Monthly Archives: November 2012

November DSMA Blog Carnival. A Review.

Just getting this in under the wire… This month’s DSMA Blog Carnival talked about Diabetes Awareness Month and World Diabetes Day, and asked the question:

What is the one thing (advocacy, grassroots) you will do different this year? How will you accomplish your task?

I saw this question after I had written the post below on November 2nd, so I’m going to show it again here and give my responses in red. Here we go…

Well, T1D Day has passed, and unfortunately, I can’t say that I have a lot to show for it. Sometimes these milestone days pass before I can make any kind of serious impact.

The good news is that it’s just the beginning of Diabetes Awareness Month. That means there are a lot of things I can still do to increase awareness and help champion our cause. So what am I doing? How do you advocate for something you feel strongly about?

First, I hate the phrase “lead by example”. Only because whenever that’s used, it seems like someone is saying that leading by example is enough. Well, it is for some. Just not me, not right now. So I want to start to lead by example. That means managing the BGs well, staying as healthy as I can, and not judging others based on their success or failure of the same. This has been an uncharacteristically difficult month in terms of keeping the BG within range. Feels like a fail, but I’ve kept after it and I’m doing better now, so it’s not a total fail.

I’m also trying to keep people informed, as much as I can. There are several D-Awareness Month initiatives out there, and I’ll be letting readers of this forum know about them as much as I can. I’ve posted and tweeted about the Big Blue Test and World Diabetes Day and other things, so I can check that off of the list.

On top of that? I got my Blue Circle merchandise from the IDF/World Diabetes Day merchandise page, and I’ll be handing out blue circle pins and bracelets to practically everyone I know this month. Almost all so far are completely unaware of Diabetes Awareness Month, World Diabetes Day, or the Blue Circle. So they get a quick info session on top of the swag. I’ve already had one person ask me about the blue circle pin I’m wearing, and that’s a good thing too. This has actually worked out pretty well. People have actually asked me about both the blue bracelet and the Blue Circle pin, and I’ve been able to take my message to people that I otherwise would not have talked to about diabetes at all. Win.

Stealing an idea from someone else in the DSMA Twitter chat this past week, I’ve started to inconspicuously place D-related reading material around the workplace. This kind of thing is generally frowned upon where I work, so I have to be careful with this strategy to avoid running afowl of the people in charge. This whole idea sounds like it has an element of danger to it, which must be why I find it so appealing. Thanks to Bea at Cranky Pancreas for this idea. Don’t know if it’s helped, but people who have no connection at all with this disease are being reminded that diabetes is a real thing and it exists. Win.

Finally, you might have noticed that I’ve updated this site, at least for November. I kinda like the blue, even though red is my favorite color. I also added the photo, showing my blue circle pin and bracelet, which I’m going to try to wear all month long. I’ve worn the pin almost every day, and the bracelet has been on my wrist the entire month. And as much as I like the color red, I’m probably going to keep the blue banner at the top for a while.

Wow, when I look back and read all of that, I realize it’s probably not that much in the way of increasing awareness. But it’s a heck of a lot more than I was doing last year, which was nothing. November has just begun, and I’m still looking for more impact. Small steps have helped me do more this year, and I feel more connected with my fellow People With Diabetes than ever before. Hope your Diabetes Awareness Month has been great.

Is there anything special that you’re doing this month? If so, feel free to let me know. I’d love for everyone to hear about it.

This post is my November entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at http://diabetessocmed.com/2012/november-dsma-blog-carnival-2
 
 
 

Advertisements

FDA Guidance on the Artificial Pancreas.

The latest FDA guidance is out on the Artificial Pancreas, and I’ve been taking a look to get a better idea of what it’s going to take to bring something like this to the market here in the USA.

I haven’t had a look at previous statements from the Food and Drug Administration on this issue, but after looking at the 63 page document recently released, I can tell you that it’s going to take a lot.

There are a number of reasons for that assessment, so let me see if I can break it down for you a bit. This isn’t a complete, detailed look, and I’m still seeking some other input on what some of the finer points really mean. For now, I’ll just try to give you some of the highlights.

When I think Artificial Pancreas, I think (like many others do) that we just need a device that will use data from our CGM to tell our insulin pumps what to do to help manage our glucose. Simple, right? Now, let’s think of everything having anything to do with that.

From the FDA’s point of view, that means anything and everything to do with your BG meter, your CGM, your insulin pump, and then your Artificial Pancreas device, which would probably be a modified phone of some sort.

If your meter, CGM, and pump have all been tested and approved before, great. Just provide all of the documentation that supports that, including the models, the way they each interact with each other, their adaptability to heat, cold, being dropped on the floor, your line getting kinked, getting wet, and on and on, ad infinitum.

