Last week, we heard about Google's attempt to measure glucose levels through contact lenses. Now imagine being able to check your glucose levels just by sticking a thermometer under your tongue for a few seconds.
Believe it or not, there's a new company on the scene working on a diabetes device that would use nothing more than a bit of your spit to take a glucose reading.
It's called the iQuickIt Saliva Analyzer (that's a mouthful!) and it's in development by Connecticut-based health startup Quick LLC, founded by two ER doctors and a diabetes specialist in that state.
Interest in non-invasive glucose testing has peaked recently among the public at large with the news of Google's contact lens project and persistent rumors that Apple's still working on a smartwatch that could that could monitor and display health sensor data including BG levels. And while many in the D-Community take news of new "pain free" testing methods with a grain of salt, it's always interesting to see new ideas surfacing.
Here's the skinny on this latest saliva-testing concept:
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Essentially, it would work in the same way a traditional blood glucose meter does. You'd have a strip that you would put the sample on and insert into a little white meter device, and that would produce a result you could to share with your smartphone or tablet using wireless technology. The difference is: saliva, not blood. You'd place the one-time use strip (called a Draw Wick) into your mouth for a few seconds to obtain a small saliva sample, and then you'd place that strip into the handheld iQuickIt Saliva Analyzer for the glucose reading.
Like many developing non-invasive diabetes devices, the brains behind this iQuickIt Analyzer believe it has the potential to "revolutionize diabetes care." Of course they think so. They're excited, as they should be. But buzz only takes you so far.
Here's the promo video (skip to about 1:58 to bypass the corny intro and get to the description of how the product works):
The minds behind this saliva analyzer are Dr. Ron Clark, the son of a type 1 diabetic who came up with the idea with another Connecticut physician, Dr. David Mucci. They saw the need based on their work in emergency rooms, and felt traditional fingerstick blood tests were a barrier for many in maintaining the best possible diabetes care. So they set out to create a better option -- and this iQuickIt Analyzer is what they've come up with. It's been in development since mid-2012.
Research shows there is a relationship between blood glucose and saliva, and interestingly it's been on the radar as a glucose-testing option going back to the 1930s when researchers first learned that tears contained glucose. But it didn't come back into mainstream consciousness until the 60s, when Eli Lilly learned that it's urine-testing Tes-Tape was turning positive from the fingertips of PWDs and they rediscovered that glucose was found in blood, sweat, tears, and even saliva.
With the many attempts at non-invasive monitoring over the years, this isn't the first saliva-testing method that's been tried. Some have failed and vanished while others are still being explored, notably at Brown University in Rhode Island and at Purdue University in Indiana (my state!). According to Clark and his team, the technology has reached a point where the past barriers of accurate calibrations and measuring saliva glucose are no longer as impossible to get around as they once were.
That Accuracy Thing
OK, this sounds cool -- but the big question as always is: How accurate will this saliva method be?
Clark says initial research shows the iQuickIt meter is "comparable" to the accuracy of traditional fingerstick meters on the market. With additional clinical studies, he's hoping to hit an even higher level of accuracy.
Mucci says they're looking closely at the question about how food or contamination in the mouth might impact accuracy of the saliva test. He says his team does not believe there will be a need to rinse your mouth out with water before testing, but there will probably be a need for "saliva testing guidelines," since their focus group research so far shows that many PWDs won't do a BG check once they start eating and have food in their mouths. Mucci and Clark hope that many questions will be answered by their clinical trial results, which should be ready by mid-2014.
The third co-founder is entrepreneur Scott Fox, who's serving as CEO, and there's another well-known name from the diabetes community who's part of this startup venture too -- Dr. William A. Petit Jr., who's a partner on Quick's medical team and is former medical director of the Joslin Diabetes Center at the Hospital of Central Connecticut (an affiliate of the big clinic in Boston).
Petit hasn't practiced medicine since 2007, the year he went through an incredible horrible family tragedy (his wife and two daughters were murdered in a break-in) that led to him create the Petit Family Foundation, a philanthropic organization that funds projects in education, chronic illness, and helping those affected by violence. His name has also been bantered around recently to possibly be in the running for a U.S. Congressional seat. In talking publicly about the iQuickIt Analyzer, Petit said he signed on with the startup "because it's an opportunity to be involved with something that could solve the long-discussed problem of how to make it easier to measure glucose levels in diabetes patients." He's also friends with president and CEO Scott Fox, who pitched him on the idea "over the course of a number of rounds of golf," according to newspaper reports (ugh, what a stereotype!).
On Timing & Money
So, what's the potential timeline on this saliva tester? Best case scenario: 18 to 24 months.
Right now, the iQuickIt Saliva team is at the stage where many such companies falter -- raising money for the next phase of development and clinical trials. An Indiegogo crowd-funding campaign set up late last year raised only $4,230 of the $100,000 goal, and they are now actively searching for investors to move development along. Clark says the hope is to submit their meter to the FDA "in the next year or so," and then ideally have a market-ready product within the next two years.
At the moment, the company's in kind of a "quiet time" as they prep for clinical trials that are expected to start in mid-March, a PR rep tells us. Those trials will begin locally in central Connecticut (not necessarily at the same Joslin affiliate hospital) and will likely expand outside the state. Recruiting hasn't started yet, but a broad call for participants will be made public for PWDs wanting to take part. They'll also kick off another crowd-funding campaign in the spring or later into 2014.
With the projected time-to-market being at least two years, there aren't any specifics available right now about cost or insurance coverage. But the startup is savvy enough to know how critical that is, and intends the saliva meter and Draw Wick strips to be "as competitive, if not more affordable and accessible" as anything currently on the market.
Once again, we're intrigued but skeptical. The one thing that seems like a great bet is the notion that at least one of all of these non-invasive glucose testing concepts ought to work out! I mean, statistically, one's got to be a winner, no?
So we'll keep watching with interest, and in the meantime, keep using what we have at our fingertips now.