Tag Archives: artificial pancreas

Clinical trial, week two.

November 4, 2013 – 8:48 am

So here’s a quick update on my latest clinical trial. Okay, maybe not so quick, but I’ll try to make it as succinct as possible.

Officially, I’ll be testing the new Dexcom CGM, the G5. Not sure at this point when I’ll be hooked up to the G5. It’s a 32 day trial. For now, I’m wearing the G4 version, which I will continue to wear for the length of the study. This week, I’m traveling back to Charlottesville to go through a series of tests. On the day of testing, I’ll have an IV in my arm. I’m not sure what all of the tests will be, but I understand part of it will entail getting my glucose up over 200 mg/dL quickly, then dosing me with insulin to bring me back down quickly. I don’t know more about it than that, but I should have a couple of stories to tell later.

The team will measure the results, taking blood samples throughout the day. That’s probably the reason for the IV.

In addition to all of that, four days of the trial will be “insulin sensitivity days”, which involve eating exactly the same meals and snacks, at exactly the same time, throughout each of the four days. So if I’m eating instant grits and turkey sausage for breakfast at 6:00 in the morning (true), then a ham sandwich for lunch at 12:15, and a granola bar as a snack at 3:00, I have to eat exactly that, at exactly the same time, on the other three days too. The hard part for me is the Stouffer dinner I picked out. Easy to do the carb count, but I’m spoiled… I am not a fan of boxed dinners.

What’s the upshot of all this testing? Let me answer a question with a question: Did I mention this version of the G5 is specifically designed to speak to UVA’s artificial pancreas technology? I know I’m connecting dots that are not even on the chart yet, but in short, if these tests are successful, it should help clear the way for at-home artificial pancreas testing. That’s where patients would get hooked up to the AP, then go home for anywhere from a few days to a couple of weeks. That’s a huge leap forward in the development of this important technology, which is why I say I’m connecting dots that aren’t on the chart yet. But I can see the natural progression of the testing, and I can understand that a day like that is coming, and not too far off into the future. Okay, now I am really speculating, so I’ll stop now.

I hope to have another update next week… Thanks for supporting me through this important testing!
 
 
 

By StephenS | Posted in Clinical Trials | Also tagged , , | Comments (2)

Minimed® 530G with Enlite®. Five questions.

October 2, 2013 – 9:50 am

So the Medtronic 530G and Enlite sensor are here, featuring a new pump and a new CGM (continuous glucose monitor) that talk to each other, with a never-before-available-to-the-public Low Glucose Suspend (LGS) feature. Essentially, when your CGM hits a pre-determined threshold, the new Med-T pump will suspend itself for two hours (or less, if you’ve recovered from a hypo event before the two hours are up).

This is a super development. It’s great that advances in glucose monitoring and insulin delivery and interaction between the two are making their way to the market.

Being the inquisitive sort, after I got excited about the news, I started asking myself questions. Five came to mind in about ten minutes. I don’t have answers to these questions. Maybe no one does. But since it’s my blog, I thought I would ask them here.

A couple of my questions came after reading a fine piece on the 530G at Diabetes Mine. They interviewed company officials and provided some information that I’ll be referencing here. If you’d like, feel free to read their story, then come back here.
http://www.diabetesmine.com/2013/09/new-medtronic-device-gets-fdas-nod-but-dont-call-it-the-veo.html
 
 
Now, the questions:

1. Who gets priority when the orders start coming in?
Will it be new Medtronic customers? Replacements? Upgrades? Influence-peddlers (bloggers, diabetes organization muckety-mucks, etc.)? In all honesty, this is kind of a non-starter for me, because a)There’s really no way for me to find out, and b)The supply will probably outstrip the demand for the product within the first year anyway. By then, we’ll forget how bad some folks wanted it right now back in October 2013.

2. In replacement/upgrade scenarios, what happens to used pumps?
I could (and should) have asked this long ago, but what happens to the old pumps? If the 530G is the greatest system out there, I certainly would like to upgrade. But if someone can’t do that, either because of cost or other factors, I would feel great knowing my Revel™ pump is still going strong, working its magic for another patient. Is that even possible? If not, will the pump’s material be recycled somehow? How does this work today?

3. New users of the 530G will work with a trainer, like they do when starting on other Minimed pumps. What kind of education will 530G users get?
I ask this question because while I was trained, I was not educated about insulin pumps and pump therapy in general before starting on my pump. I was good at getting my A1c down, but there was still a lot I didn’t know. Thanks to my fantastic endocrinologist, I was able to get up to speed pretty quickly. Still, I did not know what insulin on board meant until I read about it online. So theoretically, I could have had the 530G, stacked my boluses up to the ceiling one evening, had the threshold suspend feature kick in on my pump, and still had plenty more insulin acting in my system for a while. Without knowing what was happening to me or why.

