CGM improves T1D care in PWD over 65 - AACE

AACE just published a paper on CGM use in People over the age of 65. The paper concludes:

Insulin-requiring patients 65 years old and older in our retrospective study from a community endocrine practice achieved a significant and durable improvement in glycemic control when using PCGM. The improvement in glycemic control was comparable to that reported in younger patients. The substantial reduction in severe hypoglycemia may be of particular benefit in older patients. Lack of PCGM coverage by CMS was the most common reason sited to not start or to discontinue PCGM use. 

Significant
Substantial

The goal of every adult with type 1 diabetes, every parent of a child with type 1 diabetes and every person in the care teams of those people with diabetes is a long health life WAY past age 65.

To better understand why this matters, please read Kerri's excellent piece at diaTribe on CGM and Medicare. I trust you will feel moved to sign the JDRF's petition. Like Kerri says, use the #MedicareCoverCGM hashtag to help thread these stories through social media like Facebook and Twitter.

I fear it may be a long term process to help provide good diabetes care to those on Medicare. Long term processes star with a step. There first step is the petition. More steps to come.

Think about your story with CGM. Has it helped you? Here are some tips on how to tell you story as an advocate for CGM coverage:

Tips:

• Plain language. Avoid jargon and abbreviations, tell you story like you are talking with a sympathetic friend over coffee.
• Speak from the heart, and to it, your passion should be in the story, up close and personal.
• Talk about success, make your story be the uplifting example of how things can be better.
• Be concise. Use details from your success to connect passion and policy.
• Quality of life over numbers. We want to hear about you and your life. If you use statistics be sure the are accurate and relevant to your personal story.
• If possible, craft a way for policy makers to be a hero by demonstrating to them how their actions help you stay healthy and successful.

from: http://www.cgmsafely.com/stories/tell-your-story/



#MedicareCoverCGM


Links included in this post.
http://aace.metapress.com/content/t452w5j078414954/fulltext.pdf
http://diatribe.org/issues/67/sum-musings
http://www.thepetitionsite.com/takeaction/776/978/446/
http://www.cgmsafely.com/stories/tell-your-story/

Of Automobiles and Insulin Delivery

I applaud the New York Times for caring to write about type 1 technology. I would encourage them to take a little more time to better understand the subject next time. I'll try to help. Since we are all Americans here, lets use a metaphor we all understand - cars. Fuel efficient small foreign cars, so maybe not something we all understand.

In the 1970s I drove a VW Beatle. It had been my mom’s. It would go anywhere, including places my friend Ric broke his jeep. One year for Christmas I got a hand full of Craftsman tools and rebuilt the engine and clutch. Bugs were easy enough to fix anyone with tools could do it.  

Coming home from college one weekend, I was cut off on a highway and skidded into a gas station sign. The car was totaled. I was nearly so too. The impact of my face cracked the steering wheel and popped the windshield out. The Glass flew across the service station and landed unbroken. I remember the gas station guys talking about seeing the glass fly and marveling that it didn’t break, from my semi conscious state waiting for the ambulance. 

I still like small cars. I have a Mini. It has a host of features my Bug lacked; anti lock breaks, a host of front and side air bags, crumple zone construction, good seat belts, power steering and much more.

I bring all this up to point out the value of current automotive technology verses 1970s technology. It would be easy to say that both the Beatle and the Mini do the same job. They get me from point A to point B in relatively the same mix of shifting, steering, breaking and being a little weary of bigger vehicles. In that context the newer car’s significantly higher cost could be seen an extravagance. 

Modern cars are significantly safer (even if they don’t go up Jeep trails like a Bug.) 

I think there is a parallel to diabetes technology. Modern diabetes technology looks like it is doing the same job as the 70s stuff. 

It isn’t.

Modern insulins allow a better if not perfect parallel of physiologic insulin. Pumps provide a better delivery system and allow delivery to be programed to daily rhythms. Continuous sensing can alert patients to changes and prevent dangerous lows and highs. 

Yes, this stuff cost more than 1970’s stuff. Cost isn’t the question, value is. Air bags are mandated because some cars are gonna crash. Antilock breaks, crumple zone construction, side impact doors, safe fuel systems etc all cost more. The value is in safer roads, lives saved. 

See where I am goin’ here? 

