We've seen the sensational headlines over and over: "no more needles for diabetics!"
Maybe we'll be getting non-stop blood sugar readings just by shining a beam of light onto our skin...
Give me a break!
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Believe or not, all of the above has been in the works by enterprising researchers for years now, but not one single non-invasive concept has come to fruition as a viable product in the U.S.
Decades later, we're still dreaming...
Some of these devices are actually getting regulatory approval outside the U.S... so we hold out some sense of hope that maybe one of these dreams is inching closer to being realized.
We bring this all up because we've received a barrage of pitches lately on non-invasive stuff, including:
Optical Glucose Monitoring: Made by C8 MediSensors base in San Jose, CA, this gadget uses light to identify and analyze glucose molecules under the skin, via interstitial fluid. The resulting vibrations of the molecules are monitored by the sensor which shows readings on the a small portable monitor worn on the skin underneath clothing. The company received CE Mark approval on Oct. 25 to market this non-invasive CGM device in Europe — a good year after we wrote about this company back in 2011 and they forecasted the approval.
Note that it was approved as an "adjunct" device that is off limits to a certain number of people: pregnant women, patients younger than 18, PWDs with very light or dark skin tones, individuals with peripheral vascular disease or anyone who smokes. That leaves middle-pigmented, non-pregnant, healthy adult PWDs ;) ... but maybe there is hope for more widespread use soon, as it's OK'd for Europe now.
Stick-On Insulin Patch: Not. Even. Kidding. Pennsylvania-based drug delivery company Transdermal Specialties is developing a stick-on insulin patch called the U-Strip that delivers insulin through the skin. You may remember that the company unveiled this tech at the American Diabetes Association's Scientific Sessions in June. Well, the U-Strip uses ultrasonic waves that expand the pores, allowing the insulin to slip through the skin and seep into the blood stream. The patch would apparently last for several days, and would be compatible with mobile devices that allow WDs and physicians to monitor blood sugar levels. Initial clinical trials are being done now and the company looks to have the UK in its sights first for commercialization.
Roll-On Insulin: Again, not kidding. The Miami Lakes, FL, company Fuse Science Inc. issued an announcement in mid-October about its "patchless insulin delivery with simple roll-on." They've apparently invented a technology to encapsulate the insulin (along with other compounds) and when applied to the skin as a roll-on, deliver these medicines at a constant rate to the patient through the skin. This will make the $3 billion patch industry obsolete, the company claims! (Side note: It doesn't instill confidence that their CEO, when describing this technology, says it's a way to help the "diabetic sufferers around the world." Ugh!)
Needle-free CGM: Philadelphia-based Echo Therapeutics is developing a needle-free continuous glucose monitoring system called Symphony tCGM. It's a two-part device that monitors BGs by taking readings through a skin permeation system that removes the patient's outermost layer of dead skin within three to eight seconds and apparently leaves only a tiny abrasion not visible to the naked eye. Then the biosensor is attached to that spot to monitor blood sugar levels every minute, with a site change necessary every three days. Wireless technology will send minute-by-minute readings to smartphones, computers, tablets, and just like current CGMs, this system will have alarms and graphics to monitor. This video shows how the unit works.
And here's how they pitch it in a news release: "It is the most advanced diabetes care technology ever developed. Echo Therapeutics has revolutionized glucose monitoring with its needle-free system that reads blood sugar levels transdermally (directly through the skin). With obesity/diabetes at the top of the nation's health concern, this means the painful finger pricking to read levels will soon be a thing of the past!"
Gotta love the confidence level of those marketing folks, ay?
Of course, despite claims that they'd look to get this to the U.S. market in the next year or so, we heard back in August that Echo will first look to Europe before going to the FDA for possible approval. So no one's holding their breath. Really.
And hey, anyone remember the earlobe BG testing contraption from a company (ironically) called Integrity Applications? And the nanosensor tattoos from the really smart university folks? Now, new tiny biosensors are promising "an end to daily fingersticks" as they take blood sugar readings via tears and sweat?
Please. I've had diabetes for nearly 30 years and I just can't take it anymore. Talk to me when this stuff actually works.
But OK, I decided that maybe I'm just too cynical to think about this objectively. Maybe some experts might have a more realistic view on where things stand with all these non-invasive options we've been hearing about for so long.
Wouldn't you know? The few we asked were just as about as skeptical as I am.
Respected technology blogger and fellow type 1 Scott Hanselman had this to say:
"I've been hearing about eyeball tattoos, fancy contacts, IR imaging of the arm, glucowatches and more for years. They've told me every year for 20 years that the cure will be here in five years... I always assume that where we are NOW is where we will always be. That way I'm never disappointed."
Scott adds, "I don't mind it being invasive as long as it's super accurate."
Semi-retired industry consultant John L. Smith wrote a seminal paper 141-page article on the topic of non-invasive technology back in 2006 titled "Hunting The Deceitful Turkey" (revised in 2011). He writes that one of the most disturbing aspects in this field has been the "perennial" announcements by young companies that believe they've reached a solution for PWDs to no longer have to stick their fingers. Without exception, Smith says these announcements have been premature and are meant to generate hype, raising false hopes in people who actually would use the product.
Diabetes industry analyst David Kliff, an insulin-using type 2 and notorious devil's advocate, actually had a few laughs talking about the "reality" of non-invasive technology.
"It's one of the better scams I've ever seen in the diabetes world," he told us by phone. "It sounds so appealing with all kinds of Star Trek-y elements. They sell the hype and there's just enough science to back it up so it looks great. The mainstream media give it more play and people buy the dream."
Kliff says most companies follow the same path with an end to the road that's more mirage than reality: developing the concept and then pitching it, the search for investors and cries to "give us a few more million and we'll get there..." and they never quite seem to get to that point.
Why do people buy the dream?
Kliff says: "Managing your blood sugar is a lot of work, and really if you don't have to, why would you want to do all the work? That's the appeal. But I've contended from Day One, that whether it's invasive or not, if the person doesn't understand the number, it doesn't matter if it's given to them by God. I'm more impressed with practical technology that works and you can trust. For any patient, that's the bottom line."
Fellow type 1 D-blogger Bernard Farrell, who keeps his eyes on the latest tech industry, says he's also inclined to be cynical about non-invasive technology.
"Just think about how hard it is to use interstitial fluid, and the delays involved," he points out. "Would a non-invasive method not have similar problems?"
So we're still waiting, and awfully skeptical.
Part of me thinks maybe these companies should channel their innovative energies into improving accuracy of the technology we already have rather than chasing some far-fetched dreams.
But on the other hand, it's the visionaries and dreamers who change the world, right?
Even John Smith, the industry expert who dissed all the non-invasive efforts, sums up his paper by saying: "In spite of all the failures (and quite likely, because I have been close to so many of them), it is still my fond wish that someday, somewhere, someone will find the solution to this intensely recalcitrant problem and realize the benefits for all people with diabetes worldwide."
And so we go on waiting, struggling to be good and patient(s).