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FDA clears first over-the-counter continuous glucose monitor

783 points| bookofjoe | 2 years ago |fda.gov

426 comments

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[+] mangoman|2 years ago|reply
I recently had an unusual health event that resulted in me passing out. My wife, who is a physician, thought it might be hypoglycemia, since i'm at high risk for diabetes. She found a super friendly endocrinologist who put me on a CGM for two weeks. I never hit the hypoglycemia range during those two weeks, so it didn't really explain what my issue... but honestly the data was SUPER interesting. Just observing the various spikes made me make healthier choices, or noticing when I was feeling extra tired and seeing if that correlated to not having eaten for little while, or eating something sugary before.

It's sort of like tracking your steps when you first get a smart watch. It may not have been the reason you got the device, but seeing the data, people are encouraged to act on it, even if you don't have an acute issue. since I didn't have a prescription, I couldn't get one here (didn't want to go through some sketch online site). I tried to get one from my family in India, but the prices were really high and they couldn't get the fancier one that tracks straight to your phone, so I didn't get one.

I think this could be a god send for preventing pre-diabetic people who would take preventative steps if it weren't such a pain in the ass to measure consistently.

[+] aledalgrande|2 years ago|reply
I actually just got one of these CGMs after listening to Peter Attia's (audio)book Outlive and started monitoring my glucose and experimenting with meals and exercise to see what effects they have. Apart from the weirdness of having something attached to your skin, it's like having another watch and you won't notice after a while. It's pretty cool and a lot more people than just diabetics would benefit from this knowledge.

Like I just learned for example about resistant starches, of which one is cooled potatoes: I ate the exact same dish but the first time, right after cooking, my levels shot up (not abnormally but you should ideally never have spikes, so your body doesn't have to keep pumping insulin), and then the second time, reheated, it was like I didn't eat anything. I was surprised so I researched and found https://www.webmd.com/diet/what-to-know-resistant-starches

Everyone is different so I definitely suggest to try them out for a month and see what gives you spikes in your diet. Then try to get rid of those spikes.

[+] cleandreams|2 years ago|reply
I am prediabetic and I have one. It's partly covered by insurance. By the metrics my estimated average glucose has gone down from 129 to 98 or so (normal). I haven't had my HbA1c in awhile.

I think they are amazing. It's been SO HELPFUL. However I don't think it makes sense for normal people. I am on a reddit group for prediabetes and it's not unusual that people who are underweight (anorexic?) and have completely normal metrics come in and post in an utterly freaked out state. These are people who are somewhat compulsive and anxious. I think that if you are normal for blood glucose having access to all this data can make you compulsive and anxious.

However, for me as a prediabetic, it is really useful. It tells you what’s going on with your blood sugar in real time with no ideology. In the beginning I was spiking from things that a nutritionist would say was OK. I found whole grains didn’t work for me. I was shocked at how much I spiked from oatmeal. What causes blood glucose spikes does not map directly to number of carbs and also every body is different.

After 6 mo of lowered carbs, weight training, and getting down to normal BMI, I can now eat SMALL portions of things like brown rice. My health has improved. It's great. IMHO all prediabetics and diabetics should have one, covered by insurance. It would really improve health and reduce complications.

[+] bakedoatmeal|2 years ago|reply
What is the connection between being at risk of diabetes and hypoglycemia? Wouldn’t a pre-diabetic be very protected from hypoglycemia?
[+] lr4444lr|2 years ago|reply
What kinds of food intake/non-intake habits aside from the obvious culprits surprised you?
[+] necovek|2 years ago|reply
I personally wouldn't mind having the data if a need comes up, but this is simply overtracking for no particular purpose.

Basically, our bodies go through much "turmoil" over the course of any day, and watching over one too many parameters is like getting hooked to TV or a video game.

Generally, medical science can mostly tell you what averages or most common patterns are, so if you do not line up with them and don't understand this, you can get overstressed.

So unless you are really someone who can objectively consider your readings combined with effects you might be seeing, I'd say don't do it.

[+] oldgradstudent|2 years ago|reply
> My wife, who is a physician, thought it might be hypoglycemia, since i'm at high risk for diabetes.

Isn't hypoglycemia a side effect of insulin and other glucose lowing agent rather than of the diabetes itself?