The story of technology is the value it brings. Computers cost more than pencils, ruled notebooks and movable type presses. The New York Times assembles the paper with computers, because they bring value. We drive safer cars for the value. People with type 1 diabetes can be more productive members of society due to the value of effective technology.

Sent via email to: Elisabeth Rosenthal NYT. (without the cool images, what can ya do.) 

ps. Neither my Bug of Mini looked the good but the colors are right. 

Meth. or Insulin

“This is rather startling.” 

That was the opening paragraph of an email I received yesterday from Jeff Hitchcock. He’s not easily startled. What had caught his attention was a JAMA paper titled, “National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations.”

Just like the title says, the paper estimates Emergency Room visits for what is called IHEs or insulin-related hypoglycemia and errors. The authors’ figure is 97,648 IFEs annually, of which 29% result in hospitalization. 

Jeff had started totaling up the costs of all those visits. Emails like this make me think he likes to spin me up. Like I need help?

I found an article that puts the prices on these in another journal. The American Journal of Managed Care. There is a group that is going to be super geeky about costs, right? In, "The Incidence and Costs of Hypoglycemia in Type 2 Diabetes" they say, “costs for hypoglycemia visits were $17,564 for an inpatient admission, $1387 for an ED visit.” (remember ED here being Emergency Department, not the blue pill problem.) 

Easy enough to take the number of visits and multiply it out by the costs and - Son-Of-A... -  hypos are estimated to cost about $640 million a year. 

The JAMA piece goes on to say these IHEs are far more likely to be the elderly. “Insulin-treated patients 80 years or older were more than twice as likely to visit the ED and nearly 5 times as likely to be subsequently hospitalized for IHEs than those 45 to 64 years.” These are they very people who can’t get continuous glucose monitors (CGM) to help warn of hypos, because Medicare says CGMs are not medically necessary. 

I can think of over half a billion reasons why maybe they are needed.

Beyond the money, the JAMA piece says, “Severe neurologic sequelae* were documented in an estimated 60.6% of ED visits for IHEs, and blood glucose levels of 50 mg/dL or less were recorded in more than half of cases (53.4%).” (*I had to look sequelae up too. Thanks wikipedia, “Typically, a sequela is a chronic condition that is a complication of an acute condition that begins during that acute condition.”) So translating that here: Chronic neurologic conditions as a result of the acute event, aka hypos are, disproportionally hitting American seniors. 

That just ain’t right.  

Look at it this way, Drugabuse.gov (I swear this is the citation I’ll drag out) says, “stimulants, including amphetamines and methamphetamine, were involved in 93,562 ED visits.”

Diabetes beats Breaking Bad.

97.8K ED visits for Team Insulin over 93.5k for Meth. et al.  

This is "rather startling." 

YDMV - so your term for what "This is ____" may be more colorful. I trust they will show up in the comments. 

Sources: 

https://archinte.jamanetwork.com/article.aspx?articleid=1835360

http://www.ajmc.com/publications/issue/2011/2011-10-Vol17-n10/AJMC_11oct_Quilliam_673to680

http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

Gary is Thinking Like a Pancreas

Gary Scheiner's new blog, Thinking Like a Pancreas, has his take on sensor vs sensor. (Yes, he makes Mad Magazine references, joy.)

Have a look. http://integrateddiabetes.com/sensor-vs-sensor/

I highly recommend getting the email update or RSS feed form Gary, he is CDE of the year for a reason.

An AP by Any Other Name: Animas HHM

Artificial Pancreas is in the news again. This time the press release is from Animas. Yesterday the news was of an article in the New England Journal of Medicine.

Everyone's favorite bard said, "A Rose by any other name would smell as sweet." Sorry Bill,  I am beginning to think you were wrong.  I think the first steps of AP smell sweeter with different names.

My experience talking with other parents is that the term Artificial Pancreas is all wrapped up expectations of it doing what they really, really want. That is magically managing diabetes so well they don't need to worry about it. Being reasonably smart people, who are regularly frustrated by their child's diabetes varying in inexplicable ways, the discrepancies of life, liberty to eat and CGMs, they conclude that the present technology can't deliver that magic.

No kidding. It can't.

There is a whole bit on this in Forbes by David Kliff, Stretching The Truth About An Artificial Pancreas to which others and I replied.

Here is what matters to me as a dad of T1D kids - the NEJM article says the first steps of AP can lessen the number of hypos and keep kids in range longer. This is where the Animas release kicks in, remember the Animas press release? This is a story about the Animas press release.

