October 19, 2011

Artificial Pancreas and Egg Baskets

A friends asked this about the artificial pancreas (AP):

I have noticed over the past few days a lot of interest in the Artificial Pancreas project, the FDA and an online petition.  
I know nothing of the project beyond the controversy it caused when the JDRF supported it and people felt that money was better spent on a cure rather than technology.  
From what I have seen, and again, I need to do a lot more research, this will be a tool-a more advanced pump if you will.  If this is correct, are we looking at a tool that will only be available to those that can afford it or will it be looked upon as similar to a pacemaker for a heart patient?  
In Canada, we are still fighting to have insulin pumps covered in all provinces for all ages.  Very few have coverage for CGM.  How will the masses therefore afford to have access to another device...unless this is something for the masses again like an artificial limb or pacemaker. 
Please feel free to email me direct if you can help me to better understand this rather than clog up the list.   I don't mind standing behind something if I feel it will make a real difference.  At the moment, I am just not sure I understand the planned way forward with this. 

This was my response: 

There are a number of approaches to AP. Some use just insulin others, I think a study at Boston University uses something to raise BG as well as provide insulin. If you get the chance, go to a JDRF technology meeting. The Capital Chapter ran a great one last year. You will see AP is part, but by no means all of the story of making living with diabetes better.

You are correct about the tools involved - CGM and pumps. There is wide appreciation that improvement is needed in both sensing and insulin delivery. Faster insulins and better pumps sets. The benefits of those would also improve care outside of AP. Faster insulin would be good for everyone, better sets and sensors would benefit those who use pumps and CGM without AP. 

AP then is an set of algorithms, or an application if you will, that manages BG with the pump as measured buy the sensor. It certainly will be costly to develop and more so to get approved, particularly as there are currently not guidelines to get it approved. (in part this relates to the recent conversations about Low Glucose Suspend (LGS) and apps.) In fact LGS is a stepping stone to AP in that it does one AP function, stopping additional insulin with low BG. 

You are correct in noting AP is concerning to some. It is worth noting that JDRF's investment in AP is small compared to to their other research initiatives. I don't have the current numbers percentage numbers. 

I think you are legitimately concerned about costs and reimbursement. My good friend Scott Strummello often expresses the same concern. I think that AP will need to demonstrate effectiveness before insurance will cover it. To do that it will need to be approved by the FDA and tested, to be approved it
needs to be invented and go through trials. That is a lot of steps. 

Glucose responsive insulin (GRI) would make AP mute. I think GRI may be even more distant down the same path of discovery and approval as AP. Still one could argue that GRI is a better solution than AP and that it should be the focus. Others can rightly point out neither is a cure or a sure bet. 

I believe that better is better and perfect should not be the enemy of good.
So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I fairly sure none of it will make diabetes care easy but it may be less hard and that's better. 

I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. Any one approach to making diabetes life better may fail. Most pharma development projects start with promise but don't make it to the market. So to make life better for people with diabetes a lot of different approaches need to be tried. It is in that context that I think JDRF GRI x-prize like initiative is a good idea even after the support they have put into and the promise that is still expected from SmartCell's Smart Insulin that Merk bought. 

Let me know if this helped any. 

You can learn more at the JFDR AP website: http://www.artificialpancreasproject.com/

Share you support for the AP initiative at this online petition


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