Vizzini's View of Diabetes Data Standards

One of the earliest YDMV posts stated out my view on diabetes data:

Type 1 isn’t all about the numbers. It is about kids living their lives. That said there are one hell of a lot of numbers. We gotta deal with the numbers, so we can love the kids as kids. Nobody need love the numbers. 

There are a ton of little electronic machines that produce billions and billions of numbers (and about as many strips on the floor). At times it seems we are floundering in a sea of data points (and strips on the floor). Unfortunately each machine speaks its own language. What we need is the UN. United Numbers.

It seems that I am not the part of the diabetes universe that sees data standards as a problem.  I recently read two articles that make the case for researchers to have a common diabetes data set. Data Standards in Diabetes Patient Registries (Journal of Diabetes Science and Technology May 2011) and A Strategy of Defining Common Data Elements to Support Clinical Care and Secondary Use in Clinical Research, (AMIA Clinical Research Informatics Summit 2010) both make the case that research would be better off with standards to facilitate data that researches, “collect once, use many times.”

As I understand the issue, research reinvents the diabetes data wheel with virtually every study. Each study collects what they are interested in but since it is not a common data set few studies have data that can be combined and used to further additional investigation.

One paper even has this lovely little graphic that helps demonstrate the overlap of parties that could benefit from common data. 

The second paper goes on to talk about these stakeholders in detail:

“There were no defined data standards for primary or secondary use in T1D at the start of this project, and so it is likely that the elements we have compiled will be subject to debate and revision when vetted in a broader T1D stakeholder community, which should include perspectives from diabetes care, research, population monitoring, and quality measurement.”

Notice anybody missing from that? 

I did. 

People with Diabetes.


It is their data.

In short if researchers want people to share their health information, there should be a value for participating. The ethical term is beneficence, that the research does some good for the participants.

I think that for diabetes research to find solutions that improve the lives of people living with diabetes those researchers need to ask the right questions. Starting with: Who is a stakeholder? As the risk of sounding like Vizzini, it seems inconceivable to effectively improve patient outcomes without seeing people with diabetes as a stakeholder in the process. 

http://www.youtube.com/watch?v=D58LpHBnvsI

FTNW: Continua

FTNW for those who don't know but may care, and that is a small small group I am sure, is From The News Wire. My short hand for stuff that may be of interest.


This one is about the Continua Heath Alliance. It is something I keep an eye on as it may be a source of data standardization.

So for my few fellow geeks, here is a link to the latest state of the Alliance bit from Continua.

FTNW: Interoperablity

Ran into this blog post today:

Lack of Interoperability Limits Personal Health Solutions

One of the key recommendations is that the buyers of personal health solutions need to understand and value interoperability, and demand it from vendors.

“The project partners share the belief that if Europe wants to reap the full benefit of personal health systems, health stakeholders must understand the benefits of interoperability, and be empowered to demand those systems from vendors”, says Veli Stroetmann, researcher at Empirica. “Only if there are buyers who demand interoperable systems, vendors will bring them to market.”

 I would to have the option of demanding systems instead of systems being demanded by type 1. Veli, I don't think you get it, that kind of influence exists in discretionary markets, where folks can choose not to use products. Type 1 diabetics don't have the option of not choosing a glucose meter.  

Diabetes Data Standards - Scholar's Edition

In the Journal of Diabetes Science and Technology Volume 5, Issue 3, May 2011

Rachel L. Richesson, Ph.D., M.P.H.

Abstract
Widespread adoption of electronic health records (EHRs) and expansion of patient registries present opportunities to improve patient care and population health and advance translational research. However, optimal integration of patient registries with EHR functions and aggregation of regional registries to support national or global analyses will require the use of standards. Currently, there are no standards for patient registries and no content standards for health care data collection or clinical research, including diabetes research. Data standards can facilitate new registry development by supporting reuse of well-defined data elements and data collection systems, and they can enable data aggregation for future research and discovery. This article introduces standardization topics relevant to diabetes patient registries, addresses issues related to the quality and use of registries and their integration with primary EHR data collection systems, and proposes strategies for implementation of data standards in diabetes research and management.
J Diabetes Sci Technol 2011;5(3):476-485

http://www.journalofdst.org/May2011/PDF/Abstract/VOL-5-3-SYM1-RICHESSON-ABSTRACT.pdf

Diabetes Data Standards

I think it is well past the time for the Tower of Babel to fall.

