Standard of Care: Who Defines it, How, and Why it Matters

A primer on the ADA's "recommendations"

Editorial Illustration: A satirical take on the "Standards of Care" hierarchy. Concept and art direction by Dan Heller; AI-assisted rendering by ChatGPT.

I recently came across the word, glossolalia, which means,” the phenomenon of speaking in an unknown language, especially in religious worship.” You can imagine someone using ancient Latin, Hebrew or Arabic in religious contexts, and yet, not really knowing the literal translation of the phrases.

This term came to me when I observed how the phrase “Standard of Care” is used in advertising and other promotional material in the realm of type 1 diabetes. It turns out to be far different than conventional understanding. And the use of it is increasingly becoming more of a marketing term, much like how MARD has become for CGMs.

The original intent of MARD was to measure the “accuracy” of a glucose meter, but because it’s so easily manipulated—and decidedly does not correlate in any way to actual clinical outcomes—it has not only lost its actual value as a measuring instrument, it’s become a marketing tool that brings no value to those with diabetes. (I cover this extensively here and here.)

“Standard of Care” has become a victim of this as well, but the effects go way beyond just technologies; it applies to all sorts of recommendations, from diets to diagnostic measurements, like A1c levels, lipid measurements, and more.

This article aims to address:

• What “Standard of Care” actually means

• Who gets to declare it

• The factors that go into the rating system

• Who the intended audience is

• What are the legal ramifications (and legally, the term carries very different meaning and weight)

Throughout this article, it’s important to understand the most important truism of medicine: Every single medical technology, drug, diet, and other interventions will affect people differently. There will always be those who benefit and those who don’t.

“Standard of Care” aims to take this complexity and nuance into account by weighing the pros and cons of benefits and risks derived from credible studies and trials published in peer-reviewed medical journals. Because there are those who benefit (or not) differently, the “rating system” may seem inappropriate. If there are nuances, why give something a specific rating?

The short answer is that the audience is not your average consumer. It’s clinicians. The intention is that clinicians treat ratings as a starting point, then consider the exceptions and carve-outs to determine whether the intervention is appropriate for a given patient. With very few exceptions, the term “standard of care” is rarely ever a simple statement of support with no carve-outs.

Most people don’t know this, and as such, have very different—and often dangerously misleading—understanding of whether an intervention comes with potential risk. This article is intended to help you navigate this tumultuous process.

We’re going to use automated insulin delivery (AID) systems as an example because it has become a very hot topic within the T1D community, especially as multiple forces are emerging in both the technical and medical realms. But as you read this, be aware that it also applies to everything else you think is “established fact” about T1D management, whether it’s diets, insulin dosing methods, dosing calculators, and so on.

AID Systems and “Standard of Care”

As noted above, “standards of care” aims to weigh the pros and cons of benefits and risks derived from credible medical journals. As such, I recently posted an article that did just that for AID systems. It was titled, Medical Literature Analysis: The Performance Paradox of AID Systems. The article cited over ten years of medical literature that pointed to an emerging trend about who benefits and who doesn’t from these systems. I used the term “The Barbell Distribution of Clinical Benefit”. I said:

The true beneficiaries of AID systems are the far outliers in T1D demographic profiles—those who are either entirely unable to manage themselves, or are hyper-engaged in self-management—leaving those in the middle as either not realizing any material benefit from automation, or may be potentially harmed by it.

This drew responses from some who said, “But AID systems are Standard of Care”, and they cite two sources:

• Medtronic’s website states, “the American Diabetes Association calls automated insulin delivery systems the standard of care for people with type 1 diabetes.”

• BreakthroughT1D also makes the claim explicitly on seven discrete pages on their website, but also in congressional testimony, annual reports, and advocacy materials. Notably, none of these cite the ADA as the source—they simply declare it as fact.

This is a classic case of glossolalia. Both institutions are using a term without proper context or appropriate attribution.

Yes, the ADA does recommend AID systems, but with very specific carve-outs that have important notations for clinicians about the appropriateness for different people and conditions. It’s those exceptions—and there are a lot—that my article highlights: weight gain, loss of agency, de-skilling of self-management, limitations on efficacy, quality of life, economic impact, and the “attractive nuisance” of disengagement from self-management. The literature also points to long-term effects, such as a sedentary lifestyle, which leads to a cascading series of metabolic disorders.

