Calling All Hackers: Find a Way to Enable Patients to Have Alarms and Share Dexcom Stelo or Abbott Lingo Readings With Others and You Might Just Have a Business!

Back on August 26, 2024, Dexcom, Inc. introduced its first over‑the‑counter (OTC) continuous glucose monitor branded as the Dexcom Stelo (see https://www.fiercebiotech.com/medtech/dexcoms-stelo-first-over-counter-wearable-glucose-biosensor-hits-market for more). The Stelo CGM uses the exact same sensor as Dexcom's G7, which has a 10‑day wear time, and the same sensor as the G7 "Plus," which lasts 15 days. Abbott followed with its own OTC product, Lingo (see https://www.drugdeliverybusiness.com/abbott-launches-lingo-otc-cgm-walgreens/ for more), built on the same hardware lineage as its Libre 3/3+ sensors. In other words, neither company created new technology for the OTC market; they simply repackaged existing CGM sensors and removed the features that might trigger prescription‑level regulation or conflict.

Dexcom claimed that its Stelo product was "designed for adults 18 and older who are not taking insulin"— a group it says includes roughly 25 million people with Type 2 diabetes in the U.S. The health insurance industry has long refused to cover CGMs for this population, not because the devices lack value, but because covering them would dramatically increase insurance claims costs. The "fingersticks are sufficient" argument is simply the cost‑containment rationale which payers use to defend that position. The OTC strategy aimed to sidestep that particular market barrier: if insurers won't pay, maybe patients will. 

But Dexcom and Abbott invested very little in educating physicians or building clinical pathways for these OTC devices. And the fundamental flaw in the strategy has become very obvious: the insights provided by Stelo and Lingo don't require ongoing use and replacement. Many people wear a few sensors, learn how their food and activity affect their glucose levels, and then stop wearing them. OTC CGMs act like short‑term learning tools, instead of long‑term therapies, an awful business model. That's why repeat‑purchases look nothing like they do for the G7 or Libre devices, which have strong, predictable refill patterns among insulin‑using patients.

Pricing behavior has quietly confirmed this. 

Both companies launched their OTC sensors at premium cash‑pay prices, clearly assuming recurring use. But within a short period, the market began to tell a different story. Dexcom started leaning on subscription discounts for wearers and periodic price reductions, and Abbott rapidly expanded Lingo distribution into Amazon, Walmart, and Walgreens — a pattern that usually signals the need to widen its distribution funnel when retention is soft. Retailers began offering introductory promotions, loyalty‑program discounts, and bundled pricing. None of this is typical for prescription CGMs, which don't require front-end discounting because a clinical need drives continuous use. With OTC sensors, the pricing drift has become one of the clearest indicators that trial is impressive, but repeat demand is rather weak.

CGM Makers Can't Hide Refill Data on OTC Sensors Indefinitely

Wall Street analysts have noticed, and every quarter they keep trying to press both Dexcom and Abbott for refill and replacement‑rate data on their OTC CGMs. Both companies continue to refuse to disclose it. But the pricing shifts, channel expansion, and promotional activity tell the story anyway.

Dexcom's backdrop is even more complicated. 

Dexcom has been navigating a CEO transition while also dealing with the negative Hunterbrook investigation (I covered that at https://blog.sstrumello.com/2025/09/corner-cutting-at-scale-management.html for more), which has raised some legitimate questions about Dexcom's corporate transparency, quality controls, and handling of its known G7‑related issues. It's a challenging moment to be expanding into consumer markets, while also refusing to answer basic investor questions about retention, all while also facing public scrutiny over internal controls.

And that brings me to my headline. 

When a company ships a device that COULD theoretically provide alarms and data sharing — because the hardware already supports it — but deliberately disables those features for regulatory and commercial reasons, it creates an obvious vacuum. Hackers tend to notice when manufacturers remove functionality that users might actually want. They restore it. They always have. We haven't seen much hacker movement on OTC sensors yet, but given the size of the installed base and the obviousness of the missing features, it's hard to imagine that lasting. I personally hope that does not last.

Hence, I am inviting hackers to step-in and fill the void. Users want these things, and you are positioned to do it. 

And, it's the users' data anyway, that CGM reading information does NOT belong to Dexcom or to Abbott, it belongs to the patients. And, I would remind regulators need to beware of that not-so-little detail before they throw a stupid hissy-fit over it. In most cases, third-parties already access Libre 3/+ and Dexcom G7/+ data using the wearer's Libre or Dexcom login information. Consider third-party entities like "Sweet Dreams – Sugar Tracker" which enable users to access their CGM readings on an Apple Watch, including on Libre CGM sensors as well as Dexcom CGM sensors and it enables watch wearers to locate the readings anywhere THEY want the readings to be featured on their watch face (whereas Libre does not do it at all right now, and Dexcom limits their app to the periphery of the watch face). I don't know anything about how an OTC sensor might (or might not) be enabled, but it does not really seem to be an impossible feat to hack. 

Maybe some enterprising hackers with some time on their hands would be willing and able to crack that? By all means, please do so! As a patient, I see value in having that ability.

From "Out of Stock" to Fulfillment: How Mark Cuban Cost Plus Drug Company's 2023 HealthDyne Deal Improved Drug Distribution

Several years ago, I blogged about a PBM-powered coupon-generating app and website operated by WellDyne, which was from one of the smaller Pharmacy Benefit Managers (PBMs) and the coupon-generating app was known as WellCardRx. WellDyne is a smaller, more-transparent PBM which says it avoids rebates which defines its bigger PBM rivals. At the time, nearly every major PBM—except for CVS Caremark—had its own discount card platform. That trend has since faded. For example, United Healthcare's OptumRx sold OptumPerks to RVO Health, LLC in 2023, and Cigna's Express Scripts stopped using its mail-order pharmacy to fulfill orders from its own InsideRx coupon platform. 

WellDyne, however, continues to operate its own mail-order pharmacy business called HealthDyne. The branding between WellDyne and HealthDyne is quite similar (for example, the names for both are in lower-case letters, and use a similar color scheme), underscoring their shared corporate identity. HealthDyne is based in Lakeland, Florida (between Tampa and Orlando) and serves as the pharmacy fulfillment arm of WellDyne, a PBM which was originally founded in 1990 as WellDyne Rx, Inc. and WellDyneRx, LLC. In 2016, WellDyne was acquired by the private equity firm known as The Carlyle Group. 

You might also recall that when the Mark Cuban Cost Plus Drug Company, PBC (PBC means it is incorporated as a "Public Benefit Corporation", but the company is also sometimes known by the acronym MCCPDC) originally began selling drugs directly to patients back in 2021/2022, it originally partnered with a separate company known as TruePill as its fulfillment partner. TruePill was a separate company that Mark Cuban had already invested in. But over time, TruePill struggled to meet Mark Cuban Cost Plus Drug Company's needs due to MCCPDC's rapid growth. Some was due to TruePill's private equity owner's operational cost-cutting, which resulted in the firm's difficulty in handling rapidly-growing fulfillment volume. WellDyne's HealthDyne mail order pharmacy has already been through the cost-cutting phase and is now poised for growth.

Although data on WellDyne's PBM operations is rather limited, the Drug Channels Institute (DCI) reported in 2021 that as a PBM, it covered about 2.5 million lives, including roughly 700,000 commercial lives. DCI—itself now owned by HMP Global—was previously run by Pembroke Consulting, whose founder Adam J. Fein and his wife Paula still contribute to the blog (at least for the time-being, I suspect they won't do so forever). For comparison, Navitus Health Solutions, another smaller PBM co-owned by SSM Health and Costco Wholesale, had about 7 million covered lives, including 2.5 million commercial lives in 2021.