[+] dkarras|2 years ago|reply
how is having low blood sugar a sign of pre-diabetes? I get frequent bouts of hypoglycemia.
[+] seesaw|2 years ago|reply
Were you able to find out what may have caused you to pass out ? I had a similar incident with no root cause. But that did set me on the path to become more healthy.
[+] melagonster|2 years ago|reply
Excuse me, this is stupid question. but can't you buy Freestyle Libre?
[+] jxramos|2 years ago|reply
definitely, catching the "quantified self" bug is a real thing!
[+] cheriot|2 years ago|reply
Thanks for confirming. Normal feedback on health habits is delayed by months/years and hard to trace back to specific actions so your story makes a lot of sense.

I might have to get over my dislike of needles :|

[+] philsnow|2 years ago|reply
I dove into CGMs a little bit about a year ago, mostly just for fun. Yes, I paid money to some online prescription mill for CGMs (Abbott Freestyle Libre 3, IIRC), and then put one in my arm (the applicator is a short syringe section that has the monitor tube threaded into it, so the tube stays in your arm and your skin under the monitor remains broken) for a couple weeks. Just to see how various foods would affect my blood glucose, to see whether the “facts” I’m telling my kids about the glycemic index of various foods actually has the expected impact on a measurable result. You know, as you do. For fun.

(It actually was fun, and I’ll do it again when the data ecosystem improves.)

[+] jseliger|2 years ago|reply
Before I got cancer, I had one through Levels, and it was informative. Dessert is much worse than I'd thought. Rice, too, including brown rice. I remember eating some biryani and a small bit of naan at an Indian restaurant and thinking that I'd been pretty healthy, only to see a spike of like 80.
[+] gregschlom|2 years ago|reply
> so the tube stays in your arm and your skin under the monitor remains broken

That's not how it works, at least for the Freestyle Libre 3. The cross section of the needle has C shape rather than a O (technically I believe it's called a cannula). When you remove the applicator that C shape allows the needle to be removed through the hole at the top of the sensor, and only the flexible filament stays I your arm.

[+] haswell|2 years ago|reply
Aside from the fun, how did it go? Find anything surprising or insightful in the process?

It sounds like an experiment I’d like to do for the purpose of optimizing my daily habits and establishing a better mental model for how my eating habits impact me throughout the day. But I really dislike needles.

[+] itpragmatik|2 years ago|reply
At least for me the readings that it shows are not accurate (when verified with old style finger pricking glucose monitoring machine). These CGMs are good for knowing the general variability of glucose level in your blood based on your diet exercise etc; I don’t trust the absolute numbers from CGM like Freestyle Libre - haven’t used any other one though yet.
[+] turtlebits|2 years ago|reply
Same, but my doctor pointed me to a promotion for a free sensor. It did require a prescription, but since I don't have diabetes, it's not covered by insurance.

Trying to get it filled and picked up was slightly annoying as the pharmacy initially did not want to fill it without some prodding, and I waited a while for them to figure out how to get the promotion billed.

[+] znpy|2 years ago|reply
What's the lifetime of a single device? Are you supposed to remove it before a shower and reapply it later?
[+] barbazoo|2 years ago|reply
What symptoms would one have to present for an "online prescription mill"/"virtual care provider" to prescribe a CGM? I'm fascinated by this and would love to try it out but I don't want to bother my family doctor with this.
[+] coldpie|2 years ago|reply
I'm T1D (insulin-dependent). I used a Dexcom for a couple years a while ago, back around the G3 through G5 era or so. I ended up stopping using it because my diabetes is very well managed, and I found it didn't make a huge difference to my management. With my insurance, each new sensor every week cost about $50, and would fail in various annoying ways: sometimes it would just stop working in the middle of the week, or not work at all from the start, or disconnect randomly for a few hours. Each sensor also used a ludicrous amount of plastic for its applicator, like a tennis-ball-sized hunk of hard plastic, that you just chucked in the trash, every week. Maybe things have improved, but it was a bad combo of unreliable and expensive so I just quit using it and went back to finger pokes.

If it were like $5 per week, I might put up with it. Maybe this over-the-counter model will be affordable. We'll see, I guess.

[+] mlsu|2 years ago|reply
Dexcom and Freestyle both have options (G7, FSL2) that have a much narrower form factor than the old sensors. They end up being far more reliable, because the sensor doesn't dislodge. The new Dexcom sensors are more accurate. Less drift and no calibration.

Out of pocket cost is obviously your own situation but I think anyone with T1 should look at them. For me they are life changing, even moreso if you have a pump that can deliver based on CGM readings.