For this research, my citations included studies, trials, and meta-analyses from the following journals:

• ADA journals (Diabetes Care, Diabetes, Clinical Diabetes): Citations: 9

• Diabetes Technology & Therapeutics (Mary Ann Liebert, not ADA but diabetes-focused): Citations: 4

• Lancet Diabetes & Endocrinology: Citations: 2

• Diabetologia (EASD journal): Citations: 1

• Non-Diabetes Journals: Citations: 10

  • Endocrine (Springer)

  • Social Science & Medicine

  • JAMA Internal Medicine

  • PMC ethics reviews

  • General medical/health economics journals

And many of those articles are “literature reviews”, which are single articles that examine hundreds of other papers and distill their findings into an overview paper. In all, I covered medical literature that spans over ten years, covering hundreds of thousands of T1D patients.

Perhaps most importantly, which I even stated in the article, virtually everything outlined in my article is not just published in ADA journals and others, but the ADA itself published in its own position statement with its European counterpart: Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.

In a way, I didn’t really need to publish my article at all—the above document comes to the same conclusions. The difference, however, is that their document is a highly dense tome of clinical language that is tough to read, at least, not without a glass of cognac and a roaring fire. It’s a foreign language to the lay audience.

My target audience is not steeped in the genre of complex medical literature. Hence, my independent analysis.

The natural question then becomes: If the ADA recognizes all these problems, how/why would they “recommend” AID systems?

And what about BreakthoughT1D’s claims? And Medtronic?

Let’s start with the ADA.

Understanding What the ADA Actually Says

The ADA’s Standards of Care is a 350+ page document updated annually, covering everything from diagnosis to complications. For technology recommendations, Section 7 (Diabetes Technology) and Section 9 (Pharmacologic Approaches) are most relevant to the discussion on AID systems. Each carries a letter grade indicating the strength of evidence behind it:

• A = Clear evidence from well-conducted, adequately powered randomized controlled trials (RCTs).

• B = Supportive evidence from well-conducted cohort studies.

• C = Supportive evidence from poorly controlled or uncontrolled studies.

• E = direct evidence is lacking, so clinical Experience weighs in.

These grades are explicitly about strength of evidence, not a universal instruction. They inform judgment; they do not replace it. In fact, the ADA is very explicit that their ratings are based on the strength of the evidence, not the strength of the recommendation. An A-rating may have multiple rigorous trials that support it, but there are other considerations that should be taken into account.

Here’s where it gets complicated for AID systems. The ADA makes several related but distinct statements:

Section 7.8 covers “...early initiation, including at diagnosis, of CGM, CSII, and AID depending on a person’s or caregiver’s needs and preferences.” This carries a C rating—meaning the evidence for early initiation comes from weaker or poorly controlled studies, not large RCTs.

Here, the “C” rating is the lowest rating that has studies associated with it, so a physician needs to be diligent. Recently diagnosed patients can have very different profiles: A three year old child, or a 45 year old LADA (late-onset autoimmune diabetes) who has a medical degree, or a 20 year old college student, or a 60 year old priest. These are all distinctly different people with different aptitudes for adopting an AID system. Hence, the need for medical literature to tease out what is actually appropriate. It’s more nuanced than just an ADA rating.

Moving onto section 7.25a, it says “AID systems are the preferred insulin delivery method over MDI, CSII, and sensor-augmented pumps in people with type 1 diabetes.” This carries an A rating—meaning rigorous trials clearly show AID systems achieve better glycemic metrics than alternatives. This is the part that most people (Medtronic, BreakthroughT1D) focus on—at least, in spirit.

But wait. Let’s zoom in on that statement: “perform better on glycemic outcomes” — yes, but better than WHAT?

Here, we look at the medical literature for context: Hundreds of studies that show that AID systems perform “better” when the same person’s A1c > 8%. For them—and there are a lot of these people—AID systems get an A rating.

