Category Archives: Artificial Pancreas

Defining Moment

June 25, 2019 – 10:11 am

Every now and then, I look back and realize just how far we’ve come in less than ten years. I realize access is an issue, and it deserves its place and time. But for this moment in time, I’d like to focus on the sheer magnitude of advances we’ve witnessed over the last decade.

Part of the story of the birth of this blog comes from a radio interview heard by The Great Spousal Unit one day. She called me at work, very excited, and told me I needed to listen to it with her after work that night.

The interview was about artificial pancreas technology. The year was 2011.

I’ve told this story several times, so if you’ve heard it, feel free to skip down a little farther. If not, here’s a little background:

I had been wearing an insulin pump for about a year by this point, and my diabetes management was okay, though I really had troubles with highs and lows. The averages were good, the peaks and valleys were not.

After we listened to the interview, the conversation went something like this:

Maureen: ”Isn’t that exciting??? I mean, isn’t that really groundbreaking?”

Me: ”Yeah, well, if they could get it to work, it would be exciting. There’s a long way between here and there.”

Maureen: ”I can’t believe you’re not excited about this. You love this stuff!”

Me: ”Okay, it’s interesting. If it works. What do you want me to do about it?”

Maureen: ”Find out about it! Someone has to be writing about it… find a blog!”

The next morning, I googled “Diabetes Blogs” and found the Diabetes Online Community.

Since then, I’ve seen countless talks and presentations and read position statements and FDA guidance on the subject. I’ve seen a lot of the work that was done at the University of Virginia on the subject.

I attended early Children With Diabetes Focus on Technology events where prototypes of the Bionic Pancreas (as it was known then) were displayed and talked about. I’ve been to FDA public workshops where evidence was presented that shows time in range for blood glucose is better than the simple A1c, and backed up with clinical data on closed loop systems.

I’ve seen the likes of Dana Lewis and Tidepool’s Howard Look speak about DIY closed loop systems, part of the #WeAreNotWaiting movement that has really helped accelerate the pace of development.

I’ve watched as now, finally, every insulin pump manufacturer in America has undertaken ongoing work to bring the best of this game-changing technology to people living with diabetes.

Through it all, I’m amazed at the dedication of the hundreds of individuals who have kept this dream alive through research, and through participation in clinical trials, pushing forward, clearing hurdle after hurdle. #WeAreNotWaiting? How about #WeAreNotGivingUp?

Recently, I’ve also thought about how much of an honor it has been, and what good fortune it has been, for me to witness this time. Access issues aside, we are all so lucky to be around during this defining moment in diabetes history.

There are so many interviews I’ve done, so many questions asked, of those working on this. But I wonder if the best interviews, the best questions, the best answers, might come a few years down the line, after closed loop insulin delivery becomes de rigueur. What stories these pioneers can tell!

In the meantime, I’ll be watching and waiting, and cheering the men and women who are changing what diabetes management looks like for this generation and beyond.

By StephenS | Tagged , , | Comments (1)

Sometimes, the Diabetes Community wins.

July 26, 2016 – 9:08 am

I need to take a moment to talk about last Thursday. A day like many other days, full of commutes, and workouts, and tasks to complete. Only this time, it wasn’t exactly a typical Thursday.

Sometimes, the diabetes community wins.

Four big announcements took our world by storm that day, and the news was, to me anyway, all positive.

The day began with an announcement from Type Zero Technologies and Tandem, announcing a working agreement to use Type Zero algorithms in future t:slim artificial pancreas solutions. For a pump agnostic group like Type Zero, it’s very cool to see them working with another partner in addition to CellNovo. I hope to provide more insight on this at a later date. For the official word on Type Zero and their work with Tandem, CLICK HERE.

But wait… that’s not all. There’s more!

Thursday was a big day at the U.S. Food and Drug Administration, as a hearing took place to discuss Dexcom and its latest continuous glucose monitor, the G5, to decide whether it could be officially approved for patients to make dosing decisions. That’s not the exact wording, but in simple terms, that’s it. In short, FDA approved the measure, and now we all have to decide what that means for us, individually.

For some, this decision isn’t a big deal, because they’re dosing off of the Dexcom readings they see already. For others, they’re thrilled that they see the okay from an official government agency to do this. For still others (Ally makes some points worthy of discussion here), there are questions like “Will I now be denied test strips because insurers will want me to dose off of the Dexcom?”. Again, many sides to the issue, so it will be interesting to see what the coming years bring.

Another, important side to this story: the fact that this disposition makes it so much easier to include CGM within existing Medicare framework in the future. It will probably still require Congress to act, which they haven’t wanted to do for a while, but there’s no question a major roadblock is out of the way.

This was a real success story for the Diabetes Community, as it rallied behind initiatives from Diabetes Patient Advocacy Coalitionand diaTribe to sign petitions that were seen by FDA as important influences. They really do listen to us, folks.

But wait… that’s not all. There’s more!

