Tandem t:slim Web Application FDA Approved

Tandem Diabetes Care Announces FDA Clearance of t:connect Diabetes Management Application for Use with t:slim Insulin Pump

Their press release: http://www.tandemdiabetes.com/Content1Col.aspx?id=748

Eating, Cheating with Diabetes #NEDAwareness

I am part of the Diabetes Advocates. A friend there encouraged joining National Eating Disorders Awareness Week to share views on diabetes and eating disorders. I am happy to. You can find more links from other DA members here. This post a rerun of a previously blogged post.  In it I share some thoughts on parenting contributing eating problems.  

National Eating Disorders Awareness Week is, February 24th – March 2nd, this year's theme is, Everybody Knows Somebody. 

Cheating

I test drove a bunch of insulin pumps with saline in them at Friends For Life a few years back. Here is a clue how long ago, -  I had a Cosmo on the longest. I was very impressed with the menu structure and design that went into the user interface. (Tandem bought a brunch of their patents.) But I am not here to talk about oldie but goodie technology. 

I’m here to confess.

My name is Bennet and I am a cheater. 

I snuck food and didn’t bolus when I was on the pump.

Well more like I just flat out forgot - about half the time.
Maybe more.


As a parent of a child with Type 1 diabetes is so easy to get frustrated when the kids don’t bolus. The online forums are full of parental angst when kids don’t. We are SURE we would bolus every time if it was us.

I got news for y'all: The only thing easier than being frustrated when your kid doesn’t bolus, is forgetting to bolus.


I dare anyone to put on a saline pump, put yourself in a moderately intellectually stimulating environment and see if you remember to bolus all the time. Oh and have your favorite snacks all around when you wear it.

I flat out sucked at remembering. I would be walking out of a session all fired up about the topic talking with someone, grab a snack and keep talking. OK, ok, everyone who knows me, knows I keep talking all the time anyway, but there is a point here and that is... I forget...

... Doh! I’m wearing a pump.


What's more, if you’re not used to wearing a set everyday they’re not all that comfortable. It isn’t that they hurt. It is that they are just there, bugging you any chance they get.

The things are bastards that way.

The cord tries to pull the pump into the bowl every time you use the toilet. It thinks that is funny. I am telling you right now, you too can do in-stall diving gymnastics like a prepubescent Chinese kid looking for gold, when you know a 6 grand pump is heading for commode. If it isn’t diving for the bowl the pump is forever getting tangled up with the cell phone on your belt.

In short the pump made me well aware it was there, I just forgot to bolus.

Eating is as often a reflex more than a conscious act. There is food, it is comfort, you eat, you pay attention to what your mind is on and you forget the pump, despite its toilet diving gold metal efforts to remind you.

If you are like every other parent you and your fellow parents have designed our collective kids’ lives to keep them intellectually stimulated. We build building for that very reason. We call them school and pay taxes every month to support them. We want our kids to do well at this school thing. I mean we not only want straight ‘A’ but the class presidency, editor of the school news paper, lead in the play and league MVP would be nice too.

Kids have stuff on their minds. We go to great lengths to insure it.

• They wear sets.
• They know how to use a toilet and not do the stall Olympics.
• They can wear a pump and a cell phone without entangling the phone in the pump line to the point of an occlusion alarm going off and text without looking at the buttons. (The starting degree of difficulty value there is HUGE!)
• There are other kids in class who are 'cute.'

All that and they bolus way better than the 50% I did. More like 80% or 90%, maybe even 99% of the time.

I have a new found respect for that.

(That and I’m considering entering the 2016 Olympics in the pump/stall gymnastics event.... unless I have to wear a tight leotard, that is just unthinkable.)

I’ll tell you what is breaking the rules. Stigmatizing the very real and human slip of having a life and forgetting a bolus by using terms like sneaking, lying and cheating. Yes, it is easy to get frustrated but it is cheating to let that frustration morph into to humiliating and guilt tripping our kids. It is not about numbers it is about living with diabetes, long term, independent living.

