A valuable history lesson

A valuable history lesson

A day doesn’t pass when we don’t hear of yet another wearable device that ultimately could measure glucose levels. Prior to the official launch of the greatly anticipated Apple Watch speculation was rampant that the watch or future versions of the watch would contain a sensor that measures glucose. While we know Apple has looked into this technology we also know that given a glucose sensor would have to be approved by the FDA, the company put this idea on the backburner- at least temporarily.

Yet Apple isn’t the only company looking into this technology as nearly every wearable company sees the possibilities. In theory a wearable device that accurately measures glucose levels would be a major breakthrough and not necessarily because patients would not be required to perform a fingerstick. The true benefit here is not that glucose would be measured non-invasively rather that a patient’s life would be made much easier.

One of the things we have learned from continuous monitoring systems is that patients using these systems don’t necessarily mind that the sensor is attached to their body as they truly value the information these devices provide. Would it be more patient friendly if this data could be gathered with a wearable device; absolutely. However the fact that CGM usage has been steadily increasing shows that the real value is the data these systems provide. Still the possibility of gathering this data from a wearable device is enticing.

Believe it or not such a device actually existed, yes an honest to goodness wearable device approved by the FDA and brought to the market. Yes way back in 2002 Cygnus, Inc. launched the GlucoWatch a device which measured glucose continuously and non-invasively. While many hailed the launch of this product as a watershed moment in diabetes device history, the GlucoWatch was a commercial failure. For all the promise and hype the GlucoWatch never meet the lofty expectations expected and was eventually sold to Animas, now a unit of Johnson and Johnson (NYSE:JNJ), in late 2004 for $10 million.

How could it be that such an innovative device failed? Was this not the Holy Grail of diabetes devices? Is this not the device that everyone said would revolutionize diabetes management forever? Wasn’t this the device that patients would buy no matter what the cost or whether or not it was reimbursed? After all this was non-invasive glucose monitor, one that was actually approved by the FDA.

While there are numerous reasons why Cygnus failed the most glaring issue was this way cool very innovative revolutionary device didn’t work. Yes we know that it made it all the way through the FDA and onto the market but the fact remains that when put into a real world setting patients hated the damn thing. Never mind reimbursement issues, which did exist. Or issues with getting device onto formulary, which also existed. Forget about the difficultly the company making the device. When looked at realistically the major reason the GlucoWatch failed can directly be tied to the fact it didn’t work.

The honest truth is all the non-performance issues associated with Cygnus and the GlucoWatch would have been solved had the device worked. That some company would have come along, bought Cygnus, solved the non-performance issues had the device actually worked as intended. Yet as we have seen time and time again in the non-invasive world it’s one thing to get the device to work in a clinical setting; it’s a whole different story getting such a device, even one approved by the FDA, to work in a real world setting.

This is why Diabetic Investor continues to view all these wearable devices with a great deal of skepticism. Yes there is a need for such a device but the hurdles at getting such a device to work consistently in a real world setting are enormous.

Frankly one thing Diabetic Investor isn’t worried about is all the non-performance issues such as getting the device covered, formulary placement, manufacturing, etc. Not because these non-performance issues are not important, rather the companies in this space have tons of money. This honest truth is should any company solve the performance problem the rest of what they need could either be built or acquired.

Consider that Apple, Google, Samsung, Facebook and Microsoft besides being deep in this space also have cash to burn. Yet even with their vast resources the one thing they cannot buy is a product that actually works. Think about that for moment. Cygnus was founded in 1985, the GlucoWatch was approved in 2001, launched in 2002 and sold to Animas 2004. Fast forward now to 2015, 11 years after the GlucoWatch was sold to Animas and ask are we any closer to having a wearable device that accurately measures glucose levels. The honest answer is a resounding no.

This is the reason Diabetic Investor views this race to develop a wearable device that accurately measures glucose levels as almost an unwinnable race. That after years of research and millions of dollars spent we are still years away, if ever, from seeing such a device. Which begs the question is it now time to look for alternate solution.

What many seem to forget is that interconnected diabetes management (IDM) will only be as good as the sum of its parts; should any link in the chain fail the entire system fails. While the current systems that gather and transmit glucose may not be ideal for the most part they do get the job done. Does this mean that somewhere out in this wacky world a major breakthrough cannot come to fruition? That with all the man hours and money being thrown at this problem that a solution is not possible?

Frankly Diabetic Investor doesn’t have a clear answer to these questions. All we do know is that to date the no one has solved this very complex puzzle.

This is another reason why we use history as our guide. As Laurence Peter noted; “History teaches us the mistakes we are going to make.”