A long strange trip
This morning Senseonics (NYSE: SENS) announced they have received a date from the FDA for a panel review of their Eversense implantable CGM. Per a company issued press release;
“Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of Eversense®, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced the U.S. Food and Drug Administration (FDA) Clinical Chemistry and Clinical Toxicology Devices Panel is scheduled to review the premarket approval application (PMA) for Eversense on Thursday, March 29, 2018.”
So once again the diabetes device world, the toy markers, will gather in Maryland to discuss the merits of yet another toy. Please understand we have nothing against the good people at Senseonics as we do believe the panel will recommend the Eversense for approval. From what we have seen the Eversense system does a fine job.
This news however did bring back memories to another important date in diabetes device history December 6, 1999 for that was the day for another FDA panel only back then it was for the GlucoWatch. Now since that was some 17 years ago some may not remember the GlucoWatch or it’s company Cygnus. An understandable situation as neither is still here. But back in the day Cygnus had the coolest toy in the toy chest with the GlucoWatch.
While the FDA did end up approving the GlucoWatch the device had a slight problem; the damn thing didn’t work all that well. However as so often happens in our wacky world the GlucoWatch approval did lay the groundwork, established a path so to speak for others to follow. We would go as far to say that the current day CGM systems each and every one of them owes a debt of gratitude to the folks at Cygnus as they would not be here had it not been for the company.
The GlucoWatch story is also the perfect example for what we say all the time, anyone can build the damn the toy, yet it takes real talent to run a commercially viable toy company. Back in its time the GlucoWatch like so many of the way cool whiz bang toys we have today was all the rage. Although blogs had not been invented yet, which tells how long ago this was heck people didn’t have smartphones back then, the diabetes press with the notable exception of yours truly was fawning all over the GlucoWatch.
Yep the GlucoWatch was going to revolutionize glucose monitoring, the days of conventional fingerstick monitors were over. Not only did the GlucoWatch measure glucose non-invasively it measured glucose continuously, something that was unheard of back in 1999. Like so many of the way cool whiz bang toys we have today no one, other than yours truly, did much due diligence. As so often happens in this space the analysts and reporters ate up what Cygnus was serving without doing much independent thinking.
Cygnus like so many of today’s whiz bang way cool toys was also an example of how a company could raise millions of dollars with an excellent PowerPoint, yes, we did have computers back then, then go public and raise even more money. Now never mind that even if the GlucoWatch worked well, which it didn’t, it faced several very real obstacles. Nope just as there are companies who think patients will pay $300 for a “smart” insulin pen today, back in the day many believed patients would pay out of pocket for the way cool whiz bang GlucoWatch.
The GlucoWatch also illustrates why manufacturing process is so important, the ability to consistently manufacture on a massive scale. For this was another problem as the damn thing kept failing. Listen it’s one thing to ask patients to dish out money of their own pocket, it’s even worse when after they done this the damn thing doesn’t work and then replacement sensors don’t work either.
Now keep in mind this way back in 1999. A time when BGM companies were racking in the cash. A time when insulin pumps were new. A time when there was no such thing as interconnected diabetes management (IDM), there was but back then it was called disease management and instead of messages being sent to a patient’s smartphone, someone called the patient on a ….wait for it …. land line. Yikes.
Just in case anyone is wondering why we’re taking this trip down memory lane well as Norman Cousins once said; “History is a vast early warning system.” Or as someone once said, “Every time history repeats itself the price goes up.” Today millions are being invested in way cool whiz bang toys. Millions more are being invested in interconnected diabetes management. Yet after all these years and the millions invested nothing much has changed.
The reality is, yes, those pesky facts again, most patients still are not achieving good control. Even with all these way cool whiz bang cloud enabled toys. Even with all the new drugs that have come to market since 1999.
You would think by now the folks in this wacky world would have learned something. You would think that maybe just maybe they would realize diabetes management isn’t about the toys in the toy chest. It’s not about the drugs available to treat diabetes. It’s not about giving the patient the how to. That when it comes to diabetes management it’s all about getting patients to have the want to.
So were very happy for the folks at Senseonics, heck we’re thrilled for all the toy makers and their way cool whiz bang toys. Yes, this stuff is way cool and whiz bang. And yes, if the toys were played with a patient could benefit. But this isn’t and never has been about the toys in the toy chest. This is all about not just getting patients to play with the toys but play with them continuously.
Simply put diabetes management is all about putting the patients first and yes, it is that simple.