Fast forward to June 7, 2023: HealthDyne and Mark Cuban Cost Plus Drug Company (MCCPDC) announced a new pharmacy fulfillment partnership (see the press release at https://www.prnewswire.com/news-releases/mark-cuban-cost-plus-drug-company-and-healthdyne-announce-pharmacy-partnership-301844354.html). The deal positioned HealthDyne to expand Cost Plus Drugs' pharmacy operations, by leveraging HealthDyne's underlying infrastructure, technology and expertise.

While the press release never mentioned MCCPDC's previous fulfillment vendor known as TruePill, the timing suggests a transition. TruePill had previously fulfilled orders for Cost Plus Drugs, but it merged into a new entity called Fuze Health by mid-2023. Fuze Health also now owns the mail order pharmacy known as Aalto Pharmacy (which originally claimed to serve people with conditions such as diabetes) and LetsGetChecked. With Cost Plus Drugs growing so rapidly, the company likely sought a new fulfillment partner better suited to its evolving needs.

This transition may explain an order disruption I personally experienced when buying from Mark Cuban Cost Plus Drug Company. Back in August 2023, I blogged about how Mark Cuban Cost Plus Drug Company had taken my order, then unexpectedly listed my prescription as "Out of stock" (catch my post about that at  https://blog.sstrumello.com/2023/08/when-mark-cuban-cost-plus-drug-company.html for more details) when it had already accepted my reorder request. The lack of an ETA and sudden unavailability was disconcerting at the time, but now it appears that the shift from TruePill to HealthDyne as the fulfillment source may have been the underlying cause.

Mark Cuban Cost Plus Drug Company has frequently been cited (including by me personally) as a disruptive force for good in the deeply dysfunctional U.S. prescription drug distribution system. By eliminating profiteering middlemen and offering transparent pricing—actual drug costs plus a 15% markup, $5 pharmacy fee, and $5 shipping—the company has challenged entrenched PBM practices and made many medications vastly more affordable for millions of Americans. For people with chronic conditions like Type 1 diabetes, where access to insulin and other life-saving medications and things like testing supplies is non-negotiable, partnerships like the one with HealthDyne appears to played a meaningful role toward better patient access and affordability. While I wish there had been more transparency about what I was experiencing at the time, this appears to be the likely explanation.

After 50 Years with T1D, I Still Have Advocacy Work to Do

In July 2026, I'll become eligible for Joslin's Half-Century Medal, awarded to those who have lived with Type 1 diabetes (T1D) for 50 years. I still haven't decided whether I'll even apply for it or not, but the milestone nevertheless marks something noteworthy: a half-century of survival—more importantly, endurance—and learning to navigate life with a condition and a U.S. healthcare system that prioritizes corporate insurance company profits over patients, both of which have shaped a big part of my life. 

Although I no longer involve myself in every advocacy initiative that comes along, I'm still not done with diabetes advocacy yet. I've simply become more deliberate about how—and where—I invest my advocacy time and energy. 

Choosing My Battles 

For years, I participated in the JDRF (now Breakthrough T1D) Walks to Cure Diabetes and raised thousands of dollars for the organization. I still support the cause, but I don't participate as regularly as I once did. Sometimes I have other plans, and that's fine (after all, diabetes certainly isn't my whole life). Children with diabetes often take center stage in fundraising campaigns, and at lobbying events such as Breakthrough T1D's Children's Congress, and they probably should—kids are pretty persuasive spokespeople. But we as adults with T1D actually vote. Adults with T1D bring a different kind of power to the table, and our perspectives matter too (although it might be nice if Breakthrough T1D acknowledged that, and also made more of an effort to actually harness it, and maybe someday, it actually will do so). 

My advocacy these days is more focused, personal, and often rooted in my efforts to correct the historical wrongs I've endured first-hand of living with T1D. That includes pushing for accountability at both federal and state levels—whether through formal complaints to the FTC, or urging New York's Attorney General to enforce the violations of the state antitrust law known as the Donnelly Act against PBMs operating with impunity. To the best of my knowledge, I was one of only a few patient instigators in the diabetes community advocating for FTC action (during its 6[b] study, I even emailed back and forth with then-FTC chairwoman Lina Khan), and I wrote about that effort in great detail here: https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html and pushed for litigation which is now on hold (awaiting adjudication). 

The Pain of Enduring Repeated, Forced Non-Medical Switching

One of the most traumatic experiences in my early years with diabetes came during the involuntary shift from animal-derived insulins to the so-called "human" biosynthetic insulins, produced via recombinant DNA technology. These were promoted as advancements, but in truth, they offered NO therapeutic advantage over what came before—and up to ten percent of patients globally experienced serious adverse effects such as hypoglycemia unawareness according to a number of different peer-reviewed journal articles. 

I was one of those patients. 

Around the age of ten, I started experiencing terrifying low blood sugar episodes that sometimes came with no warning signs, no symptoms, just sudden, dangerous crashes. And remember: back in those days, we didn't even have blood glucose meters to determine what was happening, and CGMs didn't exist. When I tried to explain what I experienced, instead of being heard, I was blamed—as if I was somehow making it all up, or else I was to be blamed for doing something wrong. It was incredibly isolating. Years later, I discovered I wasn't alone. People from all over the world—Canada, Australia, the UK, Germany, Switzerland, the U.S.—described going through the exact same thing when they were involuntarily switched to these so-called "human" insulins. We weren't imagining it. We were collateral damage in a system more concerned with profits than patients. 

After the discontinuation of Iletin R, S, L and U, the cycle continued: next, Humulin S and L eventually disappeared too, and for a time, we were stuck with the same inferior alternative products such as isophane (NPH) until those were eventually replaced by analogue insulins a number of years later. These new products were marketed as superior, although their timing always just happened to align with expiring patents. Years later, I suffered routine non-medical switching from one prandial insulin to another each time my insurance company's PBM changed formularies having been non-medically switched four times in one calendar year. I promised myself that if this kind of forced, non-medical switching resulting from manufacturers "retiring" insulin was to happen again, I'd push back. 

Levemir's "Retirement" and the Next Fight 

In November 2023, it happened again. Novo Nordisk announced it would discontinue Levemir (insulin detemir). I wasn't using it at the time, but I knew the business playbook extremely well, having been through it multiple times. I also knew that no company was developing a biosimilar for detemir—not Lilly, Sanofi, Biocon Biologics, Sandoz/Gan & Lee, Amphastar/ANP, Lannett/HEC, Meitheal/THDB, or even CivicaScripts insulin efforts, all of whom were known to be developing biosimilar insulins (and many were publicly-held corporations which listed the insulin biosimilars in their drug development pipelines, so it was not kept secret). It was an opportunity for a creative entity willing to think outside of the proverbial box; they would effectively OWN the still substantial market for insulin detemir and their competitors were ignoring. 

While Novo Nordisk tried to suggest that Levemir was a rapidly-dying product, sales data suggest otherwise. Also, the rebate-contracting commercialization model favored by Novo Nordisk enabled Levemir to co-exist on a majority of commercial insurance drug formularies where Novo Nordisk insulins were preferred over those from Lilly, Sanofi or Biocon.

2022 Estimated U.S. Insulin Market Share & Revenue

First, let's look at the actual data rather than listening to statements made in Congressional testimony from a now-terminated CEO. In 2022, over 4.8 million prescriptions for insulin detemir (Levemir) were filled for nearly 1 million patients, according to the Medical Expenditure Panel Survey (MEPS) from the Agency for Healthcare Research and Quality (AHRQ) sourced from ClinCalc Drug Stats Database. Levemir's revenue figure is from Close Concerns/diaTribe News; while other estimates are derived from market share data. The pie chart and table below show selected insulin market share data (the bestsellers) and are not all-encompassing. Data sources: AHRQ MEPS via ClinCalc DrugStats Database and Close Concerns/diaTribe News.

