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FDA authorizes first wearable device that monitors ketone and blood sugar levels

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Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#101
post #88

Ketones are only going to be present if you are exceptionally bad (very high carb diet) or exceptionally good (very low carb diet) at managing your blood sugar. It's not going to be terribly useful for your average diabetic who has fairly good control over their blood sugars.

> your average diabetic who has fairly good control over their blood sugars

I think it's huge for diabetics. It's a mental toll for them. They hate having to constantly prick themselves to take readings. It's awkward, inconvenient and you have to do it multiple times to be sure you got a good reading. And worse of all, it's possible to forget to take a reading when you need to.

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#102

So she was merely ahead of her time.

You should understand the difference between taking a single drop of blood and trying to run a battery of tests on it, and sticking a probe into your extra cellular matrix to continuously monitor changes. It’s small, but it’s having a constant shifting flow of fluid at all times so it’s getting far more than one drop.

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#103

Automated glucose control will be the next frontier in so many areas of healthcare. I'm still skeptical that anyone will be able to noninvasively and accurately sense blood sugar, but I'm glad people (especially kids with T1) will have one more tool to help them. I hope they can figure out the reimbursement side to get it into the most hands possible!

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Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#104

Does anyone know if something like this is required to be approved by the FDA? Like if someone were to make one for the hobbyist/weight loss market, would that even be legal?

It depends on intended use. If it is to diagnose, cure, treat, or prevent a medical condition then it is a medical device that may need approval. If it's not intended for anything medical, it doesn't need FDA approval. For example, clinical thermometers are class II medical devices, lab thermometers aren't medical devices at all. If the device were genuinely only marketed for general wellness, it would be exempt.

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#105
post #48

Automated glucose control will be the next frontier in so many areas of healthcare. I'm still skeptical that anyone will be able to noninvasively and accurately sense blood sugar, but I'm glad people (especially kids with T1) will have one more tool to help them. I hope they can figure out the reimbursement side to get it into the most hands possible!

> Automated glucose control will be the next frontier in so many areas of healthcare. What areas do you have in mind outside of diabetes management?

"management" is the key word. Early diagnosis might help a lot not just with T1 but also T2.

Early diagnosis would save a lot of pain and suffering... and money.

I worked with an older T1 and apparently a bit less than half of kids diagnosed with T1 are diagnosed unconscious during a DKA event in the ER. "Treatment" cost, or at least requested revenue LOL, is at least $30K for an ER visit like that, and it also costs at least some months (years?) off their expected lifespan.

Figure about 0.5% of the population in the USA is T1, you read stuff like "about two million T1 diabetics" in the USA. So early T1 diagnosis would save the country overall about $30B just in DKA treatment alone at time of initial diagnosis.

If you could screen an entire population for less than $30B total lifetime cost, it would be financially rational to prescreen for T1 rather than waiting for ambulances to present incredibly sick kids. And potentially profitable.

Prescreening the entire population for metabolic disorders is quite plausible as a "tech startup idea" as the alternative is waiting for them to arrive in an ambulance while extremely sick/nearly dead. Lets say it could be done for $10B, leaving $10B for startup profit (charge insurance companies $20B which is not bad....) and $10B in lowered health care costs for the country in general, not to mention less suffering in the population. A win-win scenario.

IF blood sugar related disorders could be pre-screened for less than $10B total cost. A solid "maybe"? Plausibly a startup doing blood sugar prescreening would be a "multibillion dollar company" although not a trillion dollar unicorn. Still a good idea.

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#106
post #48

Earlier quoted context omitted.

> Automated glucose control will be the next frontier in so many areas of healthcare. What areas do you have in mind outside of diabetes management?

Cardiac surgery, burn units, ICU, neuro come to mind. All have been studied to show mortality and complications improvements with AGC, but unfortunately the commercial technology has not materialized yet.

Why is a hospital setting so different that AGC can not be used? Or is the temporary use of such not yet approved?