But, the studies also show that for individuals whose A1c <8% before using the system, they see no observed clinical benefit. In fact, if their A1c is lower than 7.5%, they tend to drift upward to 7.5% (+/- .5%), and even drift higher. That’s why the clinician should use their “Experience” as to whether the device is appropriate for any given patient. It’s not a universal “you should prescribe an AID system” proclamation.

Compare all this language to the rating for CGMs, where Section 9 states flatly: “Its use is now considered Standard of Care for most people with type 1 diabetes”—there are no equivalent qualifiers about capability, carve-outs, or even ratings. No A, B, C, or E. It’s just declared “Standard of Care”. Yes, that’s the one rare exception.

The distinction matters. When Medtronic claims “the ADA calls AID standard of care” or when BreakthroughT1D states “AID systems are now standard of care” without qualification, they’re stripping away the individualization that the ADA explicitly pairs with its ratings. They take the A-rated finding (”AID performs better in trials”) and present it as if the ADA endorsed universal adoption—which the C-rated and E-rated guidance expressly does not support.

Ok, that’s the ADA. But what about BreakthroughT1D? They’re a well-recognized organization. Why can’t BreakthroughT1D act as an authoritative voice on this?

This is an important question, and that leads to comparing them with the ADA in their structure and other aspects that lead to what carries authoritative weight.

What is the ADA’s Authority?

The ADA (founded 1940) is a professional medical association whose members are physicians who pay dues. Those dues-paying members are the intended recipients of the ADA’s communications. The ADA publishes peer-reviewed journals (Diabetes Care, Diabetes, Clinical Diabetes, and others), and has established credentialing within the broader medical establishment.

The ADA’s primary function, as it were, is to address public policy in a manner that its members can use broadly and generally to address the entire population of people who have one of a variety of forms of diabetes. This is a highly complex disease, as readers of this article are sure to understand, so the challenge is to educate, inform, and otherwise set general guidelines for those members.

The ADA derives its influence from a combination of factors rather than any legal charter:

Professional legitimacy: Their Standards of Care document is developed through a Professional Practice Committee using systematic evidence review, graded recommendations (A through E based on evidence quality), and annual revision cycles. This methodological rigor creates credibility within the medical profession.

Institutional adoption: The real power comes from downstream adoption. When CMS references ADA standards for insurance coverage determinations, when hospital credentialing committees cite them, when medical boards use them to evaluate physician conduct, and when malpractice attorneys invoke them as the benchmark for reasonable care—the standards acquire functional legal force without ever being codified into law.

Payer alignment: Insurance companies routinely tie coverage decisions and quality metrics to ADA standards, creating financial incentives for adherence. In fact, this is exactly why insurance companies, from Medicare to private companies, don’t reimburse for AID systems unless the person would actually benefit from them. (As per my “paradox” article, Medicare and most insurers require an A1c > 7%, with some cases even higher. Remember, these devices are really expensive, especially compared to MDI, where many patients achieve the same outcomes, or even outperform them.)

There’s another very important aspect that brings even greater context:

• The target audience is health care providers (HCPs), who are dues-paying members of the ADA. Not the general public.

• Most HCPs are either not trained in diabetes management, or (even if they are) don’t have the time and/or experience to give focused, dedicated attention to individuals, due to their vast overload of patients under their care.

Wait, what? That last point seems important.

According to a report by The American Diabetes Association, “the vast majority of individuals with diabetes receive care in primary care settings—not endocrinologists—including physician offices, community health centers, clinics, and pharmacies.” A report from the National Institutes of Health shows that Primary Care Providers (PCP) expressed low self-confidence in managing T1D. The result is that more than 85% of insulin initiation recommendations originated from PCPs, according to a report by ​ScienceDirect.

And this problem is getting worse. As I explain in detail in my article on America’s healthcare system, the number of endocrinologists is at an all-time low and dropping fast, as medical students are not going into this field. According to Stability Health (2022), “34.2 million Americans live with diabetes, but there are fewer than 8,000 endocrinologists to treat them.” Of those, the 2026 data shows 2.1 million have T1D, according to the CDC.

The map below shows that over two-thirds of U.S. counties lack endocrinologists, according to aggregated data from GoodRx’s article titled, “Endocrinologist Deserts: A Critical Healthcare Gap for Millions in the U.S..”

