August 31, 2012

#TwoBits from DiaTribe

Links

I am a fan of DiaTribe. Kelly’s team writes detailed and thoughtful pieces. If you don’t subscribe to the newsletter, you should, just click here to sign up.


Kerri has a great piece about advocacy there.  She makes it clear that Your Advocacy May Vary (YAMV.) In fact, it should. Advocacy is a wide ranging continuum of things that boil down to taking a position and doing something because you care.

I love this part:
Every voice matters, and every person living with diabetes or caring for someone with diabetes has a unique way of sharing, connecting, and inspiring the diabetes community as a whole. Simply touch one life and you’ve made all the difference.  
To that I add don't just use you voice use your ears and share the great stuff you hear.


The NEW NOW NEXT article in this issue of DiaTribe is about new medications that can help folks with some diabetes complications. I freely admit I am no expert on meds for complications. With a master in health communications I do know a little about sharing industry information about them.

Lucentis (aka ranibizumab; manufactured by Roche’s Genentech) entered new ground with their communication practice. Roche were the pioneers in building relationships with diabetes social media with blogger summits. One of the outcomes of these relationships is Roche is starting to treat social media as a legitimate way to communication with patients. Roche reached out and asked if a bloggers, including Kelly Close, others and I, would like to attend an online media briefing for Lucentis by Genentech. A hand full of us accepted the invitation.

What is significant is that the DOC was treated like other forms of media. Writers were invited to a conversation, treated respectfully and given a chance to question Genentech researchers. I appreciate that they fielded question and responded in detail to social media. They followed up with information requested in the call.

Social media has a long way to go to build mutually respectful relationships with industry, regulators, researchers, care givers and the rest of the diabetes ecosystem. That system is complex, interrelated and necessary to keep people with diabetes well and chasing life’s dreams. The social media communication process is not perfect. What Roche and Genentech have started is significant, they didn't let perfect be the enemy of better

I hope other follow Roche / Genentech's example of treating social media as a legitimate communication method.

August 30, 2012

#TwoBits about Containers from #DSMA

Links
#DSMA Twitter chat was rocking as usual this week. And by rocking I mean to fast to follow. That is the way of the diabetes twitter chat. I just try to surf along with the tsunami of post and find a few conversations to join. This week one of those was about repurposing diabetes stuff for other uses.

Here are tow good link that flowed out of that part of the twitter flood.

Reusing set boxes to pack home made cookies to give to coworkers. I can't think of a better use for set boxes including holding the set that came in them.


http://sajabla.wordpress.com/2010/12/22/why-are-there-infusion-set-boxes-in-my-fridge/ 



Reusing may not be the bets idea for stuff you may be consuming, aka strip bottles, food and desiccants. Strip bottles have stuff in them to suck up moisture (desiccants.) Maybe not food grade stuff.

Violence by Ubergeek

http://www.mysweetbeanandherpod.com/2012/08/sugar-shot-sweet-bean-style.html

The FDA Comment that Got Away... or Maybe Not

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I like to see the DOC represented on FDA dockets that impact living with diabetes with comments. I think living with and self managing diabetes gives  patients insights into care that only patients know. So when a FDA docket get by me without my seeing it I am disappointed at the lost opportunity. One such lost opportunity was the Draft Guidance on Mobile Medical Applications. The docket was open this time last year.

I had a very pleasant chat with one of the FDA media specialist and she said that, yes the docket is closed but comments can still be made. Obviously comments will not have the same value to a close docket. So this is what I will send, late. Very late.

Consideration of the Regulation of Mobile Apps and Diabetes Care

The FDA has proposed guidance for the regulation of mobile medical apps. The draft is significant to people living with diabetes, in no small part this is because the FDA makes numerous specific references in the draft to diabetes care. Clearly then the agency sees diabetes as an area where mobile medical applications bring vale. The FDA Draft specifically speaks to diabetes care and blood glucose testing with strips, the analysis of information and an app controlling an insulin pump. 

