This isn't new. There was an article six years ago about a bioactive tattoo ink that could measure blood glucose levels non-invasively (after the tattoo was applied, of course). The measurement required a sensor attached to an I-Phone and the sensor was estimated to cost several hundred dollars, but it would allow for frequent glucose measurements without finger sticks. Not continuous like CGM devices, but less painful and significantly less expensive.
So far as I know it still hasn't been approved by the FDA, and I don't know whether the developers are even still trying to get it approved.
Google also developed a sensor incorporated into a contact lens that provided non-invasive, continuous glucose monitoring at about the same time. Same result; not approved (that I know of) and no indication that it ever will be.
Unfortunately these companies/institutions have no experience with, and no concept of the challenges involved in approving a totally novel medical device in the US.
And double unfortunately, approving a medical technology is vastly more expensive and slower than it needs to or should be. Existing medical approval policies are strongly motivated by political concerns (we're still reeling from thalidomide) rather than any rational social optimization policy. It's very easy to scare people into excessive conservatism (in the literal sense). http://www.fdareview.org/05_harm.php
I hear that viewpoint frequently but their seems to be minimal support. The simple truth is for large numbers of medications the benefit is very minimal while the risks are huge.
Also, if you look at the approval process costs are largely focused on how studies are done not the minimum requirements for data collection.
PS: Remember, a very well funded group has a huge incentive to reduce costs in this area.
US is still just one country. You can collect data cheaply if you get approval in another country fist. However, the US approval process is fairly reasonable so this does not happen.
And yes I read what you linked it over states it's case and has very poor support.
Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win.
I can see some argument for abandoning the efficacy requirement, and only going with "safe" but so few drugs actually do anything - isn't it something like a 95% attrition rate? only 1 in 50 actually have a measurable effect?
Maybe the bar is too high. Seems like the bigger challenge, and far far greater win is just making testing cheaper.
It wasn't a victory at all; existing medical procedure failed to stop huge numbers of deformities. As a reactionary knee-jerk response, the US instated vastly overwrought medical restrictions.
>Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win.
depends who you ask.
Milton Friedman used the thalidomide reaction as a case-book example of government meddling in the private sector where it needn't be, causing vast delay in possible new therapeutics, which basically created an unquantifiable loss of value due to us being unaware of "what could have been without bureaucratic delay".
Friedman believed that if a company does sufficient harm to a population that the negative market signal will eventually destroy the 'bad-actor' company, without the need for anything like the FDA and the delays it imposes[0]
My wife has T1D and uses a continuous glucose monitor from Dexcom to keep track of her levels.
The current state of the technology is probably best described as "finicky": the sensor skin patch needs to be replaced every week or two, at which point it's much less accurate for a couple days. It also needs calibration inputs from a finger prick at least every 12 hours. In general if the sensor is reporting a high or low condition her first action is to double-check with a finger prick. More often than not the sensor is simply wrong.
With all that said, it's better to have the sensor than not. She is able to use an app [0] to track her glucose levels over both the short term and long term trends. She's been able to use that data to make dietary decisions which allow her to keep her glucose within range and she had very good A1c levels (5.4, vs a goal of "under 7" for many diabetics) at her last checkup.
I think the long term data collection ability means that a more connected sensor (as opposed to the linked tattoo) will continue to be beneficial for diabetics. The next steps in the useful technological development will be to integrate with insulin pumps (this technology is already in trials) and to integrate with diet tracking data e.g. from MyFitnessPal to assist with meal decisions.
Recently my cousin, and my friend's child were diagnosed with type 1. Following their Facebook posts I was surprised how limited and frustrating current monitors/pumps are.
The hydration one could be very useful. I don't know how many youth athlete's I've heard of having heat stroke in the Summer from not being well hydrated enough. Not that I think we should tattoo all the children, but it could help people realize that thirst isn't always the best determinate of hydration.
Personally, I'd like a tattoo of a glass of water. The glass with regular ink, and the water with hydration sensing ink. If the glass is empty, I need more water!
As a type 1 diabetic, I will gladly sign up for this. As soon as this is viable and available, I will be getting my first tattoo. Now for the design, maybe the insulin molecule?
This looks good in principle, but I feel like it needs a lot of work to make it actually usable. Will the small change in sodium or glucose concentration results in color change enough for people to recognize? We obviously don't need to look at the color change to feel the burn when the PH became 3.
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[ 2.4 ms ] story [ 31.7 ms ] threadSo far as I know it still hasn't been approved by the FDA, and I don't know whether the developers are even still trying to get it approved.
Google also developed a sensor incorporated into a contact lens that provided non-invasive, continuous glucose monitoring at about the same time. Same result; not approved (that I know of) and no indication that it ever will be.
Also, if you look at the approval process costs are largely focused on how studies are done not the minimum requirements for data collection.
PS: Remember, a very well funded group has a huge incentive to reduce costs in this area.
And yes I read what you linked it over states it's case and has very poor support.
Wasn't that one of the FDA's big victories? Perhaps you mean the FDA is far to powerful because of that win.
I can see some argument for abandoning the efficacy requirement, and only going with "safe" but so few drugs actually do anything - isn't it something like a 95% attrition rate? only 1 in 50 actually have a measurable effect?
Maybe the bar is too high. Seems like the bigger challenge, and far far greater win is just making testing cheaper.
depends who you ask.
Milton Friedman used the thalidomide reaction as a case-book example of government meddling in the private sector where it needn't be, causing vast delay in possible new therapeutics, which basically created an unquantifiable loss of value due to us being unaware of "what could have been without bureaucratic delay".
Friedman believed that if a company does sufficient harm to a population that the negative market signal will eventually destroy the 'bad-actor' company, without the need for anything like the FDA and the delays it imposes[0]
I don't know whether or not he's right.
[0]: https://www.youtube.com/watch?v=KUDV0YII6lk
The current state of the technology is probably best described as "finicky": the sensor skin patch needs to be replaced every week or two, at which point it's much less accurate for a couple days. It also needs calibration inputs from a finger prick at least every 12 hours. In general if the sensor is reporting a high or low condition her first action is to double-check with a finger prick. More often than not the sensor is simply wrong.
With all that said, it's better to have the sensor than not. She is able to use an app [0] to track her glucose levels over both the short term and long term trends. She's been able to use that data to make dietary decisions which allow her to keep her glucose within range and she had very good A1c levels (5.4, vs a goal of "under 7" for many diabetics) at her last checkup.
I think the long term data collection ability means that a more connected sensor (as opposed to the linked tattoo) will continue to be beneficial for diabetics. The next steps in the useful technological development will be to integrate with insulin pumps (this technology is already in trials) and to integrate with diet tracking data e.g. from MyFitnessPal to assist with meal decisions.
0: https://github.com/StephenBlackWasAlreadyTaken/xDrip
Thanks for the input from your wife's experience
(I kid, I kid...)
Personally, I'd like a tattoo of a glass of water. The glass with regular ink, and the water with hydration sensing ink. If the glass is empty, I need more water!