The Diabetes Technology Society held its annual meeting last Thursday through Saturday, which always takes place just about a mile and a half from my house. But guess what? This was the very first year that I found myself on the inside of this exclusive event, participating in a panel (the very last panel of the 3-day event) on “technologies to drive patient adherence.”
The term “adherence” made me bristle, too, because it sounds like that dirty word, “compliance.” But in this case, the four Type 1 members of my panel were there to express what we want in technology that will help us manage our diabetes better. We had a lot to say, and I think we jarred the audience when we started our panel session by unloading our all D-gear right there on stage: carry cases, insulin, infusion sets, meters, glucose tabs, alcohol wipes, test strip vials, syringes, snacks and all!
This was quite a departure for an event that’s basically all about algorithms — the fancy math being developed to make our pumps and monitors more sophisticated and more accurate.
Hundreds of scientists and engineers were in attendance, including folks from the US Army and the FDA. There were 65 speakers in all, and every attendee received a book of nearly 200 pages of abstracts. Yipes!
Many on hand were working on a variety of non-invasive glucose monitoring technologies (notably in the ears and eyes). I tried, but I couldn’t get too excited about these knowing what I do about what a tough nut the non-invasive dream has been to crack.
There was much talk about technologies for improving glucose control in the hospital (ICU patients), and many different aspects of working to achieve a true Artificial Pancreas.
Right after the big Artificial Pancreas panel, in fact, four members of the Food and Drug Administration took the stage to give “the FDA’s point of view.” This seemed like a bit of a snow job to me. All they did was outline some very basic rules for engagement with the FDA (which I’m sure everyone in that audience already knew inside and out), and then dodged every audience question with a benign sort of “well, come to talk to us about that” answer. Ugh! This included my question on the barriers to embedding some of these diabetes algorithms into the iPhone or other consumer devices. “It’s not impossible, but there will be some significant barriers,” the experts said non-committally. Double-ugh! My belief is that this “convergence” is an unstoppable force; it’s going to happen, whether in 2 years or 8 years — so why not accelerate the process?
In any case, I think the meeting organizer Dr. David Klonoff and everyone involved was just glad that the FDA was willing to make a showing in the first place.
On “Patient Adherence”:
One of the earlier speakers mentioned the fact that developers making medical devices “don’t often think about the utility of the device.” (!!) Uh, huh.
And from what I heard, when the FDA talks about “Human Factors” in medical device design, they’re mostly talking about how to avoiding risks of possible misuse (i.e. human error, by those pesky patients).
Photo credit: Courtney Benefiel
On the panel with me were three other people living with Type 1s: a diabetes researcher, an endocrinologist, and a nurse/practitioner who works with kids with Type 1 diabetes and their families. Despite all of our D-related professional backgrounds, we each talked mostly about how much we struggle personally with this illness, 24/7. You could’ve heard a pin drop in the room.
I went out on a limb and said that I believe most of these early technologies will fail, simply because they were not designed with patient’s quality of life in mind. For example, today’s CGM devices that require so much calibration, have loud alarms that go off all night, uncomfortable sensors with long startup times, etc., etc.
I tried to summarize the “trends” that emerged from our community crowdsourcing design contest, the DiabetesMine Design Challenge. What PWDs seem to want most are:
- Interoperability (why don’t these devices talk to each other or share data?)
- Combine, combine, combine (why do I need so many disparate gadgets?)
- Go mobile (I want it light and easy to take with me – perhaps built into my cellphone?)
Finally, I summarized my take on this “adherence” stuff: I think it’s faulty to build devices, and then ask: how can we make people adhere to this? Rather, vendors should be thinking about designing tools with us patients, that help us in the ways we want to be helped, with our overall quality of life in mind.
Suppose there’s an algorithm for that?
Amy, excellent summary.
Why do you think everyone was so dumbstruck? Did they think diabetes management was easy? I hope not.
I agree that FDA is most concerned with efficacy and accuracy, they could care less about design. And maybe that’s OK. But what about interoperability?
They could easily require that all devices provide data in a common format, if they make it extensible then vendors would be free to ‘enhance’ it. This is not rocket science. Many device vendors in other industries have learned that common formats are a benefit, think early fax machines or modems. The value of the individual device goes UP when it shares data with other things.
One day….
Adherence. Barf.
Yeah Barnard!
Let’s flip this around. Who should be adhering to what?
Are the manufacturers adhering to standards that facilitate, simplify and standardize care?
Why no. They do not.
They each invent proprietary systems that require the patient to adapt to new processes, new data formats and new software to comply with their one size fits all vision (or lack there of) of how to maintain diabetes.
There is a big medical / tech industry process to create standards for wireless care. 200 plus companies including most of the big diabetes firms are in. Zero patient participation.
WTF.
Thanks Amy for reminding them there is a patient side. Apple wasn’t the first to invent a portable digital music player. They were the first to make it user friendly. And they made it work with PC’s also. Then they stole the market because of that. These device manufacturers could learn a lot from Apple.
Great information Amy!
Adherence is the name of the game for one thing only – the bottom line. When patents expire, then we may see some improvement in products. Or… when the manufacturers and Pharmas wake up to the fact that PWD may know more than they want us to – maybe some things will change.
With the technological advances in computers and other electronic equipment, it only makes sense that there should be advances in equipment for control of diabetes… as well as equipment for other medical problems.
With the increased exposure that diabetes bloggers are getting, I feel that in a few years (too slow) that more changes will happen because of people like Amy. While I am a T2, I still have an interest in speeding up the changes (equipment) needed in all types of diabetes and medical problems in general.