It was no accident that the same coach at Friends for Life who said there needs to be consequences for behavior was also the same guy who said he never met a kid who was the problem. His experience is that it is always the parents who have the behavior problem.

It is not about numbers it is about how we lead.

What would you respond better to, being put down as a no good lying cheating skunk (sound like fighting words in an old western don’t it?) for the 20, 10 or 1% of the time you make a mistake or praised for the 80, 90 or 99% of the time you get it right? So how are kids any different? If you are not providing positive feedback 80, 90 or 99% of the time then being overbearing 20, 10 or 1% is cheating.


My name is Bennet. I am a diabetes eating cheater.

Knowing that is the key to not being one again.

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.

#SpareARose Feed Back Wanted

#SpareARose had wonderful success in social media raising awareness for the IDF's Life for a Child and helping save some kids. Some results are not in yet but it was clear the Diabetes Online Community came together in a big way very quickly to pull the program together.

How quickly you ask? 12 days from first idea as a sidebar comment to going public.

In kind of rush the focus was all about can we get something done. Now that we can breath, it would be great to know what people think worked and what could work better if we do something like it again. Maybe next time, with two full weeks or more, we could be even better

So how about taking a quick survey and sharing your thoughts on how to do it better?

http://www.surveymonkey.com/s/3PGYZ7Y

Following Footprints.

It is easy to see the Diabetes Online Community as something new, a product of technology driven communications. The reality is that the drive to help make life with diabetes better has an inspiring history. At best we are now following in the footprint many of caring leaders.

Joslin, Bating and Best, Davis and many more. Our community lost another such leader this week. Carol Lurie, one of the founders of what is now JDRF, passed away last week. Her power from passion is amazing.

Carol like others leaves big footprints to fill. Looking at a multinational organization like JDRF is daunting. Looking at what each of us can do today, tomorrow, this week to make a difference for other and doing it is easier.

Tom Karla has a wonderful account of working with Carol on his blog. Tom offers a touching account of care that we can all emulate. Go read his blog post and commit to doing something this week. We can follow in the footprints of giants, one step at a time.

...and about Fido.

I just wrote about mice and my pal Mike remedied me that there are stories about dogs and gene therapy in the news. 

So that it is a different model than than mice. 

I have joked that you can spit on a NOD mouse and cure it. Still I welcome studies in animals to help find cures. If / when science get there, there may well be a variety of things that are cure-like. I expect better treatments will come first but I digress.

So a quick read of reports on the dog study finds interesting things, promoting insulin production and insulin regulation. Both of which lost in T1D with distraction of beta cells. Both are way cool and I hope lead to more discoveries and progress.

I would caution, as the reports do, that there is the issues that the dogs don't have an autoimmune process attacking the beta cells. In this case the beta cells were killed chemically.  So it maybe the gene thing is part of the process. Stopping the auto immune process seems the big part too. 

It maybe that the ability to reproduce beta cells is there in full onset but the autoimmune process overwhelms it. Consider for example Joslin has 50 year T1D Medalists who still have some beta cell function. That sure suggests that beta cell can rejuvenate even in long term full onset T1D. (Looking for the citation and I think it was mentioned on 'Rents Blog Talk Radio with John Brooks III.)  So the a key then is also stopping the auto immune process that kills them. 

http://www.popsci.com/science/article/2013-02/gene-therapy-cures-diabetic-dogs

http://www.newscientist.com/article/dn23163-gene-therapy-cures-diabetic-dogs.html?cmpid=RSS|NSNS|2012-GLOBAL|online-news

Of Mice and Men. Again

The New York Times reports in a recent Science section report that,

"Mice Fall Short as Test Subjects for Humans’ Deadly Ills"

 No kidding! Really?


Here is a part of what the Times says:

The study’s findings do not mean that mice are useless models for all human diseases. But, its authors said, they do raise troubling questions about diseases like the ones in the study that involve the immune system, including cancer and heart disease.

That immune system bit - I would think T1D falls right in there.