While the pie chart above illustrates market share, it masks the fragmentation caused by multiple biosimilars and follow-on biologics—especially for glargine (the dark blue slice), lispro (the orange slice), and aspart (the yellow slice). We also have a good idea of WHY biosimilar manufacturers made the decisions they did and everyone and their brother is making a copy of Lantus. 

Consider this:

In contrast, detemir's (the green slice) share came from a single now-discontinued product—a gap we aim to fill. The key question: how many patients will return once non-medically switched to alternatives?

Alliance to Protect Insulin Choice

That's when I was connected with Alison Smart, who founded the Alliance to Protect Insulin Choice https://alliancetoprotectinsulinchoice.org/. We teamed up to do something about it. Alison has been much more involved in day-to-day efforts (I said I would not be doing any "heavy-lifting" but would offer relevant perspective on issues as they developed), I've been able to share strategic insight and perhaps equally important, important information. Instead of waiting for a major manufacturer, we connected with biosimilar manufacturers to reconsider the erroneous, legally-exempted rebate kickback driven sales data. Novo Nordisk initially stonewalled, falsely claiming that no company had reached out. Eventually, they agreed to speak with biosimilar manufacturers, although it has not offered much help since. In other words, Novo Nordisk did as little as they could get away with doing. 

It also suggested that Levemir was a rapidly-dying product. That's at best misleading. Thanks to the PBM sponsored rebate-contracting commercialization model, Levemir and Tresiba were able to coexist for many years, thus necessitating Novo's discontinuing Levemir in order to force patients who were not Tresiba users to switch against their will. Big PBM formularies don't usually prefer specific drugs—they prefer manufacturers who offer them fat rebates, enabling Levemir and Tresiba to coexist on most drug formularies where Novo Nordisk insulins were preferred. As long as Novo Nordisk's products are preferred, its older products remained available on-formulary in most cases. 

We've explored a few possible paths forward. One is a potential FDA Rx-to-OTC reclassification for insulin detemir, much like how older human insulins are already being sold—enabling patients to buy them directly from a pharmacist without a doctor's prescription. Another is a low-cost, cash-pay prescription model through retail pharmacies or sellers like Mark Cuban Cost Plus Drug Company. Both are likely scenarios. But success will really depend on fresh thinking—free from deeply corrupt rebate entanglements and outdated assumptions about how insulin must be marketed and commercialized. 

Quiet Influence and Strategic Nudges 

My recent advocacy isn't only about insulin. 

I've also followed the financial and strategic shifts happening in the diabetes technology space. In 2018, Johnson & Johnson sold its LifeScan blood glucose monitoring business to Platinum Equity for $2.1 billion. This past July, I wrote about how LifeScan quietly entered a Chapter 11 bankruptcy through a restructuring support agreement https://blog.sstrumello.com/2025/08/platinum-equity-plans-to-reorganize.html. 

Meanwhile, Haleon—a consumer health spinoff from GSK—is now looking to acquire new assets https://www.thisismoney.co.uk/money/markets/article-15117131/GSK-spin-Haleon-eyes-Tylenol-takeover.html. LifeScan may not be a growth rocket, but it remains a cash-generating business. Despite the hype, CGMs still aren't covered by most insurers for patients with Type 2 diabetes who don't use insulin. That's why Dexcom is selling its new CGM, branded as Stelo, over-the-counter—and why Abbott sells an OTC version of its CGM as well. But these products haven't exactly taken off. Many consumers try the OTC CGMs briefly, then stop using them once they learn how their behavior affects their glucose levels. Low repeat purchases is not a great business model. 

I don't know anyone at Haleon, but I still think if it is looking for acquisitions, then making a bid for what remains of LifeScan could be a good idea, therefore I sent a blind email to a half-dozen employees pitching the idea of LifeScan as a potential acquisition target—not because it's a rapid-growth business, but because its neither obsolete, and the business remains cash-generative. I'm not trying to close a deal—I just want to plant the seed of an idea in someone's mind who has the potential to tell colleagues who might be in a position to make something happen. That's what advocacy sometimes looks like: small, quiet nudges that might help shift the future. Whether it's a blind email to a potential acquirer or a formal complaint to the FTC, I've found that even subtle actions can plant seeds that grow into real accountability and change—especially when state laws like the Donnelly Act (New York State's antitrust law) offer tools when federal regulators ignore gross violations of fair trade and antitrust laws. 

Still in It, But On My Own Terms 

After nearly 50 years with T1D, I don't show up for every walk or respond to every campaign—but that's not retreat, and it's certainly not giving up. It's an evolution. I advocate differently now: more focused, more strategic, and informed by decades of hard-won experience. I know the battles that matter to me, and I've learned how—and where—I can make an impact. That's the diabetes advocacy work I continue to do after a half-century of Type 1 Diabetes (T1D). 

Dexcom's Management Obscures Receivables, Hides Days Sales Outstanding (DSO), and Spins a Narrative Investors Shouldn't Trust

This is certainly a "Business of Diabetes" story. Dexcom Inc., once the undisputed leader in continuous glucose monitoring, now finds itself at a troubling inflection point. What else would you call a company that rushes a new product to market using inferior materials to match a competitor's launch date, while its CEO quietly takes an extended leave before announcing his departure, and its senior executives exit en masse? Management textbooks might call it a case study in corporate short-termism, poor governance, and cultural toxicity. These aren't isolated missteps; they're symptoms of deeper management dysfunction at Dexcom, Inc.

For years, Dexcom enjoyed a stellar run. Its G6 sensor was praised, its margins were strong, and its reputation among patients and clinicians was enviable. But cracks have begun to show. In July 2025, CEO Kevin Sayer announced he would step down on January 1, 2026 (contained in the quarterly earnings release found at https://www.businesswire.com/news/home/20250730050482/en/Dexcom-Reports-Second-Quarter-2025-Financial-Results-Updates-Full-Year-2025-Guidance-and-Announces-CEO-Succession-Plan/ for details), after a decade at the helm. His successor, Jake Leach, currently serves as President and COO. Yet Sayer's extended absence (see https://www.drugdeliverybusiness.com/dexcom-ceo-takes-temporary-leave-absence/ for the news) before the announcement raised eyebrows, and the leadership transition comes amid troubling signs.

Perhaps the most telling indicator of Dexcom's decline is its over-reliance on questionable accounting maneuvers—gimmicks that forensic accountants can spot with ease. According to Nick Gibbons, an Adjunct Assistant Professor of Accounting at NYU Stern and contributor to Hunterbrook Media, Dexcom used similar tactics back in early 2024. Specifically, the quarter after Dexcom's Days Sales Outstanding (DSO's) spiked near 100 in early 2024 — an issue flagged at the time by the accounting group — the company's stock fell around 40%. The DSO number obscures weaker-than-expected earnings. Gibbons, an alumnus of ASU's Thunderbird School of Global Management, who also teaches courses on financial statement fraud for NYU, and recently dissected Dexcom's filings in a critical Hunterbrook article (see https://hntrbrk.com/dexcom/ for the article).

His analysis coincides with a wave of senior executive departures at Dexcom. 

In October 2024, EVP and Chief Commercial Officer Teri Lawver announced her retirement (see the MedTech Dive article on Teri Lawver's retirement at https://www.medtechdive.com/news/dexcom-chief-commercial-officer-retire-earnings/731135/). Hers was a high-profile exit, but it was hardly the only one. Barry Regan (EVP of Global Operations), Paul Flynn (EVP of Global Revenue), Steven Pacelli (EVP and Managing Director of Dexcom Ventures), Laura Endres (SVP of North American Channels and Payors), Andre Hoth (Head of Engineering for pump integration), and John Alvio (Treasury Supervisor) have all left the company within the past year. This exodus suggests internal instability, not just routine turnover.