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#107
post #91

Earlier quoted context omitted.

That's what I thought too, until I got my last bloodwork results and started wearing one of the OTC continuous glucose monitors. That device helped a lot to switch diet habits.

Can you be specific about what your bloodwork results showed and what special insights your CGM gave you and what behavioural changes it led to? My anecdotal experience from doctor colleagues giving CGM to patients is that it does 3/5ths of fuck all to everyone except those with actual insulin dependent diabetes (T1 or T2) because when you get down to it the insights aren’t that great and most people actually aren’t…

I did it for a month and learned what kinds of things led to spikes and what did not and it wasn’t always obvious without the monitor.

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#108

Earlier quoted context omitted.

They are specifically relevant to trying to enter a fasted state. The presence or absence of ketones in your blood can tell you whether or not (say) that coffee you just drank took you out of the fasted state (that you were in for not eating overnight). Whether or not you are in a fasted state matters not just for weight loss, but also for things like longevity (when you are in a fasted state your body cleans up dead…

whether or not (say) that coffee you just drank took you out of the fasted state A cup of coffee has zero carbohydrates, trace lipids, and about half a gram of protein. That's not going to pull anyone out of a fasting state. Now, if you're talking about a cup of flavoured milk, that's a different question...

I think I drink coffee but I really drink lattes…

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#109
post #91

Earlier quoted context omitted.

That's what I thought too, until I got my last bloodwork results and started wearing one of the OTC continuous glucose monitors. That device helped a lot to switch diet habits.

Can you be specific about what your bloodwork results showed and what special insights your CGM gave you and what behavioural changes it led to? My anecdotal experience from doctor colleagues giving CGM to patients is that it does 3/5ths of fuck all to everyone except those with actual insulin dependent diabetes (T1 or T2) because when you get down to it the insights aren’t that great and most people actually aren’t…

Seeing just how much rice can impact your blood sugar is eye opening. Sticking to a "half the normal amount" of rice when eating Indian/Asian food can help a lot with blood sugar. And keeping blood sugar in check _seems_ to have a fair amount of researching backing up the idea that it's healthier and makes you feel better

Re: FDA authorizes first wearable device that monitors ketone and blood sugar levels

#110

As someone who has to deal with type 1 diabetes every day, this is marketing nonsense. No one needs ketones in the sensor - we need high-quality sensors, and Abbott's are only mediocre at best. They are not as bad as Dexcom, which is appalling, but they are still far from the superior quality of Medtronic/MiniMed which measure glucose exceptionally well. Ketones are rare. They can kill you, but before that happens, y…

I tend to agree that making the sugar measurements more robust is worth more than measuring the ketones at all. However, low sugar and high ketones can happen. And just getting notified when ketones pick up can be worth something too. The additional measurement is not useless seen from my perspective.

As an example: I was on a study that gave T1D patients Dapagliflozin (Farxiga). During the study, while on a long hike, I was hovering at low sugar and consequently insulin supply was mostly cut off for an extended period. As I started to to feel unwell, I measured ketones. I was briefed as preparation for the study to measure ketones when something seems wrong. Otherwise I wouldn't have thought of measuring ketones. Might not even have carried the kit.

On that occasion, the ketones were way above 1 mmol/l: a very high value. Protocol would have required me to call the study doctor due to the high level. Since it was a Sunday, I spared her, shot some insulin, ate a sandwich, and continued my hike. I could do that because I was not alone on that hike. I knew that if my situation deteriorated, somebody would be around to call rescue.

At the study debriefing I mentioned the incident and they said that adding to the effect of the Dapa, I was probably dehydrated, which led to the rare situation of both low sugar and high ketones.

All in all I think that if the sensor makers exhaust possible improvements for the glucose, it can make sense to add the ketone measurement as a safeguard. Having high sugar can have many reasons, and it often takes me a while to get to measuring ketones. Getting the signal of rising ketones, I would react faster a few times a year in situations where my insulin supply is broken.

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