Plastic waste situation is still bad.

[+] bsder|2 years ago|reply
> Each sensor also used a ludicrous amount of plastic for its applicator, like a tennis-ball-sized hunk of hard plastic, that you just chucked in the trash, every week.

Erm, let's be a little defensible here.

These sensors have to be stored in sterile packaging--that means thick enough to be a barrier. That means it also has to hold the sensor in such a way that a palette can be gamma irradiated. It also needs to be resistant to drops, crushes, and other accidents.

The sensor has to not be harmful with organisms irrespective of the understanding of the person using it. Any change to that packaging has to be re-evaluated for effects on that sterilization.

And while I understand people having concerns, if the only reason we needed to use plastic was to treat folks with diabetes--I think the world would somehow manage.

[+] micro_cam|2 years ago|reply
The g7 is definitely a bit better on all counts except maybe bluetooth reliability. I use them with [open source closed loop](https://loopkit.github.io/loopdocs/) insulin pump software and it is pretty great.

Still a lot of plastic but the sensor comes in a smaller jar/applicator in a cardboard box and it pretty reliably lasts 10 days cutting down waste.

It sounds like this new sensor is just a g7 but with less stringent accuracy standards for non insulin users allowing it to last 15 days.

[+] cadr|2 years ago|reply
I just started with the G6 (still using it), and when I started I'd have that sometimes. Whatever they changed in the past year or so, it has gotten waaaaay better. (They would always replace them if they failed early, but was still a huge pain.) I'm exited to move to the G7 (mainly because of the shorter warmup time).

Also, pairing it with the Omnipod 5 is just next level. Closed loop. Never having to inject in public. No tubes.

[+] eitally|2 years ago|reply
fwiw, my wife uses Freestyle Libre 3 and the with-insurance cost every two weeks is about $40. Whenever she's had one fail (which seems to be about 1:10), Abbott has replaced it free of charge and sent a pre-paid label so she can return the failed device for QA review.
[+] Etheryte|2 years ago|reply
The plastic waste issue is one of the first things that usually comes up around this topic regardless of who you ask. It's such a shame because it's not like you have many options unless you're comfortable going without sensors.
[+] agawish|2 years ago|reply
I'm really intrigued by your statement that your diabetes is well managed, if I wake up in the wrong side of the bed, my insulin resistance change!

Wondering how you can maintain that, do you have a very rigid routine and meal plan?

I'm using Libre2 as part of my prescription and it has been working wonders by alerting early on before it is too low or too high to have enough time for a correction dose, or a small bite. The fact that you can see the trajectory of Glucose going up or down is by itself a reason to get.

[+] 1123581321|2 years ago|reply
I think your experience was unusual in that you had so many failures (hopefully you at least got your broken sensors replaced for free; both Dexcom and Libre do this) and that you are good at managing your diabetes without many measurements.

The out-of-pocket expense can certainly be rough; I use Libre right now because my Dexcom out-of-pocket would be similar to yours and Libre is a third.

I lend my CGM to people to who are possibly prediabetic. I'm very glad I can point them to an OTC solution now.

[+] ng12|2 years ago|reply
You went back to finger sticks? I am floored. Do you follow a strict low carb diet? How often are you exercising?
[+] jesprenj|2 years ago|reply
For having participated in a study, they installed an Abott FreeStyle Libre 2 sensor on me for 14 days. I could get minute readings, which is not possible with either the hardware reader nor the official app, using the almost entirely FOSS android app Juggluco.

Another FOSS web tool is Nightscout -- it generates reports and live graphs from data gathered from your CGM via for example Juggluco. My instance is at http://sladkor.4a.si. My sensor expired, so there's no more live data.

glucometerutils is an interesting repo for downloading stored data from hardware readers etc. Abott encrypted the Libre 2 USB communication to force users to use their proprietary software, but hackers managed to extract keys.

http://juggluco.nl http://nightscout.github.io https://github.com/glucometers-tech/glucometerutils http://ni.4a.si./anonymous/freestyle-keys/tree/freestyle_key...

[+] zxienin|2 years ago|reply
I use Abbott Freestyle Libre 3 and it has been deeply insightful about my progress with T2D. An increase in fasting glucose over 2-3 days tells me I need course correction (more movement, choice of food). I also noticed consistent correlation between bad sleep days and raised glucose levels over the day. Made me internalize how important sleep is.