In the Animas release they don't call it AP. Go ahead go read it. Search it for the word Artificial. It ain't there.

The story is about, "a first-generation closed loop insulin delivery system." I will give you that AFGCLIDS is no rose. They got that.  They call it HHM for Hypoglycemia-Hyperglycemia Minimizer. I would call it Hypblurglycimic Minimizing System. Then I would go for a whole Gilbert and Sullivan operetta - HMS Pancreas.  But I digress.

Like LGS (Low Glucose Suspend) the idea isn't to manage precisely to target. The goal is to help minimize bad sh*t from happening. Preventing bad sh*t, is a good thing.

Progress happens incrementally. Regulators are gonna be more comfortable regulating incrementally and payers will probably be more likely to pay if academia (see NEJM above) can show incrementally better outcomes and hopefully incremental savings in the reduction of expensive hospital visits.

Staying in range more means better long term outcomes. That may not be actually magic but it is a nice parlor trick.


Oh and my apologizes to centuries of British culture.

PODD Earnings Call Info for Patients.

The PODD earrings call is  on Seeking Alpha. Here are a few points I thought patients may like to know.

New PODDs in weeks 

For our existing customers, we will begin the transition from the original product to the new OmniPod in the next few weeks. 

Verio PDM 

... we expect to file in the coming months a submission requesting 510(k) clearance for a PDM integrated with LifeScan Verio blood glucose meter. We are hopeful that this new PDM will be commercially available in 2013  

IOB 

... one of the blocking things that was out there was our whole insulin on-board calculation and not to bore everybody with the kind of arcane way we did it, but we thought we had kind of a better mouse trap. It wasn't the way the market leader did it. So this product basically put it in line with the way the market leader did it

CGM 

.... Finally, in January, we signed an agreement with a new continuous glucose monitoring partner. The agreement calls for both parties to continue development work already underway towards the ultimate goal of an OmniPod integrated with a CGM sensor. 

In Q& A re the name of the sensor partner, 

... we have with the company until we get to the point where we think we have a final version, a commercial version, we agreed not to give involved in disclosing that 

.... we tested on pigs, so far so good. Sometime next year we'd like to be doing it on people. And we'd like to be doing it on people not as a stand-alone sensor, but in our integrated format. So the big engineering hurdles/opportunities for us is how do we insert this within the framework of the product we have? And how close can it be to the insulin delivery? And the third one is -- and we've tested this a lot now, but we still have to go through in testing it in final is can the sensor withstand ETO sterilization. 

There is more on the CGM partnership in the Q&A part the call. Hop over to Seeking Alpha if you are interested.

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.

PODD Call re: Dexcom

In writing about yesterday's Dexcom earnings call I noted that they left Insulet (aka stock symbol PODD) out of the Dexcom/Pump integration conversation. Today PODD had their earnings call and at about the 12:00 minute mark spoke briefly about CGM. They said that they have had conversations with Dexcom about integrating the Gen 4 into the new OmniPod product and expect to “soon commence” work on integration. They say that the integrated device is expected to also use the LifeScan Verio strip.

OmniPod fans may want to listen to the call and break out their tea leaf reading skill. Management did speak to the FDA process and the new device. They have been working through details with the agency. I sounded to me like they are woking on some final interface issues, the entry of some information and training. I will be honest I am not particularly well versed in OmniPod. A cold war Kremlinologist or and an experienced Pod user may be able to gleam more out of what was said than I can.

The PODD call is online here: http://investor.insulet.com/events.cfm

YDMV

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.

Of mySentry, The Great Race, the Bat Signal and Teens

We are in the early stages of using mySentry, Medtronic’s remote CGM screen. Right up front I need to say that the good folks at Medtronic have made the device available to me to try for a a few months at no charge. They did not ask me to write about it or make any request other than I give it back when I’m done and if I write that I disclose they are lending us the device and supplies.

Delaney is the guinea pig.

Initial I thoughts that mySentry is a great device for folks with younger kids, not teens. Little kids are more sensitive to insulin. Their crazy growth and activity patterns make overnights hard to manage. A remote CGM scree that alerts, loudly (and this thing is loud) I thought would be brilliant to help parents sleep better when the numbers are okay and be altered when they are not.

I didn’t think it was as advantageous for older kids. We are not using it for overnight alerts. In fact it doesn’t live in our bedroom but I do see real value in it.

