Apple Has 'Secret' Team of Biomedical Engineers Developing Sensors for Non-Invasively Monitoring Blood Glucose

[M.PaulCezanne]

A non-invasive blood sugar monitoring device would be certainly be welcome if it's consistently accurate, but that's a big IF.

In a related note, I wonder if someone should study the effects of all these watch sensors being beamed into our wrists. Sure the FDA isn't supposed to approve anything that's not "safe and effective" but hey, we know that doesn't exactly appear to be a strict rule, does it?

 

[SHirsch999]

I wish this type of information didn't get leaked. Samsung and Microsoft are now going to rush crappy imitations to market and say they did it first.

For something like this even crappy tech is still tech moving in the right direction. A lot of what's happening with diabetes technology is occurring at the grass-roots level, forcing the FDA's hand and showing the tech companies what can and what needs to be done.

 

[scottinlexky]

Sign me up!

(Type 1 Diabetic for 45 years)
(And before you go there, I was 3 when I got it. T1D is when your pancreas stops producing insulin)
(Oh yeah, I have a Class 3 Medical from the FAA too...)
[doublepost=1492042124][/doublepost]
or Dexcom... as well as Tandem Diabetic Care...

how hard was it to get your class 3 from the FAA? I too an type, since the age of 2, so 43 years here myself, with a pump and CGM.

 

[SHirsch999]

Do you use the Dexcom insulin pump with it? I used to have the Medtronic insulin pump but it was more of a pain to use. It wasn't very accurate so I also had to carry around an extra glucose tester. Eventually I just went back to syringe and tester.

There is no Dexcom insulin pump. Some of the pump companies have the Dexcom CGM technology integrated directly into their pumps, but Dexcom doesn't make their own pumps.

 

[Lepton]

The watch would pay for itself within a year just from not buying meters, expensive test strips and related supplies!

 

[Chupa Chupa]

Apple's work on glucose monitoring is said to have started with former Apple CEO Steve Jobs

Obviously. TC doesn't have the entrepreneurial spirit or creativity to hatch such an idea. Let's hope he can at least not screw it up and make it happen. As much as he doesn't want FDA approval Apple will have to if it wants to sell it as a medical device. I can see Apple making a specific model for this purpose so the consumer line progress isn't impinged.

 

[SHirsch999]

I have a feeling a lot of Apple fans are going to half-know a whole lot about diabetes technology all of a sudden.

Are you being sarcastic or just going out of your way to show your ignorance. As you can see from the previous 46 posts in this thread alone, there are a lot of people with diabetes (or are close to them) as well as medical professionals on these forums. I happen to be in both of those categories, being the father of a child with type 1 DM and being a doctor. So, yes I do think I know a whole lot about diabetes technology and am well within my rights to discuss them here. Just because you are ignorant doesn't mean there aren't a lot of others here who's opinions and knowledge aren't helpful.

 

[NT1440]

I wish the forums had a good search function, I was talking about this team two years ago. I have no idea why this is suddenly news again....

 

[CaryMacGuy]

Do you use the Dexcom insulin pump with it? I used to have the Medtronic insulin pump but it was more of a pain to use. It wasn't very accurate so I also had to carry around an extra glucose tester. Eventually I just went back to syringe and tester.

I use an AccuChek Combo pump. I used to have Medtronic but I traded it in. I wished that I had stuck with the Medtonic. I have been very disappointed with the AccuChek. However, even with the Medtronic, I used my Dexcom. I tried the Medtronic CGM and it was terrible. It never stayed connected and it was always inaccurate.

 

[mdelvecchio]

Sigh...

I'm an Anaesthesiologist/Anaesthetist. I cannot see any way that blood glucose can be measured directly and accurately in a non-invasive way. Not physically possible and you sure as hell aren't going to detect glucose with 'light' in vivo.

Pulse oximeters measure the differential absorption of two wavelengths of light through the pulsatile component of blood to determine the haemoglobin saturation (which doesn't tell you the full story about actual oxygen carrying capacity - ie. you might be anaemic). To properly check 'blood oxygen levels' you absolutely, positively need a blood sample.

The sensor on the Apple Watch simply measures the pulse by the varying absorption of light with each pulse (green or infra-read) and it's far from perfect. Are we going to suggest that we can base clinical decisions (or patient's can manage their insulin regime) with a non-medical-grade device? I don't think so...

