I did not understand the apparent anomaly between Tim's comment that Apple does not want to get into things that require FDA approval, and yet is developing the Apple Watch to read blood sugar.
Does that mean the glucose sensors will not need approval?
There is NO way a glucose monitor will not need FDA approval as diabetics lives depend upon accurate readings.
I wouldn't read too much into past statements by Tim , he's in the position of having to comment on subjects he really does not want to talk about .
IF this glucose monitoring system actually works and can be implemented on a Apple Watch I think it's a real game changer. Even people that don't have diabetes will be interested in watching how their blood sugar fluctuates during the day and what foods make it react.
Cheers to the longs.
It's more than a game changer. If they can actually accomplish this, it will be one of the great medical breakthroughs. Not only because of what it would actually do, but because this has been tried, for a LONG LONG TIME, and nobody has been able to do it yet.
My son has had Type I diabetes since he was a few years old and it's now 20+ years later. We've been waiting for this holy grail of non-invasive blood glucose monitoring for more than two decades.
The key term here is "non-invasive". All (as in, "all") current blood glucose monitoring is invasive, whether this is traditional finger-prick with a meter; or the more modern systems, introduced over the past few years by Minimed and others, which can monitor interactively (but still, invasively) using another "line", just as someone's insulin pump (typically something like the Minimed system is used in tandem with that) requires an invasive "line" to deliver insulin underneath the skin.
All existing blood glucose monitoring systems have disadvantages, which are an additive burden that has extended, essentially, forever into the horizon - because nobody has been able to solve the non-invasive problem.
- Invasive, you have to puncture the skin. There is "some" pain involved. (With that said, the pain of fingerprick measurements diminishes pretty rapidly and for most people who do this multiple times per day, physical pain isn't an issue; the fingers get calloused and lose sensitivity). 4-6 tests per day, ~15000 pricks a year, 150,000 over 10 years, you get the idea). For things like the Minimed or Dexcom systems, the invasiveness still exists but is less frequent.
- There is the ongoing cost of consumables. For fingerprick measuring, the supplies are lancets, meters, and strips. For the other system, there are more advanced and expensive supplies. This cost is significant; much of it may be covered by medical insurance, but the cost is still there.
- Type II diabetics will typically test less frequently and use only fingerprick tests with a meter, but the burden still exists for both invasiveness and cost of supplies. Many with Type II test less often than recommended for either or both of those reasons.
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All companies which have attempted to provide non-invasive blood glucose measurement over the years have all failed.
Apple has the cash and technical know-how (whether homegrown or acquired) to do this, if anyone can. If it was prohibitively expensive for anyone else to do it (pick a number, lets say, $1 billion), then who else would have or risk that kind of money on it? Not any of the smaller companies that have tried this over the past 2-3 decades. As far as funding, Juvenile Diabetes Research Foundation has raised and donated (tens of?) millions towards research over the same decades but here we are, decades later and the holy grail still exists.
This is not the only "holy grail" of diabetes - the most important search has always been for a CURE - but non-invasive monitoring, with no cost of consumables, in conjunction with an insulin pump would be a huge improvement in the daily lifestyle. Eventually, an Apple Watch that accurately monitored blood glucose COULD also be used, optionally, to control dosage through an insulin pump, providing a least-expensive "closed loop" system that would be a functional equivalent of an artificial pancreas. (Closed loop systems are already available from Minimed etc but as I mentioned earlier: the monitoring component is invasive and has consumables and cost that go along with it; and there's the "extra" of having another site attached, for monitoring, in addition to the site for insulin delivery. Not everyone with Type I and an insulin pump wants that extra component).
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If an FDA-approved Apple Watch existed today (or next year; or the year after);
that would non-invasively monitor blood glucose;
that would not need consumables;
that would have some additional price premium attached (but still, it would cost? in the $hundreds)
that would have the same sort of usable battery life as the regular Apple Watch;
The market for this would be huge. It would be a game changer. Everyone with diabetes, Type I or Type II, would get one. They'd be crazy not to. Even if insurance didn't help pay for it. (BUT, it would)
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For those who don't have diabetes: with a properly functioning pancreas, there should be little, if any, fluctuation in blood sugar, so there wouldn't be any value in monitoring (or at least, not if you needed a special Apple Watch model to do this, and likely at additional cost)... although there could still be value in it for the non-diabetic as a warning mechanism, just as heart rate monitoring in the existing Apple Watch can be a valuable warning for serious issues (rapid or irregular heartbeat etc).
If it was a different model (and you'd think that it "would" be), I don't see a market for non-diabetics.