Someone clued me into this gentleman’s work & was asking about the validity of it.
But he doesn’t cite things well, and this graph isn’t well labeled.
Has there been a big increase in the number of adverse event reports we are all filing in association with the automated systems? Is that a thing?
Someone wrote the following to me, in response to the question,
“Has there been a big increase in the number of adverse event reports we are all filing in association with the automated systems?”
Here’s the source of the data if we want to look at it more closely.
In the post the paragraph above references this paper which contains the chart:
R. D. Butterfield and N. M. Sims, “Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations,” in IEEE Open Journal of Engineering in Medicine and Biology, vol. 5, pp. 593-599, 2024, doi: 10.1109/OJEMB.2024.3408092. Performance of a Continuous Subcutaneous Insulin Infusion (CSII) Pump With Acoustic Volume and Flow Sensing in Simulated High-Consequence Situations | IEEE Journals & Magazine | IEEE Xplore
Note the paper was paid for by Deka and is part of the justification of its marketing claims for the occlusion detection system in the Twiist.
The raw number of reports doesn’t mean much, especially when you consider the time period shown is when AID systems came on the market and became the standard of care therefore the number of pumps in use increased. To make this data useful you’d at least need to account for the number of patients using pumps.
I was at a breakthroughT1D shindig recently and during the keynote the speaker had a slide saying Finland had the highest incidence of T1D. When the next slide came up and it was clear she was moving on someone in the back of the room said it was because Finland has a comprehensive nationwide screening program, the speaker acknowledged it was true.
Dan is (was?) a member here. @argv did you review publications that normalized the MAUDE data before choosing the one you included?
So we DON’T believe Finland has any genetically higher incidence, it’s just higher testing? Are you mentioning this because it’s in my DOJ complaint? 
Oh no. I misled the DOJ.
My, this paper was long ago. I don’t recall the specifics anymore. I do know that my citations are well-documented, and there are a few good, credible ones. I may not have as closely scrutinized the Deka paper enough, but I do recall that the paper did seem to check out on the science and background.
The question that seems to be at hand is whether there are more adverse events given the growth of automated systems. We presume the real question is whether the ratio of events is rising, rather than absolute numbers. I’m not following this sort of thing, so I couldn’t say. That said, Jan S. Krouwer, an independent researcher, published a peer-reviewed paper titled, “More Focus is Needed to Reduce Adverse Events for Diabetes Devices.” She’d be a much better source for tracking this, methinks.
As for the countries with the highest per capita prevalence of T1D, they are predominantly found in Northern Europe and the Middle East. The International Diabetes Federation (IDF) and academic studies list these countries in order of prevalence:
Finland
Sweden
Kuwait
Qatar
Canada
Algeria
Norway
Saudi Arabia
United Kingdom
Ireland
Research points to a combination of genetic and environmental factors.
1. Genetics:
Genetic Predisposition: A strong genetic component is a major factor in T1D. Studies show that a person’s risk is influenced by inherited genes, particularly those in the human leukocyte antigen (HLA) complex.
European Ancestry: T1D is most common in populations of European ancestry, and the high rates in countries like Finland and Sweden are often attributed to the frequency of certain high-risk HLA genotypes in these populations.
Improved Healthcare Systems: High-income countries with well-developed healthcare systems, like those in Scandinavia and Western Europe, often have more comprehensive screening programs, better access to healthcare, and greater awareness among medical professionals. This leads to more accurate and earlier diagnoses, which can contribute to higher reported prevalence rates.
In contrast, in many low and middle-income countries, a significant number of T1D cases may go undiagnosed or misdiagnosed, leading to a lower reported incidence even if the true prevalence is higher. This is a critical factor to consider when comparing data across different nations.
I suspect that is not what is actually being done in practice, rather the absolute number is also a factor in the reportage.
I would expect the ratio to rise because the traditional ADA advised diabetic diet is HCLF. In other words, “Never let their blood glucose drop.” Overall my impression over recent years is that there is near paranoia and quite a lot of money in “low blood glucose”.
Possible negative correlation: HbA1c vs incidence of low blood glucose events.
Possible fix: record high blood glucose events too. I don’t think I can ever get the medical establishment to regard low BG as less medically significant that high BG because I don’t myself. I run high, around 120mg/dL and I target never going below 70mg/dL because I find it more debilitating than going over 180mg/dL.
Nevertheless TIR is useful to remove the BS; yes, TIR below 70 is relevant but so is TIR about 140 and above 180 and certainly above 250. Looking at one number, one statistic, is always a mistake.
Apologies Dan @argv, I saw Sept. and assumed this year. I wasn’t criticizing your choice of graph, the post mentions events going up, chart shows events going up, it works.
I was going to suggest to @mohe0001 they can just download the MAUDE data and query it but while searching if someone was already hosting the data in a more accessible way than the FDA I found Evaluation of reporting trends in the MAUDE Database: 1991 to 2022 - PMC Turns out there have been more than a couple of regulatory changes that have driven up reporting rates.
Anyone know about the post market surveillance studies the FDA often mandates? I see the mandates in PMA’s and 510(k)'s but I’ve never found the studies themselves. Maybe they have the data @mohe0001 is looking for.
I’m reminded of a politician’s statement “we wouldn’t have so many Covid cases if we didn’t test so much” and the other: “If I hadn’t taken that pregnancy test, I wouldn’t be pregnant”
The sources were solid. I wish we had a lot more to go on to better understand. It’s something we might all consider taking a look at.
“I wish we had a lot more to go on to better understand.”
What exactly are you looking for? What do you want to understand better?
I gotta tell you, @spdif, Diabetics are now allowed to join the army in Finland.
https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00200-0/fulltext
I think it might actually be the magical land inhabited by ONLY diabetics that I imagine it to be.
There’s something seriously weird about the flow-rate results in the Butterfield&Sims paper. They apparently show that the three pumps other than Twiist over-deliver insulin at a constant rate per hour. That’s plain weird but I haven’t had enough time to drill down into the paper.
re: The number of adverse events
