{Note: this is second in a two-part series aimed not only at patients, but those in the Pharma industry as well.}
I was interviewed the other day for an upcoming story about Sanofi-Aventis’ new strategy to not just offer individual diabetes products, but become a “full diabetes management vendor.” They are not alone. Medtronic, Roche, Bayer, Abbott and others are among the big industry players talking about more of a “systems approach” to diabetes as well.
These Big Pharma companies are looking for a “full solution” for two reasons: 1) they’ve finally caught on that patients need a full array of tools to support this complex illness, and 2) related, they realize that they can no longer stay competitive selling just one kind of device or treatment (i.e. for example, glucose meters are becoming ‘commoditized’.)
I agree that a “full management system” is what we need! Not just a meter that happens to connect to some proprietary data logging software. And not just a pump that happens to connect to the same company’s CGM system. But a “powerful, complete, and integrated system that allows you to implement, document, and evaluate your program.” This means both technology components that talk to each other, and also help from health professionals in uploading results, and changing program and meter/pump settings, etc.
While I think it’s great that companies are looking towards integrated systems, I want to note that it can’t simply be an excuse for them to lock patients in to buying seven different products only from them, because these items only communicate which each other.
What I’m saying is: we need interoperability here! There ought to be a standard protocol so that all products storing diabetes data can ‘talk to each other,’ and connect to each other and to computers and Smartphones using standard data formats and standard cables.
If this seems like an impossible task in the Pharma arena, just take a moment to think back a few years in the history of enterprise and consumer technology. There was no USB. People were still shouting at Bill Gates about holding users hostage; Microsoft acquiesced, promising open connections and data portability. If they can do it, the Diabetes World can do it too.
Have a look at one patient’s vision, the “Diabetes Data Cloud,” an entry in last year’s DiabetesMine Design Challenge:
And finally, speaking of standards: why are there none even for important features like how insulin dosing is handled on pumps? I recently learned that every pump manufacturer has a different 
way of dealing with IOB (Insulin on Board), either accounting for corrections or not. This can lead to the scary eventuality of over-correcting and overdosing on insulin — which btw endangers patients much more than an automatic insulin shut-off feature in case a patient’s BG drops too low (something Medtronic can offer with its Veo combo system in Europe but has not been approved for use here). Are you listening, FDA?!
Now is the time that our collective patient voice is finally being heard. Now is the time to speak up and demand better, more interoperable D-management systems. IMHO.
It would be amazing if all of these were interoperable (and thanks for the new word!). While I don’t have a ton of diabetes STUFF yet (my diagnosis was only 6 months ago), it would make me feel less locked in to the pump I decide on and would allow me to make choices based on what I think works best for me rather than what seems most convenient because of integration.
While I can certainly appreciate technological devices and components working in concert with each other, saying ” Medtronic, Roche, Bayer, Abbott and others are among the big industry players talking about more of a “systems approach” to diabetes…” is not actually true.
A “systems approach” to diabetes would include optimizing all the systems within which a patient lives. The device stuff (meter, pump, CGM etc) is only one system in a “systems approach.” Other systems are the access one has to healthy food, whether your neighborhood is safe enough to be physically active outdoors, do you have support at home, one’s family dynamic… etc. In other words, the social system which a PWD is part of.
While we all want our devices to work seamlessly, I think it’s telling that pharmas are so singly focused on the hardware. We know for a fact if a person’s life systems aren’t supporting the daily management of diabetes it doesn’t matter a lick how advanced and seamless our devices are. So, a good step on the part of pharmas, and now let’s look at the other half of what patients need – the behavioral tools to change and sustain new habits.
Re IOB, I see no reason why this can’t be a user-programmable default so that each person can choose for himself whether he wants meal boluses included in IOB.
Great post Amy! Given the standards like USB that have evolved in the computer world, you have to wonder(?) at the continuing efforts of pharma to create islands. Surely it would be less expensive to design to standards wouldn’t it? (I am NOT calling you Shirley, BTW!)
Somewhat similarly, I never understand WHY it takes the FDA so long to approve the ability of our pumps and meters to send DATA(!) from one device to another or to a computer. Now if the FDA was pushing back on the pharmas by saying, make this device communicate using standard USB/Blue-tooth protocols, then I would understand.
Fair Winds,
Mike
Pharma is where the technology companies were a few decades ago. Remember when you couldn’t connect modems from two different companies? Once standards were in place, modem sales took off and everyone won.
Michael, the FDA is not involved in data standards issues. They can only look at efficacy and safety when deciding to approve something. In terms of efficacy (does it work), if the readings from a device can be downloaded accurately to software from the device maker, then it’s a pass. They can’t disapprove a device because of a lack of a standard protocol. Look at the early OneTouch UltraMini meters, they had no download ports.
I have a suspicion that the artificial pancreas work will drive some type of standards. It would need to so the CGM and pumps can communicate effectively with software that’s figuring out how much insulin to give you.
After writing my paper (PDF) proposing a standard, simple, diabetes data interchange format, I started a diabetes data wiki to try and document the current formats that are used by different meters. I’m hoping that someone will take this information and use it to develop and interchange converter…if only I had the time myself.
Just curious but wasn’t it Medtronic that sued Smith Medical for infringement on their bolus calculations that ultimately put the Cosmo out to pasture? I know that Medtronic uses their bolus calculations as a unique feature of their pump. Regardless, if that it the case, standards will never be set across companies.
I agree Amy. I made similar comments back in this post:
http://www.ydmv.net/2007/08/swimming-in-data-stream-looking-for-un.html
And Bernard was my hero back then too.
More recently I have been looking at the Continua Health alliance as a possible source of standards. Some of the big D firms are members. I post information on it as I see it but they didn’t have insulin pump standards last time I talked with them (they were scheduled for a release this year I think) They also had no CGM data standards on the map and to be honest they probably spin off so much data that they are hard to deal with.
So that isn’t a realistic path for standards anytime soon.
Bennet,
Too funny! “A device that listens to the device that goes PING!…”
Bernard,
Yes, I get that the FDA is not involved in data standards, only efficacy and safety, yet manufacturers often get held up trying to show the efficacy of sending DATA – pretty cut and dried I would think – maybe even binary sends the data or it doesn’t, NEXT!
Fair Winds,
Mike
Actually, Riva, that is what I meant. Details coming soon.
Thanks all, for the great feedback — especially Bernard for the link to that paper!
About that, I’m working on something similar to that, I mean, I’m developing an Android app which upload your BG to your Google Health profile in order to save and share your data.
The data can be read using your glucose meter connected by bluetooth to your phone.
It’s more or less the same concept and there’s a prototype on Android Market. Right now I’m working on adding features and fixed some bugs, but after I finish that I’d like to begin with thinking about giving more useful information (regarding Real Diabetes Management Part 1: Making Our Data Speak to Us).
Any help to reach that goal will be appreciate, the project website is : https://sites.google.com/site/glucosemeterandroid/ for more information or drop me an email
loved the post and series as well and i remember once you have posted a diabetes gadget competition on some innovative ideas where some university students won it i think ! I really appreciate the work you have done in making diabetics live better and longer ! Needed more posts like this from you !
Another great post Amy – thank your for spurring on some additional conversation around this. There’s a long way to go, but we have to start somewhere, right?