Diabetes is managed through the use of data. That data belongs to the user, the patient. It is theirs. Managing data should not a tool to strengthen a vendors proprietary grip on patients. Sadly patient data is almost universally maintained in proprietary formats guarded for the commercial advantage of durable device manufacturers market share.

I believe this is wrong. I believe it is a detriment to better health individually and for patients as a population. I believe that proprietary data puts a burden of maintaining data management on durable device manufacturers that increases the cost of devices. I believe when heath insurance mandates specific formulary brands and those brands do not share data well the insurance company is reducing the opportunity for better diabetes management to reduce cost.

I think it is time for patients to start asking their medical device manufacturers to open data standards and work towards a common language for diabetes devices. I think in the long run manufacturers’ costs for data management in the long run be reduced by benefiting from shared standards. I would like to see their energy spend on innovative devices not maintaining proprietary data standards. I would like to see patients and their advocate organizations have a voice in data standardization.

If you agree I would love to hear from you. I would love you to share your thoughts. Let start by seeing who all is interested. Bernard has an old thread on the topic at TuDiabetes. If you are interested in some grass roots advocacy on data standards please introduce your self there, like this:

I am Bennet and I am interested in promoting standards.

I’m Not Clark Kent

... so that rules out superman too.

Clark is an ace reporter. I am not so good at the who, what, where, when, how but then come to think of it I never noticed Clark doing much actual reporting either. For actual play by play of the Medtronic social media event I think there may be more accurate recounting by the folks who were taking notes on laptops. Keep your eyes open I am sure the reports will start flowing in.

Here roughly the outline of the day. I try to add some color commentary:

• Amanda Sheldon, Director Medtronic PR opened and we got her talking and ran into the time that was allotted for:
• Katie Szyman who has been President of the diabetes business unit for a year and a half.
• Lane Desborough who’s title was Product Specialist. He is an engineer who recently joined MM from other larger industrial chemical engineering endeavors following his son’s T1 DX.
• Brad Monosmith introduced an app for that where that is diabetes and the long arm of the law keeps the device and the app from talking to each other.
• We took a picture:

• We talked more about a closed look and connectivity With Lane and Todd Robin director of CGMs.
• Dr Francine Kaufman spoke from clinical and medical research perspective and shared some research on a pump in Europe that turns off insulin with hypos. Due to certain Minister of Magic regulations we’ll just call it the Pump the Can Not Be Named.  (I’m kidding FDA, it was a Joke, no need to call out the Dementors from the IRS)
• Dr. Richard Rubin of Hopkins talked about diabetes burnout. Great stuff. One key point - Joking around about diabetes is good (that FDA as the dark arts bit was strictly medicinal I swear! Oh wait that means I need to wait years for clearance before using it...)
• There was a cool tool tour of the sensor manufacturing plant.

We interrupted and talked over everyone of these folks and led them down all kinds of digressions. Scott Johnson drank all the diet Dr Pepper.

Probably the most shocking utterance was early in the day when Lane used a dirty word:

"Control."

Yeah I know! The nerve of that guy. It sets off all kinds of emotional responses doesn’t it?  But he didn’t mean it like ‘you diabetic scum need to be compliant and be in range all the time - how hard can it be? what the heck is wrong with you.’ He used it as an engineer.

Engineers speak a different language. To them control isn’t profanity.  It is a process of transferring variability from one place to another. In the diabetes case to transfer some variability in blood glucose to variability in electrical current. Then to use that electric variation as feed back to have an impact on BG. He went on to talk about the success of that transfer in two time frames; first the moment and second over time. It was all very geeky and since I am a little geeky I thought it was all very fascinating.