Ready to move on to the AP itself? Okay, let’s talk about that. You’ll still need to detail how each piece of your AP system is going to work in a real-world setting. Detail how your device will interact with the CGM and pump, including how you plan to calibrate the CGM with each change, and how you plan to communicate that to the AP itself. Detail your algorithms, who they’re designed for.

Will the device be unidirectional (information moving in one direction only)? Or multi-directional (information moving between each piece of the system)?

A big question: How will the device combat hypoglycemia and hyperglycemia? And in that vein, will the device help in the proper delivery of just insulin? Or possibly insulin and glucagon? Or, as written here before, the delivery of insulin and amylin?

What about security? How can you ensure that the device won’t be hacked in some way? How can you be sure that the radio frequencies being used for the system won’t impede other systems? And while you’re at it, please detail how your system won’t be impeded by other systems like magnetic resonance imaging (MRIs), or even cell phones, computers, iPads, etc.

Once you’ve documented all of that, you can get down to the business of detailing the human factor. How will humans interact with your system? Will someone be allowed to override parts of your system? What about incorrect entry of key elements? What happens when someone leaves their CGM in “beyond the sensor wear period, when CGM results may be compromised” (actual language in the document)?

Now let’s talk about Clinical Study progression… including Early Stage testing, which includes proof-of-concept testing and studies regarding the effects of modifications to algorithms. Then later-stage feasibility studies, including some basic outpatient testing. After that, there’s “Studies to Demonstrate Performance of Risk Mitigation Strategies” (I think we all know what that means).

Finally, the Pivotal Clinical Study, designed to “gather data to support the safety and effectiveness of the device”. Real-world testing including individuals that the device is intended for. The patient population information detailed in the guidance on page 31, 32, and 33 is very important and worth the read.

Also worth the read are the very detailed Study Endpoints noted from page 33 through 35 that should include “objective characteristics or variables that reflect how a patient feels, functions, or survives. Surrogate endpoints should predict meaningful clinical outcomes and be based on valid scientific evidence”. This includes information on the use of CGM data, how the device handles hypoglycemia and hyperglycemia, how the device helps A1c results, how much the device helps the patient keep BG within range and what that range is, and how much time is spent within the range. Add in detail about safety mechanisms like low-glucose suspend and how high glucose and elevated ketones are dealt with. A final statistical analysis is expected.

But wait… you’re not finished yet. You have to include all of the documentation you intend to give the end user in:
– A User manual, written at an 8th grade level
– Training materials
– Professional documentation for prescribing physicians
– Package inserts for the AP device and any components that are packaged separately from the device itself
– Box and container labels for the AP device and any components that are packaged separately from the device itself

Don’t forget to describe how your device will be manufactured, including anything having to do with sterile parts of your system, if applicable.

And finally, you’ll want to include detail of the protocol of any Post-Approval studies you’ll want to conduct, assuming you’ll get approval in the first place.

That’s the very basic, 50,000-foot level view of what needs to be included in anyone’s application for an Investigational Device Exemption (IDE) or premarket approval (PMA) for their artificial pancreas device. That’s a lot, isn’t it? And to tell you the truth, I can’t find a whole lot in there that isn’t useful in defining how something will work, how it will be studied, and how it will keep us safe. But despite everything that’s necessary to bring this closer to the everyday patient, I’m still looking to the future with a hopeful eye. I’ll let you know if I find out more.
 
 
 

Holidays, Blah-lidays.

This post contains some raw, random thoughts hashed out over a couple of days. But please, please, please don’t leave an “I’m sorry for you” comment”. If anything, feel good for me. I’m not struggling, I’m just figuring my way through something I never experienced before a couple of years ago.

Okay… I thought I was good. I thought I was doing great. I thought that I was way over whatever had possessed me at this point last two years.

Apparently, that’s not the case. Don’t be alarmed (don’t you always hate when a sentence begins like that?)… I’m still much better than I was last year. But whatever got hold of me then has reared its ugly head a couple of times in the past week. I’m dealing with it, first by reminding myself how good I really have it and then by trying to recognize those moments when I feel bad, using some outside tool (not drugs) to try and snap myself out of it. Doing something, anything different really works for me.

I’m not a bah-humbug kind of guy. In fact, I used to be someone who very much looked forward to the holiday season, enjoying every tradition and celebration with enthusiasm and joy.

But the last couple of years I’ve been, well, I don’t know. I don’t know exactly, and that’s part of what’s frustrating about it. It’s like I’m looking through this clear glass door at a room full of holiday partiers. I know I can walk through the door and join the party any time I want, but I can’t bring myself to do it. Is that weird? It sounds weird.

It’s my own fault, really. It’s not because I don’t want to join the party. I think that I’m ready to join the party, but I want everything to be perfect before I walk in. Everything. Everything in my life must be perfect, according to my idea of perfection. Otherwise, I’m worried I’ll be rejected because I’m not ready, or not deserving, or whatever.