Adding to the growing list of concerns, Dexcom is now facing a surge in customer complaints about its newer G7 sensor.  And, I'm not even mentioning Dexcom's over-reliance upon legally-exempted rebate kickbacks paid to PBMs contingent-upon "formulary-exemption" which aims to prevent patients from having access to rival CGM products such as Abbott's Freestyle Libre products, although I have written about that in the past (catch my coverage of the Nick Jonas Superbowl ad fiasco HERE).

Dexcom's G7 CGM sensor with built-in transmitter

That product, rushed to market, has been plagued by (in)accuracy issues and regulatory scrutiny. According to FDA documents published by Hunterbrook (see FDA warning letter at  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dexcom-inc-700835-03042025/ for more detail), Dexcom made unauthorized changes to a critical component: the membrane coating on the sensor filament. Originally sourced from a third-party silicone compound, the coating was designed to block chemical interference—especially from acetaminophen—and to help ensure accurate glucose readings. Dexcom replaced it with an in-house formulation, developed by individuals with questionable scientific credentials. The FDA privately warned Dexcom that its own tests showed the new coating performed worse.

This isn't just a technical hiccup. 

It reflects a corporate culture that consistently prioritizes commercial speed over science. Only the financial consequences of that are just starting to become evident. For example, Dexcom's gross margin has declined for 15 consecutive quarters, falling to 59.5% in Q2 2025. While the company offered various explanations or excuses, analysts at Goldman Sachs and JPMorgan have flagged the Dexcom margin pressure as structural. Excess and obsolete inventory charges, likely tied to product flaws and returns, are weighing heavily.

Hunterbrook's article (again, see https://hntrbrk.com/dexcom/ for the article), provocatively titled "Dexcom's Fatal Flaws," may lean toward some hyperbole, yet the underlying concerns are genuine. Many newly diagosed patients do not realize that CGMs don't actually measure blood glucose directly; they measure correlated substances found in interstitial fluid. That's why clinicians recommend verifying suspected erroneous CGM readings with a fingerstick test. Yet many newly diagnosed patients and caregivers don't even realize this and rely upon Dexcom readings as if they were not subject to error, and yet the G7's inaccuracies have led some to abandon Dexcom altogether. Longer-term patients have the luxury of knowing how flawed CGMs actually are.

Riva Greenberg, a longtime diabetes advocate and writer for Huffington Post and diaTribe News, blogged earlier in 2025 how she switched to Abbott's Freestyle Libre 3/Libre 3 Plus. Covered by traditional Medicare with a Medigap supplement, hence she made the transition after frustrations with the G7. In her blog, Diabetes Stories, she candidly described her disappointment with Dexcom's latest offering (see https://diabetesstories.com/2023/07/21/im-sorry-to-say-im-not-loving-dexcoms-g7/ for her post).

Others have conducted side-by-side comparisons of the G6 and G7. Among them include Dan Heller, a former CEO of a molecular diagnostics firm based in the Bay Area, who happens to be a person living with T1D himself, ran both sensors concurrently and documented the discrepancies. His Substack article, which draws heavily from Hunterbrook's reporting, adds a personal layer to his technical critique demonstrating the G7's flaws. His Substack article chronicling those comparisons can be read at https://danheller.substack.com/p/dexcoms-tumble-and-the-ill-fated-g7-sensor/.

Taken together, these developments paint a picture of a company (Dexcom) in trouble—not just operationally, but culturally and financially. Whether Jake Leach can reverse the tide remains to be seen. But the warning signs are no longer subtle. Dexcom's reputation, once built on trust and innovation, is now being tested by the very patients it was meant to serve.

On the upside, even while my own insurance company's PBM is collecting kickbacks from Dexcom contingent upon "formulary exclusion" of competing CGMs, and even while Aetna/Caremark cover about 37% to 40% of Dexcom sensor costs pre-deductible to ensure that kickback cash continues to flow to Caremark, as I blogged back in December 2023 (catch my coverage at https://blog.sstrumello.com/2023/12/abbott-gets-real-about-formulary.html for more), patients can use a manufacturer coupon from Abbott even if their insurance company tries to prevent you from using any CGM other than Dexcom. 

Below is Hunterbrook Media's video of its article "Dexcom's Fatal Flaws" which can be seen at https://youtu.be/_ogUlKUEVmQ?si=d3lmMOQhfvS8S8Tq or below. 

On Immunization, Blue & Purple States Declare Independence from Disproven Federal Anti-Vax Policies Imposed by Trump HHS Secretary

This was both predictable and inevitable.

The United States now finds itself navigating a fractured public health landscape, a direct consequence of the Trump administration's appointment of Robert F. Kennedy, Jr. (RFK Jr.) as Secretary of Health and Human Services (HHS). Mr. Kennedy is a lawyer with no medical training and a long history of promoting anti-vaccine misinformation. Under RFK Jr's leadership of HHS, he discontinued Emergency Use Authorization for COVID vaccines, and while the FDA has approved new ones with narrower eligibility similar to what were in place before the pandemic, plus he has also dismantled federal immunization guidance by firing the independent panel who make public recommendations. In doing so, that has left local health departments scrambling to respond to a crisis manufactured not by science, but by political ideology. The result is a nation where residents of states with competent public health leadership are likely to remain protected, while those in states governed by underfunded, incompetent, or politically-compromised agencies face renewed vulnerability to largely preventable infectious diseases.

For decades, public school districts across the country have required students to be immunized against a host of transmissible illnesses—polio, measles, mumps, rubella (the preceding three are just a single immunization!), hepatitis B, chickenpox, diphtheria, tetanus, and pertussis among them—before attending taxpayer-funded schools. These policies have not only proven effective, but have also enjoyed widespread support from public health officials and the general public. Parents opposed to vaccination have always retained the right to homeschool their children, although those children may still be subject to standardized testing. Alternatively, some families have opted for private religious schools that offer exemptions, though these come at a financial cost many cannot afford.

The principle behind these policies has always been clear: individuals may make personal health choices, but they do not have the right to endanger others in public institutions. If parents wish to avoid immunizing their children, they must seek alternatives outside the public system. Otherwise, they are expected to comply with established public health requirements.

That clarity has now been upended. 

In states like Florida, Republican-led efforts to eliminate vaccine mandates for school children threaten to reverse decades of progress. Florida's Surgeon General Joseph Ladapo has championed these changes, despite pushback from qualified medical professionals within the state. If Florida proceeds with its plan to dismantle vaccine requirements, it will not only expose its own children to preventable diseases, but also risk exporting contagions to other states and countries. In order to protect their children, parents in Florida should consult with pediatricians rather than relying on state guidance, as the science remains unequivocal: immunizations work, and children in public schools should be protected.

The broader national immunization system—once a model of consistency—has become unsustainable under Kennedy's leadership. His tenure has been marked by the removal of CDC Director Susan Monarez, the replacement of the CDC's independent vaccine advisory committee with known vaccine denialists, and after that, four more top CDC leaders resigned claiming political interference in their duties. Then, on June 23, 2025, Robert F. Kennedy, Jr. then fired all 17 members of an advisory panel for vaccine recommendations, replacing several of these advisory panel members with people who allegedly had previously spread proven misinformation and falsehoods about COVID-19 vaccines. The imposition of these more restrictive policies clearly aims to limit access to COVID booster shots. In fact, even eligible individuals have struggled to obtain vaccines due to confusion about new prescription requirements as well as supply chain disruptions. Senator Bill Cassidy, himself a physician, has accused Kennedy of "effectively denying people vaccines," a charge Secretary Kennedy has been unable to refute with evidence.

