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Apple Watch Blood Glucose Team Gains New Lead

jz0309 said:
Type 1 diabetics depend on accurate blood glucose data for insulin intake. a "general" high or low doesn't do anything for them, it also does nothing for Type 2 diabetics, it might be useful for those with pre-diabetes though.
So for accurate CGM (continuous glucose measurement) it becomes a "life or death" medical device, thus high regulatory scrutiny.
The whole premise here is to not rely on intrusive sensors anymore, so sensor in the watch alone.
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They’re all general readings. The FDA approval for finger stick meters and CGMs is to be within 15% of a lab result… but only 95% of the time. You might see this yourself, if you stick yourself 3 times and get 3 different readings… 98, 104, 109. That’s all fine. With a CGM, the context is more important. Maybe you’re at 140 before a meal, but what was it 15 minutes ago? 30? Is it going up? Falling down? When did you eat last? These should all factor in to how you use that info to calculate the correction you give yourself before you eat.
 
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jz0309 said:
Type 1 diabetics depend on accurate blood glucose data for insulin intake. a "general" high or low doesn't do anything for them, it also does nothing for Type 2 diabetics, it might be useful for those with pre-diabetes though.
So for accurate CGM (continuous glucose measurement) it becomes a "life or death" medical device, thus high regulatory scrutiny.
The whole premise here is to not rely on intrusive sensors anymore, so sensor in the watch alone.
Click to expand...
I don't think the CGM sensor would be considered invasive. High regulatory classification is also dependent on what the device was approved to be used for. That's why I said would an Apple CGM if approved as a general wellness device but NOT to be used as a diagnostic device without the correlative reading of another approved device. This is where knowing WHAT level of approval is being requested and having to think through FDA guidance on what is constituted as a general wellness device.

I work on investigational devices and drugs as part of my living but not necessarily the entire gamut. But when I get the time, I'll read through general wellness device guidelines again and parse them out with the idea of a CGM as general wellness.
 
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msackey said:
I don't think the CGM sensor would be considered invasive. High regulatory classification is also dependent on what the device was approved to be used for. That's why I said would an Apple CGM if approved as a general wellness device but NOT to be used as a diagnostic device without the correlative reading of another approved device. This is where knowing WHAT level of approval is being requested and having to think through FDA guidance on what is constituted as a general wellness device.

I work on investigational devices and drugs as part of my living but not necessarily the entire gamut. But when I get the time, I'll read through general wellness device guidelines again and parse them out with the idea of a CGM as general wellness.
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It depends on the implementation. If it breaks the skin (needle) then it is invasive. Things like infection prevention then become significant. A device like a pulse oximeter is non-invasive.
 
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Apple needs to get in gear. There are a number of Chinese/no-name Fitbit clones that do BP and CGM now. I bought one. BP seems to always be spot on with the BP cuff at the house. CGM is way off compared to the finger stick. The trend is there with Glucose going up and down after meals and while I sleep but usually 60 points too low. Not anywhere close enough to be useful for a diabetic. BUT it seems to be getting a reading that follows the trend which is decent first step.

Oh, when Apple gets it figured out, I will be first in line. Tried the invasive CGM (DEXCOM and Freestyle Libra) and they do not stay or get in the way for me. My wife loves hers with no issues
 
msackey said:
Maybe this is pedantic but it was this year that I learnt there is a difference between blood glucose monitoring and continuous glucose monitoring (CGM). I work in the health field. CGM is an estimate of your blood glucose because it isn't actually accessing your blood, but rather the glucose of the fluid that is between cells. Here's how NIH describes it: "CGM sensors estimate the glucose level in the fluid between your cells, which is very similar to the glucose level in your blood" (https://www.niddk.nih.gov/health-in...naging-diabetes/continuous-glucose-monitoring ).

In other words then, measuring the glucose of the fluid between cell spaces is a surrogate for blood glucose.

