Don't use a smartwatch or smart ring for blood glucose monitoring just yet

Posted:
in Apple Watch

As more wearables promise noninvasive ways of measuring your blood glucose levels, the Food and Drug Administration has gone on record saying the technology hasn't earned its seal of approval.

Apple Watch health tracking
Apple Watch health tracking



On Wednesday, the FDA released a statement warning patients against using smart rings and smartwatches that claim to measure blood glucose levels non-invasively, citing fears of inaccuracy. It suggests that patients do not buy devices for this purpose and instead continue to use traditional devices that require a patient to prick their skin.

And the FDA makes a good point -- individuals with diabetes rely heavily on accurate blood glucose measurements to manage their condition. However, if these measurements are incorrect, it can lead to serious errors in diabetes management.

For instance, taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose can result in dangerously low glucose levels. This can lead to mental confusion, coma, or even death within a few hours.

Apple has shown interest in adding noninvasive glucose monitoring to its flagship wearable, the Apple Watch. In 2021, a series of patent applications showed Apple was developing terahertz electromagnetic radiation sensors, which would would allow the Apple Watch to monitor glucose levels non-invasively.

In February 2023, it was reported that Apple had reached the "proof of concept" stage.

In September, Apple's vice president of platform architecture in charge of developing Apple Silicon, Tim Millet, was assigned to head the Apple Watch glucose tracker project.



Read on AppleInsider

Comments

  • Reply 1 of 19
    Honestly speaking... I never understood why we need this function.. 
  • Reply 2 of 19
    avon b7avon b7 Posts: 7,661member
    Honestly speaking... I never understood why we need this function.. 
    For type 1 diabetics it will be a godsend. For type 2 diabetics it should greatly help with glucose control. For the rest of the population it will be a key indicator for potential long term health issues.

    Pulling it off with enough accuracy has been very hard and I think we are near to a breakthrough. 
    narwhal
  • Reply 3 of 19
    Honestly speaking... I never understood why we need this function.. 
    Because it’s not all about you.  Hundreds of thousands of people would find this feature extremely useful.
    narwhalgrandact73watto_cobraStrangeDays
  • Reply 4 of 19
    Honestly speaking... I never understood why we need this function.. 
    You may want to look in to the massive numbers of people who had no idea they had heart conditions until they put on Apple Watch.
    narwhalwatto_cobra
  • Reply 5 of 19
    If Apple or some other company can pull this off, it will be a windfall for that company. If Apple succeeds, it should create a new product line separate from the watch just for glucose monitoring devices.
    watto_cobra
  • Reply 6 of 19
    Honestly speaking... I never understood why we need this function.. 

    Keep me from dying.
    watto_cobraStrangeDays
  • Reply 7 of 19
    flydogflydog Posts: 1,123member
    Honestly speaking... I never understood why we need this function.. 
    You meant you don't understand why you need this function right?
    watto_cobraStrangeDays
  • Reply 8 of 19
    sflocalsflocal Posts: 6,093member
    Honestly speaking... I never understood why we need this function.. 
    Obviously, you're not afflicted with diabetes then.  For many of us that do, it will be that "killer app" for the Apple Watch.  I can easily see non-invasive glucose monitoring as being a holy-grail.
    watto_cobra
  • Reply 9 of 19
    To be fair, up to this point all the health related sensors are relevant to everyone, pulse, heart, O2 level etc.

    An accurate, non-invasive glucose monitor would be an absolute godsend for those that need to keep a close eye on their sugar levels, but it isn't something that everyone needs. It would likely had a big impact on sales, with people buying it for that functionality alone, however for the rest of the population, it wouldn't be needed but might be "nice" to be able to see.. So I guess there is a reasonable argument to be made that if it's sensors require sacrificing something else, or require the watch to be bigger, or shorten battery life, that there would be two lines of apple watches, ones with and ones without the glucose monitoring.
    watto_cobra
  • Reply 10 of 19
    avon b7avon b7 Posts: 7,661member
    tangey said:
    To be fair, up to this point all the health related sensors are relevant to everyone, pulse, heart, O2 level etc.

    An accurate, non-invasive glucose monitor would be an absolute godsend for those that need to keep a close eye on their sugar levels, but it isn't something that everyone needs. It would likely had a big impact on sales, with people buying it for that functionality alone, however for the rest of the population, it wouldn't be needed but might be "nice" to be able to see.. So I guess there is a reasonable argument to be made that if it's sensors require sacrificing something else, or require the watch to be bigger, or shorten battery life, that there would be two lines of apple watches, ones with and ones without the glucose monitoring.
    I would disagree on the point regarding the wider population. 

    We can now say with relative clarity that changes in the food industry combined with lifestyle changes have led to a massive increase in sugar related illnesses which typically take many years to develop. Especially in the 'western' world. 