Even if it were possible it's one thing to collect the data, and another thing entirely working out what to do with it all. For diabetics it's useful. For the rest of the population it's a complete waste of time. You don't need to constantly measure your blood glucose levels during the day.

All this just reeks of techno-narcissism with a good dollop of the Dunning-Kruger Effect helping drive it.

Phew, it's a good thing we have you to speak for all apple customers! Who better to represent us than Dr. Sleepy Time!? And if you, an anaesthetist can't think of how to do something, it surely CANNOT BE DONE! Send Cook the memo, will you!? "Waste of time, guys, sorry. I can't think of how to do it, so....shut 'er down."

Man, the hubris.

 

[JeffyTheQuik]

how hard was it to get your class 3 from the FAA? I too an type, since the age of 2, so 43 years here myself, with a pump and CGM.

A few things I tell anyone that will get an SI (Special Issuance) Class 3 Medical:
1. Contact an AME (Aviation Medical Examiner) for a consultation appointment for Type 1 Diabetic. This will get you rolling on what you need, which is:

1. The applicant must have had no recurrent (two or more) episodes of hypoglycemia in the past 5 years and none in the preceding 1 year which resulted in loss of consciousness, seizure, impaired cognitive function or requiring intervention by another party, or occurring without warning (hypoglycemia unawareness).
2. The applicant will be required to provide copies of all medical records as well as accident and incident records pertinent to their history of diabetes.
3. A report of a complete medical examination preferably by a physician who specializes in the treatment of diabetes will be required. The report must include, as a minimum:
   1. Two measurements of glycosylated hemoglobin (total A1 or A1c concentration and the laboratory reference range), separated by at least 90 days. The most recent measurement must be no more than 90 days old.
   2. Specific reference to the applicant's insulin dosages and diet.
   3. Specific reference to the presence or absence of cerebrovascular, cardiovascular, or peripheral vascular disease or neuropathy.
   4. Confirmation by an eye specialist of the absence of clinically significant eye disease.
   5. Verification that the applicant has been educated in diabetes and its control and understands the actions that should be taken if complications, especially hypoglycemia, should arise. The examining physician must also verify that the applicant has the ability and willingness to properly monitor and manage his or her diabetes.
   6. If the applicant is age 40 or older, a report, with ECG tracings, of a maximal graded exercise stress test.
   7. The applicant shall submit a statement from his/her treating physician, Examiner, or other knowledgeable person attesting to the applicant's dexterity and ability to determine blood glucose levels using a recording glucometer.

Note: Student pilots may wish to ensure they are eligible for medical certification prior to beginning or resuming flight instruction or training. In order to serve as a pilot in command, you must have a valid medical certificate for the type of operation performed.

It was a stack of paperwork about 1/2" thick.

Then, after you have all of this, do a "real" AME visit with your form 8500-8 (Form for getting a Medical) and 8500-7 (Eye exam - the normal Ophthalmologist one we get every year) in hand, plus the treadmill test, and your endocrinologist's letter. Once you do the "real" AME visit, the clock starts ticking, and you have a time limit on getting the tests done.

Thus, begins the process... It will get deferred to Oklahoma City, and after about a month, start calling them. Mine took 11 months from start to finish, and once you have it, with BasicMed, you have it for life (or as long as you follow the BasicMed guidelines).

Amazingly, my insurance (I have really, really good insurance, but check anyway...) covered all of the tests, but not the AME visit (around $100, depending on where you live).

Recertification under Class 3 is pretty simple, compared to the initial one. Don't get an ambulance called to your house for diabetes related stuff, and see your endocrinologist every 3 months. My A1c is 6.1-6.3%, so that helped too.

Here's a couple of places to start:
AME guide: https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/guide.pdf
Web Guide for Diabetes:
https://www.faa.gov/about/office_or...guide/dec_cons/disease_prot/diabetes_insulin/

One last thing... You can consult with Dr. Brian Chien over at the AOPA site. He's kind of frustrated with me, because I didn't do exactly what he said*, but he's eminently qualified to give advice.

*Where I work, we have an AME that spent a half hour looking at my paperwork, and said, "send it in!". Dr. Bruce disagreed, and I figured I had nothing to lose, so I did.