I use to post reports with the tag Mice because they seed so promising. Then I came to realize that Mice get cure all the time. It isn't quite like you can spit on one of these special non obese diabetic mice and it is suddenly cured but it sure sometimes seem that way. I stopped posting about mice.

Research in mice is valuable, I am sure that a lot of good basic science happens there.

Still if you are newly diagnosed T1D family and you read theses stories read and remember this Times article. Hope is a magic thing and I want you to be hopeful. Hopeful and confident that your child can grow and be successful pursuing his or her individual dreams in a long happy useful life. T1 Diabetes doesn't prevent any of that. Just remember that stories about mice and diabetes are a long way from being stories about THE cure.

If you want to read about cure progress I suggest reading Josh Levy's blogs. One is about studies with people and another is about studies with mice. Here's my two bits on his blogs.
http://cureresearch4type1diabetes.blogspot.com/2011/12/two-essays-on-progress.html
http://t1dcuredinmice.blogspot.com

Be informed, Be hopeful and take what your read on the internet (even here) with a little skepticism.

Also see:

http://www.pnas.org/content/early/2013/02/07/1222878110
http://www.nytimes.com/2013/02/12/science/testing-of-some-deadly-diseases-on-mice-mislead-report-says.html
http://www.ydmv.net/search?q=Mice

FDA Asks for More Study of Degludec

Good friend of the blog Scott Strumello sent me a link to Pharmalot that says the FDA is looking for more studies and will reject the application to market insulin degludec pending those studies. http://www.pharmalot.com/2013/02/sticking-point-fda-rejects-novo-nordisk-insulin/

I applaud safety and scrutiny on cardio risks is part of safety. However it is not the only safety issues with insulin.

I wonder if the current basal insulins would pass the same level of safety and long term risk for cardio issues. The FDA panel IMHO seemed any potential benefits of the insulin the benefits saying there was already an approved drug so we can be tougher on cardio here. One benefit seemed to be fewer hypos. Hypos have risks and the benefit of a reduction of those risks appeared to me, as non physician lay observer who clearly could be missing the mark, to be brushed over.

It is hard to balance all that out but there should be a conversation about it.

My comments at the hearing are here:
http://www.ydmv.net/2012/11/fda-endocrinologic-and-metabolic-drugs.html

Yo Ho Unfortunate Events

The diabetes online community is all about helping folks. Most of the people who create content do so primarily to help others. That is as it should be.

The problem come in when creativity gets poached. On one hand it is good to get the the message out to more who may benefit but not at the expense of profiteering by poachers.

First in the community we need to be respectful of other's content and LINK it. Say something specific about the post and encourage people to go read it. In the land of 140 characters, RT don't copy.

When the poacher is a site that exist to spin other content to make a living off other folks work you are dealing with a low life. I found one today that is talking my good friend Scott Johnson's content and brazenly mixing with with instructions on how to spin other's work. I have no intention of posting a link that will give them SEO value or clicks. But here is a link to the one and only original Scott Johnson http://scottsdiabetes.com.

If this happens to you (when this happens may be more accurate) here is a link to a handy little letter to sent the site host: http://www.plagiarismtoday.com/stock-letters/

Turn It To 11, #SpareARose

Sinal Tap fans get 11. It's one louder, isn't it? 

11 is better.

This Valentines Day think 11 roses, they can be better than a dozen. Spare that one rose and join others in the diabetes online community who are sending the value of the 12th flower flower to the International Diabetes Federation's Life for a Child program this week.

One flower. It doesn't seem like much money but it is. It can mean life for a child for a few days, maybe a week. Your Valentine will still know you love them with 11 flowers.

I found a site on the internet that says, "11 roses represent(s) 'You are my treasured one; the one I love most in my life.'" It is on the internet, so its gotta be true right?

So let your valentine know, "You are my treasured one; the one I love most in my life and I also love some kid who needs that 12th rose to have a life."

Make 11 more than 12. 

Spare A Rose, Save a Child.

It is easy. Use PayPal.