This is for real, People. Now we know what the mystery medical device is that Google X staffers have been secretly meeting with the FDA on: they're developing contact lenses that can sense glucose readings while they correct your vision just like regular contacts do. WOW!
If it were any company other than Google, I'd probably be laughing right now...
But this is Google, and when it comes to innovation, they've got some chops -- having recently been named the greatest innovator in the world right now, even topping Apple.
Here's a statement from today's news release by Brian Otis of the Google X team:
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We're now testing a smart contact lens that's built to measure glucose levels in tears using a tiny wireless chip and miniaturized glucose sensor that are embedded between two layers of soft contact lens material. We're testing prototypes that can generate a reading twice per second. We're also investigating the potential for this to serve as an early warning for the wearer, so we're exploring integrating tiny LED lights that could light up to indicate that glucose levels have crossed above or below certain thresholds. It's still early days for this technology, but we've completed multiple clinical research studies which are helping to refine our prototype. We hope this could someday lead to a new way for people with diabetes to manage their disease.
We're in discussions with the FDA, but there's still a lot more work to do to turn this technology into a system that people can use. We're not going to do this alone: we plan to look for partners who are experts in bringing products like this to market. These partners will use our technology for a smart contact lens and develop apps that would make the measurements available to the wearer and their doctor. We've always said that we'd seek out projects that seem a bit speculative or strange, and at a time when the International Diabetes Federation is declaring that the world is "losing the battle" against diabetes, we thought Project Iris was worth a shot.
Hmm, just last year there were reports that Microsoft was developing the same thing?... And UK researchers at the University of Akron are doing similar work, creating contacts that would change color depending on your glucose levels. For the record, there's also a small group in Washington state called InsuLenz, that's working on lenses that will deliver insulin. No kidding.
I had a phone briefing with Google X team leader Brian Otis (also of the University of Washington) earlier this week and was able to ask a lot of questions about Google's approach. I learned the following details:
* this technology is based on tiny electrochemical sensors embedded in the lens
* it is not an "optical method" of measuring glucose (like some failed attempts in the past), but rather takes direct measurements of glucose levels in your tears -- a body fluid that has been nearly impossible to collect and measure in the past
* the glucose sensor, integrated circuit (electronics), and even the contact lens itself were all developed in-house by Google -- although they "don't want to get into the business of manufacturing contact lenses" and are thus looking for development partners
* these "smart lenses" will look and feel like normal soft lenses and will also be able to correct your vision (!) They'll start with daily wear, and hope to progress to extended wear lenses at some point (even possibly overnight, Brian says)
* if the user doesn't need corrective lenses, they can still wear a "plain" version of these smart lenses that just does the glucose sensing
* the glucose readings can be transmitted to "any form factor" -- so the receiver could be a smart phone, tablet, separate handheld device like we have with continuous glucose monitors now, "or even a pair of glasses," Brian says, referring to the Google Glass technology that can receive and display any kind of data
* early clinical studies have already been conducted in cooperation with endocrinologists and opthamologists and leading clinical partners (they won't say which), and their current talks with FDA are about what full-scale studies would need to look like to meet FDA requirements?
* those early IRB-approved studies monitored the comfort and functionality of the lenses, plus the "correlation" of predicting glucose readings based on tears, i.e. accuracy
That's where I stopped him. 'Cause WHAT ABOUT ACCURACY?
Getting a "sense" of our glucose readings doesn't help anyone, I told Brian: we need readings we can rely on.
"We realize that accuracy is the biggest challenge," Brian says. "Just like with CGM measuring interstitial fluid, there will likely be a time lag between the tear readings and plasma glucose readings you get with fingerstick tests."
So not surprisingly, the lenses will likely be another form of "adjunct therapy" like current CGMs (i.e. not approved by FDA for stand-alone use for treatment decisions).
(Click here to download & read Google's SMART CONTACTS ONE-PAGER.)
Brian says that the Google X team has been given the luxury of resources and support to tackle "big problems" and "the freedom to possibly fail."
We talked about the three essentials for success among the diabetes community:
- cost - there has to be substantial insurance coverage, and the out-of-pocket costs for patients cannot be too burdensome
- convenience - this can't be just another layer of work for patients; the special lenses have to make life easier!
- accuracy - per above, we're already having to stage a national protest over the poor accuracy of the most accurate tools available, fingerstick meters; so these new lenses had better be able to deliver the goods
Meanwhile, it's pretty exciting to see a powerhouse like Google publicly hailing their commitment to creating new tools for diabetes. "It's a big problem in our society, and we think we can help," Brian says. "But Google is purposely keeping the messaging extremely humble," he adds. "We're not experts in medicine, or in contact lenses. We can't do this alone."
Know any good partners for Google in developing the Smart Lenses? Let's lend a hand where we can to make this a reality!
** UPDATE: July 15, 2014 **
News reports say Google is now partnering with Swiss drug company Novartis' eye care division to create these non-invasive glucose-reading "smart lenses," and Google claims they may be available for consumer sale within five years. See this Novartis news release for more detail.