Of those endocrinologists who do treat diabetes, the overwhelming majority treat Type 2 diabetes—which represents approximately 91% of all diabetes cases versus just 6% for Type 1. Given that T2D prevalence is roughly 20-25 times that of T1D, this leaves perhaps 15-25% of endocrinologists with meaningful T1D caseloads.

Put it all together: It’s a reasonable inference that 5-10% of all endocrinologists are truly proficient in modern T1D management (AID systems, CGM interpretation, exercise physiology, carb-ratio optimization).

With 2.1 million T1Ds in the US, chances are pretty high that your doctor is not in that 5-10% of endos that are truly experienced in T1D management.

This is why the ADA finds themselves in a tough spot. Their guidelines are addressing a problem that’s more akin to public policy: They are trying to provide a safety net at the bottom end of the health spectrum by streamlining healthcare guidance to physicians that are largely ill-equipped and inexperienced at T1D management.

Automated insulin pumps are not necessarily seen as the best way to manage T1D—as the evidence shows—but they do accomplish a very urgent need: Provide a quick and easy solution for medical professionals under stressed conditions, and who do not have the time or resources to learn the true nuances of management that they can teach to patients.

That brings us to BreakthroughT1D, who purports to be advocates for T1Ds. Shouldn’t they provide that additional education and support for T1Ds so they can learn how to better manage their disease? To be less dependent on automation that literature shows may not be suitable for everyone?

BreakthroughT1D (JDRF)

BreakthroughT1D (formerly JDRF) is structurally different from the ADA—it’s a research funding and patient advocacy organization, not a professional medical association. Their stated mission is to “improve the lives of people living with type 1 diabetes,” and they’ve done genuinely important work: approximately $2.5 billion in research funding since their founding in 1970, significant contributions to CGM development, and tireless awareness campaigns that have shaped public understanding of T1D.

But advocacy organizations and clinical standard-setting bodies serve different functions. BreakthroughT1D doesn’t convene panels of practicing clinicians to issue clinical practice guidelines through peer-reviewed processes. They don’t grade evidence on A-through-E scales. They don’t publish journals that require methodological transparency. When they make proclamations about “standard of care”, they’re engaging in advocacy, not guideline-setting.

There’s nothing necessarily wrong with advocacy of this nature, but patients need to be mindful of the source and strength of recommendation. Its Industry Advisory Panel—comprising Abbott, Dexcom, Insulet, Medtronic, Tandem, and others—explicitly shapes the organization’s “advocacy and research priorities.” According to its website, the IAP’s purpose is explicitly to shape advocacy priorities:

Breakthrough T1D’s Industry Advisory Panel (IAP) is a forum whose purpose is to develop an open dialogue and strengthen relationships with our industry partners. This includes sharing our development and organizational strategies, advocacy and research priorities, and marketing initiatives. In turn, the IAP provides members an opportunity to provide feedback on these updates as part of a collaborative and synergistic relationship with each IAP member.

The question is what countervailing process exists.

This raised a question I hadn’t planned to explore, but which is relevant to the larger point: what internal mechanisms does an advocacy organization have for stress-testing its public claims against the evolving clinical evidence, especially when its advisory structure includes manufacturers of the technologies it publicly advocates for?

Searching for context, I came across a 2016 article by Rebecca Robbins, who was a reporter for Stat News at the time (now at the NYTimes). The article, The risky bet behind the first ‘artificial pancreas’ for diabetes patients, chronicled how the JDRF (formerly known as the Juvenile Diabetes Research Foundation) went on a costly, and risky, campaign to enlist academic researchers, global companies, members of Congress, and even federal regulators to embrace the concept of a device that could take over much of the process of regulating blood sugar in patients with diabetes.

As the article stated, JDRF “spent roughly $16 million more to fund companies working on the technology,” while also receiving funding from the same companies, “including more than $5 million from Medtronic” (per the 2016 Stat News investigation). Current figures are not publicly itemized, and sponsorship “levels” (which are tiered by dollar amounts) are not the only way to contribute money. From that article,

Those close ties with industry have sparked some criticism — mostly out of concern that advocacy groups won’t be able to freely fight for patients if their finances are tied to the fate of a corporate partner.