 

[dernhelm]

I have honestly little or no interest in purchasing an Apple watch. But if this ever happened I would definitely buy one. I have a feeling that's true for a lot of people. Apple's stock would skyrocket if they could pull this off and it really worked.

 

[guzhogi]

I really like how Apple is making it easier to do fitness/health tracking. Researchkit seems like a great idea. Make it simple and widespread to join and do medical research, and medical researchers gain that much more data. If Apple doesn't want the watch to go through the FDA process, maybe watchbands? Also, open up the little connector thing so that 3rd parties can make their own medical wristbands.

 

[JeffyTheQuik]

Don't spend your time on people like this, useless.
[doublepost=1492079988][/doublepost]

They already have dogs sniffing for cancer on an experimental basis.

Go to http://servicedogacademy.com/wp/training/coopers-puppy-manners-impress-seattle-diabetes-crowd/
Cooper is mine.
[doublepost=1492087642][/doublepost]

Every day I LIKE TO EAT two buckets of chicken wings, one grass fed beef steak, a big bag of french fries, 8 egg whites for breakfast, a big bottle of coca cola for drinks and a glass of detox tea. I LOVE TO complain about high priced medications and need to control my blood sugar. Great that Apple is here to help me. Trusted company ! I will eat a large Big Mac menu to celebrate !

There are at least two types of diabetes.
T1, which is where your pancreas stops making insulin. I was 38 lbs and 2 weeks from my 3rd birthday when I got it.
T2, which is where your body doesn't use insulin as well as it used to. A significant portion of people that have this are overweight, but there are also other factors, like heredity (African Americans and American Indians have a higher number percentage-wise, regardless of weight or BMI)

I'm sorry that you have this perception and feel a need to castigate all diabetics with this broad brush.
[doublepost=1492087737][/doublepost]

Special Issuance?

Oh yes... and 1/2" stack of papers, and an 11 page letter to OKC.

It only took 11 months to get, from original appointment to issuance.

But I am grateful to those that reviewed my application and saw that I was able to control my diabetes.
[doublepost=1492087817][/doublepost]

Basic Med on May 1st.

For those reading, you still have to get the SI (Special Issuance), and then you're covered by BasicMed.

I'm going to be flying with CAP, and they haven't figured out what they're going to do about BasicMed, so I'm going through the re-cert drill now.
[doublepost=1492087961][/doublepost]

Coming up on 28 years for me in June, diagnosed when I was 12. I would LOVE LOVE LOVE this technology. How it can be approved sans FDA is a mystery to me, but let's go!

I imagine it can be done through the bands and the super secret ports on the side. That way, only the band has to be certified.
FDA certification wasn't needed for the Apple Watch when Dexcom used it for displaying the blood sugars, but if it's part of the hardware, then, maybe it does...
[doublepost=1492088287][/doublepost]

Do you use the Dexcom insulin pump with it? I used to have the Medtronic insulin pump but it was more of a pain to use. It wasn't very accurate so I also had to carry around an extra glucose tester. Eventually I just went back to syringe and tester.

I use the Tandem pump. Exciting things are in the pipeline for them, like Dexcom integration and then automatic dosing in 2018/2019. Plus, with Dexcom, now you can dose off of the readings with the G5 technology. From what I hear, G6 will require calibration once every 1 or 2 weeks.
[doublepost=1492088587][/doublepost]

I use a Dex as well and have the complication on my watch too. But would be interesting to see a product that was skin surface only, rather than the sensor fiber in our flesh.

I wish the Dexcom complication could be used in workouts too. Nothing like riding the bike home, and then seeing my blood sugar at 70 and double arrows down... :O

 

[Tycho24]

I wish the forums had a good search function, I was talking about this team two years ago. I have no idea why this is suddenly news again....

Usually when you have these types of curiosities; you can just read the related article.
(for your convenience; it is always those few paragraphs immediately preceding the comments you are making)
It appears that this team is "suddenly" in the spotlight again due to the fact that they are currently conducting clinical trials of the tech they've been working on over the two years since you were last talking about them.

 

[JeffyTheQuik]

Non invasive? You need the actual blood to get accurate blood measurement.

