I think the differentiator here is T2 usability vs T1 usability. No doubt, for a T2 it could be something worthwhile and the vast majority of diabetics are T2 who are not insulin dependent and don't test often. Likely, that is who Apple would be targeting (T2's) until the non-invasive tech is there to get it FDA approved for dosing decisions.Most? I think you're giving glucose meters more credit than they deserve.
Are Blood Glucose Meters Accurate? New Data on 18 Meters
Results from the Diabetes Technology Society’s Blood Glucose Meter Surveillance Program identifies only six out of 18 meters that passed. Did yours make the cut?diatribe.org
Difference there is Apple Watch numbers will theoretically be provided through continuous monitoring. How many diabetics actually test multiple times a day? I'm Type 2, non-insulin and I just test in the morning and before bed. That's it. In between, it's a major hassle to test.
I can see how results from an Apple Watch could be helpful as an early warning for severe lows and highs that would otherwise go undiagnosed. Kinda like a nudge to check/verify blood sugar levels with a blood glucose meter and then take steps to correct (or avoid in future).
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Apple Watch Series 8 Suppliers Developing Blood Glucose Monitoring Components
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On this point, I definitely agree. As a Type 2 trying to manage diabetes mostly via diet and exercise, an Apple Watch with non-invasive glucose monitoring would be very helpful.
Besides, wouldn't most (all?) Type 1s be eligible for an actual CGM anyway?
My insurance is with Kaiser and I don't meet their requirements for CGM (probably because the tech is still expensive) so I can't get one prescribed.
I've looked into getting CGM OTC and just paying out of pocket. Alas, it seems in the US, you can't get CGM without a prescription.
I'm in the same boat as you: T2, managed with diet and exercise. Can't get a CGM because I'm not on insulin. (I have Medicare not Kaiser, but that's the requirement for every insurance I know about in the USA.) Can't get a CGM OTC because I can't get a prescription.
For some reason, the medical community long ago decided that diabetics with T2 don't need to test very often... maybe just fasting in the morning and an A1C every few months. No surprise that T2 was seen as always progressive and uncontrollable. Of course it was. Testing is needed for control. I think that's gradually starting to change — more in other countries than here. Hopefully we'll catch up soon.
Until then, even a vague sense of what's going on could be helpful if, as I mentioned before, the ranges are defined. It's not just different ranges for diabetic vs non-diabetic. What's "high" before a meal is different than what's "high" after one.
P.S. to the person who suggested I ask my doctor for strips... Thanks, I guess. I've had the discussion about how much I test multiple times with my doctor. I never said I couldn't afford to buy extra strips. That was not the point of my post.
That is interesting. I have definitely seen a paper before, when researching something, that gave an opposite impression.
Quite a few, going by my experience on diabetes forums. A lot of people will test before and two hours after meals to see how they respond to certain foods, and really try to micromanage the post-prandial readings. This is especially true of those on low carb high fat diets who want to avoid medication and go into remission.
Here in the U.K. it is not routine to offer glucometers on prescription for those not treated by insulin or medications which risk hypos, supposedly because it is considered unhelpful. It is not just a financial thing as even self-funding is heavily dissuaded. Sadly from my experience on forums that reason seems true, as people try to manage to the decimal point (in mmol/L) and get paranoid over every little thing. Sadly there are always enough people on the sites that will tell new people it is something they need to do and it just causes confusion and fear.
Instead non-insulin-treated diabetics get education courses and, with pre-diabetics, get an HbA1c test every three months until under control, then every six months to monitor progress. Which is more reliable than spot readings anyway, which can have multiple causes affecting them.
Based on your linked page saying how inaccurate many standards compliant glucometers are, would you really trust an Apple Watch that is even less accurate?
On the other point, that will depend on the country, and obviously Apple will want to be ablw to include this feature in as many as possible and not just the U.S. But here in the U.K it is still pretty difficult to get C.G.M. on prescription. Essentially it requires a specific medical condition or intensive testing requirement to qualify.
I do feel it will be eventually opened up more. It is not that much more expensive than providing test strips in the volume required by those on M.D.I. insulin, at least with the FreeStyle Libre system. And the benefits of better control, and being able to upload data that can be reviewed by a hospital team so reducing the number of appointments required, will show it to be more beneficial overall.
