Not an easy path
Diabetic Investor truly hates to rain on a parade but when it comes to developing a closed loop insulin delivery system it’s critical to separate fact from fantasy. On the surface it seems perfectly logical that a closed loop insulin delivery systems would be a major advancement in the treatment of diabetes, especially for Type 1 patients. Think of how much better it would be for all involved if all the patient had to do is calibrate the system and then not think about it. What could be better?
As Diabetic Investor has already reported on several flaws in this line of thinking but will add one more item for everyone to consider; actually we’ll add 6725 reasons to consider. According to the FDA’s press office “From the time period or 01 Jan – 21 Dec of 2009 we received over 6700 MDRs related to insulin pumps.” (MDRs= Adverse events reports) While searching the FDA MAUDE database, Diabetic Investor found another 25 MDRs related to continuous glucose monitoring systems over the same time frame.
It should be noted that the two critical components of a closed loop system are an insulin pump and a continuous glucose monitor. Now Diabetic Investor is not contending that all 6725 are system failures this would be a ludicrous statement. Even the best trained patients can have failures related to user error. However, the sheer number of MDRs should send a message to anyone who believes that the path to developing a closed loop system is an easy one. It should also send an even clearer message as to why the FDA is conducting a panel meeting regarding insulin pumps.
The simple fact is that all it takes is one failure with a closed loop system and you’ll have the worst MDR of all; death. As Diabetic Investor has previously reported we have already seen two deaths associated with Medtronic’s (NYSE:MDT) semi-closed loop system.
Keep in mind that Diabetic Investor is not necessarily against the pursuit of this dream. Theoretically it does make sense. The problem here is in theory you can it possible for an elephant to stand on card table without the table collapsing. The question is; is this really something we need.
So before everyone gets too excited and all caught up in this dream take a step back and ask yourself would you trust a machine with life and death decisions. Then ask yourself given what we know today would you invest millions to turn this dream into reality. This is not like the millions spent to develop glucose monitors, which has turned into a multi-billion dollar market. This is a market that even by the most aggressive estimates will peak at perhaps $3 billion worldwide. Does anyone really believe that the majority of insulin pump patients will actually use a closed loop system; because that’s what it will take for such a system to just break even.
The fact is the FDA is not even close to developing a regulatory path for a closed loop system, heck they can’t even get a simple glucose monitor to be accurate. What makes anyone think that the FDA can develop a reasonable path for a system that by its very design is making life and death decisions? Diabetic Investor can provide several reasons why not and now we know of another 6725.