The consequences have been swift and severe. Measles, once considered eliminated in the United States since 2000, has reemerged in outbreak clusters among unvaccinated populations. More than 1,400 cases have been confirmed, a grim milestone that underscores the dangers of abandoning science-based policy.

Kennedy's appointment was always controversial. His questionable background includes a decade of work for the anti-vaccine organization Children's Health Defense, and he has also publicly admitted to long-term heroin abuse. His advocacy for disproven COVID treatments like ivermectin and hydroxychloroquine—neither of which has demonstrated efficacy, and both of which pose potential harm—further discredits his leadership. As Pete Buttigieg aptly noted in a recent Substack article (see https://petebuttigieg.substack.com/p/what-rfk-jr-is-taking-away-from-you/ for more), "Robert F. Kennedy, Jr. is not just a quack; he is a quack with power, and he is using that power to undermine public health."

Mother Jones magazine offered a similarly scathing assessment (see https://www.motherjones.com/politics/2025/09/rfk-jr-is-living-in-a-pretend-anti-vax-world/ for detail), while Axios reported on the growing resistance among Democratic-led states (refer to https://www.axios.com/2025/09/05/rfk-vaccine-rule-states-democrats-vaccine-rules/ for more). That resistance has now crystallized into action. NPR offered another article about actions being taken at the state-level found at https://www.npr.org/sections/shots-health-news/2025/09/06/nx-s1-5532121/states-vaccine-guidance-washington-oregon-new-mexico.

States Seeking Alternatives to Federal Immunization Guidance

In early September 2025, the governors of California, Oregon, Washington (and subsequently joined by the State of Hawaii) announced the formation of what they are calling the "West Coast Health Alliance", a multistate coalition to coordinate public health guidelines separate from the CDC, with a commitment to upholding scientific integrity in public health. Their joint statement (https://governor.wa.gov/news/2025/washington-california-and-oregon-launch-new-west-coast-health-alliance-uphold-scientific-integrity/) condemned the politicization of the CDC and pledged to restore evidence-based policy.

Colorado, often considered a purple state, joined the movement. Governor Jared Polis issued Public Health Order 25-01, directing state agencies to ensure access to updated COVID-19 vaccines (see https://governorsoffice.colorado.gov/governor/news/governor-polis-cdphe-take-swift-action-ensure-easy-access-covid-19-vaccines-coloradans-fall/).

Pennsylvania (another purple state; residents outside the major urban areas of Philadelphia and Pittsburgh sometimes refer to the rural, Appalachian parts of their state as "Pennsyltucky") followed suit. Governor Josh Shapiro empowered pharmacists to follow guidance from trusted medical organizations like ACOG, AAP, AAFP, and the FDA, rather than relying solely on the CDC (https://www.pa.gov/governor/newsroom/2025-press-releases/state-board-of-pharmacy-votes-to-protect-vaccine-access-across-p/).

Massachusetts Governor Maura Healey issued a standing order allowing pharmacists to administer COVID boosters to residents aged five and older, and mandated that insurers cover all state-recommended vaccines without out-of-pocket costs for people in Massachusetts (refer to https://www.mass.gov/news/governor-healey-announces-immediate-steps-to-ensure-vaccine-availability-in-massachusetts-amid-trump-rfk-rollbacks/).

New Mexico's Health Secretary Gina DeBlassie issued a public health order to remove barriers and expand access to COVID vaccines statewide (see https://cv.nmhealth.org/wp-content/uploads/2025/08/PublicHealthOrderCOVID19Vaccine-20250830.pdf).

New York Governor Kathy Hochul signed an Executive Order (EO) allowing pharmacists to administer COVID vaccines to eligible patients without a prescription, with plans to renew the order until the legislature modifies state laws to reduce reliance on federal guidance (https://www.governor.ny.gov/news/governor-hochul-signs-executive-order-expanding-access-vaccines-amid-uncertainty-washington/). She said she intends to renew the EO every 30 days until the State legislature can reconvene and change state laws to offer credible alternatives to CDC guidance on immunizations, and the legislation is expected to also expand the ability for pharmacists to prescribe the COVID vaccines off-label even for those who are not currently eligible in accordance with the existing FDA label.

Connecticut and Maine have also reaffirmed their commitment to broad vaccine access. Governor Lamont issued a statement (https://portal.ct.gov/governor/news/press-releases/2025/09-2025/governor-lamont-statement-on-access-to-vaccines/), while the Maine CDC emphasized the importance of timely, safe, and effective immunizations (https://www.maine.gov/dhhs/mecdc/diseases-conditions/immunization/).

In sum, a number of blue and purple states are now doing what the federal government under Secretary Robert F. Kennedy, Jr. refuses to do: protect their residents from infectious illness. By asserting their independence and restoring access to life-saving vaccines, they are not just defying a quack—they are defending public health itself.

Author P.S., September 18, 2025: In a move very similar to the West Coast Health Alliance, a Northeast Public Health Collaborative was formally announced on September 18, 2025 which includes the states of Connecticut, Maine, Massachusetts, New Jersey, New York State, Pennsylvania, Rhode Island, as well as the City of New York (NYC) which was documented in a press release from the NYC Health Department found at https://www.nyc.gov/site/doh/about/press/pr2025/announce-northeast-public-health-collaborative.page — its objectives are very similar to those of the West Coast Health Alliance, which is to coordinate public health guidelines separate from the CDC, with a commitment to upholding scientific integrity in public health. The State of Maryland also subsequently joined the Northeast Public Health Collaborative (see HERE). While it is able to follow CDC guidance if the science is valid, the collaborative is also free to rely upon viable alternatives to CDC guidance which has become politicized rather than based upon scientific integrity under HHS Secretary Robert F. Kennedy, Jr., a known vaccine denialist (it is invalid to refer to him as a vaccine "skeptic"). New York State Governor Kathy Hochul said that the Northeast coalition had agreed that updated COVID-19 vaccines should be given to children ages six months to 18 years, older children and adults with certain risk factors and adults older than 64. The group also said that all adults are recommended to be vaccinated.

Author P.S., December 8, 2025: Axios is reporting (see the Axios article at https://www.axios.com/2025/12/08/maha-group-state-election-endorsements for details) that MAHA Action, Inc. which is a fairly new political advocacy group that looks a lot like a Political Action Committee or PAC (except that this one does not have very much money) which is dedicated to advancing Robert F. Kennedy Jr.'s well-known anti-vaccine agenda, evidently recently made its first state-level election "endorsement" in December 2025 by wading into a key farm state's gubernatorial race. While Axios never explicitly mentioned exactly which "farm state" governor's race it was referring to, we know that the state happens to be Iowa, whereby MAHA Action, Inc. made its first gubernatorial endorsement in the Iowa governor's race. The group endorsed Republican Zach Lahn in the 2025 Iowa governor's race according to a press release (see the press release at https://www.prnewswire.com/news-releases/maha-action-inc-endorses-zach-lahn-for-iowa-governor-302632193.html for more).

Diabetes Mine Innovation Project Study on GLP-1 Therapies and T1D

Some of my followers may recall that once upon a time, there was a diabetes blog started by Amy Tenderich which was called "Diabetes Mine" and it described itself as "a gold mine of straight talk and encouragement for people touched by diabetes. We offer a unique mix of the latest diabetes news, views, and reviews. We also act as a strong voice of patient advocacy, working to foster innovation in diabetes care."