And those forum members probably number in the thousands at best. A drop in the bucket compared to the millions diagnosed with diabetes. I've only been diagnosed recently and wanted to try monitoring before and after meals but emergencies that kept cropping up at work put an end to that.
Problem with just relying on A1C, you can have uncontrolled diabetes and still get okay A1C results.
Trust but verify. I've still got the regular morning and evening finger sticks to compare with Apple Watch results.
Also, I keep a glucose meter in my purse so in case of a severe low or high, I can verify if the Apple Watch readings are correct. The difference here being I wouldn't even be aware of these episodes if I just relied on 2x a day finger sticks whereas I would get a warning with CGM or flash glucose monitoring via Apple Watch.
Besides, we don't know yet how accurate it will be. It could very well provide reasonably accurate results even if Apple doesn't get FDA approval initially. Non-invasive doesn't translate automatically to crappy.
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Consider the FreeStyle Libre 3 is already approved in Europe just a couple months after the FDA approved the FreeStyle Libre 2. Does that mean the Libre 3 is inaccurate? Nope. Just means the FDA is slow.
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There are two forums I am thinking of and are recommended for people to visit by healthcare professionals, though. And one of them belongs to the U.K.'s main diabetes charity. You are right only a tiny percentage sign up, and of those only a tiny percentage become regulars, but a lot more will read them even if only once.
As for your HbA1c example, that seems to apply to diabetics who are being treated and how that is managed.
For undiagnosed people having regular random hypos would be uncommon. But these would be necessary to counter the highs to keep the average in the normal range, and for as long and by as much as they are high.
Even if that is happening, someone would have hypo symptoms and seek help for those, as to naturally lack hypo awareness would also be rather unusual. Probably they will also be having symptoms of the highs too, though I have never felt a high (and have tested over 30 mmol/L / 540 mg/dL a couple times).
So the number of people like to be missed by an HbA1c test is extremely small. And the small amount by which they go low and high would likely fall within the margin of error of testing to make the Apple Watch unlikely to help them. (Because if the highs are highs are particularly high then the lows would need ot be particularly low to cancel them out on the HbA1c, and that would see them hospitalized.)
Besides, we don't know yet how accurate it will be. It could very well provide reasonably accurate results even if Apple doesn't get FDA approval initially. Non-invasive doesn't translate automatically to crappy.
Wave of the Future: New Glucose Technology Could Revolutionize Care
For decades, researchers have sought to develop a noninvasive method to measure blood glucose levels, which – if effective – could revolutionize diabetes care. One company in Israel now has such a device in development. Learn about the origins of this technology, its early success, and what this...
Consider the FreeStyle Libre 3 is already approved in Europe just a couple months after the FDA approved the FreeStyle Libre 2. Does that mean the Libre 3 is inaccurate? Nope. Just means the FDA is slow.
But what some of us have been arguing is that if Apple's testing is that accurate, regardless of whether they are registered as a medical device, they will have made a product that would revolutionize testing and that no medical company has been able to achieve. How likely does that seem?
Even accepting that may Apple have uniquely come up with a method of reasonably accurately measuring blood glucose levels, would they just keep that as an Apple Watch feature rather than spin it off for use in actual medical devices? Does Tim Cook really want to be seen as the next Shkreli, someone that can offer safe monitoring but forces the requirement of an Apple Watch and iPhone to use it? And especially in hospitals, where C.G.M.s are increasingly used alongside testing.
And current C.G.M.s work by measuring interstitial fluid, so as well as having lower accuracy than finger prick testing, they are also delayed. Showing what the blood level was around ten minutes ago at best. So the revolution that Apple's testing would bring would not simply be that it is non-invasive but that it would be allow continuous monitoring of blood glucose.
We do not know how accurate Apple's technology will be, but we can reasonably assume it will not too accurate or it would be developed as a medical device and not a consumer watch feature.