Ten years later, as longer-horizon evidence accumulates, the same governance question becomes more important: how does an advocacy organization keep public-facing claims synchronized with the evolving clinical literature when its advisory structure includes manufacturers? There does not appear to be a formal, independent clinical-evidence review process comparable to a guideline body, and I’ve found no publicly documented independent clinical review board to evaluate the claims being made.

The concern isn’t that BreakthroughT1D receives money from device companies or that BreakthroughT1D doesn’t actually believe the narrative themselves. These are unrelated. Many organizations, including the ADA, also receive money from corporate sponsors, and at much greater levels. In fact, there has been considerable concern about this for years.

This is not an assertion of wrong-doing, nor that BreakthroughT1D is villainous. Advocacy organizations are supposed to advocate. They’re supposed to push for broader access to technologies they believe help patients. The problem arises when advocacy statements get confused with clinical guidance. It’s one thing to say, “we believe everyone should have access to AID systems” but it’s another thing entirely to say “AID systems are standard of care for everyone.”

The ADA, despite its own industry entanglements, maintains structural firewalls: a Professional Practice Committee with conflict-of-interest disclosures, an evidence grading system that distinguishes strength of evidence from strength of recommendation, and peer-reviewed journals that create accountability. When the ADA rates AID systems, it also adds caveats about individual circumstances—caveats that are documented in its own peer-reviewed medical journals and get cited in public discourse.

One more note worth considering: The FDA requires extensive disclosures when drugs are advertised—those rapid-fire lists of side effects you hear voice-overs say during a commercial. Drugs must also demonstrate efficacy in large-scale clinical trials before approval, and the FDA increasingly encourages (though doesn’t always require) comparative data showing how a drug performs against existing treatments. Medical devices like AID systems face a lower bar: they only require demonstration of safety and efficacy for their intended use.

There is no patient advocacy organization that is advocating for these changes, to educate patients on a variety of self-management methods, or to clarify the nuances that the ADA does.

Legal Considerations

Perhaps the most underappreciated aspect of the phrase “standard of care” is that it carries implied legal and institutional weight, even when it is used casually.

To put this into context, the lawsuits that Dexcom is facing for wrongful deaths are based on an assertion that Dexcom changed a component in the manufacturing process—a change the FDA later discovered—which affected the G7's accuracy. The claims against Dexcom are not about misrepresentation.

That’s distinctly different from representing a product as “standard of care” because it implies representing something about professional consensus, as if it were a settled, universally applicable conclusion. When public-facing materials fail to explain the caveats clinicians are supposed to apply, the phrase can function less like guidance and more like persuasion.

Promotional health claims in general are expected to avoid material misrepresentation, and the more a statement sounds like an authoritative medical consensus, the more scrutiny it can attract—informally (from clinicians and patients) or formally (from regulators or litigants). When broad public declarations shape patient expectations and clinical conversations, that can matter if disputes arise later.

The practical risk is often not a courtroom verdict; it is being named in a lawsuit and subjected to discovery—subpoenas, depositions, demands for internal communications about how the ‘standard of care’ claim was substantiated. Then comes the downstream cost of controversy, reputational damage, and time-consuming demands for substantiation.

The legal ambiguity of ‘standard of care’ is compounded by a historical pattern: the ADA’s own guidelines have reversed course when evidence accumulated that earlier recommendations caused harm, which are worth considering for a broader view.

Future Developments

It’s important to put this into a chronological perspective. When AID systems were introduced, they provided promise for T1Ds: To relieve the burden of self-management, to potentially automate a highly complex disease, and to achieve healthier glucose control than what the patient can do for themselves.

And there’s no question, that has been achieved for a large number of patients. But as time went on, it became evident that the beneficiaries were not everyone. That the systems’ performance seemed to reach an apex. That there were other unanticipated physical and mental health concerns. That the costs were much higher than comparable methods (MDI) for equivalent control. And more.

