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FDA clears first over-the-counter continuous glucose monitor

fda.gov

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Re: FDA clears first over-the-counter continuous glucose monitor

#121

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…

Experimenting with GCMs is by far the most useful and fun biohacks I've tried. I was part of the early beta for Levels Health.

Even if you don't suspect underlying health issues, the data provided for health optimization and gamification is worth it.

I used the GCM for 4 weeks and mostly tested how my body responds to various types of foods and meal timing. I also used an Oura ring to track sleep.

Main lessons learned: fat loading in the morning with a bulletproof (ghee) coffee didn't spike glucose and provided sustainable energy. Carbs for dinner helped with sleep but only if the meal was several hours before bed, allowing enough time for the double glucose spikes to return to baseline.

And Japanese sweet potatoes massively spike my glucose unless they're slightly undercooked. Cooking methods significantly changed how my body responded to the food.

Re: FDA clears first over-the-counter continuous glucose monitor

#122
post #95
post #3

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, o…

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.

Yeah, I feel like prices are on a downward trend the last couple years, which is great. For me personally, I try to spend absolutely as little time and effort as possible thinking about my diabetes. So having to call the manufacturer or fill out forms and receive a package (more waste) and ship a thing back (even more waste) is just too much time and effort for me to want to bother. I hope they keep improving, it's cool tech and I'd like to like it. Just not there yet.

Re: FDA clears first over-the-counter continuous glucose monitor

#123

Earlier quoted context omitted.

This is why it made me upset to see this Doctor on TikTok telling people unless you have Diabetes, you don't need a glucose monitor and making fun of people who had one. Where is the harm in getting data on how your own body deals with glucose?

False positives in medicine can cause unnecessary interventions that carry their own risks. Believe it or not, there is an optimum level of ignorance for maximum health.

What sort of risky false positives and interventions are you anticipating from knowing glucose levels?

Re: FDA clears first over-the-counter continuous glucose monitor

#124
post #43

Earlier quoted context omitted.

What happens when an officer confiscates your glucose monitor today? I assume you die and they claim they did it for some valid reason or the other.

Type 1 diabetics have been managing their insulin for decades with occasional blood sugar testing - i.e. certainly not testing for every dose. They’d be fine to manage things for a period without a confiscated monitor.

Hi, Type 1 diabetic here.

I can fast for days, my blood sugar does not go down.

On my last 4 day fast, my blood sugar stayed within about 20Mg/Dl.

And no, I cannot manage without my medical devices. Or are you telling me that I should fast for the entirety of police custody?

Re: FDA clears first over-the-counter continuous glucose monitor

#125

Earlier quoted context omitted.

Sadly it will probably receive very little consideration.

There's a reason most regulations are written in blood.

While there is usually some big case that then defines things like this, I'm worried whether any incidents of a person dying or developing life-threatening issues due their phone being confiscated will change much. We've historically erred on the side of police exercising their power to enforce laws.

Re: FDA clears first over-the-counter continuous glucose monitor

#126

Earlier quoted context omitted.

This is why it made me upset to see this Doctor on TikTok telling people unless you have Diabetes, you don't need a glucose monitor and making fun of people who had one. Where is the harm in getting data on how your own body deals with glucose?

False positives in medicine can cause unnecessary interventions that carry their own risks. Believe it or not, there is an optimum level of ignorance for maximum health.

The unnecessary interventions are done by licensed doctors? Why?

Re: FDA clears first over-the-counter continuous glucose monitor

#127

Earlier quoted context omitted.

It would be interesting to see whether a group of 20-100 people could manually calibrate their readings by fitting their CGM readings to their fingerprick glucose readers. I wonder what the accuracy would be after a very basic personal curve fit. I do this with a lot of consumer measurement devices. Both for thermometers and scales (food, human, and cheap 0.1mg scales). As well as thermostats, like the kitchen oven.…

Calibrating my scales and thermometers would be nice. What procedure do you use for it? is it documented online anywhere?

I basically use an Excel sheet. Make a scatter plot of the "true" values on one axis, and the "measured (slightly wrong)" values on another axis. Then do best-fit to y=mx+b and manually adjust it according to that equation using my phone calculator in the future.