More fascinating was the idea that some problems have been solved in other disciplines and those solutions can be transferred to diabetes care. Engineers transfer variability in large complex refineries to systems that manage outcomes in the moment and over time. It keeps the plants from blowing up. Possibly the algorithms, logic and processes used there can be brought to bear on the reality of your diabetes varying.

That I found this interesting is proves what I said, I am a geek at heart. So is Lane because he appreciated the need to minimize the space on a kids’ Bat Belts (and bat bellies) for all the stuff this may involve.

Somewhere in all this we got a first pass at the idea of data standardization. Since Bernard (BandYard) Farrell missed his flight to to a snow storm, the rest of us were more than happy to provide a little of the open honest feedback our Medtronic hosts were looking for. I happen to have ranted about data standards a bit, not as long as Bernard. He is the patients’ Superman of Data Standardization. I am more of the Jimmy Olsen on the beat.  When I get into trouble he saves me. Interestingly the engineers seemed to agree that data standards would be valuable and I don’t know that the business / lawyers side of the equation feels the same way. I am fairly confident Medtronic heard the standards message, more than once. It is one of the messages I was there to share.

That is a conversation worth having. We are the market. If we as the market start and keep demanding it it may happen. When there is a movement to standards, it will have to get past the whole secretive FDA dark arts process. I don’t expect them soon.

Zen and the Connected Type 1 Diabetes Devices Don’t Exist

I wish they did. I have a radically different view of the technological future of diabetes care. It isn’t as much a Artificial Pancreas as it is a peace treaty between armies of robotic healthcare devices fighting over our data for their proprietary sales gain.

This treaty would make diabetes data available to, and this is the really radical part here, patients. The data will be presented in ways that would facilitate using all the information to help individuals understand how each little bit represents one of the variables that makes any type of diabetes vary.

The treaty would also facilitate patients picking the equipment and using the every day devices they already use to manage their diabetes. Now that may not sound radical but it is the opposite of what happens now. Our every day devices don’t help manage the whole of life with diabetes as our tools don’t share the little bit of information on our lives that they know. In fact they tend to guard our data as a hostage to the continued use of a given device.

I should talk about what prompted this version of my ongoing diabetes information rant. I have a RSS feed for Continua Health. Continua is, in theory, a means of connecting medical devices. Diabetes has been part of the Continua marketing line from its earliest days. Big diabetes firms are part of the Continua Alliance. Diabetes care keeps popping up in the press stories about Continua. Recently Med Gadget had a post about about a health data router for home heath care devices that said “One can imagine this device as being a central control unit for continuous glucose monitors.”

Not if one has ever used a CGM they can’t. Getting past the hurdle that no CGM is bluetooth enabled or Continua certified why would a CGM user want device with less functionality than the CGM’s own receiver? By less I mean less ability to interact like calibrating the CGM. Why would they want to carry Yet Another Device Already. (YADA)

Insulin users carry something to deliver insulin, a pump YADA, a pen YADA , a syringe YADA. They carry a meter YADA. Increasingly folks wear a CGMs YADA. Being normal every day folks they probably carry a cell phone YADA. It sound like a Seinfeld bit - Yada Yada Yada.

In case anyone is wondering those things for the most part don’t talk to each other very well. The solution isn’t Yet Another Device Already. Sadly the trend is to make for more devices and or less choice. Some may say, ‘Our pump displays meter and even CGM readings.” OK but only if we use the proprietary combination of strip meter, CGM and pump. Notice that the marginally usable food database left the pump and went into the meter with one pump so if you want the food data you gotta now carry YADA. Oh and for fun, to get the data out of any device requires proprietary software, running though a special cable, to a desk top PC, running a old operation system you probably don't use anymore.

