Tag Archives: iLet

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 | Posted in Advocacy, Artificial Pancreas | Also 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
 
 
 

By StephenS | Posted in Artificial Pancreas | Also tagged , , , | Comments (1)
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