The Big Con

While Dexcom (NASDAQ: DXCM), Abbott (NYSE: MDT), Medtronic (NYSE: MDT) and a host of others battle it out in the expanding CGM space many investors are looking beyond diabetes as growth area for CGM. Although CGM usage continues to expand with patients with diabetes already investors are looking at other applications outside of diabetes. These investors see big dollars should patients who do not have diabetes begin to use this technology.

The area outside of diabetes that garners the most attention is using CGM as a weight loss tool. Needless to say, should it be proven that CGM usage helps people lose weight this opens the door to a huge, excuse the expression, new market. Many believe this is why companies like Apple and FitBit are investing heavily in CGM technology as they are looking beyond the diabetes market.

The general belief is non-diabetics when they see the impact of their food intake will make changes to their diet. Sure, most people know its not a good idea to eat fast food everyday or gobble down bags of snacks, but they have never seen how these foods impact their glucose levels. As one highly respected diabetes researcher, who does not have diabetes but was wearing a CGM, said to us once he’d never eat a baked potato ever again after seeing the impact it had on his levels.

This has led many to believe that these devices which are intended for people who do not have diabetes would not have to go through the rigorous and costly FDA approval process. That they do not have to be as accurate as CGM used by patients with diabetes as no dosing decisions will be made from the data. That this data will merely be used as discovery tool for non-diabetics.

This is where things get a bit tricky as just how accurate is accurate enough for non-diabetics? What stands in the way of a diabetic using one of these devices even though it has not been approved by the FDA and then using it to help them manage their diabetes?

Some believe these devices intended for non-diabetics wouldn’t show any numbers. Rather they would show how often a person is in different zones – think red for bad green for good and yellow for neutral. Too much time in the red zone would mean a diet too heavy in carbs and therefore adjustments should be made. Of course, it goes without saying that these devices for non-diabetics would come with apps which collect and interrupt the data.

Still many in and out of the diabetes world believe should these devices come to be, and should the FDA fail to step in it opens a Pandora’s box of problems. Rather than get into all the issues being debated we have a simple solution, ignore the debate and go with the established players in CGM. The fact is the shortest distance between two points is a straight line and the shortest distance between expanding CGM usage beyond diabetes is to change current FDA approved technology.

Now some will say that current CGM systems cannot be adapted to new applications because they are invasive. That since sensor must be inserted into the body non-diabetics won’t use them. Hence the reason the Holy Grail in sensing has been updated to non-invasive CGM. But just as the non-invasive argument didn’t hold water with BGM it will not hold water with CGM either. The fact is, and yes, we realize that facts get in the way sometimes, the newer CGM’s and future versions under development make this a moot point. The FreeStyle Libre and the coming slap it on turn it on system from Dexcom prove this.

As we keep saying in the future none of these systems will require calibration, all will send data to a smartphone and all will come with apps that collect and interrupt the data. Let’s be honest Dexcom working with their partner Google could easily develop an app for people who do not have diabetes, the same goes for the folks at Abbott or Medtronic. Using a CGM for weight loss is not that different than using it for diabetes, this is not about getting the data. This is all about getting the user to understand the data then act as a result.

But as always everyone is fascinated with the toy and not how the toy is played with or even if its played with. They see non-invasive as the ultimate in way cool whiz bang yet fail to understand that invasive or not this isn’t why people don’t use these toys. To their credit they see how big this market could become and how it easy it could be to expand usage beyond patients with diabetes.

Yet like so many who have come before them they believe in technology which looks good on paper but won’t work in the real world. They have failed to do their due diligence falling for the fancy PowerPoint presentation rather than doing any real research. They think if enough money is thrown at a problem it will fix that problem even though with non-invasive some problems just aren’t fixable no matter how much money is thrown at them.

Apple has fallen into this trap as has FitBit. This in turn has spawned a collection of copycats who see easy money since the Big Boys in the Valley have opened their wallets. Yep, you can’t swing a dead cat these without hitting yet another start-up that has a way cool whiz bang non-invasive CGM under development, most likely a wearable, who’s out swindling money from unsuspecting investors. The only difference between these guys and their forefathers is in the old days it was non-invasive BGM today it’s non-invasive CGM.

The reality is this is an old con just with new technology.