The solution is that all the devices need to talk a common language. Continua is right about that part. Then the data can be combined to make something that resembles sense. Meter data by itself only has value in as point in time. CGMs are good at stringing those points in time together and making trends. Knowing the amounts of insulin taken would help make sense of those trends as would what was eaten (and a lot of folks enter that into a bolus wizard on their pump.) The data exist it just needs to play nice. Set the information free! Common language is the start of a treaty.

In a glorious world somehow activity, stress, hormone cycles and a partridge in a pear tree. Oh and a button to just reject freak events would be handy too.

The Continua model is data is collected sent to an electronic health record and via some mysterious process (using YADA above) doctors will have the time and be compensated for looking it over and making recommendations. If that happens, and that is one big ass if, I am sure the doctor will be using some kind of data collection device with logic tools that sift out relevant data and trends.

Why not keep that local? People living with diabetes are there own primary diabetes care giver. Cut the loop short. Get the logic into the users' smart phones. The phone they choose to use not some goofy medial phone.

Artificial pancreas fans are saying OK - why not just make the whole thing automatic? Make it all just work without any patient input. My answer is that there is value in knowing. There is value in being cognizant of the implications of what specific choice and events do to the individual. As in, wow that really work well maybe I should try to do that more often or opps that wasn’t so great how can I avoid doing the same thing again or wholly crap six hours after a really physical work out I crash and burn like the Hindenburg.

More awareness of how one live life is better than less. I think that is true on the purely physiological level and that the physical has a big impaction the emotional and spiritual levels too.

Counting CGMS Before they Hatch

For OmniPod and Animas users looking for CGMs integration the news is more FDA reviews. Dexcom’s Earnings call of Nov 4 was released on Seeking Alpha on Sunday Nov 7. It is a long and nuanced call. I am sure a fair amount of that nuance sailed over my head. I recommend folks have a look for themselves if only to get a glimpse at the magnitude of the complexity of the regulatory process.

Here is a way over simplified overview of what I get: The FDA came back to Dexcom and is requesting more data. There is quite a bit of candid conversation in that call. About CGM pump integration and about the FDA looking at insulin pumps with a more heightened scrutiny.

Attempting to translate the call into the simple what does it mean for my pumper language for families living diabetes it comes down to this; CGM integration into OminPod and Animas pumping systems is at pushed back. Taking a SWAG maybe a half year, probably more. This looks to be in part about CGMs and part about tighter regulation of insulin pumps.

Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear.

the FDA is undergoing sweeping changes to its review and approval policies and procedures, and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products.

With regard to Generation 4 of the Dexcom system which is what Animas is looking to work with:

we (Dexcom) expect to complete a small additional clinical trial with the Gen4 sensor paired with our next-generation receiver and transmitter, and file an amendment to our Gen4 PMA supplement during the first half of next year. Although we cannot predict the ultimate decision or timing for a decision by the FDA, we believe this amended Gen4 submission will be incorporated into the current Gen4 180-day review cycle, give or take a few months.

OmniPod has some decisions to make about how to proceed. They were expected to launch before Animas based on using the current generation 3 Dexcom product. However the FDA seeking more information means OmniPod may want to look to Gen 4

Insulet, as you'll recall, is paired with the SEVEN Plus. The Animas product, when complete and filed, will be paired the Gen4 sensor.

The Insulet situation's a bit more difficult to describe, only from the standpoint that Insulet's got to make some decisions as to what they want to do going forward, either to move forward with the SEVEN Plus, or if they make the decision to go to Gen4

While there is additional scrutiny in the USA the EU combined Animas/Dexcom system continues to be expected in the first half of 2011.

we remain committed to filing for CE mark approval before the end of this year and expect to be in a position to launch the combination product in Europe during the first half of next year.

In closing my post, I thought this was a particularly telling comment in that I think every patient, parent and partner of a pumper is accurately aware of the seriousness of this statement:

I've long said it amazed me that the pumps were 510(k) products that carry around anywhere from 180 to 300 units of insulin, which is a potentially lethal amount of insulin.