My question then really is whether the development of glucose monitoring in Apple Watches would be measuring the actual blood glucose, or whether it is measuring a proxy such as fluid glucose.
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Do we have any research showing that blood glucose is a better thing to measure than fluid glucose?

Is it possible that the fluid glucose actually ends up being a better thing to monitor? And that we only measure blood glucose because we have no ready technique for measuring fluid glucose.

In some other areas, we are seeing some interesting differences between blood levels of substances and those in, say, cerebrospinal fluid.
 
It's funny how an article about glucose-testing devices turned into a conspiracy theory thread!
I'm a Type 1 diabetic (late onset in early 2020, before the 'vaccine') and use a CGM for monitoring my glucose. I don't have to have a prescription to buy them here in NZ but they are rather pricey (but soon to be funded by the government, yeah, go socialism!). If the watch was accurate it would be an instant buy for thousands like me and a hell of a lot cheaper than a conventional CGM.
 
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iZac said:
I wish Apple hurried up with this thing, I’ve wanted to get one for my type 2 diabetic mum from the moment I heard about it years ago!
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Theranos hurried up and ruined it for everyone. We want Apple to take longer than we want to get it right. If Apple screws this up, we won't see anything like it for another 5-10 years.
 
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macmac30 said:
Rockley had an investor slide deck that heavily suggested they were deep in bed with Apple (as well as many other tier 1 companies)
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There are LOTS from these small R&D businesses that CLAIM, in their slide decks & investment briefings, that they are closely corroborating and coordinating with top tier big name corporations. So much of that is often just hot air. Basically it’s just a scam wrapped in a real nice shiny package. You always need to do you own due diligence, never just trust what someone tells you.
 
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macmac30 said:
Rockley had an investor slide deck that heavily suggested they were deep in bed with Apple (as well as many other tier 1 companies) on the development of their non-invasive blood glucose monitor solution. I believe they stated Apple had spent $75M investigating this with Rockley. Then Rockley went bankrupt and all my shares went "poof"...
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Apple doesn't like it when their suppliers call them out by name, so that was just plain dumb on Rockley's part.
I worked for a company that made a chip for iPhones, we were not even allowed to use the company's name in internal meetings, they were referred to as "Company X" ...
 
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Crowbot said:
It depends on the implementation. If it breaks the skin (needle) then it is invasive. Things like infection prevention then become significant. A device like a pulse oximeter is non-invasive.
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Just off the top of my head there’s an exception for blood sampling when applied to diagnostic procedure and diagnostic device:

21 CFR 812(f):
Noninvasive, when applied to a diagnostic device or procedure, means one that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive.
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I don’t know if FDA guidance has additional text about fluid sampling such as that of CGM.

As you might know, regulations and guidances from the FDA work together in complex ways to define the regulatory landscape for devices.
 
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TSE said:
I just want an Apple Watch that insults me, tells me to work on my love handles and lose the jelly rolls, and to man up. How difficult is that?
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I could make an app that does that :p.

In all seriousness though, this would be an absolute game changer for everyone. It would almost guarantee most diabetics would buy an Apple Watch. I use the FreeStyle Libre sensor and I've always wished it'd last more than 2 weeks at a time, but I do like the convenience of not having to prick my finger. Not having to change a sensor every 2 weeks would be very nice and having it integrated into the health app, again, big game changer.
 
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polyphenol said:
Do we have any research showing that blood glucose is a better thing to measure than fluid glucose?

Is it possible that the fluid glucose actually ends up being a better thing to monitor? And that we only measure blood glucose because we have no ready technique for measuring fluid glucose.

In some other areas, we are seeing some interesting differences between blood levels of substances and those in, say, cerebrospinal fluid.
Click to expand...
I have not heard of this before because it is blood glucose that we are measuring for diabetes. It’s a biomarker for that. The cellular fluid is a proxy for blood glucose. That’s as I understand but I could be wrong.
 
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