Some classically trained engineers may tell you the "true" value should always be plotted on the x-axis as it is often considered to be the more "independent" variable...but this is highly debatable, and you can skip some simple algebra later if you put the measured value on the x-axis. Then look at the shape of the scatter plot. Ideally it will be linear, so you ask Excel to do a linear curve fit (y=m*x+b). Write this on the scale, and now whenever you take a measurement on the scale, whip out your phone and do "measured_value * m + b". And that's your true value. If it's not a linear fit (quadratic, log, etc) ... that's interesting, and often it's likely "wrong", but also "it is what it is". Classically trained engineers will say you have to do a linear fit if that's what the theory says is appropriate, but for one-off home device calibration...do whatever works for you. Just as long as you don't overfit with some stupid 4, 5, 6, etc-term equation. Any reasonably simple equation with 2-3 terms is fine IMHO.

I use a set of heavy objects whose mass I know fairly precisely. They're not perfectly 10.000lbs, 20.000lbs, etc ... they're just "around 10lbs, around 20lbs" and I've used a good actually-calibrated scale (at work, some commercial business with calibrated scales that you can access, whatever) to weigh them and wrote their weights in sharpie on a piece of tape stuck to the objects. Ideally you'd go for around 10% increments. If the scale can weigh 400lbs, that would be every 40 lbs or so. But it really doesn't matter as long as you have enough good points around the range you truly intend to measure, and then a few outside of that target range at semi-regular intervals.

For my 0.1mg-resolution mass balance I have some actual calibration weights, but they're a relatively affordable OIML "M1" class, and did not come with expensive calibration certificates. The OIML tolerance ratings go E1, E2, F1, F2, M1, M2, M3 (from best to worst). For a 100g test weight, M1 precision gets you +/- 0.005g, guaranteed, for $50 ($135 if you want a calibration certificate). E1 gets you +/- 0.00005g at 100g test weight, for $500 ($1200 with cal cert). For smaller calibration weights like 10mg you'll generally want to go a step up from M1 (+/- 0.25mg) to F2 (+/- 0.08mg) for about $27.

For temperature, it's a bit trickier because the only "true" temperatures you can create are -6°F/-21°C and 228°F/109°C. If these temperatures are helpful to you, you can create them by pouring shitloads of salt in water and stirring+heating it until no more salt will dissolve and you just have a pile of salt in the bottom of the container. You can try to go for "0°C/100°C" using distilled water and it would probably be close enough but you can't know it exactly unless you use super pure de-ionized water and use extremely absurd lab technique (usually involving washing your glassware and tools with de-ionized water over and over for several days straight to get rid of trace contaminants).

So instead, to get "true" temperature in the range I care about, I use some thermocouples attached to a high-quality multimeter or oscilloscope. Then I calibrate these thermocouples using the method above, and average their reading for the oven temperature. This works and extrapolates well enough outside the range of calibration because the error of a thermocouple is basically guaranteed to be a very linear error.

In this link[0] topics 1-6 ("weeks") get into the fine details of all this and provide some worksheets/excel sheets already made up for this type of thing. If you're really getting into the weeds with this, understanding propagation of error[1] really helps but is super unnecessary for 99% of people unless they're doing actual engineering.

0: https://pages.mtu.edu/~fmorriso/cm3215/laboratory_exercise_s...

1: https://pages.mtu.edu/~fmorriso/Pintar_Error_Analysis_or_UO_...

Re: FDA clears first over-the-counter continuous glucose monitor

#128

Earlier quoted context omitted.

The other insane thing is studies have shown that type 2 diabetes can be reversed by fasting. Fasting is problematic to the medical industry because it is zero cost. "Some studies found that patients were able to reverse their need for insulin therapy during therapeutic intermittent fasting protocols with supervision by their physician." https://clindiabetesendo.biomedcentral.com/articles/10.1186/...

> Fasting is problematic to the medical industry because it is zero cost. No, fasting is problematic because people don't like it. Health conscious people don't understand how much resistance the average patient has to advice about lifestyle modifications, or how difficult it is to get patients to adhere to recommended lifestyle changes. A good example is sleep apnea and CPAP machines: In theory, a CPAP machine shoul…

It's also rare for a doctor to tell a person they are too fat and to lose weight. The assumption (and most cost effective solution) is that patients just want a prescription for something and be sent on their way.

US healthcare is crisis focused, not health focused.

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