It would follow that the ADA is likely to continue to revise their rating systems and provide greater context in future documents. And this is very common, as we can see from some examples:

Aspirin for primary prevention: For decades, diabetics with cardiovascular risk factors were told to take daily aspirin. Following the ASCEND, ARRIVE, and ASPREE trials (2018), the ADA now recommends against aspirin for patients over 70—the risks outweigh the benefits.

Tight glycemic control: “Lower is better” was gospel until the ACCORD trial (2008) had to be halted early because patients aggressively targeting A1c <6% had 22% higher mortality. The ADA now emphasizes individualized targets.

The 50/50 basal-bolus rule: A mainstay of insulin education for decades, now flagged in the 2025 guidelines with warnings about “overbasalization.” It should be noted that most AID algorithms still require a minimum basal rate that exceeds physiological needs, a problem that the FDA needs to address, and is one of the leading concerns about AID systems. I cover the whole topic of overbasalization in a four-part series, Ye Olde Basal Rate: Its Effect on T1D Management and Long Term Complications.

Blood pressure targets: The once-standard <130/80 recommendation for all diabetics was relaxed to <140/90 for most patients after evidence showed aggressive targets didn’t improve outcomes. (Recent medical research appears to be heading back to the <130 target again. Stay tuned.)

The Low-Fat Diets (1980s-2000s): Dietary guidelines demonized fat, believing that dietary fat caused cardiovascular disease, leading to products that replaced fat with sugar. The result: population-wide weight gain and the Type 2 diabetes epidemic. Current guidelines now distinguish between healthy and unhealthy fats. I talk about this in my article, Extending T1D Longevity: Balancing Lipids, Insulin, A1c.

High-Carb Diets: For decades, diabetics were told to eat high-carb diets because it made glycemic management “easier” (especially before CGMs). The result: blood sugar volatility, increased insulin requirements, weight gain. The ADA then shifted to low-carb diets, but later found that, in excess, it leads to cardiovascular disease. The ADA now recommends carb and fat balancing that’s more physiologically balanced for exercise. I cover this in my article, The Paradox of Low-Carb Diets: A1c vs. Metabolic Health.

These reversals aren’t failures—they’re evidence that guidelines evolve as data accumulates. But they share a common pattern: confident recommendations based on the best available evidence at the time, followed by years of accumulating data that revealed unintended harms, followed by quiet revisions.

AID systems are on a similar trajectory. The harms aren’t acute—there’s no single adverse event that triggers an FDA recall. They’re diffuse and delayed: gradual weight gain from overinsulinization, metabolic dysfunction that compounds over years, disengagement that forecloses the development of self-management skills. These are the kinds of harms that only become visible at population scale, after enough time has passed.

Summary

The topic is how to better understand ADA “standards of care” claims, and it can apply to many things (as we just covered). We used AID systems as a case study of how the phrase “standard of care” is both misunderstood and misused in the T1D space by institutions. In a word, it’s glossolalia.

No one—patients or doctors—should look at “standard of care” attributions as though they are black and white, case settled, known benefit, little risk.

Remember the rule at the top of this article: Nothing in medicine is universally beneficial, and there are often hotly debated topics that are left unresolved. In November 2014, the FDA convened a public workshop on insulin bolus calculators that revealed deep divisions among experts. After lengthy debate, there was no consensus. The FDA ultimately issued guidance in 2015 requiring regulatory oversight for apps that “use patient-specific parameters and calculate dosage,” but the fundamental tension remains: these tools can cause as much harm as good, and reasonable experts disagree about the balance. (I discuss the risks of IOB and dosing calculators in my article, The Insulin Absorption Roller Coaster and What You Can Do.)

The takeaway isn’t that guidelines are too ambiguous to trust. It’s that “standard of care” is a phrase that deserves scrutiny, not reflexive acceptance. Who’s saying it? Based on what evidence? With what accountability? And—perhaps most importantly—does it apply to you?

The best defense against borrowed authority is informed skepticism. Understand the difference between advocacy and clinical recommendation guidelines. Read the primary sources. The good news is that literature is there. Yes it’s dense and often biased and hard to read. The aim of my substack is to bridge that gap by translating glossolalia into language that the non-technical, non-medical audience can understand. And like the ADA, when evidence reveals new information and new understandings, I revise articles to be up to date with current science.