Who’s kidding whom?

Who’s kidding whom?

Yesterday the Juvenile Diabetes Research Foundation (JDRF) announced that a clinical panel had recommended the next steps for testing an artificial pancreas. According to a press release from the JDRF; “Diabetes experts at a meeting convened by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took the next step in advancing efforts toward the development of an artificial pancreas: putting forth clinical recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations.”

Many believe that Diabetic Investor is somehow against the development of an artificial pancreas, a belief that is misguided but understood. Since this project was announced Diabetic Investor has pointed out the numerous hurdles that must be overcome to achieve this ambitious project. We have noted the many failings with current insulin pumps and continuous glucose monitoring systems two critical systems for the artificial pancreas. While insulin pumps and CGM has improved dramatically, neither technology has reached a leave that would place control of the patient’s life in the hands of a very sophisticated piece of technology.

We have also noted that such a system as advanced as it would be would also be very costly.  It’s questionable to believe that insurers would provide reimbursement for a system that is likely to cost somewhere north of $10,000.

There is also some question if such a system is even needed. The simple fact is tight glycemic control is being achieved today using existing technologies. Technologies which are controlled by the patient, that do not leave life altering decisions up to a machine.

The reality here is an artificial pancreas is something that would be nice to have but not the game changing technology some think it is.

Given current events there is also another reason to doubt the future of this project. Is there anyone in the diabetes space who seriously believes the FDA has the capacity to approve such a sophisticated piece of technology? This is an agency that can’t even tie their own shoes let alone deal with the multifaceted issues facing an artificial pancreas. Has anyone at the JDRF, a great organization, asked their experts what it is like to deal with an agency where the rules change minute by minute? Is the JDRF aware of the furor over the new 510K process? Are the millions being spent on this project, which even if approved, would only be used by a handful of patients, really worth it? Or perhaps a better question is- are there not more pressing issues that need to be addressed that would benefit a greater percentage of patients?

The stark reality is the diabetes device world continues to be obsessed with whiz bang technology while ignoring market realities. Although the current crop of diabetes technology is not perfect, it is far better than what it was ten or even five years ago. Glucose monitors are more accurate, require smaller blood samples, deliver results quickly and communicate with the patient’s computer. Insulin pumps have become smarter, more reliable and also communicate with the patient’s computer. Same goes for CGMs. It is not an overstatement to say that patients have access to some of the greatest tools to help them better manage their diabetes.

Still even with all these great tools one fact remains unchanged as nearly two-thirds of all patients are not properly controlling their diabetes; a fact that won’t change with the introduction of an artificial pancreas. The problem is not a lack of technology; the problem is getting patients to use available technology effectively.

As we noted yesterday this fascination with whiz band technology is a one reason so many companies are pursuing the mythical non-invasive glucose monitoring system. While it was not mentioned yesterday another reason such a system would not have a material impact on patient outcomes is the simple fact that for the majority of patients they have no idea what these test results mean or how to apply the results so they more effectively manage their diabetes. Invasive or non-invasive really does not matter when the patient does not value the information provided by the test.

The bottom line here is that it is actually easier to develop whiz bang technology than to teach patients how to effectively use this technology. Companies have no problem spending millions on developing this technology but ask them to spend a fraction of this amount on patient education and you would think you where asking them to climb Mount Everest blindfolded. Never mind the mountain of data which clearly states that education is the most effective tool for achieving better patient outcomes, nope let’s spend even more millions on technology  a mere handful of patients would use or understand.

One just might think these experts would speak up, no correct that, that they would scream at the top of their lungs, that some money, any money for that matter, be put towards patient education rather than another piece of super-duper technology. That companies in the diabetes device world who are seeing their margins erode and usage decreasing would spend some bucks on educating patients who armed with this education would actually use more of the products they make. While Diabetic Investor is not aware of any study looking at the impact of pretty colors and glucose monitoring, we’re confident testing has not increased because the patient’s glucose monitor looks pretty and matches their attire.

Diabetic Investor is all for better, more patient friendly technology, however this great technology is worthless unless the patient understands how to use it to more effectively manage their diabetes. The unfortunate fact is no one, no one so far anyway, is willing to acknowledge the 800 pound pink elephant in the room and embrace patient education. As John Locke wrote; “A great part of mankind…. unavoidably given over to invincible ignorance.”