Tag Archives: bionic pancreas

Sometimes, the Diabetes Community wins.

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.

#WeAreNotWaiting: Meet the iLet.

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
 
 
 

Innovation is good. Innovation WORKS.

My co-workers and I were talking the other day about our recycling, and one of them mentioned that they now put out more recycling every week than they put out actual garbage. I’ve actually lived in places where a couple of decades ago, there were people arguing that recycling pickup wasn’t worth the cost to have it picked up on a regular basis. Now many of us are throwing out less than we’re recycling. Where would we be if we were still throwing everything away?

Just like when there was no such thing as recycling newspaper, plastic and glass bottles (heck, I can remember when all bottles were glass), cardboard, and metal, there was a time when performing a blood glucose check at home was a pipe dream. There was a time when an insulin pump (no injections? get out!) was something out of a sci-fi novel.

But lo and behold, over time, those devices not only became a reality, they’ve become a fixture in our diabetes lives. New things do get developed. New technology emerges. New therapies are perfected.

That’s why I get a little sad when I hear people say bad things about the artificial or bionic pancreas. It’s disheartening to hear someone dis remote monitoring of their CGM.

The reality is that these two ideas are coming to fruition at a rapid pace. We already know that artificial/bionic pancreas technology, when filtered through an appropriate algorithm, functions far better, with far less effort, in a safer way, than the average patient does on their own. Side note: Can I just refer to it as artificial/bionic pancreas now? Even now, after years of development and testing, this technology is changing further to include a bihormonal (insulin and glucagon) solution. Can you tell me you were thinking about that ten years ago?

And what about remote monitoring of your CGM? We know that Nightscout has already rolled out a solution that can allow parents to send their children to school or to sleepovers with a little less apprehension. Adults can use the CGM In The Cloud to keep their family members in the know, on a real-time basis. Was this on your list of cool diabetes ideas six or seven years ago?

I know it takes a long, long time for products to come to market. But I know that with the help of technology and some extremely smart cookies, new diabetes devices and software are going from concept to go live faster than ever before.

I know that there is still so much about diabetes that will remain dangerous, even after the latest innovations come to our doorstep. But I also know that fear of what still exists is not worth not taking steps to erase some or all of the fear of dangerous nighttime lows.

I know that a cure is still out of our grasp. But I also know that I am willing to live with incremental improvements in care and delivery systems until a cure becomes reality. And I am not willing to wait on everything until a cure is within reach.

I don’t believe I’ve ever written this before. But for the record, I am 1000 percent behind the #WeAreNotWaiting movement. Where last year there were only a few isolated pockets of innovation and collaboration in diabetes technology, there are now visible signs that collaboration and innovation are occurring and are at work right now. And that leaves me thinking that with the speed of technology, #WeAreNotWaiting will soon go from a fringe idea of faster implementation of new ideas, to an inventive steamroller that eventually leaves non-believers thinking #WeShouldn’tHaveWaited.

I was not prompted by anyone to write anything on this subject, but I was inspired by this blog post, and this one too.
 
 
 

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