Don’t get me wrong, I do look at the overnight trend lines. CGM is brilliant for managing overnight trend lines. I made a few minor tweaks to her night time basal. Little adjustments that would not have been possible with finger-sticks unless I got up every 20 minutes or so. This is great but not the surprise that makes me see value in the remote CGM screen with a teen.

The value is mySentry helped me not nag my kid about diabetes. No small feat.

There are time all d-parents worry about their kid’s diabetes. Most of these times our kids are not actively worrying about there diabetes. They are going about their lives as if they have actual lives. Smart.

A quick glance at mySentry could show me that everything was okay and not go nagging her about her blood sugar. Not bugging the kids based on my fears is a good thing. Now that didn’t mean I didn’t talk to my kid. It meant that I knew to shut the heck up about diabetes or If I did say something to positively reenforce good behaviors. So we would talk about her latest sewing or other creative adventure and I could say nothing about diabetes or I could say “Max” says you are doing a great.

“Max” is the Delaney gave the CGM’s. Loosely after Perter Falk’s character in the Great Race. The guy Jack Lemmon’s Professor Fate would tell, “Push the button Max.” Classic film. Go rent it now... No wait... buy it, its a keeper.

Max also is a great way to see how fast insulin from a bolus takes to start being effective and how long it lasts. I found out that her bolus doesn’t really kick in for 45 minutes to an hour. Then it seems to trend down for about three hours. Good to know. I do most of the dinner cooking and so I know when dinner will hit the table. I can give her a pre-bolus heads up sooner than I was to better match dinner. I also a clearer idea of the time there is IOB. This is good information that your typical teen could care less about but dad can adjust in the pump settings.

Not nagging you teens is good.
Giving teens positive feed back is good too.
So are better pre-bolusing and IOB understanding.

What about when things are less than good? Well sensing shows trends and sometimes those are heading the wrong way. (This is gong to get confusing because while “Max” is the CGM sensor the other mySentry parts have other names. The relay station in her bedroom that listens to the pump and retransmits that signal to the screen down stairs Medtronic calls the mySentry Outpost,  we call it the “Bat Signal” because it is a night light with stuff on the light part. That makes the mySentry screen either the “Bat Computer” or “Commissioner Gordon.”)

Sorry I digresses.

Anyway if Max tells Bat Signal something is amiss then Commissioner Gordon gives me the opportunity to intervene before it becomes a real big issue. The key here is not to be  seen as an idiot. Not easy for a parent of a teen.

That is not to go running over and say “Max lit up the Bat Signal and Commissioner Gordon sent me over on an emergancy call.” First that sound ridiculous. Second the key with teens is to build a relationship of trust and they aren’t gonna trust Max if he is a stool pigeon. So when it is clear she missed a bolus, I can stop by her room and chat about about her latest sewing or other creative adventure and as I am leaving casually mention checking and correcting. The message here being the stuff she is interested in is more important than diabetes and oh yeah don’t forget the diabetes.

Still, she is not a huge fan of Max. It is another thing to wear and carry (I didn’t ask her to try to learn to use a new pump too.) inserting a sensor is a little less than user friendly and at times so is taking it off. As a result I find I like Commissioner Gordon more than she likes Max.

It is her body and her diabetes so ultimately it is her call how much she wares it. I think that is very important, maybe the most important thing for me to take away from the mySentry experiment. Using it is her choice.

Charging for CGM Download at Endo?

My friend Ann Bartlett has an interesting story up on her blog. It seems that her endo charges for downloading and looking at the CGM data. Check out her post here: /www.healthcentral.com/diabetes/c/9993/154668/data-appointment?ap=2008

She is looking for anyone with similar experience. If so leave a comment there.  

Diabetes Pump & CGM Integrated on a Cocktail Napkin

I got into a rousing conversation about the possibility of over bolusing based on CGM information over drinks at FFL. To be specific we were talking about over bolusing or stacking insulin based on high BGs on a CGM screen. I started drawing on napkins at which point there may have been a case to be made that I over bolused beverages.

Someone pulled out their pump CGM combo and showed a little tick mark that indicated a bolus. Good start. However I think it would be great to see more. How about putting the insulin on board on the CGM trend line as an area chart. This would be a clear visual there is IOB. 