I believe, next major uptick will come from CGM in wearables like Apple/Samsung watches [1][2]. I hope, even non diabetic folks use it to improve their health.

[1] https://www.macrumors.com/2023/09/14/apple-watch-blood-gluco... [2] https://www.macrumors.com/2024/01/23/samsung-racing-to-beat-...

[+] NoPicklez|2 years ago|reply
These are so interesting and not just for diabetics who benefit from them the most.

Top athletes have been using them for exercise to make sure their blood sugar remains in the correct ranges.

But Diabetics are using them to help identify how particular foods impact their blood sugar levels (obviously). The reason being is that whilst some foods might be considered high/low in sugar, each of us reacts differently in how we absorb those foods or drinks. So a bagel you eat might not spike your blood sugar like someone else, or conversely it does. You can then correlate that spike or reduction in blood glucose with how you're feeling throughout the day, how your blood sugar levels impact exercise.

Also it allows you to see how combinations of foods and the order that you eat them in impacts blood sugar. If you eat a chunk of white rice without any fibre you might find it spikes, if you each a bunch of vegetables in the bowl before hand you might find it doesn't rise as high or give you a steadier release of blood sugar.

I'd use one for a few months just to see how foods impact my blood sugar and how I can make different choices. It's one thing to interpret a label, but it's another to see it's impact on your body in real time.

[+] metabagel|2 years ago|reply
I put something like this on my cat, because the vet thought she may be pre-diabetic, but stress response can also cause blood sugar to spike, so we needed to see what her blood sugar was like multiple times per day.

The device worked for 5 days until she had managed to dislodge it enough so it wouldn't get a reading. The skin glue lasted another 5 days before the device fell off. Since then, she has had a "crop circle" behind her shoulder where her fur was shaved away, and which is ever so slowly filling in.

Her readings were fine, so we are feeding her low carbohydrate food, because the vet thinks she may become diabetic in the future.

Unfortunately, I had to place the reader device almost directly on the sensor, which was a pain, because my cat likes to hide under the bed. So, I had to squirt her with water to get her out, which was undesirable, but didn't seem to affect the readings.

The device was the Freestyle Libre 2.

https://www.freestyle.abbott/us-en/products/freestyle-libre-...

[+] anonfornoreason|2 years ago|reply
I would recommend anyone to experiment with this. I did, and found out I was more glucose sensitive than I expected. This led me to get more broad labs done, with which I was able to find additional treatable issues that are likely the cause. If I hadn't done this, I would have found out via symptoms years later, after irreversible damage had already been done.

You are your only medical advocate, no one else is going to do it for you. The standard of care is shit, don't rely on it.

[+] briandw|2 years ago|reply
I did this for fun using the veri.co service. It was interesting how little my diet immediately affected my blood sugar. Non diet things were much bigger. Do hard exercise -> spike. Take a hot shower -> spike. Fast for 48 hours -> blood sugar still rises in the morning.

Walking was by far the most effective way to keep blood sugar down after a meal.

Most of what I ate didn't cause a problem. However tend avoid sugar and carbs. The worst offender was a PB&J sandwich. That was surprising.

[+] autoexec|2 years ago|reply
It'd be pretty interesting to see that kind of data, but it looks like this product violates my policy on not buying hardware that requires a cell phone app to use, and my policy on keeping as much of my medical information as far away from my mobile device as possible. I'm not sure exactly who the app itself sells/leaks the data being collected to, but even having that kind of data on the device would make me uncomfortable.

A quick read of their privacy policy suggests that the mobile app is full of personalized ads and they use your data for "direct marketing" as well as "research". They offer your data to third parties for both "marketing" and "analytics" reasons. They'll send your data overseas whenever it suits them, even to places where your data will not have the same protections, and they'll keep the data they collect forever unless you submit a request for them to delete it and they are actually required to do so by law.

Since I'm only mildly curious to see what the numbers would look like, I'm fine with waiting until someone puts one on the market that saves its data to storage that can later be copied over to an offline PC.

[+] JoeAltmaier|2 years ago|reply
Some of us can't be trusted with continuous stat reporting. I hit Update on HN often enough. I don't even wear a watch, I kept looking at it every twenty seconds and then realized I still didn't know what time it was, it was just a reflex.

I learned to leave my phone someplace else, upstairs, wherever, just check it a couple times a day. Else I'd go crazy.

I took the speedometer off my bike, I was looking at it more than the road.