Proactive intervention by patients will bring about change.
Bob
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That was a very good post and addressing the issues with algorithms that I have been speaking about for the last year too, as it affects all chronic illnesses with devices, and yes there has to be a human side. I post quite a bit about the devices coming out left and right, hopefully as an awareness item so consumers are aware of what pops up next.
The key to using devices and algorithms is implementation as if not done properly, you will have disruption, huge disruption. We all still have to function as humans and can’t have devices interrupting that course of our lives.
Who knows one day the FDA might have to approve our cell phones too. The areas that used to be defined in different areas are running together now so there’s a lot of gray. I used to write code and developed an EMR years ago so this gives me some insight here as there were many times when what I thought was a good idea was actually not a good software design and had to go back and change when working with the family practice doctor. We call it “eating our own dogfood” in the software side of things. Actually eating one’s own dogfood though is how it should be, otherwise you do not know how designs, devices, etc. will work in the real world. There’s a huge difference between what is called proof of concept and the real world!
Also, with devices you need to know where your information is going too and with all the web based software applications that come with devices this gets a bit gray too. I feel it should all go to a personal health record where it keeps the patient in control. All of this is confusing the average patient by all means and this is not what is supposed to be going on.
Devices and drugs are also changing delivery methods, many to inhalants as there are devices that can track this. I have posted about these items with correspondence from the likes of Cambridge Consultants, one of the companies who designs such devices and sells the license and product to healthcare companies. Some of what I hear sets me on edge as well. Yesterday I posted about Best Buy joining in the device business as well as selling other fitness products.
http://ducknetweb.blogspot.com/2009/11/best-buy-announces-personal-health.html
UCLA has a study going on about participatory sensing with devices and i hope they have some results soon too!
http://ducknetweb.blogspot.com/2009/06/are-cell-phones-enabling-anyone-to-be.html
In summary, you can’t just through devices out to consumers and expect results if they do not have a model to implement without total disruption of life, I agree 100% on this. Some of what I see out there scare me too! Again, I think perhaps if some of the experts actually got involved themselves and used some devices to get some first hand experience as to what the patient can expect, we might have some different expectations, so I am back again to eating one’s own dogfood.
We are being driven crazy with compliance I agree and how to go about it with a human model and just simply meeting the parameters of the algorithms they design is not going to work. I stuck the word “algorithms” smack center on my blog so hopefully consumers can learn what this is all about and how to make sense of what is being designed without real world human experiences and rather relying on a “proof of concept” notion. I deal directly with physicians too and they are frustrated on their side of the coin too as they watch all of this evolve as well.
Bottom line is to not forget we are humans and all healthcare is the people business. We can’t stop technology but we can all certainly voice our opinions and remind everyone at all levels that we are in fact all still humans and need to be cared for as human beings. This entire area of devices that report data is becoming so fragmented and confusing to everyone all the way around and there are no real laws and regulations for so much of it as it is so new.
The FDA is still catching up with getting their technology act together, literally as of at the end of 2008 there were employees there who were still writing studies out in longhand and not using a computer! That is scary in itself but I believe now that is quickly being corrected throughout.
This “adherence” stuff just goes back to Marketing 101 and Business 101 – you make a product that people need. Here, it seems to be, we create a product that is almost what you need, but not what you want, but we will market the heck out of it to convince you that you can’t live without it. It’s almost a snake oil salesmen approach, and until they get it right, this adherence BS will be around.
Sure seems that the FDA should be lighter and quicker on its feet. What outside forces exist to ensure the FDA is efficient and sensible vs a slow, oblivious, powerful Washington D.C. bureaucracy?
I think the deficiencies with devices are not because the manufacturers do not understand what the patients need and want, it’s because that is all the current state-of-the-art technology can do. Certainly they are pushing to get devices to fail-safe status as then sales of the devices would take off and they might actually make some money.
Amy,
I heard your discussion at the Diabetes Technology Conference and I am enjoying your blog. I am a former FDAer and share many concerns that others have. However, I thought the FDA presence at the conference was impressive. I see them at a lot of conferences (different folks, same agency) and they have constraints on what they can and cannot say. This was definitely one of their better efforts.
I am also a type 1 for 25 years or so (who’s counting?). I was about the same age as you at my onset. I spoke at a session on clinical trials in a pre-conference workshop. I wrote a brief account of the conference, from a different perspective, on my blog: Carl’s Blog on FDA Stuff. Stop by sometime. The words below are very difficult for an old man with bad eyes. I’m on my second attempt.
Cheers,
carl-
NON-EVASIVE!!! Just because the strips and lancets are a multi billion dollar per year industry is the only possible reason we do not have the technology to have a hand held device to take a reading instead of the “blood letting” that I have been putting my precious daughter through for 14+ years of her 16 1/2 years on this earth! When she was 4 I got on a first name basis with the head of the FDA to try and get a hearing scheduled for a manufacturer of such a device, when she stopped answering my persistent calls I spoke with the Surgeon General who got her to call me! There was a hearing but the FDA said they didn’t have enough time to research the testing company, they only had 2 1/2 years to do so. We can send rocketships that take close up pictures of planets how many miles away? Technology??? No, it’s ALL about the money!!
I am not diabetic but have lived with it for 35 years with my husband, youngest son(at age 15 1/2) and now oldest grand daughter at age 6. Thank you for all the good comments. It is all about the money!!!!
GOOD POST!
Great post (and comments) here Amy. I bet it was really something to get to see things from the inside. I appreciate you sharing it all with us.