Surprisingly, even the commercial blood glucose meters aren't that "accurate", with 10% error rates. The CGM's out there measure interstitial fluid to get their readings, and I'm surprised at how close they are to the fingerstick readings. Maybe sweat or other micro-fluids that come off your body has the same qualities?
[doublepost=1492089077][/doublepost]

I'd rather they work on a Touch ID sensor and multitouch screen that will work with wet fingers & underwater.

Walk
Chew gum

They can do two things at once.
[doublepost=1492089155][/doublepost]

There's some kid on YouTube who had a call (ans swears by it!) from someone who works at Apple and according to them watchOS 4 will unlock the ability to record blood glucose on existing watches as the sensors are already there. We've all heard this rumour since day one. Personally I can't imagine this is correct whatsoever but you never know. Perhaps the sensors do exist but the implementation is just not accurate enough to get past the appropriate authority body.

Dexcom already puts that into the Health App every 5 minutes, when you have it paired to your iPhone.

 

[OneMike]

Apple should have a "secret" team of engineers making a USB-C iPhone. Because no one wants Lightning.

I don't see this happening in the near future. Will force Apple to take profit cuts in all those cables.

I would love to see it though

 

[JeffyTheQuik]

Better...

Add a caloric intake sensor that alerts the wearer: "It's time to stop eating."

Stop diabetes before it begins.

Crap... I should have stopped eating those Oreos when I was 3, but my brother gave them to me, and they tasted so good.

Not all diabetics are Type 2. Heck... you think with a moniker like "Type 2" there had to be a "Type 1."

Yeah, I can snark back, and when my blood sugar is 140-180, it gets ruthless.
[doublepost=1492089704][/doublepost]

For those interested in the clinical aspects, what gets measured is glucose in the subcutaneous interstitial fluid (ISF). As others have stated, measuring ISF glucose has been around for awhile, but not in the form of a mainstream product for a variety of reasons, including consistency and reliability because ISF glucose levels lag behind blood glucose levels and can vary between different parts of the body. The lag/latency of ISF glucose is due to the time it takes for glucose to travel through capillaries into tissues, so the lag time can vary from 10-20 minutes.

For more, see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769894/ and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2903977/

My opinion:

• this could be very useful for early detection and management of Type 2 Diabetes (T2D), much less useful for Type 1 Diabetes (T1D);
• The US Centers for Disease Control (CDC) calls T2D an "epidemic" (https://www.cdc.gov/chronicdisease/resources/publications/aag/diabetes.htm) that will eventually affect 100 million Americans, so a watch that could help that population could be very, very popular

Something else to consider: with the ongoing healthcare debate in the USA, what are the implications for a third of the US population to develop a pre-existing condition called diabetes? Are "risk pools" a viable approach with that many people in them?

I'm not sure what you mean by "mainstream"... I guess since a doctor needs to prescribe a CGM, that my hinder the mainstreamity of it. However, for this T1D, having a interstitial fluid BG measurements that I can just pull up on my Apple Watch, like I do currently, is a lifesaver. This is mainly due to the rate of change indications it gives. With finger sticks and syringes, my best A1c was 7.5%, and with the pump and finger sticks, it improved to 7.0%, and with the CGM, it's been consistently 6.1-6.3%.

Plus, my coworkers and family have the ability to see my blood sugars as well.

 

[smirking]

Non invasive? You need the actual blood to get accurate blood measurement.

It doesn't have to be the gold standard to be useful. Even if they can manage to make this accurate within 20%, it could be useful to people who are borderline diabetic or have it well controlled. I doubt this is ever going to be anything that is going to replace a continuous glucose monitor or finger stick readings just like I don't think chest strap heart rate monitors are going away anytime soon for people who are serious about HR tracking during high intensity exercise.

Man, the hubris.

Quite frankly, I think he's got good reason to be skeptical. This does smell like something that's improbable. Being an anesthesiologist doesn't mean he knows everything, but it does mean that he most likely knows more than you or me about certain things (like the science behind obtaining vital signs).

I'm hopeful they can come up with something modestly accurate, but if this were a kickstarter, I'm hanging onto my money.

 

[JeffyTheQuik]

You obviously aren't up to speed on physiology & biochemistry. It's not possible... but it's amazing how much people think just throwing 'smart' and lots of money at a problem will somehow magically fix it. It's bordering on religious fanaticism.
[doublepost=1492054362][/doublepost]

Yes, and to measure that (inaccurate) level requires breaking the skin - ie. *invasive*.