So my post today is an attempt to change that pattern. During the next month plus, I’m going to give myself permission to ease up on the things that are driving me crazy right now. I’m going to say it’s okay to join the party for a while, and then look again at the imperfect parts of my life to see if they’re still as important as they seem today.

I’m going to go out and take part in some holiday gatherings, among people who smile and laugh and share in the festiveness of it all. You’ll probably see a few extra pictures in the next month as proof that I actually did what I said I would do.

And if you encounter someone like me this year? No pity, please. Just talk to me. Strike up a conversation. Ask me about something. Anything to snap me out of my self-imposed malaise. Keep me engaged… don’t let me emotionally wander away, because I could be going off to a bad place. For absolutely no good reason.

The holidays are strange, aren’t they? I’m not in any immediate danger or anything. I just wish I felt more like celebrating. A lot of others want to celebrate too. Is that too much to ask for?
 
 
 

Heightened Awareness.

Due to this being Diabetes Awareness Month, and the fact that I’m more aware of diabetes in general in the past year, I almost wasn’t surprised when I found this on the walk outside of my gym:

Hope your post-Thanksgiving week is off to a great start!
 
 
 

Happy Thanksgiving.

THURSDAY, NOVEMBER 22, 2012. Today is Thanksgiving Day in the USA, a national holiday set aside to give thanks for all of the blessings in our lives.

I know it’s the easy way out to do a post like this today. But I also know that sometimes the only thing that keeps me from cracking up during this time of year is to give in to a little sentimentality now and then. So in no particular order (except for the first thing), here are a few things I’m thankful for today:

– Any message of thanks has to begin with The Great Spousal Unit. Maureen has been my rock and my champion. She’s put up with a lot of crap from me, especially this year, the busiest year I’ve had in recent memory. And through it all, she still meets the original criteria: When I wake up in the morning and think, “Who’s the most fun person I can hang with today?”, the answer is always her.

– While we’re at it, I’m happy to have The Live-In Niece around today. Rachel is absolutely different from The Live-In Nephew who came before her, but I mean that in a complimentary way. She’s adapted to Baltimore and learned about my diabetes with boundless enthusiasm and a big smile. As for Brian… here’s a kid who came to us with all of his possessions in a duffel bag. Eight years later, he has a great job, a home, a wife, and a daughter born on my 50th birthday this year. To say I’m proud is to damn with faint praise.

– I’m thankful for a roof over my head and a dry basement, especially after hurricane Sandy. Even though you’re not reading this New Jersey, my thoughts and prayers are with you today.

– I’m thankful to my endocrinologist. When I look back on all of the doctors I’ve trusted to help me with my care, less than half have been good. So when you get a good doctor, who speaks your language, who encourages you, who helps you with useful suggestions that actually help you manage your BGs better, they’re worth their weight in gold. And after going through so many absolutely horrible doctors prior to her, I’m even more aware of how great that is.

– Can I say that I’m thankful that the election is over? I’m glad the bickering is over for a couple of years. Now, get down to business. We’ve still got a long way to go to climb the rest of the way out of this crummy economic hole we’re in. You can start by ensuring that we don’t have another economic meltdown by clamping down big-time on the shadow banking industry. If you don’t, I’ll be putting my money under the mattress waiting for the next meltdown.

– Thanks to all of the writers you see in the left column of this page. In case you’re wondering, I read all of you. And day after day, I’m reminded that I’m still in the learning process with this thing because I see smarter, more inspirational, more thought-provoking prose than I’ve come up with. Thanks for showing me how to do it. It’s not an overstatement to say you’ve changed my life for the better.

– A special note of thanks to the Center for Diabetes Technology at the University of Virginia School of Medicine, where they’re working on Artificial Pancreas technology. I was lucky enough to be in the right place at the right time, relentlessly asking a ton of questions. And they not only answered them, they invited me to an open house at the center this summer, allowing me to get up close and personal with the AP, doing my first real in-depth story on something that I find positively fascinating. And right now, necessary. Right now, FDA.

– And I am so thankful for this blog. For the chance to tell my story, in my words, without an editor for the first time in 30 years. Thanks to all of you who have left comments over the last seven months. I still get a twinge of excitement every time I see a new one. But even if no one bothered to read or comment, I’m grateful for the outlet that’s helped me unload some of the things I’ve been feeling over the past few years.

I hope your day, Thanksgiving or not, helps you to remember to be thankful for the things you hold most dear. I’m not a bible thumper, but my favorite passage is still in the book of Luke, chapter 17. Where Jesus comes into a town, ten lepers ask to be healed, he heals them, and one comes back to thank and praise him. And Jesus says something like “Were not ten healed? Where are the other nine?”. I am very lucky to have my life. And very thankful.
 
 
 

%d bloggers like this: