(wow) Words Of Wonders Level 869 Answers – I sometimes get citation warnings when my previous research papers or articles are cited. Over the past few years, I have received notices when new consensus guidelines or studies are released that reference the Open Source Automated Insulin Delivery (AID) section. This time of year, the ADA Standards of Care are released for the coming year, and I usually find them through referral alerts.
In 2019, it was a single sentence indicating their existence under the AID subheading “systems of the future”. In 2020, the content at the end of the HELP section was switched to a full paragraph (that year was simply called “Sensor Boost Pump”). In 2021 it was the same paragraph under the AID section heading. 2022 was the year it earned its name with a special evidence-based recommendation! 2023 is essentially the same as 2022.
(wow) Words Of Wonders Level 869 Answers
He pointed out that patients use open-source AID (which they emphasize as a closed-loop system). This falsely suggests that healthcare professionals can't prescribe these systems (in fact they can – providers can prescribe all kinds of products off-label – there are many “prescribing” points. Except if the person needs grad school (or similar). whose policy only “recipe” devices are supported.
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And then, most importantly, it points out that regardless, health care providers need to support diabetes management and support patient choice to keep people with diabetes safe. YES!
“… It's extremely important that people with diabetes are safe when they use these methods to deliver insulin automatically. Part of that includes making sure people have a backup plan in case their pump fails. In addition, most DIY systems adjust insulin doses, based on pump settings for base rate, carb ratio, correction doses and insulin activity, so these settings can be evaluated and changed based on individual insulin needs.
This should apply to *any* AID system or standalone insulin pump. This highlights that the health care needs of people who use open source AIDs are no different than those who choose other diabetes treatments and technologies.
It is really important that they specifically claim to help people living with diabetes. Regardless of the choice of technology, people with diabetes should seek support from their healthcare providers. point. This is being emphasized and emphasized at a rapid pace thanks to the movement of people using open source automated insulin delivery. But its benefits are not limited to those of us who use open source automated insulin delivery. It spreads and spreads to people through different types of BG meters, CGMs, insulin pumps, insulin pens, syringes, etc.
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Regardless of the choice of tools or technology, people with diabetes need to be supported in their choices. Choice is not limited by health care providers recommending only specific tools in which they (health care providers) are trained or familiar, but by patient choice.
In the years ahead, I expect to see an ADA standard of care for 2024 and beyond for a section on open source automated insulin delivery.
The evidence rating should be increased from “E” (which stands for “expert consensus or clinical experience”), as a full randomized controlled trial of the “open source” automatic insulin delivery is now available in the New England Journal of Medicine. . to continuity. Results (24 weeks post-RCT; full 48-week data) were accepted for publication (presented at EASD 2022) and many other studies from retrospective to prospective studies. The evidence is there, so I hope that this level of evidence and the text of the recommendation will evolve accordingly to keep up with the available evidence. (The standards of care are based on the literature available as of the middle of last year; most of the above cases appeared later in 2022, so it is reasonable not to include the method in a later year; these new articles are mandatory. The 2024 edition will be compiled from searches to for July 2023.)
In the meantime, I wish more people with diabetes were aware of the standards of care and could use them in discussions with providers who may not be so happy with their choices. (Which is why I wrote this post!)
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I also wish that we patients didn't have to be aware of this and that we didn't have to discuss our cases to support our choice of healthcare providers.
However, it is hoped that over time this patient choice support model will continue to develop in the culture of health care providers and truly become the standard of care for all, without the need to promote personal promotion.
One of the most common questions I've been asked over the past 8 years is whether or not we are submitting OpenAPS for regulatory approval to the FDA.
Regulatory approval is often seen and discussed as a way to validate and validate safety and efficacy.
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As background, you need to understand what OpenAPS is. We took a pre-approved insulin pump that I already had, a continuous glucose monitor (CGM) that I already had, and found a way to read data from those devices and send instructions back. To use the commands already built into the pump. To automate insulin delivery using a decision-making algorithm we developed. The OpenAPS algorithm was a major innovation, as well as the realization that this already-validated pump had these capabilities. . The innovation was in how we put all the pieces together, although the innovation was the algorithm itself.
However, the caveat is that even though the pump I was using had regulatory and market approval, as I already had, it was later withdrawn after the researchers, the manufacturer, and the FDA realized this. You can use already created commands. In the basic structure of the pump. So these pumps, as long as they have not harmed anyone and there are no recorded cases of failure, are no longer sold. It wasn't a big deal for the company. It was a voluntary recall and people like me often chose to keep our pumps if we weren't concerned about this potential risk.
We have found out how they interact with other devices. We can submit our system to the FDA. But because we were using pumps that were already off the market, the FDA couldn't approve it. And at the time (circa 2014) there was no vision or path for interoperable devices, so they didn't have the infrastructure to “just” accept an automated insulin delivery algorithm. (That changed several years later, and now they have the infrastructure to evaluate interoperable pumps, CGMs, and algorithms they call controllers).
Another important fact is that the FDA's jurisdiction is based on the Commerce Clause of the US Constitution: Congress used its authority to authorize the FDA to regulate interstate commerce in food, drugs, and medical devices. So if you plan to be a commercial entity and plan to sell products, you need to submit regulatory approval.
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This is another aspect that many do not understand. Not all paths lead to regulatory approval, as not everyone wants to dedicate all of their time to building a company and spending 5+ years. This is what we need to do to try to get the company to comply with regulatory approval.
And the bottom line is this: because of such a strict regulatory environment, we (speaking of Dan and Scott) don't want to commercialize anything. Therefore, there was no point in submitting it for regulatory approval. Whether or not the FDA could approve the situation at the time, we didn't want to start a company, spend years of our lives dealing with regulatory and compliance issues full-time, and maybe end up getting permission to sell something. . . (which we don't care about selling).
The regulatory approval aspect is a red herring in the story of OpenAPS awareness and the impact it has and can have.
Yes, we could start a company. But then we wouldn't be able to spend the thousands of hours we spent improving the open source system and helping thousands of people use the algorithm and later the system for various pumps, CGMs, and open mobile devices. Automatic insulin delivery system. We have deliberately chosen this route to avoid commercialization and are therefore not seeking regulatory approval.
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We created OpenAPS when there was no commercial option. Now there are some commercial opportunities.
But it's also an important note that I and thousands of others still choose to use open source help systems.
Just because it's available to order (and not all countries have adopted the HELP system!) doesn't mean it's available or affordable.
Insurance companies still fight against covering pumps and CGMs as separate devices. There are new trading support systems