Major artificial pancreas clinical trial starting in 2016

A long-term clinical trial of an artificial pancreas developed by University of Virginia and Harvard University researchers with almost $13 million in funding from the U.S. National Institutes of Health will begin early this year. The AP will be tested for six months in 240 people with type 1 diabetes at nine sites in the United States and Europe. Researchers will compare this system to current diabetes management with an insulin pump. Then, 180 of those patients will be followed for another six months.

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Have they picked all the people that they are going to use for this trial? I am T1 for almost 34 years. I got diagnosed at the age 14. The family doctor that diagnosed me never told me about other sites on my body to take shots. I had been using my legs for several years. I can’t use my Insulin pump on my legs, they are humped up and insulin won’t go into them like it should. I am having problems with my sites. I used to change my site ever 3 days. My Endo. doctor has me doing it ever other day. Sometime I still have problems. My Endo. doctor does know this and I tried some different types of sets. I use the quick set. That is the easiest for me.

Diabetes is on my dads side of the family. Right now I am the last one on my dads side of the family to have T1. I have the Hyper& Hypo Glucemia Unawareness. My boyfriend has found me on the floor a few times. I got on a minimed insulin pump in 2001. I am on Disability since 2002. I have a lot more auto-immune diseases. I think that is ONE big reason that they wouldn’t use me. My Endocrinologist has been T1 about as long as me and he has a minimed pump too.

VERY exciting!

Interesting. This is not the dual chamber AP with glucagon, is it? In prior testing pts have had to use three sites. Wondering if the final AP will need two or three sites…

For this particular trial, my understanding is that the system to be tested will be based on an insulin-only pump and a CGM, so two sites.

I’ve been told that participants for this trial have not been selected yet. Inquiries about this and other trials involving technologies developed by the University of Virginia can be sent to artificialpancreas@virginia.edu.

From my viewpoint, I don’t consider a device to be a true AP unless it is a bi-hormonal system (i.e. insulin plus glucagon.) Any step in the right direction is appreciated, however.

How do people get chosen??? I really would like to be part of this.

Hi Wendy, you can send an email to artificialpancreas@virginia.edu and tell them you would be interested in University of Virginia AP trials. Hopefully they will reply and provide more details. Sorry, I do not have any more info at this time.

You can also do a search at the us governments website to see where the trials recruiting locations are at.

This is just one that I found .

The other one that I know of is for Medtronic 640 G system

exciting something to keep my eye out for.

i just saw info on the Minimed AP which intrigued me because they claim one site for both the cgms and insulin. As well as Damiano saying he was going to invent one set for both glucagon and insulin. There would be two lines, that join into one, and one site going into the body. However, I do not know if Damiano’s set has two canulas. In other words one set with two prongs to go into the body, kind of like a fork. Ditto with Minimed. Just because it is one device it could still hold two needles going into the body. In Damiano’s case there would also be the Dexcom. The Minimed AP had surprisingly few lows but I don’t believe the control is as tight as Damiano’s AP. The Minimed predicts low pattern and shuts off flow of insulin until blood sugar stabilizes. As DD has pumped for 8 years, now on MDI and Afrezza, I would have to sell her on the AP and might be able to do it if there was truly one site. So hoping the Minimed has one canula… The APs are working much better than I had expected, particularly since they are working with the old slower insulins. Don’t know why that works; I would assume the insulin is just too slow for real time. But they are working!

I suppose I can see … from the neck up … why the idea of “only one insertion/infusion site” might seem appealing to someone at first glance. I consider it to be a terrible idea based on my experience.

Consolidating the CGM & insulin infusion site into one is a great way to increase revenue for the device maker. I change my infusion sets at least every 3 days and I’m leaning toward doing it sooner than that. A CGM on the other hand should last at least about week, perhaps longer. But if you combine them, then you will have to kill a perfectly functional CGM insertion just because you need to change the infusion site.

Now consider the implied costs of having to pull the whole mess should you run into a bad infusion site.

I also tend to have different preferences for CGM insertion versus infusion set locations. I really don’t like the thought of having my hands tied as to what can be placed where on my body by combining the sites.

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