our fifth generation sensor is now being tested in humans in connection with our in-hospital product.

http://seekingalpha.com/article/89295-dexcom-inc-q2-2008-earnings-call-transcript?source=wl_sidebar&page=3