No Shame

No Shame

As we noted just yesterday we aren’t thrilled with OneDrop’s marketing tactics. While OneDrop may use self-reported data combined with fuzzy math to come up with these outrageous claims their product does work and is FDA approved (the meter anyway). And while we don’t agree with what they define as a study there is enough empirical evidence to indicate that patients using the OneDrop system are benefiting from it.

Our problem with OneDrop isn’t that meter does not work, it does. Our problem isn’t that coaching and providing advice to patients doesn’t work, it does. Our problem with OneDrop is there is NO hard evidence to support the company’s outrageous claims about improvements in A1c. As we have stated consistently if this system is as good as they claim it is it should stand up to the rigors of a REAL clinical trial. There is no place for using self-reported data combined with fuzzy math when it comes to diabetes.

Although it seems incomprehensible OneDrop doesn’t hold a candle to another company when it comes to making outrageous claims supported by no real evidence. Meet the World Global Network a company which has a wearable device called the Helo. Recently several representatives of the company reached out to us as the Helo will soon … wait for it … measure glucose and will do so … wait for it … non-invasively.

Yes, wearables all the rage these days and that dead cat, which is taking a beating these days, cannot be swung without hitting one company or another developing a wearable that measures glucose. What makes this company stand above the rest, which is saying something, is it’s a complete scam.

Yesterday we spoke with two representatives from the company who noted that World Global Network is set up as multi-level marketing company. Or what we like to call a pyramid scheme. Now yes there are legit multi-level marketing companies, but World Global Networks is not among them. Yet what makes the company notably despicable is they are pawning off their device to patients with diabetes as a tool that can help them more effectively manage their diabetes. This is not just contemptible it’s downright dangerous.

When we asked if the company had any clinical data we got the standard we haven’t gotten that far yet answer. When we asked what technology this piece of junk was using neither representative was exactly sure that apparently is someone else’s department. So, we checked out the company’s web site which in turn redirected us to story that appeared on the NewsHub web site. Per the story;

“Final testing is underway for a wristband device which will be able to measure blood sugar without the need for finger pricking.

The Helo device, which pairs with a smart phone app, will set users back around $270.

The idea is that people with diabetes or pre-diabetes can monitor the effects their lifestyle choices have on their blood sugar.

The makers warn it’s not intended to diagnose or treat any diseases, and there’s still more testing to be done before it’s released later this year.”

We then started surfing the web and found an excellent article entitled “Wor(l)d International Review – Legit Company or Nasty Scam? Written by Jeremy Smith who has a blog which appropriately is called Mr. Smith goes into great detail and basically concludes what we concluded this company is nothing more than a pyramid scheme.

What’s truly sad here is that World Global Networks as despicable as they are do not stand alone in the despicable Hall of Fame. As we have noted over the years millions has been spent on the quest to develop a non-invasive glucose monitor. A quest which has now morphed into a searching for a non-invasive continuous glucose monitor. Which has now morphed into the quest for a non-invasive continuous monitor on a wearable device. As we said earlier that dead cat is getting a serious workout.

While there are far too many companies like World Global Network some very legit companies have joined in this quest. The most notable being Apple, yep the makers of all things way cool whiz bang have been working on a non-invasive continuous monitor which if you believe the reports will be contained on the way cool Apple Watch.

From what we have been able to learn the Apple effort is based on an old technology that doesn’t work. Some may recall a now defunct company called C8 Medisensors which back in the day claimed to have a non-invasive continuous monitor. A company which duped GE Health into investing $8 million into their effort. Yet like so many of these efforts the damn thing didn’t work, and the company eventually folded. Only to be resurrected when Apple bought up the technology and then hired some of C8 employees to spearhead their effort.

Using their vast resources Apple accumulated some additional assets and people. Who if you believe the reports coming out of the Valley are working diligently at a secret location on this quest. Which is somewhat ironic as Apple has been very public about their relationship with a real CGM company Dexcom (NASDAQ: DXCM).

So, let’s assume for a moment that Apple can do what C8 couldn’t and get the damn thing to work; what then? Considering that Apple as far as we can tell is a good corporate citizen we do not believe they will like others try and circumvent the FDA approval process.

Just to digress for a moment it just burns our ass that some companies believe they don’t need FDA approval as their toys won’t show a number only glucose trend information. That their toy since it won’t be used for dosing or treatment decisions they can circumvent the FDA. Listen this may be fine when a device is just counting steps, but this is diabetes we’re talking about. And you can bet the ranch some patient will use this unapproved device to make dosing decisions. This is just human nature.

Folks while we aren’t big fans of government regulations and we do understand that the clinical trial process is lengthy and costly but there are reasons these things exist. Can you imagine the uproar that would ensue if a patient died because they used one of these devices that was not approved by the FDA? Think of the lawsuits that would happen if a patient dosed their insulin based on inaccurate data from a device that had not undergone the rigors of the clinical trial process.

Ok rant over now back to Apple. Let’s say by some miracle their way cool whiz bang toy makes it through the FDA, what problem have they solved. Neither the FreeStyle Libre nor the recently approved Dexcom G6 require fingerstick calibrations so they cannot claim they have eliminated the need for fingersticks. About all Apple could say is their toy is wearable while the Libre and G6 are worn on the body. But is this really an advantage?

Keep in mind we are talking about continuous glucose measurement, what happens when the patient isn’t wearing their Apple Watch? Now we’re not sure but our guess is most people do not wear their Apple Watch 100% of the time. The device does need to be charged and let’s be real as way cool and whiz bang as the Apple Watch is people don’t wear it 24 hours a day 7 days a week 365 days a year.

Now this does not mean this toy could not be used as a supplement to a real CGM. Nor does this mean that patients who do not use a real CGM would not benefit from having this data. Yet as we keep saying getting the data is the easy part IT’S GETTING PATIENTS TO ACT ON THE DATA THAT’S THE HARD PART.

The saddest part of all is that no one seems to get past the toys in the toy chest. Everyone is fascinated by the technology. Yet no one seems to be able to get beyond what happens after the patient has the data, what then? To illustrate just how big of a problem this is try and think of this from the perspective of a patient with diabetes. Yes, we understand this is a unique concept but give it a try.

From the moment a patient is diagnosed their lives are turned upside down. They now have a chronic disease which they do not understand, didn’t want in the first place and requires a fair amount of work to manage properly. They are constantly being told what to do and when to do it. Yet they get little if any positive reinforcement for their efforts. Is it any wonder so many patients tune out and become disengaged?

Here’s the real kicker let’s assume just for a moment a patient uses the toy and in addition to gathering data it offers advice too. And let’s further assume the patient not only listens to the advice but acts on it. What then? Now some will say they will experience better outcomes which may be true but are better outcomes what matters to the PATIENT. Even if they do get under control this is only half the battle as once they get there they must STAY there. Think of it this way it doesn’t do anyone any good to lose 10 pounds only to gain back 15 after they go off their diet.

This is what no one seems to understand. Managing diabetes is a job most patients hate. Even those that attempt to do all the right things many end up tuning out because it’s just too much damn work and there are no tangible rewards that keep them motivated to continue working.

To us all this fasciation with the toys in the toy chest is just lots of white noise. It’s merely a distraction from the real and much bigger problem of getting patients not just insulin using patients at minimum semi-engaged with their diabetes management. As Momma Kliff used to say; “There are reasons why so many don’t want deal with the real problem, why it’s easier to deflect or divert attention away from what really needs to be done. Yet what these people ignore is that while it may be a tough task it will also be the most rewarding.”