FUDiabetes

Future of Diabetic Engineering

Dexcom and Xdrip+ are great tools for managing Diabetes. In the interview given by Dexcom CEO Kevin Sayer:

“You’ve got to understand, medical device companies and hacking, those two concepts don’t go together well. So we were very upset and we were pretty aggressive speaking out that this is not a good thing.

“But in all reality, the hackers are Dexcom patients. They purchase product from us, they’re so dedicated to it that they use it and try to make their lives better by developing tools that they think are better than ours. The right answer for this community is to put the features into the system that they want to make it better and make it more usable for them. We have ideas to help this community and ideas to embrace and engage them.

“Now let’s go to the flipside of that. The FDA is concerned about this and they’re going to regulate this. I see a day where, maybe not of our own choice, we will have to tighten up our product to whereby that doesn’t happen. And if FDA requires it, we will.”

It seems that he is using “CEO-speak” in order to advocate for the death of the open source community. To me this is unacceptable as the Dexcom software doesn’t allow the user to control their own data or alerts and hides info from the user (ie transmitter battery levels…) that gets shipped back to the corporation. Given that many new sensors stay in the lower ranges for the first couple of days or can have accuracy issues, not controlling alerts prevents users from sleeping and leads to associated blood sugar/health problems.

Labeling the open source engineering as “hacking” gives bad connotations too since the software developed by the community has rigorous testing and transparency and has led to the improvement of the proprietary software. As an engineer, I am much more comfortable using products that I understand and can modify. The purpose of CGM is to deliver blood sugars, not control the entire user experience while extracting as much money from their bank account as possible.

Alex Azar (head of Dept. Health) is anti-diabetic and responsible for dark lobbying efforts and the quadrupling of humalog prices and its associated effects. As such, the FDA’s relationship to Dexcom is not aligned towards helping the patient.

What can be done to improve these issues?

4 Likes

@MarkP
Thanks for the thoughts. Welcome to FUD and great first post!

A lot of the things he said are cringe-worthy. I did not get to where I am by following the diabetes rules.

Things the FDA has a say in - such as the Medtronic 670G BG targets in the first and only commercially available closed-loop system (the only commercial system that adjusts for both high and low BG) - are completely inferior to home-grown solutions.

These comments put a chill-wind on the future of what we can do with it.

I think a big indicator will be what Insulet and Tandem are able to do with their closed-loop systems. How hard did they push against the FDA? That will be an important thing to see.

2 Likes

I disagree. I read this as the CEO is looking at what he perceives as being the likely future. If the FDA tells Dexcom they have to do something than Dexcom has to do that. The alternative is for Dexcom to fold up and go out of business.

It is not the place of Dexcom to fight the FDA.

2 Likes

@MarkP Welcome to FUD! I think we are pretty much fully aligned on this subject.

I don’t think that there is any way that a for profit company under the thumb of the FDA can come close to doing what the open source community has accomplished. XDrip+ probably is what Dexcom software will look like–in ten years if ever.

When I was a kid going to school we had honors classes for kids who were more able. These days those honors kids are just as likely to be held back by the lesser able kids. That’s Dexcom’s philosophy. They want to hold back the patients who want to work for more and better.

If the open source development is purposefully held back I think there will be a rebellion in the diabetic community.

4 Likes

Thank you, I think that it is important to realize that there isn’t a one type fit all formulaic approach towards t1d management.

I remember speaking with a nutritionist who told me that my approach towards dieting would never work. I asked her how many of her patients had a1cs less than 5.3 and she said 0.

Xdrip+ is beautiful software and has taught me a lot about community driven development. It is much better than 99% of what I have seen in corporate settings.

4 Likes

You found the right place @MarkP.
:grinning:
Glad to have you here.

2 Likes

I tend to agree. I think the “FDA made us do it” is a great cover for tightening the grip on their products and locking out the open source community.

1 Like

With that being said, the FDA could require it, but the good news is there is usually paperwork that proves it. Saying it without publishing the letter would be tantamount to what you are suggesting. That is what open record requests are for.

3 Likes

Thank you. Yes, I just think that it’s tough to worry about the moving goalposts and that there should be paths towards being able to manage one’s own technology whether it be through waivers or course certifications.

2 Likes

I totally agree, but honestly diabetes is one of the few places where the successful patients need to self manage to an unbelievable degree as well as self adjusting a “dangerous” drug. This is pretty unusual in the medical model and expecting the FDA to adjust, is asking a lot. Hopefully someone in a key position has a T1 kid so they get it.

5 Likes

This is what I was talking about. The FDA and companies like Dexcom are only concerned with the patients of the lowest common denominator, who find it almost impossible to be successful.

Those of us who are so successful in self management are left to have the open source community to make our journey better.

3 Likes

That was the 8G wasn’t it? It was said that some change had made is so that xDrip+ couldn’t do a restart, but then xDrip+ was apparently modified so that it could, or the original report was false, then the 8H came out and, apparently, it just works.

If Dexcom wanted to stop restarts from xDrip+ they could by revisions to the transmitter, but then they would probably lose something that obscures bugs in their own transmitter and controller (“receiver”) software not to mention the Dexcom approved apps.

If the FDA wants to mandate no restarts or even no control by non-authorized apps it could and Dexcom might be able to achieve it. However the FDA would be stepping outside its jurisdiction if Dexcom did not release a US-specific transmiter; it would be globally regulating medical devices and it would be doing so for the benefit of US corporations, because that is who it [the FDA] works for [best government money can buy etc].

We shall see, Dexcom isn’t the only tech out there. However I do observe that, if the OP report is accurate, Kevin Sayer is stating precisely the opposite mentality of Microsoft and precisely the opposite of the mentality that allowed Microsoft to build a moderately successful and remarkably long lived range of products.

That’s a trawl; the purpose of Dexcom is to make as much money for their shareholders as possible. If that were really to involve controlling “the entire user experience” and “extracting [* * *] as much money from their bank account[sic] as possible” then the statement would have merit, however Dexcom != CGM and, anyway, it’s not clear that producing a defective product (one that doesn’t meet user requirements) is a viable long term strategy.