Unusual but it happens. By chance, I was setting up the bluetooth connection on my dad's glucose meter to his iPhone so he took a midday reading he normally wouldn't. The result was 54 mg/dL but he said he wasn't feeling any symptoms. Tested again after a minute and it was 49 mg/dL so he had a snack. He still doesn't test midday so I wonder how many hypo episodes he's had that we just don't know of.
Apple's not the only one working on this. Pretty sure I read somewhere that Google is, too (they own Fitbit now) plus the companies who specialize in medical devices. We don't know who'll be supplying the sensor to Apple and whether it will be exclusive to Apple or be made available to others. Honestly, I'm quite doubtful about the AW8 getting it. I expect it's still too early.
As for consumer watch vs medical device, FDA approval takes years. If it does come to fruition, Apple could generate billions of revenue from the new Apple Watches before the technology is approved for medical use.
Apart from diabetics, there are also the health and fitness enthusiasts who are interested in tracking blood glucose data.
Heck, there are (expensive) services providing CGM (FreeStyle Libre) to non-diabetics.
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For Apple, I'd say profit is a very good reason to put it on the Apple Watch.
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Sorry, I was only referring to non-diabetics. It is not unusual for diabetics who experience them to lose hypo-awareness. I am fully aware of mine, but I have gone from no one caring about me hypoing so long as Ia m aware of them (while obviously trying to avoid them) to my current doctor considering having more than three per year to be a problem!
But most non-diabetic people will not go low unless it is caused by a health problem or they do intensive fitness work without loading up first. So they will not be frequent enough for the body to get used to them, as they would have sought help or adjusted their diet before reaching that point.
I am not sure I am ready for (or believe in) a world where hospitals and clinics tell people that an consumer watch is better able to monitor glucose levels than they are,
I hope this is true I’d buy one in a minute. Not to mention all the money being saved from buying test strips which are at least $1.00 each and that’s with insurance. You’ll get your money back in 1 year easy.
Plus being able to test any time when your out and at work. No need to carry your meter with you.
Plus being able to test any time when your out and at work. No need to carry your meter with you.
NICE, the public health body in the U.K. which produces guidance on clinical practice, released their draft updates on glucose monitoring today.
They intend to recommend that all T1 diabetics be offered real-time continuous glucose monitoring. And those with T2DM who are treated with an M.D.I. regimen and also have issues associated with finger prick testing (hypo awareness, extensive testing requirements etc.), should be offered flash monitoring. Whilst it is only advice, it does form the basis for prescribing decisions by the local health boards, and is something patients can use to contest funding decisions.
I do not what proportion of T2 diabetics need basal-bolus insulin, but it is possible that by the time the next Apple Watch is released, many of those requiring insulin in the U.K. will already have access to free C.G.M. anyway.
Quite possibly anything Apple come up with will not be medically certified in the U.K. and unavailable here simply because there will be no business case for them to apply for it.
They intend to recommend that all T1 diabetics be offered real-time continuous glucose monitoring. And those with T2DM who are treated with an M.D.I. regimen and also have issues associated with finger prick testing (hypo awareness, extensive testing requirements etc.), should be offered flash monitoring. Whilst it is only advice, it does form the basis for prescribing decisions by the local health boards, and is something patients can use to contest funding decisions.
I do not what proportion of T2 diabetics need basal-bolus insulin, but it is possible that by the time the next Apple Watch is released, many of those requiring insulin in the U.K. will already have access to free C.G.M. anyway.
Quite possibly anything Apple come up with will not be medically certified in the U.K. and unavailable here simply because there will be no business case for them to apply for it.
You probably are spot-on right with respect to diabetes about which I know little. But there are other issues which can cause hypo- and/or hyper-glycemia such as issues with thyroid hormones, and teprotumumab (used in Thyroid Eye Disease). And poor control of blood sugar can affect the management of thyroid hormones.
Add them up, that could be a lot of people who might well wish to know their blood sugar levels. I suspect quite a number would not be eligible for whatever NICE advises and would be willing and able to pay. Although I am less affected than many by thyroid issues, I am one who would like to have some ability to monitor my blood sugar.
The possibility of this sort of function is one reason I have, yet again, decided not to buy an Apple Watch for now.
(Also, as a technicality, NICE officially applies in England with each of the other three nations sometimes diverging from that guidance.)
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