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FDA clears first over-the-counter continuous glucose monitor

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

#271

I just heard about a related device from a family member who is an endocrinologist. https://www.fda.gov/news-events/press-announcements/fda-clea... First off, he had discomfort with the study methodology. Didn't go into details, but was surprised that the FDA was less conservative than himself in this case. Secondly, it has been common in his practice for someone to have an unusual event. Someone does something out o…

> But there's no way for the patient or the physician to adjust the treatment.

This does not parse. This device is for patients that are managed with oral meds and not insulin. Yes, sulfonylureas carry some risk of hypoglycemia, but not as much as insulin proper and its fast- and slow-acting friends.

If someone is on a pump, they sure as heck will be using prescribed equipment.

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

#272
post #217

Earlier quoted context omitted.

Momentary high blood sugar is perfectly fine after eating carbohydrate-rich meals.

This was down voted, but it's all about the time scale. A major pathway of transporting energy from your food to your cells is via glucose in your blood and your cells then use or store it for later. Insulin production reduces the spike, but that response isn't instantaneous. So on a second by second basis numbers that would be concerning across an hour are fine. Similarly your average over an hour post meal can be m…

Yup. A1C, which is the main diagnostic measure, due to the way it’s measured is a roughly 90 day moving average with somewhat of a recency bias.

Like most things, it’s mostly about area under the curve, as long as the extremes aren’t too much so.

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

#273
post #269

I just heard about a related device from a family member who is an endocrinologist. https://www.fda.gov/news-events/press-announcements/fda-clea... First off, he had discomfort with the study methodology. Didn't go into details, but was surprised that the FDA was less conservative than himself in this case. Secondly, it has been common in his practice for someone to have an unusual event. Someone does something out o…

This is just monitoring, not a pump. There is no learning or tuning or dosing. If it’s anything like the Freestyle I wore for a while there’s a self calibration process that takes a couple hours, but that’s per-sensor, and those get changed out every two weeks.

You are correct, I think he was talking about a different device:

https://www.fda.gov/news-events/press-announcements/fda-clea...

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

#274

Earlier quoted context omitted.

Desserts can definitely send your levels quite high but I don't think I'd qualify some biryani and naan with a reading of 80 as unhealthy. You probably ate a healthy portion and left it at that. Is 80 not well within the normal range?

He probably means it spiked 80 from where it was (e.g. 100 to 180)

Which is still pretty normal, low for a full meal if anything, if not presiding with insulin.

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

#275

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 va…

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 :|

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

#276
post #101

I don't know why modern days we get so many problems wrong. A -> B, then B -> A => incorrect In a fire, we see firefighters, that doesn't mean firefighters cause fire. In diabetic patients, we see high glucose level. That doesn't mean eating high GI food causes someone to have diabetes. If we look at the Blue Zone, many people eat mostly carb. So carb/high GI food definitely doesn't cause diabetes. Devices like this…

Glycemic index is only sort of useful for people who actually have diabetes, where blood sugar dysregulation makes insulin regulation equally as precarious. For anyone who doesn't have diabetes, GI doesn't really mean anything other than that their insulin may or may not spike in a short period of time related to a food. Glucose spiking, hence insulin spiking, is not something you want, but this also doesn't mean that something with a lower GI score is better for you and doesn't cause you to release as much insulin. Whether it's table sugar or whole grain pasta, they'll become glucose that the body will use or store in one way or another. Fasting glucose will still remain higher.

> Devices like this will make other people fearful of high glucose and think they're getting diabetes.

Elevated glucose is exactly what causes type 2 diabetes. Take away the glucose supply, and you don't have elevated insulin. Fear of glucose that is too high too often is entirely justified and is not something that should be going on if people can avoid it. Sugar molecules are damaging to cells and are related to other things like cardiovascular calcification.

> If we look at the Blue Zone, many people eat mostly carb.

So-called "Blue Zones" are not science. They are anecdotal, cherry-picked, uncontrolled, and can't be tested. Also, some of those zones, such as Okinawa, are mythical. Okinawans historically have eaten a lot of pork, and still eat a ton of pork. They also used to not keep much in the term of birth records, so there was really no way to know how old any of those people were back when they were studied.

> So carb/high GI food definitely doesn't cause diabetes.

Propose a model of type 2 diabetes that doesn't involve dysregulation of blood glucose and come back to us.

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

#277
post #10

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.

"In other countries"... right... opening it up to a market of 340 million people with rampant metabolic problems is what's special about it.

80$ a pop for 2 weeks and most people cannot access it long enough

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

#278
post #101

I don't know why modern days we get so many problems wrong. A -> B, then B -> A => incorrect In a fire, we see firefighters, that doesn't mean firefighters cause fire. In diabetic patients, we see high glucose level. That doesn't mean eating high GI food causes someone to have diabetes. If we look at the Blue Zone, many people eat mostly carb. So carb/high GI food definitely doesn't cause diabetes. Devices like this…

> If we look at the Blue Zone, many people eat mostly carb. So carb/high GI food definitely doesn't cause diabetes.

While obesity is known to be the greatest risk factor for T2DM, you can induce insulin resistance in weight-stable individuals just by shifting the macro composition of their diet towards saturated fat:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5291812/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171936/

Sugar, amusingly, doesn't seem to have the same effect.

Given that the typical recreational CGM wearer (in my experience) is a low-carb/keto type (who ruined their insulin sensitivity), you should probably take the comments in this thread touting CGM use with a grain of salt.

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

#279
post #101

I don't know why modern days we get so many problems wrong. A -> B, then B -> A => incorrect In a fire, we see firefighters, that doesn't mean firefighters cause fire. In diabetic patients, we see high glucose level. That doesn't mean eating high GI food causes someone to have diabetes. If we look at the Blue Zone, many people eat mostly carb. So carb/high GI food definitely doesn't cause diabetes. Devices like this…

Glycemic index is only sort of useful for people who actually have diabetes, where blood sugar dysregulation makes insulin regulation equally as precarious. For anyone who doesn't have diabetes, GI doesn't really mean anything other than that their insulin may or may not spike in a short period of time related to a food. Glucose spiking, hence insulin spiking, is not something you want, but this also doesn't mean tha…

> Elevated glucose is exactly what causes type 2 diabetes. Take away the glucose supply, and you don't have elevated insulin. Fear of glucose that is too high too often is entirely justified and is not something that should be going on if people can avoid it. Sugar molecules are damaging to cells and are related to other things like cardiovascular calcification.

No, it doesn't: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6602127/

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

#280

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 va…

What kinds of food intake/non-intake habits aside from the obvious culprits surprised you?

Long-term they will likely make no changes because human desire, habits and behaviors are rarely unknown to us.

The parent comment mentioned feeling tired after consuming something with a lot of sugar, was that really a mystery prior to using CGM? I doubt it.

Sure it's interesting to correlate to your perceived wellness (or lack thereof) with a wearable spitting out data but after the novelty of this discovery wears off my guess is that people will simply stop caring to check what they already know to be the case.

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