Areas of the FDA draft where I think there may be a concern for people with insulin dependent diabetes.
  • The draft does not create a regulatory path for applications that process information from all the different devices people with diabetes use daily.
  • The draft reaches beyond mobile by suggesting regulation cloud based applications, if they are viewable on mobile devices. 
  • The draft is not clear about the distinctions between logging and analyzing data, particularly from the perspective of diabetes logging. 
  • Good apps are needed to improve quality of live. Failure to regulate in a timely fashion is a public health risk.

Multiple Devices
Effective care for people living with diabetes, particularly type 1 diabetes (YT1D), balances a variety of diverse things. Blood sugar is influenced by food, insulin and activity. Beyond the absolute level of blood sugar a trend, up or down, and the rate of that change also has an impact on diabetes management decisions. Different devices help people assess each of these different aspects of living with diabetes. The vast majority of the time T1D patients take self management actions independently based on data from multiple devices based on the training they have received from their health professionals. 

The draft says, “The FDA plans to address in a separate issuance mobile medical app intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device.” This is particularly significant for the diabetes community. As mentioned above people with diabetes use multiple devices routinely throughout everyday to analyze how to manage diabetes. We use blood glucose meters, continuous glucose sensors (CGM), insulin pumps and carbohydrate food indexes. So while this draft makes specific examples of individual diabetes care apps, the integration of information from the multiple devices mentioned in the draft into one app is specifically excluded from the guidance. 

I see the next significant increase in the improvement in the quality of life for people living with diabetes coming from this integration of diabetes data with mobile devices. I see an increased amount of time in target rages and decreases variability in blood glucose through the integration of diabetes data from multiple devices. The fact is each device is used for only a part of the balancing act that is life with type 1 diabetes. Patients continually juggle blood sugar levels, the direction of change in blood sugar, insulin carbs and activity. An effective diabetes management app will consider the same multiple sources of information that people balance now. This draft specifically precludes applications that interpret data from more than one device. That exclusion maintains a status quo of regulatory uncertainty in the development and commercialization of tools for better diabetes self management.  

Artificial pancreas projects are being developed at a number of research facilities and health care firms. They will rely on data from CGM to control insulin pumps. The advanced logic of these devices may well be processed in mobile devices. These systems are in development and their commercialization will depend on the Agency being prepared to consider them as apps that interact with multiple devices. Yes the Agency is developing AP guidance. 

Low Glucose Suspend, a stepping stone to artificial pancreas, is available in virtually every market but the Untied States. However industry could not bring it froward for regulatory consideration in the USA because the FDA was slow to develop LGS guidance to evaluate it. The Agency should avoid following that unfortunate precedent, specifically where a lack of multiple device mobile medical app guidance inhibits AP.

Cloud
Cloud based diabetes software offers great potential for housing and considering data collected from multiple diabetes devices. The draft attempts to define what constitutes a regulated mobile medical application. In doing so they include applications that, “can be executed (run) on a mobile platform, or a web-based platform, or a web-based application that is tailored to a mobile platform but is executed on a server.”

This seems to allow regulation of cloud based computing platforms as mobile devices because the user has mobile access to output from that cloud system. That seems to be an excessively broad inclusion of essentially all cloud based systems as mobile. However in another section of the draft the FDA notes that it was previously determined that, “it would be impractical to prepare an overreaching software policy to address all the issues related to the regulation of all medical devices containing software.” It seems that reasoning should be applied to the cloud as a software containing entity. The attempt to regulate cloud based software, that can be seen on a mobile device, is also impractical. 

Log
The draft makes the distinction that apps that log general health and wellness information not intended for treatment are not regulated. In diabetes there is not a distinction of logging general health and for treatment. Further the distinction between logging and analyzing logged information is not clear. Many people with diabetes log blood glucose information as there is no manipulation of the values, the same values are simply visually represented. The display of that information as a table or a graphic such as chart should viewed similarly as displaying log information. Charts are simply a means of viewing logged numbers. A chart is not an analysis. This is particularly true when the device that an app connects with, such as a blood glucose meter, may already provides charts of the logged data.

