If it walks like a duck, squawks like a duck – it’s a duck

If it walks like a duck, squawks like a duck – it’s a duck

For years the Holy Grail of diabetes devices has been the non-invasive glucose monitor. Inventors, investors and diabetes companies have poured millions, if not billions, of dollars into the quest. Like the quest for the actual Holy Grail, this quest has continued for years yet with no tangible results. To be fair not each attempt at this Holy Grail has been a scam designed to do nothing more than bilk investors out of their hard earned money. There are actually true believers who think one day we will have a commercially viable non-invasive glucose monitor that works. There are also people who still believe in Santa Claus, the Easter Bunny and the Tooth Fairy.

The constant theme throughout this quest has been the mistaken belief that the reason patients with do not test is the act of performing the test is too “painful.” In this respect this quest is not dissimilar to another equally futile quest, a non-injectable form of insulin. Like their non-invasive glucose brethren the non-injectable insulin believers claim the reason more physicians do not prescribe insulin and more patients do not use insulin is the “pain” of injecting. These two comrades part company as the non-injectable insulin companies have actually produced products that work; their problems are more related to commercial viability.

Another theme that has been consistent with the non-invasive glucose monitoring companies is their ability to constantly reinvent themselves. The path for a non-invasive glucose company is typically to state that they have some sort of whiz bang technology and that with a little seed money they will be able to bring this technology to market. When the money begins to dwindle they go back to investors stating that they are oh so close and just a few million more will get them across the finish line. Once the well has run dry, the reinvent themselves under a new name and start the process all over again. The reason they can continually bilk investors into giving them more and more money is the belief by investors that this technology will make them billions.

Yet every once in a while Diabetic Investor comes across a new company that has developed a new twist to the same old scam. Seeing the growing usage of continuous glucose monitoring (CGM) systems, we are now seeing companies developing non-invasive CGM systems. The theory is really no different than conventional single point monitors, in that, the so-called “pain” factor is present. These companies believe CGM would see even greater market penetration if the patient did not need to insert the glucose sensor under the skin. Also like other non-invasive attempts their exit strategy is the same as they too claim they will eventually be bought by a bigger player in the industry and therefore their investors will profit handsomely from their investment.

One company that fits this new twist on an old idea is C8 MediSensors located in San Jose, California. Diabetic Investor began looking into C8 after hearing about the company from people who attended EASD in Lisbon. The question, which we have heard several times in the past, is the company for real or just another ill-fated non-invasive company doomed to fail. We’ll we sorry to say that while C8 may be a new twist on an old idea, the results will likely be the same and this will just one more company that tried and failed.

Just like others in this space C8 believes it has whiz bang technology, Raman Spectroscopy. Which according to their web site;

“If light of a single wavelength (single colour) illuminates a sample, molecules in this sample may reflect, absorb, or scatter the light in some way. A very small number of the incident photons will cause the molecules to vibrate when scattering off of them. The light will lose some energy during this interaction, which causes it to be scattered with a different wavelength, or colour. This is known as the Raman effect.

Raman scattering is a very weak effect, it cannot be seen with your eye or detected with a common digital camera. Only about one in 100,000,000 incident photons of light will produce a single Raman-scattered photon. The other 99,999,999 photons interact with the sample in other ways, generating a large amount of light that must be eliminated from the measurement in order to accurately measure the Raman signal.

The colours generated by Raman scattering are very specific to the exact chemical structure of the molecules in the sample. The molecules’ various shapes, sizes, atoms, and types of chemical bonds will generate unique Raman spectra that may be used to identify the specific molecules present.

Glucose is a relatively large molecule that can vibrate in many different patterns, each of which can cause Raman light to be generated at different colours. This unique spectral “fingerprint” can be used to non-invasively measure how much glucose is present beneath the skin.”

While that sounds pretty cool the fact is the technology doesn’t work all that well. A fact acknowledged by a paper sent to Diabetic Investor from the company itself. The paper called “Requirements for Calibration in Noninvasive Glucose Monitoring by Raman Spectroscopy” was published in the Journal of Diabetes Science and Technology back in March 2009.  Here is what one of our experts said when we asked about the paper and an investor presentation sent to Diabetic Investor from the company;

“A mean absolute relative difference (“MARD”) of 38% means that the average reading is off by 38%–not bad at 300 mg/dl, but devastating at 100 mg/dl and potentially lethal at 65 mg/dl—the average reading with a true value of 65 would be anywhere from 35 to 95 mg/dl—and this is just the average error (MARD is given as mg/dl, 30 in this case, for glucose values under 100 mg/dl; the percentage error of 38% is used for values above 100 mg/dl). They also don’t describe how complex the calibration procedure is or how long the calibration holds before needing to be repeated.

The newer data set they included in your presentation has few details about how the data were collected, and almost all the points are between 70 mg/dl and 250 mg/dl. They mention a measurement exposure time of 5 minutes—that’s incredibly long, and I’m sure any movement at all during that time would degrade the results. I don’t think the new results are from clamp studies—they mention in the 2009 paper that those are the only ones that count.

This level of accuracy has been achieved many times in the past—Sensys generated investment of over $100M in 10 or 11 rounds, but never got beyond this level. Even when they tried to include “wearable devices” (something glued onto the arm to locate the sensor at the same place). InLight stalled at the same (or slightly better) level of accuracy after 20 years of investigation by some of the brightest people I’ve ever met. The amount of money raised is not an indication of the quality of the science, but of the ability to make presentations and tap dance for investors.” (Highlighting added by Diabetic Investor)

When we went back to the company to see if they had done any clinical trials to back up their claims, we got the standard “of course we have and you’ll see that data real soon and it will blow you away.” If we had a dollar for every time we’ve heard that we wouldn’t have to charge for Diabetic Investor and could give subscriptions away for free. This is like saying the Bears played a pretty good game on Sunday even though their offensive line was terrible, their offense looked totally out of sync and they kept taking stupid penalties – if it weren’t for that and the fact they lost game it really wasn’t all that bad. Or as a good friend of Diabetic Investor likes to say; “Other than the fact your husband was shot, did you like the play Mrs. Lincoln?”

Another red flag is that company is claiming that they have raised $30 million from individuals, private equity firms and family offices, they could raise a few million more but that should be enough to get them all the way to approval in Europe. Again something we have heard too many times in the past and another lie as these companies are also very consistent at always going back for money.

Now we suppose it is possible that Diabetic Investor is all wrong about C8, although we have yet to interview any industry expert who disagrees with our view, and that their technology is really as great as they claim it is and that this yet unpublished data from their clinical trials really will blow everyone away. However the more we investigate, the more digging we do the more we don’t believe C8 passes the smell test. It may be a new twist on an old scam but to Diabetic Investor if it walks like a duck, squawks like a duck – it’s a duck.