Bigfoot Biomedical also heard from FDA on Thursday, getting approval to move ahead with stage 1 clinical trials on their smartloop™ automated insulin delivery system. Bigfoot has been working hard, and there are so many visible, familiar, lovable faces associated with this company that it’s hard not to root for their success.

The stage 1 clinical trials will be starting shortly, in the San Francisco Bay area, in Santa Barbara, California, and in Denver, Colorado. If these trials are successful, they hope to move into stage 2 trials by the end of this year. Yay Bigfoot!

But wait… that’s not all. There’s more!

Ed Damiano, one of the main driving forces behind the iLet bionic pancreas solution, was named by Boston University as Innovator of the Year for his work on their unique dual-hormone system.

Many people have written about Dr. Damiano and his systems over the years, so there’s not much more I can add, except to say that this recognition is long overdue, and if I were to name the ten most important living scientists working on diabetes-related causes right now, his name would be very near the top. What he and his team have been doing has been influencing all of us, whether we know it right now or not.

Can you believe that all of this good news came out over a single 24 hour period? As my news feeds popped up with each new story Thursday, I could hardly contain my happiness.

Particularly gratifying to me were the many tweets and Facebook status updates from people in the Diabetes Community who feel like there’s a reason to hope again. And boy, do we need some hope. For that reason alone, Thursday was a very good day.

Sometimes, the Diabetes Community wins. Thursday was a great day. Thank you for doing your part to help make it happen.

**Note: the original draft of this post noted Bigfoot Biomedical as a non-profit. It was my mistake, which I am happy to correct.

By StephenS | Also posted in Advocacy | Tagged , , , , , , | Comments (5)

#WeAreNotWaiting: Meet the iLet.

July 10, 2015 – 9:36 am

Some news (read: a lot of tweets and Facebook posts) came across my desk yesterday due to the announcement of the iLet, announced yesterday at the Friends for Life conference in Orlando.

Dr. Ed Damiano and the team in Boston (including Scott Scolnick, whom I met at the Diabetes UnConference) have been working on a bionic pancreas system for some time now. That development took a remarkably different turn with the push to develop a bi-hormonal system beginning, if I remember correctly, about two years ago. Since then, things have moved along quite a bit.

First is the unique nature of this technology, which will essentially have two pumps in one: One for insulin, one for glucagon. Seeing the announcement yesterday tells me that the team is confident enough in the liquid glucagon solution they’ll be using to make this a reality. So, while I obviously can’t predict it, don’t be surprised if some sort of liquid glucagon makes it to the market around the same time the bionic pancreas does. But I digress.

The other thing that’s new with the iLet is that it will have its own dedicated device to manage everything. We’ve known for some time that the finished device would not have the iPhone with it as a controller (remember?). Yesterday’s news confirms that. The device will include a 4.3 inch touch screen, with which the user will manage settings and boluses.

So… there’s an actual dual hormone pump… there’s a dedicated hand-held controller… and algorithms that will help the system pump insulin or glucagon in appropriate amounts every five minutes. Those algorithms have been and are being tested to make them as responsive as possible.

Now you may be asking: Where is it? When can I get my hands on this groundbreaking technology?

The good news is that Dr. Damiano and the team believe their devices will be approved by the U.S. Food and Drug Administration and be ready for the public by 2017, which is the time frame they’ve been shooting for for a while now.

There’s a lot to learn, and I certainly don’t know everything yet. Take a look at the pump and controller HERE (controller, in this case, may not be the optimal term, but I can’t think of another word yet). Exciting things are happening, and I realize I’m taking a lot of creative liberty to say it, but:

#WeAreNotWaiting
 
 
 

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Hey! You look just like me!

September 15, 2014 – 9:33 am

A number of times, I’ve read blog posts from people who have seen someone wearing an insulin pump in public. In many of those instances, the writer can’t quite bring themselves to say something to the person wearing the pump. And I never understood why, until it happened to me too this past weekend.

I got up early Saturday morning to help my best friend get things set up for a flea market his group was sponsoring. It turned out they didn’t really need my help at all, so after 45 minutes or so I stated the obvious: “You don’t really need me now… I’m going to go home. I’ll call you later to see if you need me to help break things down when it’s over”.

I said my goodbyes, and as I walked out and toward my truck, I saw a guy, about my age, with exactly the same pump, in the same color, that I wear.

I stopped in my tracks as he walked by. I couldn’t believe it. I mean, yeah, nearly 30 million people in America live with diabetes. But I thought I was the only one in Baltimore. Okay, I knew I wasn’t the only one here, but sometimes it seems like it. Anyway, I thought hey, this is a perfect opportunity to meet someone else from the pancreatically-challenged part of the population. I should run and grab this guy by the arm and have a long conversation with him!

But before I could catch up with him, I noticed something else. He was enjoying himself. He was enjoying his day. I watched him from a distance, for about five minutes or so, and I realized this is the life that we had hoped for when insulin pumps were brought to market for the first time. Heck, this is what we want when artificial pancreas systems make their way to the market.

