Apple has an amazing opportunity given the history of these devices.

Another T1D here with 2 decades direct experience with Medtronic, Tandem, Dexcom, and Abbott. I'm an outlier, but that doesn't make this story less empirical. I've got many years of data to prove it and while I can't match real autonomy's millions-of-points-per-second firehose, I do have years of hundreds of point-per-day.

It's n-of-1 for sure, but one way of looking at that is just that there's a lot of latency on the data gathering, particularly in emerging stories in healthcare where the entire system is weaponized against the truth reaching wide audiences, but I digress. Back to the objective facts vs. the subjective reality.

I'd just like to confirm the findings here in that it's a wicked problem, just like T1D:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529400/

The fact that CGM or non-invasive requirements follow suit should be of little surprise to anyone.

It's challenging enough that I wore 2 CGM's concurrently over the past year: Dexcom G6 and Freestyle Libre 2. They both have poor data veracity, particularly at the times that I need them most - when fasting; that would be sleep and exercise. Both critical periods for any diabetic. I should know because the former put my T1D brother-in-law in an early grave.

I realize that some people have great success with these devices and that's something we should celebrate. However, we should not celebrate the fact that there are legitimate lawsuits against these companies. I've been outspoken about the risks given my family history, exercise, and experience working in medical devices that have a history of injuring patients:

https://en.wikipedia.org/wiki/Therac-25#Problem_description

https://www.11alive.com/article/news/investigations/the-reve...

The amount of time that I spent on the phone with Dexcom support was excessive and frequently at all hours of the night since the problem would present with alarms that cannot be disabled and are able to disable do-not-disturb mode on the smart phone and sound like an alarm system from the Austin Powers series.

That leaves the patient with two choices: tolerance (which is unrealistic at 3 AM) and powering the phone completely off, which silences it while having the side effect that alarms can't save the patient from potentially life-threatening hypoglycemia given that alarms emanating from the Tandem t:slim X2 alone are not sufficiently intense to wake me.

Dexcom has responded to this crisis by following the letter of the law: since I first reported the problem, they have replaced 2-3 dozen sensors under warranty while following the typical corporate communication playbook of not admitting design flaws or any legal culpability while not admitting the rather serious problem of the fact that, when the G6 is used in concert with a hybrid closed loop system such as the Tandem t:slim X2, inaccurate sensor readings on the low side have the potential to underdose the patient, and inaccurate sensor readings on the high side have the potential to overdose the patient. This is because near-autonomous, near-realtime basal rate adjustment is responding to sensor measurement that can often be at odds with reality and not closely monitored at times like sleep and exercise.

This isn't just theory!

I've seen both of these scenarios play out while exercising and sleeping - two events that cannot be precluded, are frighteningly difficult to handle given failures in the aforementioned design of the alarm system, and no one at either Tandem or Dexcom seems to admit, document, or address which is distressing given that these are FDA-regulated devices in markets that aren't Therac 25 but have the potential to end badly in large populations.

I've tried to alleviate the problem by wearing two different CGM sensors concurrently. I wore an Abbott Freestyle Libre 2 from spring through fall 2022 in addition to my Dexcom G6 where I have little choice given the joint venture design chosen by Tandem. That has done little to alleviate the problem since both sensors tend to move in parallel showing the same inaccurate readings in fasted states around sleep and exercise.

Worse, the only evidence I've seen that anyone in the mobile software design side of equation understands the problem is xDrip and the various people working in OpenAPS:

https://scholar.google.com/citations?user=rt1_gOgAAAAJ&hl=en...

https://jamorham.github.io/

I don't believe they are getting the attention, credit, or remuneration they deserve.

I hope that the situation does not turn out like American insulin pricing, where the first person to perish not being able to afford insulin was documented several years ago:

https://www.snopes.com/fact-check/alex-smith-died-couldnt-af...

If we think social media needs regulated, I'm pretty sure what we call healthcare in the United States qualifies for better regulation than that given FDA's lack of oversight.