    My brother was overweight and happy until he had a wobbly in a supermarket and was eventually diagnosed with type 2 diabetes and told that the problems really began around 15 years earlier. 

    He is now on medication and has lost 15kg through lifestyle changes. It's a great response on his part but 'reversing' the situation, although probably possible, will take a long time and a lot of effort. 

    With today's recent discoveries related to how industrial food processing, sugar and lifestyle, a constant non-invasive glucose monitor for those apparently 'healthy' folks (combined with AI) could flag future problems years before they actually appear. 

    We don't need technology to eat well and do exercise but we know people fall into bad habits easily and a continuous monitoring system could provide a track record which can be anonimysed and used by AI to help  current and future generations.

    The other long term 'silent' illness is non-alcoholic fatty liver disease and some smartscales are trying to give indicators on that too.

    Pulling all the sensor information together for analysis could have a major impact on general health for people who consider themselves 'healthy' in spite of obvious signs that they aren't, along with reducing the cost of treating these kinds of chronic illnesses. 
    StrangeDaysmuthuk_vanalingam
  • Reply 11 of 19
    The only way to accurately test your blood sugar is by actually testing your blood, which means doing the finger prick and using a blood sugar monitoring device.  It cannot be 'good enough' because the wrong result and incorrect medicine dosage can kill you, especially if you are type 1 or have an insulin pump.  I would never trust a non-invasive method if I was feeling 'off' and needed to check my blood sugar, and I am type 2.
    watto_cobra
  • Reply 12 of 19
    I am a type 1 diabetic and have been since 1966 almost 50 years. The technology has changed so much since I started with having to boil my glass and stainless steel syringes and sharpen reusable needles. Blood sugar testing was only available at hospital visits every 3 months. I now use Abbots Freestyle Libre 2 which penetrates the skin and stays attached to my arm for 2 weeks at a time before I change it. I have to scan the device with my iPhone to get a reading (for me that's about 15 times per day),
    It is more convenient than finger pricking but nothing like as accurate. It is off either + or - 20 points on each reading when compared with a finger prick device. This is deemed normal by 'the diabetic specialist who prescribes it. 

    I wonder how much the proto-type Apple Watch sensor is off? if it's more than this the FDA is correct in not approving it.  

    I would suspect the companies that make the 2 most common current devices approved, the Freestyle sensors and the Dexcom G6 CGM have the FDA in their pockets, and the standard they impose for Apple is higher than this simply because it's 'Apple'.
    watto_cobra
  • Reply 13 of 19
    avon b7avon b7 Posts: 7,661member
    Rogue01 said:
    The only way to accurately test your blood sugar is by actually testing your blood, which means doing the finger prick and using a blood sugar monitoring device.  It cannot be 'good enough' because the wrong result and incorrect medicine dosage can kill you, especially if you are type 1 or have an insulin pump.  I would never trust a non-invasive method if I was feeling 'off' and needed to check my blood sugar, and I am type 2.
    Type 1 diabetics will not depend on anything that doesn't match the precision of a meter using a blood sample. At least for insulin injections. 

    That doesn't mean a non-invasive system is of no use to them. 

    A calibrated non-invasive device that can track trends is of use to everyone (type 1 diabetics included). Especially if a continous, but invasive, option is not feasible. Nocturnal hipoglucemia for patients (especially long term type 1 diabetics) is a real problem for those with low sensitivity who do not wake up easily after the onset of the drop in glucose levels. 

    Type 2 diabetics and people in general will benefit from real-time readings. Of course, assuming the devices themselves are accurate enough to track trends.

    All invasive CGM solutions still require pin pricks for fallback readings in case of anomalous readings. 
    muthuk_vanalingam
  • Reply 14 of 19
    avon b7avon b7 Posts: 7,661member
    DavidAI said:
    I am a type 1 diabetic and have been since 1966 almost 50 years. The technology has changed so much since I started with having to boil my glass and stainless steel syringes and sharpen reusable needles. Blood sugar testing was only available at hospital visits every 3 months. I now use Abbots Freestyle Libre 2 which penetrates the skin and stays attached to my arm for 2 weeks at a time before I change it. I have to scan the device with my iPhone to get a reading (for me that's about 15 times per day),
    It is more convenient than finger pricking but nothing like as accurate. It is off either + or - 20 points on each reading when compared with a finger prick device. This is deemed normal by 'the diabetic specialist who prescribes it. 

    I wonder how much the proto-type Apple Watch sensor is off? if it's more than this the FDA is correct in not approving it.  

    I would suspect the companies that make the 2 most common current devices approved, the Freestyle sensors and the Dexcom G6 CGM have the FDA in their pockets, and the standard they impose for Apple is higher than this simply because it's 'Apple'.
    My wife uses the Libre 2 too. Although not a match for a real blood sample meter it has helped her cut down massively on pin pricks and helped manage swings when things get out of control. 