I don’t want a new user of the 530G to find out about IOB the hard way like I did.

4. The Diabetes Mine piece mentions that the 530G will not communicate with Medtronic’s MySentry remote monitoring system because the FDA didn’t clear it to communicate wirelessly. Isn’t the CGM communicating wirelessly already? And why do they need FDA approval for something like that?
I remember being at the JDRF Research Summit in Bethesda, Maryland back in March. People working on artificial pancreas technology at the University of Virginia’s Center for Diabetes Technology presented, and among the things they revealed was a remote monitoring feature. Parents in attendance were super-interested in this, and they asked the presenters about whether something like that might be available soon. I remember the UVA presenters said that they didn’t anticipate rolling out the remote monitoring ahead of any device they might be working on. But they also said that they didn’t believe something like that needed FDA approval, because it wasn’t doing anything medical. It was just reflecting what was already going on with the AP system, and the remote monitoring itself wasn’t being used to make any medical decisions for patients.

And like I said above, the Enlite CGM will be communicating wirelessly with the pump already. Shouldn’t be too hard to get it to talk to the MySentry too.

5. Finally: What’s all this artificial pancreas posturing about?
You knew I would ask this, right? This is a little touchy for me. Rhonda at FifteenWaitFifteen wrote about being uncomfortable about this too. Medtronic, and by extension now, many in the media, are using the term “Artificial Pancreas” when referring to this system. The LGS feature in this system is very AP-like. But after seeing numerous talks about artificial pancreas technology, from more than one source in the past year and a half, I can tell you that the 530G is not an artificial pancreas device in the way I think of one.

Last time I checked, no one copyrighted the term “artificial pancreas”, so Med-T is within their rights to tout it as an AP device if they want to. But I worry about two things: First, will using the term with this device, which doesn’t have all of the features of artificial pancreas technology, cause non-D friends, family, and co-workers to think this is the holy grail, and now we shouldn’t have any trouble with our diabetes from here on out? Second, will using the term “artificial pancreas” like this eventually dilute the term for all of us, to the point where just a CGM that talks to a pump will be considered an AP device? We’re just now making big strides in technology that will benefit many with diabetes. When an outfit uses the term “artificial pancreas”, I don’t want it to be less than I’ve been led to believe it will be. Just my two cents. Feel free to disagree.

Full disclosure: Okay, half disclosure. I have a particular interest in this topic, especially right now, and I recognize that this may skew my viewpoint. More about that next week.
 
 
So those are my five (plus) questions on the Minimed 530G with Enlite. As with almost everything, time will probably provide the answers. Do you have any questions of your own? Have any answers for mine?
 
 
 

By StephenS | Posted in Diabetes | Also tagged , | Comments (8)

I’m going to be a guinea pig.

March 19, 2013 – 9:44 am

Well, not a guinea pig really… but I am going to take part in a clinical trial. Where did that guinea pig thing ever start anyway?

Sponsored by the National Institutes of Health (NIH), the idea of this trial is “to assess an investigational simulation-based educational tool for persons with type 1 diabetes”.

Since the trial hasn’t started yet, it’s probably easier for me to tell you what I’ll be doing rather than what it’s all about right now.

When the trial begins, I’ll be starting on a Continuous Glucose Monitor (known to most of us as a CGM). It will be the Dexcom G4™, and I’ll be wearing it every single day for several weeks. During most of those weeks, I’ll be sharing data with the research team on a daily basis. I’ll be telling them about my CGM trends, my insulin usage, my diet, my exercise, how I’m feeling… the whole nine yards.

The information I’ll be giving will be used to fuel an algorithm that will be used to provide feedback so patients can potentially adjust insulin intake or make other adjustments, if necessary, to achieve optimal target BGs in the future. I guess the general idea is to see if an idea like this will achieve positive results. In the end, researchers want to find out if this tool “can be useful in diabetes management with the artificial pancreas system”.

I hope that explanation made some sense, at least. I’ve read everything about it a couple of times, and I’m still waiting for it to sink in all the way. What I can tell you for sure is that I’m very much looking forward to potentially helping other Type 1s through my participation in this study. As I go through the different phases of the trial, I’ll let you know more.

I went for my initial medical screening last week. Not having done this before, I can’t tell you that they are all the same. But I will share my experience on this occasion.