We just want to live our otherwise normal lives, in a normal fashion, just like people without diabetes do. Somehow, watching this fella enjoy the flea market, I was able to enjoy knowing he felt like the rest of the people around him.

In this case, I could really appreciate the fact that Diabetes Man, living his life, doing the same things as everyone else around him, was more important to me than getting to talk with someone locally who lives with diabetes 24/7 like I do.

It was a good indication that I need to remember to be grateful for the amazing advancements that have already made our lives better, even while we advocate for even better advancements for the future. As I headed home, my full heart and my big smile were indications that diabetes can and will be lived bigger and better every day by myself and Diabetes Man at the flea market. Nothing will stop us from enjoying life to its fullest.
 
 
 

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Clinical Trial Conclusion. What I learned.

June 9, 2014 – 9:53 am

This is one in a series of posts detailing my participation in a clinical trial with an artificial pancreas element. I’m writing about this to chronicle my experience, and because if I were reading, I’d want to know about every aspect of what was going on. For more on this clinical trial, click here and here.

Last week were the final two days of my clinical trial in Virginia. This week we went through everything we went through the previous week, and everything at the same time as last week. So if I ate breakfast at 7:00 a.m. the first week, breakfast the second week was at 7:00 a.m. And it was the same breakfast. Everything, food, exercise, the whole thing, exactly like the previous week. The real difference is that in the first week, the algorithm running my artificial pancreas system was based on the data collection week I had gone through earlier in the trial. The second week, the algorithm was based on my own pump settings. The idea was to compare the special (or experimental) algorithm with something based on what I work with every day. Note: I believe this explanation is different from what I had written before. Sorry about that. Sometimes I don’t get a complete, exact idea of what is transpiring until it transpires.

I have no idea how everything turned out. Which algorithm worked better? I don’t know. And I don’t care. Because what worked best doesn’t matter. Gathering data is what matters in a trial like this. Like an A1c, the scientists working on this artificial pancreas solution need data to help them decide how to improve the device going forward. Good or bad? There is no bad data.

DSC01607

What was it like being hooked up to an artificial pancreas device twice in two weeks? It was… interesting. It wasn’t as “set it and forget it” as I had convinced myself it would be. And that’s one of the takeaways from this trial that really hit home for me. No matter how my external organ will perform for me in the future, I will still need to be an active participant in managing my diabetes. It’s just that an AP device would make things easier, in theory, while providing me extra protection from dangerous lows, particularly overnight.

The other big takeaway for me has to do with how an AP system is designed to work. The idea of small micro-boluses every five minutes sounds great, until your glucose starts to get up into the 200 mg/dL range. When I see a number like that a few hours after a meal, I immediately want to perform a correction bolus. A full correction, to get my BG down to the 100 mg/dL target. So in my case, if my number was 220, I would bolus three units of insulin to bring me back down to 100.

DSC01610

But an artificial pancreas doesn’t work that way. First of all, instead of trying to correct that number to exactly 100, maybe it would try to correct that number to a range instead. That might require a different amount of insulin. Also, my device was not going to administer all that insulin at once. It’s still going to give me small amounts, every five minutes, until I softly land in a good range (for this study, that was between 80 and 140). I think the largest amount I was given at any time (other than meals) was 0.25 units. When you look at your CGM graph on the artificial pancreas, you’ll see gentle rolling hills, instead of high mountains and deep valleys. I love the thought of that. But for me, not attacking a higher number immediately will take some getting used to. Really, it will require a completely different way of looking at my diabetes.

So in the final analysis, scientists learned something from this clinical trial (I hope), and I think I learned a lot too. When an artificial pancreas device actually hits the market at some point, I’ll be viewing it through an entirely different lens. And that’s okay. Because the older I get, the more I realize that I’m not perfect, and opening myself up to different ways to manage my disease could possibly lead to something great in the future.
 
 
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Here once again is my push for clinical trial participation. Clinical trials meet a very necessary need when it comes to developing drugs, devices, and therapies that will help all People With Diabetes lead better lives. I strongly encourage you to think about volunteering for a clinical trial.

The USA’s National Institutes of Health has a complete list of clinical trials taking place all over the USA, and even some outside of my country. To find them, go to www.clinicaltrials.gov and enter “diabetes” into the search box. A recent search found 11,175 studies.

In the United Kingdom, the UK Clinical Trials Gateway is a great resource for finding out about trials happening all over Europe. To perform a search and find out more, go to http://www.ukctg.nihr.ac.uk

JDRF has a very helpful web page that lists multiple sources for registering and finding out about clinical trials. Just go to www.jdrf.org/research/clinical-trials/ to find out more.

To read more about the University of Virginia’s Center for Diabetes Technology, including staff bios and more on Artificial Pancreas technology, visit the center’s website at www.medicine.virginia.edu/research/institutes-and-programs/cdt/the-center-for-diabetes-technology-at-uva.html
 
 
 

By StephenS | Also posted in Clinical Trials | Tagged , , , | Comments (9)