    Great for night control as well. 
  • Reply 15 of 19
    tangey said:
    To be fair, up to this point all the health related sensors are relevant to everyone, pulse, heart, O2 level etc.

    An accurate, non-invasive glucose monitor would be an absolute godsend for those that need to keep a close eye on their sugar levels, but it isn't something that everyone needs. It would likely had a big impact on sales, with people buying it for that functionality alone, however for the rest of the population, it wouldn't be needed but might be "nice" to be able to see.. So I guess there is a reasonable argument to be made that if it's sensors require sacrificing something else, or require the watch to be bigger, or shorten battery life, that there would be two lines of apple watches, ones with and ones without the glucose monitoring.
    with a sensor like this, a lot of people will use the readings to modify their lifestyle and avoid type 2 diabetes as a result. Half of older adults have either diabetes or pre diabetes. 
    StrangeDays
  • Reply 16 of 19
    Honestly speaking... I never understood why we need this function.. 
    For the Muggles (non-diabetic folk), blood sugar monitoring can help with weight management.  I was a thin non-controlled Juvenile* Diabetic, and when I got in control without changing my eating habits, but using insulin to bring my blood sugar down, my weight went up.  The take away from that is that there is a corresponding insulin dosage to weight gain relationship.  Now that I’m losing weight, the weeks I’ve used less insulin have a larger weight loss.

    So, at least for me, and maybe you, knowing if you have sharp rises in blood sugar that result in more insulin being delivered by your pancreas (assuming that you have a working one) can work with your weight management.  


    *(I’ve had it for 52 years, so readers, please don’t lecture me on T1/T2)
  • Reply 17 of 19

    Rogue01 said:
    The only way to accurately test your blood sugar is by actually testing your blood, which means doing the finger prick and using a blood sugar monitoring device.  It cannot be 'good enough' because the wrong result and incorrect medicine dosage can kill you, especially if you are type 1 or have an insulin pump.  I would never trust a non-invasive method if I was feeling 'off' and needed to check my blood sugar, and I am type 2.
    But even the one touch can be off if we don’t wash our hands…. But yeah, when the Dexcom is off, I do the finger stick.
  • Reply 18 of 19

    avon b7 said:
    Rogue01 said:
    The only way to accurately test your blood sugar is by actually testing your blood, which means doing the finger prick and using a blood sugar monitoring device.  It cannot be 'good enough' because the wrong result and incorrect medicine dosage can kill you, especially if you are type 1 or have an insulin pump.  I would never trust a non-invasive method if I was feeling 'off' and needed to check my blood sugar, and I am type 2.
    Type 1 diabetics will not depend on anything that doesn't match the precision of a meter using a blood sample. At least for insulin injections. 

    That doesn't mean a non-invasive system is of no use to them. 

    A calibrated non-invasive device that can track trends is of use to everyone (type 1 diabetics included). Especially if a continous, but invasive, option is not feasible. Nocturnal hipoglucemia for patients (especially long term type 1 diabetics) is a real problem for those with low sensitivity who do not wake up easily after the onset of the drop in glucose levels. 

    Type 2 diabetics and people in general will benefit from real-time readings. Of course, assuming the devices themselves are accurate enough to track trends.

    All invasive CGM solutions still require pin pricks for fallback readings in case of anomalous readings. 
    By “accurate”, the OneTouch is pretty much the standard for finger stick tests, and >75mg/dl, 100% of readings are within 15%.  What this means is when it reads:
    100, it can be 85-115
    150:  127.5 - 172.5
    200:  170 - 230

    All of this follows the bell curve, but for both Dexcom and finger sticks, the Dexcom is 20% above 80 mg/dl.

    https://support.onetouch.com/s/article/OneTouch-Ultra-Test-Strips-Performance-Accuracy-And-Statistics
  • Reply 19 of 19
    so far, I have used a few smart watches for glucose, uric acid, cholesterol, blood pressure/heart rate, and BMI.bodyfat %. I have a health and fitness obsession, so I'm always curious how my body is responding to what I do and diet changes.

    The blood glucose measurements have been way off, the uric acid is way off, the cholesterol measurement is surprisingly accurate (no idea how the heck they can do that), the heart rate is spot on, and the blood pressure is dead-on accurate for the systolic (top) number, but the diastolic (bottom) number always reads 10-15 points higher than it is. I test blood pressure often during the day upon waking, during and after exercise, in moments of sedentary nothingness, when working on projects, etc. I also use a cuff to test in the morning and at night. Systolic has always been accurate and. diastolic has always. been 10-15 points higher than reality. BMI/bodyfat % reads high compared to professional measurement, but not crazy far off. 

    I just had a thorough blood test on Friday and received results online today through Quest and the most recent watch failed big time regarding uric acid and blood glucose measurements.

    If someone can figure out glucose monitoring on a watch, they'll take the crown. Same thing goes for blood pressure.
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