In advance of my visit, I had to complete about six pages of paperwork. Everything from doctors and emergency contacts to all the drugs that I take. You know, the usual. I also had to detail my pump’s basal settings and my insulin usage over the previous week. There were some additional questions in there that I probably shouldn’t share—not because they’re particularly personal, but because of the proprietary nature of the study. Nothing too shocking though. I also had to make sure I familiarized myself with the Dexcom™ online tutorials, so I’d have an idea of what I was getting myself into.

After I arrived and handed over my paperwork, I sat down with the clinical trial coordinator and signed a few important papers, answered a few questions, and asked a few too. After that I had a question and answer session with the endocrinologist working on the study. I don’t want to give short shrift to this part of the screening… there are important parts of the study that they’re covering in these meetings, and I was giving them information that they would need to determine if I was even eligible to participate.

Once I finished these two sessions, it was time to get my blood drawn. Again. Two weeks earlier, I had donated blood. A week earlier, I had blood drawn at my endo’s office for lab tests. And now I had to get blood drawn again for the study. It turned out that my Hemoglobin A1c result was 0.3 percent higher than it was the week before. Still in the good range, but WTF? Maybe they just didn’t take the blood out of the good arm this time. Whatever that means.

Finally, I met with the principal investigator on the trial. I got a basic explanation of the tasks I was expected to complete for the study. And we had a brief discussion of what I can and cannot blog about regarding this adventure. One of my basic rules applies here: When in doubt, leave it out. I’ll tell you as much as I’m sure I’m allowed to tell you without compromising the study.

Not having worn (or even seen up close) a DexCom™ unit, I’ll be looking for some advice on best practices. Got any ideas? Think about it and get back to me, if you can. The study will commence in about two weeks. Thanks!
 
 
 

By StephenS | Posted in Artificial Pancreas | Also tagged , , | Comments (4)

#JDRFSummit 2013, Part Two.

March 13, 2013 – 9:51 am

DSC00615

There was a lot of information shared during the Summit last Saturday (don’t miss Part One), and not all of it was during the formal sessions. But I’ll begin with that, in the second part of the day, and cover some other things at the end. So if any of this starts to bore you, remember to check out the end of this post.

The second part of the day started with Roy Beck from the T1D Exchange. Roy is founder and Executive Director of the Jaeb Center for Health Research in Florida. Right now, T1D Exchange operates in three parts: A Clinic Registry, with over 65 clinics participating and 26,000 individual participants; A Biorepository, sharing and exchanging meaningful data related to diabetes; And MyGlu.org, which “is an active and diverse type 1 diabetes (T1D) online community designed to accelerate research and amplify the collective voice of those living with T1D”. Roy revealed some very interesting statistics that they’ve compiled from their participants. As in… All of the T1D Exchange participants were averaging home BG monitoring at least 5 to 6 times per day. But also in the data is the fact that none of the participant age groups had hemoglobin A1c results under 7.4. The numbers were better for those using a pump, but overall, they still averaged 7.4 or higher in all age groups. Wow.

To finish out the day were a couple of Andersons. Daniel Anderson, PhD, talked about new materials and drug delivery systems as they relate to possible islet cell encapsulation. The idea is not to create a little pancreas, but to create lots of little pancreases to start doing what the original gave up on a while ago. Drug therapy would have to come up with something that would keep the beta cells from coming under attack after the surgery to encapsulate, but still be able to detect glucose, and help foster an environment that would produce insulin.

Randy Anderson, PhD, provided a lot of detail about commercial development of drug/bio products to treat and possibly cure diabetes. He told us that there were 12 products related to diabetes in commercial development back in 2004. Today there are 94. He spoke about Roche’s Diaport idea. And his feeling is that the best hope in this area would probably be something called a Curative Hematopoietic Stem Cell transplant. His description kind of went over our heads at the table we were sitting at. Plus, we wondered about the availability of viable stem cells. But the ideas expressed were interesting, and I want to do a little more investigation about this.

Okay… Yesterday, I mentioned a few brushes with D-celebrities:

In the exhibit/vendor space, I came across Christopher Angell from Glucolift and his dad. Always ready with a smile and a handshake, I was happy to see they were doing well. But I need to remember to catch up to them early, before they sell out of everything.

I met Amy Ryan, who’s out promoting her book, Shot: Staying Alive With Diabetes. It’s the first D-book I can ever remember reading (other than one on my day of diagnosis– but that’s another story), and I’m enjoying it so far. There may be more in this space about it later.

I got an unexpected surprise in meeting Scott Strumello and Bennet Dunlap. They were in the exhibit space talking Diabetes Advocates, Diabetes Hands Foundation, and Friends for Life. Always nice to put a face with a name, and Scott asks great questions.

