On November 3, the FDA will host an unprecedented discussion between the diabetes community and its senior agency leadership (both drugs and devices). The event will be live webcasted from 1 - 4 pm, and will include a panel of people with type 1 and type 2 diabetes, as well as representatives from ADA, JDRF, and diaTribe. As a community of people touched by diabetes, we have a huge opportunity to present the numerous challenges we face each day, and we need as many opinions as possible to be a part of this discussion! With ADA, JDRF, and dQ&A input, we have created a survey posted at www.diaTribe.org/survey. We are asking the entire diabetes community (type 1, type 2, gestational, caregivers, etc.) to please fill out this short survey and share thoughts on what's important when it comes to living with diabetes. This feedback will go DIRECTLY to the FDA and help influence the conversation on November 3.
I had applied to be on this panel and have learned that I have been selected. This is a real opportunity. For years the FDA, the healthcare system and companies have privately made decisions about drugs and medical devices. They have said they are working on behalf of patients, but we have not been part of the conversation. They have come up with measures that they thought were important on safety and effectiveness, etc but they have not considered the patient view. Diabetes isn't like strep throat, it is patients that are at the center of the vast majority of daily treatment decisions. But things seem to be changing and the FDA is eager to hear from us. I believe that we as patients can not only help the FDA make better decisions but we can also take part in the process with things like surveillance programs to make sure that drugs and devices work properly and to collect additional information on adverse effects. The FDA is listening and this is the time for us to step up and say something which will be heard. I urge you to take the survey. Post a message here. Or privately message me.
Brian - I'm happy to read that you've been selected. Yeah, medical researchers and device manufacturers have talked a good game about consulting patients during the process but the end results look more like paternalism to me. They give us what they think we need without really listening.
Little things tell the tale. My insulin pump does small internal housekeeping tasks that can take, say five seconds. During this time, it disables all user input. I can be pushing buttons like crazy and it simply ignores me. Well, I can just hear the engineer saying that these tasks have to be done and we can just wait a few seconds. That makes sense until you walk in the user's shoes.
We lead busy lives and try to do all the necessary minutia to make our diabetes life work. Let's say you're waiting at a bus-stop to catch a bus to the restaurant. The bus is pulling up and you remember that you need to bolus. As you try to dial up your dose the damn thing decides it needs to take care of some internal business and shuts you out. By the time it releases control, you need to climb aboard a crowded bus. I've had this happen and then forgot to bolus until I arrived at the restaurant. That deprives me of the substantial benefit of pre-bolusing. I could wait to eat but then I'm faced with the social awkwardness of the people in my party.
The pump has 99% of its time to take care of this kind of business. Why doesn't the human rate over the machine? The machine can just wait until I'm done and then do its thing.
This seems like such a small thing but when it falls into the context of the real world, the solution seems obvious. It's plain to me that a diabetic was not in on this discussion, only the engineer's needs were met!
This kind of thing appears in many design decisions. What about the engineering/business decision about which screen to incorporate into a pump or CGM? Should it be readable in bright sunlight? The diabetic was not in on that one!
I could go on and on. All this talk about "patient-centered" sometimes seems disingenuous. I know some policy makers are truly trying to do the right thing by us. I hope the panel you're on is one where they'll listen and incorporate your ideas into policy. I'm glad you're involved. I took the survey.
Totally agree, the little things matter and seem trivial when you don't suffer a permanent, daily burden to manage a disease. The imposition of "safety" steps on pump operations (Tandem Tslim is a notable example) illustrates how the FDA really doesn't get the daily reality of this disease. Pump user friendliness lags so far behind consumer tech, it is a joke. I suspect most of this is due to arcane and overly safety-conscious FDA requirements. It takes so much risk and cash to R&D a medical device that by the time a company engages the FDA approval process, they will acquiesce to anything to get it through.
I’m not so sure that the “overly safety-conscious FDA requirements” are at the root of this process breakdown. What we really need is an utterly transparent process that allows patients to see how these transactions actually take place.
The manufacturers religiously hide details during the developement process citing proprietary information. By the time they bring their wondrous technology down from the FDA mountain, it’s forever etched in stone. And they blame the FDA for these shortcomings.
We need a seat at the table, every step of the way. We also need to hold significant sway over these decisions. Business may chafe at this but the notion of real patient involvement would strengthen the quality of their final product, not diminish it.
That is great you were selected! I just did the survey too. I said I want insulin and everything we need available at low cost without rx. Somehow I don't think they will listen to that one though, lol.
Done. Not a lot of it was pertinent for me. The D doesn't limit what I do---all my other chronic illnesses do, for instance. There was a way to make that more or less clear, I think. I also can't comment on meds and the only device I count on is my meter.
Thanks, Emily, for making this available. While I applaud the FDA for taking on the community's responses, the more meaningful gesture will be knowing the outcome of their considerations. Will there be some way for us to track FDA's progress, decisions, policies based upon the community's input?
Judith, I am wondering whether it might be worth your time (and anyone else who feels it useful) to pen your relevant concerns under separate cover to FDA, also stating that the survey didn't quite cover your concerns.
Transparency would be great. I am guessing and placing most of the blame on the FDA but you're right, who knows? I see that pump products change only incrementally from their original designs and I can only guess that the FDA process discourages improvements. Advanced features like Super Bolusing or simultaneous Extended Boluses are probably non-starters because the companies don't want the hassle and expense of clinical trials and safety tests.