Some devices are coming to market that do preform rudimentary analysis. For example some blood glucose meters now identifying blood glucose trends. The display of that information to an app is simply a second screen.  As such that second screen should be viewed as an accessory to the original approved device and not an independent regulated device. 

Failure to Regulate
The proposed guidance states, “The FDA believes that this subset of mobile apps pose the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.” It is significant the Agency considers the risk of a lack of devices. The agency should expand on that  logic. Yes, there is a risk if devices are not available and that lack of a devices is a potential public health risk. 

The FDA should consider the risk of a lack of devices stemming from regulatory uncertainty as urgency to develop the regulatory frame work for devices that can improve the quality of life and even possibly save lives.

Therefore I see the lack of diabetes apps as a public health issue.  So too is the lack of guidance for integrating multiple devices in an app. Consider for example that the diabetes community has mourned numerous children and teens who have died in the recent years ‘dead in bed.” Most likely due to extended over night hypoglycemia. These deaths should be considered as the outcome of the Agency failing to act to bring tools like low glucose suspend into the regulatory structure here in the United states. In that context the Agency should consider the lack of guidance for apps that “analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device” a public health risk. 



Possible form letters form this. 
Warning My Spelling May Vary!


The Honorable (You Congressperson or Senator here)
(Their address)
Washington, DC Zip

Dear (You Congressperson or Senator here),

The FDA is currently in the process of finalizing guidance for industry on how they will regulate Mobile Medical Applications (see http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm.) I (my child) live(s) with diabetes. 

Effective care for people living with diabetes, particularly type 1 diabetes (YT1D), balances a variety of diverse things. Blood sugar is influenced by food, insulin and activity. Beyond the absolute level of blood sugar a trend, up or down, and the rate of that change also has an impact on diabetes management decisions. Different devices help people assess each of these different aspects of living with diabetes. The vast majority of the time T1D patients take self management actions independently based on data from multiple devices based on the training they have received from their health professionals. 

The draft says, “The FDA plans to address in a separate issuance mobile medical app intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device.” This is particularly significant for the diabetes community. As mentioned above people with diabetes use multiple devices routinely throughout everyday to analyze how to manage diabetes. We use blood glucose meters, continuous glucose sensors (CGM), insulin pumps and carbohydrate food indexes. So while this draft makes specific examples of individual diabetes care apps, the integration of information from the multiple devices mentioned in the draft into one app is specifically excluded from the guidance. 

I see the next significant increase in the improvement in the quality of life for people living with diabetes coming from this integration of diabetes data with mobile devices. I see an increased amount of time in target rages and decreases variability in blood glucose through the integration of diabetes data from multiple devices. The fact is each device is used for only a part of the balancing act that is life with type 1 diabetes. Patients continually juggle blood sugar levels, the direction of change in blood sugar, insulin carbs and activity. An effective diabetes management app will consider the same multiple sources of information that people balance now. This draft specifically precludes applications that interpret data from more than one device. That exclusion maintains a status quo of regulatory uncertainty in the development and commercialization of tools for better diabetes self management.  

Please connect the FDA and urge them to develop guidance for mobile medical applications that integration and manage the multiple devices diabetes patients use to self manage the condition. 


The Honorable (You Congressperson or Senator here)
(Their address)
Washington, DC Zip

Dear (You Congressperson or Senator here),

The FDA is currently in the process of finalizing guidance for industry on how they will regulate Mobile Medical Applications (see http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm.) I (my child) live(s) with diabetes. 

Cloud based diabetes software offers great potential for housing and considering data collected from multiple diabetes devices. The draft attempts to define what constitutes a regulated mobile medical application. In doing so they include applications that, “can be executed (run) on a mobile platform, or a web-based platform, or a web-based application that is tailored to a mobile platform but is executed on a server.”