This IOB area would be linked to what ever the pump uses for IOB calculations. For simplicity imagine it runs off evenly over three hours. So when you bolus it puts a little triangle on you CGM screen. The peak is the total units bolused and it slopes down over three hours to zero. So if just after at 6:00 pm bolus for a quick dinner your CGM would show IOB reaching out beyond the current time.  Say something like this:

If you extended the bolus it would take a different shape. The point still is to make IOB clear on the integrated pump cgm screen. 

Say that bolus was part of an imaginary day that started off okay with overnight bouncing around 130. You pre-bolus a little for breakfast and manage to only spike a little to about 200 and work your way down. Dash for lunch try to pre bolus a little spike a little more but come down too much. - because what is a day without a low? Grab a juice to treat the low and pre bolus for dinner. At the time you pre bolus maybe you day’s cgm IOB looks like this: 

(BG scale on the left IOB on the right.)

Brilliance right? And it only took a few drinks. 

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. 

Technology #TwoBits: Carb Counting Blues by @CelloBard

Marie Smith aka @CelloBard has a fun post sharing her observations on sensing. She likens her Dexcom to a school hall monitor and a bit of an unwelcome snitch. With good humor Marie shows the value of sensing to improve carb counting. Oh and oatmeal gets outed.

I also love her picture. It is great to see an image that make me hear.


On the topic of technology it stands to reason that some technology is out of date. DiabetesInControl.com makes that point about meters. Some where in this post there is a grain of common sense about meter accuracy and making sure you use supplies that are not expired (even if I don’t love the semi condescending tone of patient blame. Hey who teaches the patient anyway?) Still the post is on point, use a modern meter with test strips that are in date and have been properly stored. It also gives me a chance to suggest that folks never buy a meter.

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.

Medtronic Remote CGM Monitor Approved

Medtronic announced that the FDA has approved the mySentry(TM) remote CGM monitor. It is a second screen that allows a parent to remotely see CGM data. Here's a picture from the Medtronic Blog where you can also find more information about the thing. The full press release is here.

Version of something like this have been seen and talked about for years. It is great to see that Medtronic and the FDA managed to find a way to make patient information more available. For parents this has significant value. Particularly over night. Imagine checking BG without getting out of bed. 

Here's a Youtube bit by Medtronic about it:

Happy New Year.  

Medtronic iPro®2 CGM Approved by FDA

From the News Wire: 


MINNEAPOLIS – November 22, 2011 – Medtronic, Inc. (NYSE:MDT) today announced the Food and Drug Administration (FDA) approval of iPro®2, a next generation Professional continuous glucose monitoring (CGM) system and the latest in a series of recent diabetes technology approvals and innovations from the company. iPro2 simplifies Professional CGM and enables healthcare providers to obtain a more complete picture of glucose control for the patients they treat.  Professional CGM is used by healthcare providers to reveal low (hypoglycemia) and high (hyperglycemia) glucose excursions that can lead to the dangerous health complications of diabetes.  These excursions often go unnoticed with traditional A1C tests and standard glucose meter measurements.

CGM Sensor Trials

Most folks in the diabetes online community recognize a need for better CGM sensors. Part of getting them to market is testing them in clinical trials. Medtronic has news today about a CGM trial:
  

MINNEAPOLIS – Nov. 9, 2011 – Medtronic, Inc. (NYSE: MDT) today announced a new United States investigational device exemption study to evaluate the accuracy of six-day use in adults with diabetes of its Enlite™ Sensor, the company’s latest innovation in continuous glucose monitoring (CGM) technology for people with diabetes. The study will evaluate Enlite, a glucose sensor for CGM designed to offer improved hypoglycemic detection and comfort compared to current CGM sensors. CGM provides a more complete picture of glucose control because it can reveal high and low glucose levels that periodic fingerstick testing might miss.

The first two patients in the study were enrolled at Rainier Clinical Research Center in Seattle, Wash., and at AMCR Institute in San Diego, Calif., by the sites’ principal investigators (PI), Ronald Brazg, M.D., and Timothy Bailey, M.D., respectively. 

Full press release info here 

Trials may or may not be your thing. Full consideration is needed for joining any study, but if you are interested in participating see: http://clinicaltrials.gov/ct2/show/NCT01464346 

This is not the only CGM trial of interest.  For more on other CGM studies is also available at clinicaltrials.gov: http://clinicaltrials.gov/ct2/results?term=CGM