As a parent of type 1 kids I don't take that lightly at all. We accept that as a means to a living more normal, better manages lives. The point of all this technology is to make diabetes secondary to living pseudo normal lifes and pursuing dreams.

Full disclosure: I own shares in Dexcom. I think CGM is a good idea. Dexom is a pure CGM play. Your Investments May Vary, mine sure do.

Jumping in with Amy

Amy has a piece up on data systems and I thought i would jump on the bandwagon with a re-run. This is a previously aired YDMV bit. Summer is like that you get re-runs.  I hope it helps sound a call for data interoperability. (Sorry. I'll stop using big words like that now.)

Swimming in the Data Stream Looking for the UN. (Aug '07) 
or Becoming a Commie Pinko

Type 1 isn’t all about the numbers. It is about kids (and adults) living their lives. That said there are one hell of a lot of numbers. We gotta deal with the numbers, so we can love the kids (and adults) as kids (and adults). Nobody need love the numbers.

There are a ton of little electronic machines that produce billions and billions of numbers (and about as many strips on the floor.) At times it seems we are floundering in a sea of data points (and strips on the floor.) Unfortunately each machine speaks its own language. What we need is the UN. United Numbers.
Brenard responded to my post ...and I would like a side order of Holy Grail while I am at it too
saying:

One of the key parts to this (and the thing I've been preaching about for a while) is a unified data standard for diabetes data. Something that all device makers (pumps, meters, CGMS) follow. That would make it possible to actually take data from several devices and combine it into a single package for graphing and analysis.

Doing!
Brenard is brilliant. Bernard for President. (The heck with that constitutional provision about natural born citizen as long as he doesn't change us to left side of the road driving.)

Everyone at FFL with any kind of a {in my best Monty Python imitation} ‘Machine that goes PING’ (by the way when I wrote this Animas hadn't named a pump after a Monty Pyton bit yet) was touting some kind of undefined wireless connectivity to some tool that alerts someone, most likely the doctor, (who is way too busy with patients in the office to be taking PINGs from machines that go PING.) I call this the machine that listens to the machine that goes PING and tells someone else.
 
In one of these sessions we got to talking about the school setting. One guy said there were three, count'm THREE, pumpers in his daughter’s one classroom. Wow!

So the big idea of the focus group was this new undefined machine that listens to the machine that goes PING and tells someone else could alerts the nurse if one of the three kids in the class was trending south.

How techie cool would that be?

But wait! What if each kid is wearing a different pump and CGM?

Does the school have to buy three different machines that listens to the machine that goes PING and tells someone else? One that listens in each of the three different languages, that each of the different machines that all go PING speak?

Or do three different insurance companies have to pony up (fat chance.)

Sounds a wee bit inefficient to me. It is like every machine is it own nation.

Imagine if we could get all these different Nations United or at least talking. We need the UN!
If all the machines that go PING spoke the same language then one machine in the classroom could listen to any manufacturers’ device and call the school nurse.

Just think, all the manufacturers could all reduce the cost of R&D spent on the machine that listens to the Machine that goes PING if they didn’t each have to invent a new language in the process. Hey guys in expensive suits! Lower expenses means more profits and bigger bonuses for the guys in expensive suits or they could then invest that saved R&D money into better design, clearer user interfaces and compete on usability! Yeah I think it would go to bonuses too.

Anyway - Bernard for President of the UN!

I look at it like this, there are a standards for a USB port, bluetooth, driving on the right side of the road. Well OK there is the whole UK exception for the last one but you get my point ...well Bernard may not.

I know that some companies want to invent the wheel, patent it and keep others from rolling. Who gets hurt in this deal they say - we invent the spoked wheel, we should have exclusive rights to it.
I’ll tell ya who get hurt – kids - maybe two of the three kids in the classroom. It is the kids’ data transmitted through We the People’s spectrum. There is an interest here that takes precedence.
OK call me a communist - I want to see a Reaganesque rising tide that lifts all boats.

I did promise to write a number of medical companies a letter about this when I was bending their corporate ears at FFL.