So I understand my limits and take steps to keep my self from compulsive behaviors. I guess(?) other people do better and can handle these things.

[+] cooldevguy|2 years ago|reply
I am diabetic type 2 and I've used the Abbot Freestyle Libre 2 for a few years now. You don't need a prescription in Mexico to get it, but it is expensive ($1548 MXN ~= $91 USD). The data you get is pretty interesting but at least on my experience, the difference between readings from the CGM and actual blood test can vary from 10 ~ 40 mg/dL so you have to have that in mind. However it was really helpful to discover that, while I'm pretty active since a few years ago it was troubling for me to wake up on readings over 140 mg/dL which thanks to this turned out to be just that my body does it naturally and my blood sugar spikes while asleep and an hour or so before I wake up, which my endocrinologist just attributes to my body getting ready to work out.

Even as an experiment, I'd say most people should get one just to understand their bodies, and their specific responses to certain foods, once in a while.

[+] gamepsys|2 years ago|reply
I like this trend of the FDA making more and more things OTC.
[+] csours|2 years ago|reply
I wish Theranos had worked on a more reasonable goal - like an implantable CGM.

I had T2D, well controlled now, my A1C is below the diabetic diagnostic range.

I used CGMs, and they taught me a lot about how my body reacted to food and exercise.

But I sweat a lot and they would always fall off, halving the useful life of each monitor. I would probably still use them from time to time if they didn't sweat off; and if an implantable version was available for a reasonable price (under $500, with no ongoing costs), I'd probably get it.

I feel like a lot of prediabetic people could learn a lot about their situation with this. I think this is a very good thing.

[+] 005|2 years ago|reply
I don't think this is particularly special. In other countries it's possible to obtain Dexcom's current line up by purchasing it online (G6, ONE, G7) and other brands too like Abbott's Freestyle Libre.

It seems like this is a stripped down version of the G7 (albeit with a longer wear time) as the ONE is a stripped down version of the G6.

[+] henrikberggren|2 years ago|reply
I've been wearing one for 6 years straight and wrote a post back in 2018 when I first got one. As someone who lives with Type 1 diabetes its been one of the absolute biggest game changers for my health

https://blog.steady.health/the-wearable-that-changed-my-life...

I also started a company focused on CGMs which was too early and didn't work. Maybe its time to try again? :)

[+] komposit|2 years ago|reply
My son was diagnosed with diabetes about 4 weeks ago. The first two weeks we were measuring him through fingersticks multiple times daily. Now we have the cgm it has become so much easier to manage his condition.

The interesting thing to observe is to see in real time the metabolic spectrum of the foods we consume. Liquid sugars cause glucose spikes within 6 minutes. Solid carbs 30-120 minutes depending on carb complexity etc. Proteins 3h+. Fats can be six hours or more.

The thing is there are a variety of insulins available, some of which are rapid acting and others act more slowly. So to keep my son in range with multiple daily injections you are playing this game of giving him the right mix of foods where his carb digestion matches the profile of his rapid acting insulin.

Pizza is an interesting case study. It is by far the most carb rich deal we've tried and it is almost impossible to manage. With so many carbs it's hard to get the insulin dosage right, and once he is high, once he is coming down from that the digestion of the fats kicks in and he remains high through the night.

I think it would be a great thing for people to wear even just for a couple of weeks.

[+] FigurativeVoid|2 years ago|reply
I'm a T1 diabetic, and CGMs are a great tool for blood sugar management. Combined with a closed loop system, they are literally life changing.

I am glad to see an increase in access to live changing medical care for a disease that is mostly just bad luck.

[+] rkagerer|2 years ago|reply
When your smartphone becomes a critical health device to support/treat a condition I wonder how that will impact case law around things like police confiscation.
[+] UI_at_80x24|2 years ago|reply
It's worth mentioning that in Canada, you do not require a prescription to get a CGM. However only the Abbot Freestyle Libre series is available here. It cost ~$100 and last 2 weeks.

I've found it to be mostly accurate.

Placing it on the back of the arm was always a problem for me, it was constantly getting knocked/pulled, and otherwise disturbed. I had to buy adhesive patches that covered the entire unit. I later discovered that another decent place to apply them in on my chest between my collar-bone and shoulder-joint but lower (towards the nipple). I always had decent reliability/accuracy there. It also hurt less (from the adhesive) then on the back of the arm.

Having a CGM is amazing, and if you have medical coverage that will pay for it then you should get it.