Amy subsequently hired people to manage the content published on the diabetes blog she had started, hence it was run by people who were paid to report on topics relevant to people diabetes, and all of the authors all had diabetes themselves so they shared that perspective which so few publications share (most articles about diabetes are written by people who have no clue what is important to people with diabetes, yet they assert things to be the biggest new improvement when those news items are rarely big or even improvements. But Amy decided to sell the Diabetes Mine blog to an entity known as Healthline Media, Inc. back in 2015, which continued publishing and updating it until 2022, at which point, Healthline decided to discontinue updates to Diabetes Mine. No updates have been made to Diabetes Mine since that time.

The decision to discontinue publishing on Diabetes Mine was made in early 2022, with the closure taking effect in April 2022 after 17 years online, according to DiabetesMine.com's Facebook page. Amy Tenderich, the founder of Diabetes Mine, is now focusing on the Diabetes Mine Innovation Project, while Mike Hoskins was to remain with Healthline's broader editorial team. However, Healthline itself went through a series of acquisitions who had little interest in diabetes. Today, what remains of Healthline's assets are now in an entity known as  RVO Health—a joint venture formed between the private equity firm Red Ventures and UnitedHealth Group's Optum. RVO Health was the acquirer of United Healthcare/Optum's "OptumPerks" coupon-generating website/app, only it no longer enjoys the benefit of having access to any of its sister company's services, such the PBM known as OptumRx's prescription drug formularies and is today primarily focused on selling things that telehealth firms are big sellers of, such as ED and baldness medications rather than more widely-used therapeutic categories such as statin drugs.

Regardless, after selling her blog, Amy Tenderich continued something she called the "Diabetes Mine Innovation Project" https://ddataexchange.com/, if episodically. Earlier in 2025, the Diabetes Mine Innovation Project conducted a nationwide survey of nearly 200 people (technically, 186 respondents) living with Type 1 diabetes to better understand real-world use of GLP-1 receptor agonists (referred to as GLP-1 therapies henceforth) GLP-1 therapies. From access challenges to clinical outcomes, the findings highlight how patients are currently navigating off-label use — and what's working (or not) in daily life. That study has been published at https://drive.google.com/file/d/1WD5LCh07-fbCKR1t3tdjkaojJiG1Zb3W/

The findings, while somewhat interesting, remain fairly limited.

The biggest limitation is that it was a survey conducted using a non-scientific "convenience" sample rather than a truly representative sample of adults with T1D, which means that the survey findings may help researchers to better understand off-label usage of GLP-1s among patients with T1D, but they are not truly representative of anything other than the opinions of a few people who answered the survey questions. Right now, there is little quantitative data on T1D GLP-1 usage.

There is also another limitation: the survey itself: it refers to GLP-1s generically, without specifying any particular brand or version of GLP-1 treatment. Novo Nordisk previously tried unsuccessfully to attain FDA "label extensions" on its GLP-1s, but the FDA denied those attempts as little more than an effort to sell the expensive products to a larger audience. Most "studies" have involved only the newest, patent-protected and overpriced GLP-1 treatments, rather than generics.

But, since 2024, the FDA has approved three generics of liraglutide, and even more generics of that product (and others, does anyone remember Lilly's Trulicity?) are currently pending FDA approval decisions. With each new generic that hits the market, prices on all of the others tend to fall even further. The advent of cheaper generics should assuredly be explored, in part, not only because the branded GLP-1 treatments are expensive, but their biggest innovation is they are extended-release products, while generics are dosed daily. But daily dosage offers T1D patients a major advantage of being able to adjust therapy daily based on how glucose levels are impacted. With the newest GLP-1s, patients can only adjust insulin because the GLP-1 lasts all week. That is a limitation of the GLP-1 treatment being commercialized. But generics are readily available now and cost vastly less money.

Key Reasons for Previous FDA Denial or Lack of Label Expansion on GLP-1 Products such as Victoza (liraglutide) in T1D:

• Mechanistic Limitations: GLP-1 agonists help to stimulate insulin secretion from functioning beta cells. In autoimmune T1D, complete beta-cell destruction limits this mechanism, thereby making GLP-1s less effective as a monotherapy. However, many of the Type 2 studies which were combined with insulin were not a basal/bolus regimen, but were conducted on GLP-1s with basal-only insulin which is unheard of in Type 1 diabetes. A well-designed study should be a GLP-1 with a basal/bolus regimen but never with basal-only insulin.

Safety Concerns:

• Increased risk of hypoglycemia when used adjunctively with insulin.
• Gastrointestinal side effects (e.g., nausea, vomiting) may complicate glucose management in T1D.
• Insufficient Efficacy Data:
• Trials have shown modest improvements in weight and insulin dose reduction, but not enough to justify label expansion.
• No consistent evidence of improved glycemic control or reduced complications in T1D populations.

Regulatory Caution:

• The FDA has emphasized the need for far more robust, T1D-specific Phase III data before it would even consider label changes and Novo Nordisk did not want to undertake separate studies on T1D, merely as a leg of a study for T2D and/or obesity. As a result, Novo Nordisk has not submitted a formal supplemental Biologics License Application (sBLA) for its GLP-1s in T1D.
  
  The thinking at the company was that it was already having severe difficulty keeping up with demand among the obese populations without any form of diabetes, so the company never bothered (although it could). That opens an opportunity for peer-reviewed studies not designed by the drug manufacturer which are much more objective (and less tainted by the sponsor company) in nature aiming to sell more of a particular treatment, including those which study different GLP-1 therapies including generic GLP-1 products such as liraglutide from Teva, Hikma or Meitheal Pharmaceuticals, respectively. Academic reseach would appear to be the best vehicle to undertake such objective research.

While the Diabetes Mine Innovation Project study does answer some important, unanswered questions, much more robust and well-designed research is clearly needed. So far, however, these are not on generic GLP-1 products, only the newest, most expensive new GLP-1 therapies. But generics offer an advantage in that they are not extended-release products, enabling more adjustment by the patients either on the GLP-1 or the accompanying insulin dosages.

Biocon's Kirsty Becomes Second Insulin Aspart Biosimilar to Receive U.S. FDA Approval

Just a few weeks ago, on July 15, 2025, Biocon Biologics announced that the U.S. Food and Drug Administration (FDA) had formally approved its Biologics License Application (BLA) for Kirsty™ (insulin aspart-xjhz), a biosimilar copy of Novo Nordisk's first-generation prandial insulin analogue branded as Novolog® (insulin aspart). The Biocon insulin aspart product will also be sold under other brand names through different marketing partnerships which Biocon has established. This means Kirsty joins Sanofi's Merilog as the second FDA-approved biosimilar insulin aspart in the U.S. in 2025, however, Kirsty has the distinction of being the first biosimilar of insulin aspart which has the FDA distinction of being "interchangeable" with the innovator product, meaning pharmacists can substitute Kirsty for Novolog unless the doctor writes "No subsitutions" on the prescription. FDA has approved several copies of the basal insulin analogue Lantus already, and now Novolog, as well as one follow-on biologic copy of Humalog (specifically, Sanofi's Admelog). But, there are quite a few other biosimilar insulins which have yet to receive FDA approval decisions. I expected those to have decisions already, so FDA is running behind schedule rendering decisions on those products.

When Sanofi's insulin aspart biosimilar was approved earlier this year, FDA actually issued its own press release on the decision (see that release at https://www.prnewswire.com/news-releases/fda-approves-first-rapid-acting-insulin-biosimilar-product-for-treatment-of-diabetes-302377321.html for more), but since then, there have been unprecedented staff cuts at FDA which means no more FDA press releases about biosimilar insulins until the Trump/DOGE era with massive staff cuts is over. 