Think they will like this?

Maybe I should write my congresswoman too. I think I'll skip the commie pinko part in her letter and maybe the Regan bit. She's a D.

FTNW: Bluetooth BG & Nokia

From MobiHealthNews:

Nokia has teamed up with Entra Health Systems to release a similar app that works with a Bluetooth-enabled glucose meter and on more than 50 Nokia phones.

Officially, Nokia has inked a deal with Entra Health Systems to include Entra’s MyGlucoHealth app in the Nokia Ovi Store, but the app enables users to transmit blood glucose testing results from a MyGlucoHealth Wireless meter through the user’s mobile phone to a personal health record. Here’s the official description from the Ovi Store:

“The MyGlucoHealth Mobile diabetes management system permits blood glucose testing results on the MyGlucoHealth Wireless meter to be transmitted from your mobile phone to your personal health record portal using Bluetooth technology. Patients can also review their most recent blood sugar test results, view line charts, pie charts and histograms, as well as enter, fitness, weight, exercise and nutritional data.”

From The News Wire: Accu-Chek Continua Certified

MobiHealthNews.com reportes that Roche's Accu Chek Pix Device Reader earned Continua certification. Hopefully this is a step towards data standardization.

Diabetes management tools just got a step closer to medical device interoperability.

A few hours after news broke that A&D Medical’s Bluetooth-enabled blood pressure cuff and Bluetooth-enabled weight scale had received Continua Health Alliance’s stamp of interoperability, the organization announced that Roche Diagnostics’ Accu-Chek Smart Pix Device Reader, which currently interfaces with blood glucose meters and insulin pumps to transfer data from the devices to the user’s computer, gained Continua certification for USB connectivity.

The Smart Pix device connects to the computer with a USB cord but it interacts with the medical devices via infrared. Once the data transfers to the computer a report appears in the user’s default Internet browser to be saved later, printed out or simply viewed on screen. Roche says the system helps diabetics make timely and well-informed decisions about day-to-day self-care.

So what the heck is a Smart Pix? Roche's web store says:

With the ACCU-CHEK Smart Pix Device Reader, you can quickly collect data from your ACCU-CHEK blood glucose meter or insulin pump, create easy-to-understand charts to analyze your diabetes management program and act on self-care goals.
By making the most of the valuable data held within your blood glucose meter and insulin pump, you can make timely, well-informed decisions about your day-to-day self-care. These efforts can pay off today as you have more energy and feel your best, and down the road with a reduced risk of long-term diabetes complications. 1

Just set your meter or insulin pump near the reader, and the ACCU-CHEK Smart Pix system does the rest. It's truly plug and play for greater convenience and faster downloads—there's no software installation or special knowledge required. You can set personal targets, time ranges and preferred report styles, and print out reports and graphs to share with your healthcare team.

Download directly to your PC

The ACCU-CHEK Smart Pix Device Reader is compatible with:

ACCU-CHEK Compact Plus blood glucose meter
ACCU-CHEK Aviva blood glucose me
ACCU-CHEK Spirit insulin pump
ACCU-CHEK Advantage blood glucose meter
ACCU-CHEK Compact blood glucose meter
ACCU-CHEK Active blood glucose me
Disetronic D-TRONplus insulin pump
ACCU-CHEK 3600 data management system

I think that means it is a $125 dongle. What it does and what gets the "standardized data" treatment I don't know. Continua's big shot dude told me that there will not be continua standards for pumps until the Continua 2.0 release some time like next summer. So how does this costly IR to USB dongle deal with their pump and what data gets dealt with how?

I'll try to find out more.

Here is some initial things that make me go Hmmm.
- $125 for a an IR dongle. Ouch
- IR? Hello what is with the dongle in a Bluetooth world.
- PC what about MAC, hell what about iPhone.
- What are the reports coming out of a PC app a browser based app?
- What are the reports?
- - (UPDATE looks like sample reports here)

- How does the data standardization of Continua help us share data between our diabetes toys?