This seems to allow regulation of cloud based computing platforms as mobile devices because the user has mobile access to output from that cloud system. That seems to be an excessively broad inclusion of essentially all cloud based systems as mobile. However in another section of the draft the FDA notes that it was previously determined that, “it would be impractical to prepare an overreaching software policy to address all the issues related to the regulation of all medical devices containing software.” It seems that reasoning should be applied to the cloud as a software containing entity. The attempt to regulate cloud based software, that can be seen on a mobile device, is also impractical. 

I support practical regulation of medical devices. I worry that impractical regulation may delay life saving advances. I particularly a concerned that innovation created by American firms are delayed from entering the market here due to impractical regulatory rules. The diabetes community has seen such delay. Please contact the FDA and express my appreciation for practical regulation of mobile medical applications but not what the Agency itself has called overreaching. 

August 29, 2012

#TwoBits Getting Diabetes Types Right / DC School Do Right

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So often we see news coverage that does not get diabetes types right. This one does and my friend K2 is right in there helping them get it right. Members of the online community often complain about bad coverage, here is an opportunity to leave a comment where they did good. How about slicking over and giving the paper an attaboy.

The most recent Diabetes Forecast has a story about the DC school system failing a family with diabetes. Scott Johnson wrote about it on his blog and I mentioned it on Diabetes Mine. Good news there is a settlement. 

Joshua Levy on Faustman

Links
Joshua Levy writes a blog called Current Research into a Cure of Type-1 Diabetes.

Josh is super smart and articulate. I find his reviews of research to be excellent. They are not light reading. He just published a piece on Dr. Faustman's  phase 1 trial. I strongly encourage those interested in possible cures to subscribe to Josh's RSS feed. Also those interested in this particular research should have a look. I have only started reading it, it looks like it will take me a few re-reads to fully digest his summary of her work.

In the mean time if you are interested in digging in yourself, here is the link:
http://cureresearch4type1diabetes.blogspot.com/2012/08/details-of-dr-faustmans-phase-i-results.html

#TwoBits - Congratulation Cherise & Christel

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Join the Diabetes Community Air Force! Well kinda.

DCAF is officially a not for profit corporation.

Diabetes Community Advocacy Foundation, Inc.

Congratulation Cherise.

http://diabetessocmed.com/2012/we-are-officially-a-legal-corporation/

AND

in that announcement is the news that diabeteicfeed is coming back as a DCAF program.  WoHoo! Word fail at sharing how excited I am about hearing Christel again. Her show is where my DOC journey began.

Yay Christel!




#TwoBits - It makes dots on Mikey

Links

Here are two lovely bits from around the DOC today:

Jessica Apple’s Washing It Away: A 3-Year-Old’s Take on Diabetes

“It makes dots on Mikey,” may be the best ever explanation of diabetes ever.




Riva on Accuracy

I am a big fan of Riva so it should come as no surprise that I think her comments on accuracy in diabetes are fantastic.

Enjoy!

August 28, 2012

FDA and DOC Interview

Links
Chris over at The Life of a Diabetic asked me some questions about the FDA. Guess what? I went long. Hope over and have a look:

http://thelifeofadiabetic.com/interview-with-bennet-dunlap-fda/

August 27, 2012

Can Diabetes Parents Talk?

Links

My bet is we can. 

Lots.

I think the smart money is on: Can they ever shut up? 
We’ll find out starting tonight on DSMA Blog Talk Radio. 9:00 PM Eastern Time and every other week after. Who knows, we may get so good at it we go weekly. 



Tonight I will be Lorraine guest and in a stroke of inconceivable scheduling coincidence Lorraine of ThisIsCaleb.com  will be mine! We are co-hosting the show and I am honored to be working with her.