As a result, Biocon decided to issue its own press release on the FDA's approval of its insulin aspart biosimilar, and you can read Biocon's official announcement at https://www.globenewswire.com/news-release/2025/07/15/3115973/0/en/Biocon-Biologics-Expands-Diabetes-Portfolio-with-FDA-Approval-of-Kirsty-the-First-and-Only-Interchangeable-Rapid-Acting-Insulin-Aspart-in-the-United-States.html. The FDA notice of approval and letter which was sent to Biocon Biologics for Kirsty can be viewed at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761188Orig1s000ltr.pdf. 

Shreehas Tambe, CEO and managing director of Biocon Biologics, said in a news release "With Kirsty, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care."

Biocon originally submitted Kirsty for FDA approval back on July 16, 2020, but in early 2023, the FDA issued a Complete Response Letter (CRL) to Biocon Biologics due to manufacturing concerns at its Johor, Malaysia facility. The FDA's feedback did not question the insulin aspart biosimilar's clinical data, but it cited procedural deficiencies related to the company's adherence to Good Manufacturing Protocol (GMP), particularly issues identified during an earlier inspection of the Johor, Malaysia facility where the insulin is actually manufactured. Until those issues were resolved to FDA's satisfaction, and the site was re-inspected by FDA, no other FDA approvals would be issued for any other insulin products made there. Biocon's 2023 CRL disclosure to shareholders can be viewed at https://www.biocon.com/biocon-biologics-receives-complete-response-letter-from-us-fda-for-biosimilar-insulin-aspart/. 

The successful 2025 insulin aspart FDA approval demonstrates Biocon's ability to successfully resolve those compliance issues without support from Viatris (formerly Mylan), which previously handled regulatory operations for the company's biosimilar joint venture. Biocon acquired Viatris' half of their biosimilar collaboration on November 29, 2022, assuming full responsibility for the regulatory process. The acquisition details are at https://www.prnewswire.com/news-releases/viatris-completes-biosimilars-transaction-with-biocon-biologics-301688467.html. 

Kirsty has already received regulatory approval for sale in more than 40 countries, including Canada, Japan, Australia, and across most of Europe. Health Canada granted its approval on October 12, 2021, and the insulin aspart biosimilar entered the Canadian market in 2022. It has also been approved in markets such as Germany, the UK, France, Spain, Portugal, the Netherlands, Norway, Denmark, Sweden, Finland, and Iceland. Documentation of Health Canada's approval is available at https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00570.

In the United States, since March 6, 2025, Biocon has a commercial agreement with Civica, Inc., a nonprofit pharmaceutical organization and that organization will procure insulin aspart from Biocon Biologics. Under that deal, Biocon will exclusively supply insulin aspart for Civica's U.S. insulin program. The other two insulins included in Civica's original biosimilar insulin announcement — notably insulin lispro — will presumably still continue to be manufactured by GeneSys Biologics of India.  However, Biocon Biologics previously signed a supply arrangement with Civica for insulin glargine which suggests that once Biocon is able to copy insulin lispro, Biocon Biologics could potentially supply that to Civica as well (however, because Biocon does not already sell a Humalog copy, it first has to replicate that).

Civica will carry out its own "fill and finish" manufacturing operations at its newly built manufacturing facility in Petersburg, Virginia. It also has a confirmed device supply agreement for the UnoPen disposable insulin pen with Swiss company Ypsomed, which will be used across all three of Civica's insulin biosimilar offerings. Civica and Biocon's collaboration announcement can be viewed at https://www.prnewswire.com/news-releases/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-the-united-states-302394010.html. 

While Biocon has not publicly disclosed a specific injection pen device used for its branded Kirsty insulin pens (it already sells the glargine biosimilar Semglee in a pen device and presumably it will be the same model), regulatory filings and manufacturing locations could possibly suggest that the source could be from SHL Medical, which is a Swiss company that produces disposable insulin pens which are made somewhere in Malaysia. SHL's Madie® pen device is one such device. However, Biocon Biologics describes itself as a "vertically-integrated" manufacturer and it is most likely that a section of the company's massive Johor Bahru, Malaysia manufacturing facility includes not only labs where the insulin molecules are cultured and packaged, but also likely the disposable injection pen devices themselves are made. And, FDA inspection reports and Complete Response Letters (CRLs) repeatedly reference Biocon Biologics' Johor, Malaysia facility as the site for both "insulin drug‑product" manufacturing as well as "device assembly".

Although it has been selling Semglee since 2021, navigating the U.S. insulin market may still prove challenging for Biocon. The entrenched rebate-driven pricing system controlled by Pharmacy Benefit Managers (PBMs) means that companies must offer steep rebates to gain favorable formulary placement. When Viatris introduced Semglee on behalf of Biocon back in 2021, it had to dramatically raise the U.S. list price (by more that sixty-five per cent!) in order to meet the 75%+ rebate demands from PBM's such as Express Scripts and Prime Therapeutics. An overview of those rebate dynamics can be found at https://www.drugchannels.net/2021/11/why-pbms-and-payers-are-embracing.html. 

However, the insulin pricing landscape in the U.S. is now shifting. The American Rescue Plan of 2021 removed the cap on Medicaid rebates for drugs whose list prices outpace inflation, which historically allowed insulin makers to keep increasing prices to fund PBM rebates without having to pay any more to Medicaid. Simultaneously, the Federal Trade Commission (FTC) launched litigation against major PBM's over anticompetitive contracting and formulary practices along with subsequent litigation against the PBM's. Discussion of these policy changes appears at https://progressivepolicyinstitute.medium.com/are-we-on-the-cusp-of-a-new-drug-pricing-paradigm-fdf611c009b3 and my own blog post found at https://blog.sstrumello.com/2025/01/why-i-pushed-for-ftc-litigation-against.html. 

Meanwhile, Civica's nonprofit insulin initiative, supported by funding from Breakthrough T1D (formerly known as JDRF), aims to bypass the PBM rebate model entirely by offering insulin aspart, glargine, and lispro at a maximum retail price of $30 per vial or $55 per box of five pens. The pricing strategy is meant to provide transparent, low-cost alternatives without formulary restrictions. More on Civica's insulin initiative is at https://blog.sstrumello.com/2022/03/civica-rx-were-entering-us-insulin.html, while Breakthrough T1D/JDRF's announcement of Civica's price commitments is available at https://www.prnewswire.com/news-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin-301495050.html and Civica's own statement is at https://www.businesswire.com/news/home/20220303005321/en/Civica-to-Manufacture-and-Distribute-Affordable-Insulin. 

Following the FDA's approval of Biocon's Kirsty insulin aspart biosimilar, Novolog now becomes the second insulin analogue — after Sanofi's Lantus — to face competition from more than one biosimilar and/or follow-on biologic product from several different manufacturers in the U.S. In February 2025, Sanofi's Merilog became the first FDA-approved biosimilar of Novolog. Several more biosimilar versions of insulin aspart are still awaiting regulatory decisions, with applications currently pending from Sandoz/Gan & Lee, Amphastar/ANP, Lannett/HEC, and Meitheal/THDB a few years later. 

Commentary on my assessment of the backlog of biosimilar insulin drug decisions is available at https://blog.sstrumello.com/2025/01/ask-fda-why-arent-insulin-biosimilars.html. Reporting on recent major FDA staffing disruptions attributed to DOGE and current Department of HHS leadership can be seen at https://www.nytimes.com/2025/07/08/magazine/fda-collapse-rfk-kennedy.html. 