I don't know... maybe Apple will link a little needle stab to the 'Stand Up!' warning at 10 minutes to the hour? :eyeroll:

100 years ago, when your kid got T1 Diabetes, you might as well start planning their funeral, then Banting and Best discovered insulin.
45 years ago, when I got T1D, it was "you're going to die before you reach 30" It was Regular and NPH for me.
Blood sugar tests were too expensive for home use. I did the Clinitest, with the fizzy tablets and urine.
Then, came the BG strips.
Then came the BG meters.
Then came Novolog.
Then came insulin pumps that were affordable.
Then came CGM, which you couldn't dose by, but everyone that is diabetic did. (BTW, my Cgm is usually 1-3 mg/dl from the fingerstick reading)
Then came CGM, which you can "legally" dose by.
Now, Dexcom is working on a CGM that has to be calibrated every 1-2 weeks (don't have the exact number)

My vision for this is to have the sensor not penetrate the skin, like the Dexcom/Minimed/others, but be on the surface. You calibrate it, until the technology becomes so that you don't have to.

I guess it comes down to hope, which is the most magical and irrational of things. It sees the good in the bad, and the promise of better things to come. It drives our minds to be creative and not see things how they are, but how they should be. Our minds are even more incredible. In the last 6000 years, we have come from the caves with life expectancies of 20-30 years to seeing people that are 100 as not that uncommon.

 

[yanki01]

type 1 since 2008 and would love something new. i feel technology in diabetes is behind. i do have a dexcom g5 so i can read it on my watch but will always welcome something new.

 

[rp2011]

Are you being sarcastic or just going out of your way to show your ignorance. As you can see from the previous 46 posts in this thread alone, there are a lot of people with diabetes (or are close to them) as well as medical professionals on these forums. I happen to be in both of those categories, being the father of a child with type 1 DM and being a doctor. So, yes I do think I know a whole lot about diabetes technology and am well within my rights to discuss them here. Just because you are ignorant doesn't mean there aren't a lot of others here who's opinions and knowledge aren't helpful.

whoah whoah whoa relax. You're barking at the wind. You've gotten your panties twisted over imagined nonsense.

I'm sure you're a half-expert in psychological medications though.

 

[JeffyTheQuik]

There is no "dexcom insulin pump", though there is at least one that will show the value from a dexcom sensor on the screen. The dexcom g5 sensor (the current one) is being used on all of the automated insulin pumps that are being trialed except the medtronic one. I had a medtronic one before and it was always off and a lot of sensors had to be tossed because inserting them made me bled. I've been happy with dexcom, I've been using them through 3 generations of their products.

The current dexcom g5 works on its own, sending the blood sugar to your iPhone and then to your apple watch if you have one. It pairs to your phone via bluetooth. After you change the sensor you attach the transmitter to it and hit a button in the app, after 2 hours it asks you to calibrate it with 2 blood sugars. After that it needs to be calibrated twice per day. The sensor needs to be replaced every 7 days though they can be restarted. Lots of people have luck going 2-3 weeks with the same one but I haven't gotten more than 10 days out of one before it went wonky.

Their software can generate reports which also suggest some patterns that need adjustment. I would never go back to syringes but it would work just fine without a pump. Insurance companies don't like to cover it but medicare just approved coverage of it and usually the insurance companies will follow medicare's lead.

Every time Minimed calls me, I tell them that their CGM engineers fell in love with their design, and are unwilling to make it physically better. I too went with Dexcom with the 7, and never looked back.

 

[Rafterman]

I commend them for this research, but "through the skin" solutions for anything are often iffy. For example, delivering insulin with one of the needle-less guns isn't recommended due to differing skin thickness and diffusion rates - you might not get the insulin level dialed up, I have to think the same thing in reverse is true too - reading blood through the skin would end up in possible data loss/skewering, based on numerous factors that differ between people.

But then again, people a lot smarter than me are working on these things, so who knows. It would be an amazing thing if they pull this off.

 

[BoulderAdonis]

You mis-spelled hypochondriacs.

You mis-spelled "fitness". If people in general were more aware of how what they *ate* affected their blood sugar levels, and insulin response - we might be able to reduce the obesity epidemic, and increase the general health of the population.