As we figure out what we are doing, we will to talk with:
  • Parents of kids with diabetes
  • Parents with diabetes
  • Folks making cool stuff for parenting kids with diabetes
  • Maybe some researchers, school advocates and any one else we can find to chat with us.


Our hope is not to solve the age old question, if Parents Talk radio happens on the internet and nobody is there does it make a sound? Yes, it will be recorded for iTunes. But it will be much more fun with call in guest. 

So Join Us!

August 22, 2012

Fron the News Wire: Pancreatic Stem Cells?

Links
Genetic Engineering & Biology News has a short article that suggest that a means of identifying pancreatic stem cells in humans amy have been identified. This would be good news in the process of replacing broken pancreas cell. It is a very early step, in avery long process.

Stem cells can differentiate into specific cells. A pancreatic stem cell is significantly down the path of differentiation to the kind of specific cell people living with T1D are short of. The ability to identify and possibly reproduce adult pancreatic stem cells would help elevate the concerns of those who have issues with embryonic stem cells.

As the article makes clear this is very early in the process. Treatments are the result of a lot of steps. The work need peer review and duplication and then a a very long way from a possible treatment. Still int is interesting reading.

http://www.genengnews.com/gen-news-highlights/cell-type-proposed-as-insulin-producing-progenitor/81247218/

August 16, 2012

YDMV at the 'Mine

Links
I am happy to say the team at Diabetes Mine asked me to share a guest post on Safe at School. That post just went up today and I am proud to stand with them, Scott Johnson and others in the DOC to support safe schools.



If you have not read this month's diabetes forecast, the cover story is about a family form DC that has had more than their fair share of school struggles.

I probably should have asked in that piece at Diabetes Mine for school success stories but as usual I ran long. I think success stories can be a source of coachable best practices so if you have a great story about diabetes school success please share it.



August 10, 2012

Free Safe At School Webinar - Limited Seats Still Open

Links

If you have  Child With Diabetes in School

A Few Registration Slots are Still Open

Free Parent Advocacy, Back to School Webinar - August 14th

 [ Edited ]
safe-at-school-logo-165x125.jpgAmerican Diabetes Association: Safe at Schools                              
Have You Wondered------  What are my Child’s Rights? How Can I Negotiate?                                

Attend the FREE Back to School Parent Advocacy Webinar                                                     
     
Date:  Tuesday, August 14, 2012
Time:  8:00 PM Eastern (7 Central, 6 Mountain, 5 Pacific)
Space is limited. Register today!

Participants Will Learn About:
  • Resources that address issues of  adequate care and access
  • How to negotiate and secure accommodations
  • Federal laws related to children with diabetes in schools
  • What to include in individualized health plans regarding diabetes management
  • What to include in 504 plans to address necessary accommodations

It's Official if it is on Twitter - DSMA Parents Talk

Links

There it is.

Lorraine and I will be hosting a version of DSMA - Live focusing on parents of children with diabetes. Every other Monday st 9:00 pm on the DSMA blog talk radio channel. While a bit terrifying because I have no idea how to host a radio show, I know connecting with other parents is the only way I have managed to stay sane through our family's diabetes journey. The opportunity to help other is far more important than any petty terrors I may have screwing up an internet radio show. That and Lorraine is cool. We'll be fine.

Lorraine and I are proud to be expanding on the diabetes community services created by DSMA including:

DSMA Live http://dsmalive.com

TweetChat (#dsma) http://diabetessocmed.com/tweetchat/
DSMA Blog Carnival http://diabetessocmed.com/category/dsma-blog-carnival/
WDD Blue Fridays Initative http://diabetessocmed.com/wdd-blue-fridays-initative/

DSMA Live en EspaƱol http://dsmalive.com/dsma-live-en-espanol/

Thanks to Cherise Shockley of her vision and commitment to acting to help empower, connect, support and educate people living with diabetes. 

August 8, 2012

PODD Call re: Dexcom

Links
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


August 7, 2012

Kind Words for the FDA / Dexcom Earning Call

Links
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.