Oh, and I inadvertently got to meet Miss America 1999 and T1D Nicole Johnson, the event moderator. At the lunch break I realized I had left my meter in my truck. So I headed across the room since that was the general direction I needed to go. I stopped to say hello to Molly McElwee from the UVA Artificial Pancreas team, and then I turned and practically ran into Nicole. She said “Here’s a guy who looks like he knows what he’s doing”, and asked if I would snap a photo of her and a fan. So I did. I feel a little guilty about admitting this, but I sort of messed up the first one just so I would have to take a second:). Don’t ask me why I didn’t get a photo for myself. It just didn’t occur to me at the time.

All in all, a great day filled with lively discussion, some of it over my head at times, but nonetheless very enlightening. Also, the lunch talk with my table mates, who are parents of Type 1 kids, was worth the trip all in itself. It might not seem like it, but I’m hearing that T1D kids are growing up in the USA with increasingly less stigma tied to diabetes. In other words, while things are far from perfect, they’re living more normal lives than similar kids have ever lived. Here’s hoping their lives will someday include a cure for this curse upon us all.
 
 
 

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

#JDRFSummit 2013, Part One.

March 12, 2013 – 9:39 am

Saturday was a beautiful, sunny early March day. And I spent it inside, at the 2013 JDRF Type 1 Diabetes Research Summit. As I mentioned in last Friday’s post, it was a day filled with lots of discussion and presentations on Artificial Pancreas development, islet cell research, and more. Also, a few brushes with D-celebrities. Many thanks to the local JDRF people who made this event happen. I don’t know how you did it with so few volunteers, but it was great.

Diving right in…

We were welcomed by Tad Wood, Executive Director of Maryland’s JDRF chapter, and a wicked bike rider. Look for him at the ride for a cure in Vermont later this year. Our moderator throughout the day was Miss America 1999 and fellow T1D Nicole Johnson, who stressed how cool it was that there were so many families in attendance (there was a separate children’s program). She talked about our “AHA” moments, and I suppose there were more than a few for some at this event.

Bill Parsons, JDRF International board member and chief of staff to congressman Chris Van Hollen of Maryland, gave the JDRF “Less Until None” speech. The idea is to systematically remove the burden of diabetes until a cure can be found. That means making diabetes less of a burden for patients, less invasive, with less complexity. That would be nice.

Next up was the Artificial Pancreas team from the Center for Diabetes Technology at the University of Virginia. They covered a lot of the ground that I’ve already covered in this space (click here for more). What was really interesting to me were two things: One, I enjoyed looking around the room and watching the look on people’s faces when it clicked and they finally understood what all this Artificial Pancreas stuff meant. Two, the part about the remote monitoring that I wrote about in this post. When parents saw this, there was an immediate reaction. In short, parents want this like now. Later, at the question and answer session with the panelists, they were asked if they had contemplated releasing the remote monitoring prior to any AP approval. It wasn’t said, but I’m thinking this is not happening right now, even though it would be great. First, for it to work the way it’s designed right now, it requires an AP device, which hasn’t been approved yet. But, I’m wondering… could there be an app for that in the future? In other words, the CGM data uploads to an app on your mobile phone in real time, and the information is made available in a secure way through mobile technology. In theory, it sounds doable to me, but it would also require resources from the AP project to work on this piece alone. My guess is that JDRF is not funding something like that right now, but again, it would be great.

Also included was a talk from clinical nurse trial coordinator Molly McElwee, another Type 1 who spoke about her own experiences working on the project. She spoke about her worst day with diabetes (she described her talk as her own “Diabetes Naked”, in front of everyone). She took the low she experienced from that day, her pump and CGM data, and they put it through an AP algorithm at the center. In the algorithm, she would have received an alarm 37.2 minutes prior to hitting the 70 mg/dL mark, telling her she was trending down quickly. How cool is that?

Now, let’s get into islet cell talk. Chris Newgard, PhD, spoke with a great deal of passion about the research that’s being done to both discover why islet cells die in people with Type 1 Diabetes, and why it’s been so difficult to figure out how to successfully implant islet cells and make them expand. He feels they’re getting closer, and there are a few possible ideas being investigated. Including something that looks a lot to me like the BioHub thing that everyone was complaining about last week. I have my doubts, frankly… but even if islet cell transplantation or expansion of functional cells doesn’t happen, they’re still learning an awful lot about this important aspect of Type 1 Diabetes.

All right… I can see that this is getting long already. So there will have to be a part 2, hopefully tomorrow. So much to share with you.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (3)