Tuesday, November 15, 2011

My take on the Artificial Pancreas Project

The other night we sat in on a lecture about the Artificial Pancreas Project.  In all honesty, I have paid very little attention to this project. I heard the hub-bub when the JDRF announced that they were funding research that was not cure based.  I have seen the online petitions asking for the FDA to move the project along a lot faster. Other than that I have been fundamentally ignorant.

I have however slowly worked to educate myself whenever possible.  I had many concerns about the project and looked forward to learning and seeing if my fears were founded. Sadly I think that they are.

Dr's. Anhalt and Krishna (his first name but his last name is far too long and complex for me) explained that the project had many levels.  They were working on simply suspending insulin during a low and ultimately reaching the point where they could truly close the loop.  Their main focus at the moment was to see a viable product on the market sooner rather than later (within 4-7 years).  The bringing together of glucometers, CGM, insulin pump technology and human intelligence was a huge obstacle.  These things work fabulously apart but bringing them together brought many new issues. To make matters more complex, regulatory bodies have never before been asked to rule on the safety of medical devices that make decisions like this one will.

For me, one of the obstacles to an Artificial Pancreas as I envisioned it was the number of sites and devices that one had to carry and use.  I asked how this was to be handled.  They stated that it was a real challenge. You cannot get down to only one site (which my son would want) because you cannot deliver insulin and measure glucose levels in the same area. They would work towards one device but felt that the loop may never truly be closed.  It was also stated that artificial intelligence would not be put into the system in the foreseeable future. 

Another issue is in the fact that sensors lag behind in what they say the blood glucose level is.  Insulin lags behind in its action time.  There is no way, at the moment to get immediate results to immediate problems. We need more accurate and timely sensors as well as faster insulins. To date there is only predictions and educated guesses.  This is very concerning to me. 

Larry voiced his concerns as well. At the moment we are talking about devices "talking" to one another.  We have so many devices that we use on a regular basis, how could we be guarenteed that they would not interfere with one another? He wondered how my son could sit in his room with his cell phone, his laptop, his XBox head set, his pump, and his CGM and not have any of it interfere with each other.  We were told that this was a real concern.  At the moment they were working to secure specific radio frequencies to ensure that there would be no interference but we still had worries.

My final concern, and the concern of many others in the room was cost.  This is a huge project.  The actual dollar figures were not available but we all knew that it was way more than what we had in our pockets. Some of the cost of the project will most likely have to be recouped in sales at a later date. Would the Artificial Pancreas then be out of reach to those who need it most? 

We were assured that the JDRF in the US was working with insurance companies so that when the product did come to market, they would cover the device.  This does not help those of us in Canada.  Our system works differently and while it is important that private insurance companies are onside with this device, it is even more important that provinces recognize its value.  Who will be working on that angle? Currently we are asking our governments to cover the pieces--pumps, glucometers, CGMs and supplies.  Will they cover the Artificial Pancreas when it comes to market? We can hope.

While there are many issues to be overcome, the project does have some positive points as well.  Moving forward with sensor technology will hopefully provide us with more and better data on blood glucose trends. This data can be used to keep A1c's down and reduce the chance of complications.  These same sensors can ideally act as our watchdogs at night.  They can wake our children or ourselves when a blood glucose level is rising or dropping to a dangerous level. That is one thing that would help this mother sleep a lot easier at night. Now to just convince my son that this would be a far better system than him building me a room in his house!

1 comment:

  1. At this point I would be satisfied to have the VEO pump in the US because, for those who can tolerate wearing the Minimed sensor, it would turn off for a couple of hours when one's blood sugar hit fifty. That alone could save lives. However, I do not think the Minimed harpoon... er... sensor is for the faint of heart. If the sensor companies were truly interested in saving lives, they would have the option to make the alarms long and loud. Currently, without either a baby monitor or a Radio Shack mike, few can hear the alarms. Next on my list would be a pump that would deliver insulin when blood sugars are very high, but I would not want the pump correcting to target. For safety's sake, I would like the pump to correct to about 170 in the event of a very high blood sugar. This will leave a little room. While still high, the pt will not be extremely high. What I really want, though, is a more carefree future for our child. To that end, I would prefer something like SmartInsulin, glucose responsive insulin to loading her down with three devices, pump, sensor and computer. I don't even think she would use the AP if it were available. But for those who would use it, I would like to see it come to market.