Just as it did with its glargine insulin biosimilar which is branded as Semglee, Biocon could theoretically offer both branded Kirsty sold via PBMs and a separate unbranded insulin aspart product in the U.S. (although with insulin list prices falling on all insulins in the U.S., see https://www.drugchannels.net/2025/01/inflation-adjusted-us-brand-name-drug.html for more on that development), an unbranded insulin aspart product may no longer be a necessity for Biocon; for example, Novo Nordisk announced it will be discontinuing its unbranded insulin products by the end of 2025), in multiple delivery formats including 10 mL vials as well as in disposable insulin pens. Although Biocon has not announced that it intends to sell Kirsty in a package of five 3 mL cartridges as an option for patients who prefer to use refillable smart pens such as the Medtronic InPen (a smart pen which logs insulin dosages and tracks insulin-on-board), theoretically 3 mL cartridges might have demand in the U.S. However, there was news that a self-filled injection device called the Go-Pen ApS quite recently received FDA clearance, and the fillable 3 mL cartridges used with that product could potentially be a work-around for that, although that product has not yet launched in the U.S. (see https://www.drugdeliverybusiness.com/go-pen-fda-nod-user-filled-insulin-pen/ for more). 

With rising pressure on insulin list pricing, increased regulatory scrutiny of PBM's unlawful behavior, including from the Federal Trade Commission which is now suing the big PBMs and their rebate-contracting pharmaceutical sales model in the U.S., and the emergence of nonprofit options such as those from Civica, the dynamics of insulin pricing in the U.S. are finally shifting and list prices are falling in the U.S. The entry of multiple biosimilar insulin aspart products — especially those developed outside of (or working around) the rebate-contracting sales model — could mark a long-awaited turning point for U.S. insulin affordability. 

In my opinion, it is about time.

Author P.S., October 16, 2025: Civica, Inc. via that company's CivicaScript operating unit, announced that the company's insulin glargine biosimilar known generically as Insulin Glargine-yfgn which will be manufactured by Biocon Biologics, is expected to be available for patients to buy in retail pharmacies nationwide in January 2026. Initially, it will be sold under the State of California's CalRx brand but is expected to be available for sale in pharmacies nationwide, including Costco Pharmacy. See the press release at https://civicarx.org/civica-to-launch-long-acting-insulin-glargine-in-the-us-in-january-2026/ for more details. 

Platinum Equity Plans to Reorganize LifeScan Diabetes Testing Business in Chapter 11 Filing

As a person living with Type 1 diabetes (T1D) and hypoglycemia unawareness, I rely on traditional fingerstick blood glucose monitoring (BGM) to stay safe. CGMs may be the future for some, but they're not a reliable replacement for patients like me. CGMs can miss dangerous lows until it is too late, or report erroneous data at critical moments. The collapse of a major Blood Glucose Monitoring (BGM) supplier like LifeScan isn't just a financial story — it's a potential threat to patient safety.

Back in 2017, Johnson & Johnson (J&J) began retreating from its diabetes business. First came the shutdown of Animas Corp., its insulin pump unit. Then it offloaded Calibra Medical, maker of a wearable insulin patch, to CeQur. Finally, in 2018, J&J sold LifeScan https://www.prnewswire.com/in/news-releases/johnson--johnson-announces-binding-offer-from-platinum-equity-to-acquire-lifescan-inc-677074533.html — maker of the OneTouch blood glucose meters and test strips — to the private equity firm Platinum Equity for $2.1 billion https://www.globenewswire.com/news-release/2018/10/02/1588268/0/en/Platinum-Equity-Completes-2-1-Billion-Acquisition-of-LifeScan-From-Johnson-Johnson.html.

I'm not a big fan of the idea of private equity in the healthcare space, but the reality is that Platinum failed to cut LifeScan's expenses or grow its revenues, while also increasing rebates paid to Pharmacy Benefit Managers (PBMs) contingent upon "formulary exclusion" of all competing BGM brands.

At the time of sale, LifeScan held about 45% of the traditional fingerstick testing market. But even then, the future was clear: Continuous Glucose Monitors (CGMs) were ascendant among insulin users, and BGM was already being commoditized thanks to PBM profiteering.

Fast-forward to 2025, and Platinum's LifeScan acquisition has hit a wall. On July 7, 2025, the firm announced plans to restructure the business through a Chapter 11 bankruptcy filing https://www.businesswire.com/news/home/20250715827575/en/LifeScan-Reaches-Milestone-Transaction-to-Improve-Financial-Flexibility-and-Enable-Future-Focused-Investments/.

LifeScan's restructuring plan has support from its first- and second-lien lenders, meaning Platinum keeps control without putting in another dime. But third-lien creditors — namely insurance company–owned PBMs — are still waiting for a bankruptcy court to decide what, if anything, they'll get.

According to Bondoro Insights https://bondoro.com/lifescan/, LifeScan owes nearly $676 million in unpaid rebates to the three biggest PBMs: 

• CVS Caremark (Aetna): $244.7 million
• OptumRx (UnitedHealthcare): $234.9 million
• Express Scripts (Cigna): $196.3 million

And here's the kicker: the PBMs might walk away with nothing.

A commenter on my blog summed it up perfectly: "I find it highly amusing that PBMs are getting the shaft from private equity. Is there no honor among thieves?"

It's hard not to chuckle. PBMs are notorious for pocketing manufacturer rebates intended to reduce patient out-of-pocket costs, only to use those funds to enrich themselves — and their commercial health insurance company parent companies. Now they're on the losing end of a financial shell game they usually run.

Max Frumes of 9fin, who oversees global coverage of distressed debt and restructuring, called LifeScan's BGM business a "melting ice cube" https://9fin.com/insights/lifescan-deal-platinum-equity/  — a fading revenue stream in a CGM-dominated world. Still, fingerstick testing isn't obsolete. Most insurance plans still don't cover CGMs for non–insulin users (which explains Dexcom's big announcement that its Stelo product would be sold OTC; rival Abbott also sells an OTC CGM which is branded as the Libre Rio), plus most doctor's offices still use BGM for triage.

Again, for patients like me, CGMs are not an entirely dependable substitute. I need fingerstick tests to detect and confirm hypoglycemia that CGMs can be too slow to pick-up or even miss completely. This isn't a matter of convenience — it's a matter of survival.

Interestingly, while LifeScan was circling the drain, Roche — another BGM heavyweight — took a different approach. Unable to sell its own BGM business and not being on many insurance company preferred formularies, Roche partnered with Mark Cuban's Cost Plus Drug Company back in 2022 to offer Accu-Chek supplies directly to consumers https://www.accu-chek.com/news/roche-and-mark-cuban-cost-plus-drug-company-team-deliver-affordable-access-diabetes-testing/. That partnership bypassed PBMs entirely, offering patients far more affordable prices without the rebate games. 

Roche's cash-pay model had its roots in a fiery 2009 patient summit with Roche, where I was present. Patients challenged the company's presumption that insurance always covered test strips — ignoring growing deductibles and cost-sharing. Roche eventually realized that rebate contracts weren't the only viable route to market.

That insight proved prescient. In May 2025, Aetna/CVS Caremark informed patients it was dropping OneTouch in favor of Accu-Chek as its preferred BGM brand — effective around the same time LifeScan filed for bankruptcy. Now, those same PBMs may get $0.40 on each dollar they're owed, although it's also a possibility they'll never collect a cent of the rebates LifeScan owes them.

Aside from Roche, one other major BGM manufacturer which remains is PHC Holdings Corp's Ascensia's Contour system. That company is jointly co-owned by another private equity firm Kohlberg Kravis Roberts & Co. (KKR), as well as Japan-based Mitsui & Co., and the electronics giant Panasonic.

Some analysts argue PBM rebates should be prioritized in bankruptcy because they're "essential" to the business. But let's be honest: PBMs are more like financial parasites than partners. Their rebate-driven sales model has distorted prices, stifled competition, and hurt patients for years. Maybe it's about time their influence shrinks.

What's next for LifeScan?

Realistically, Platinum overpaid in 2018. Ideally, the LifeScan business would have been included as part of its spinoff of former businesses including Band-Aids and Tylenol called Kenvue, but Platinum Equity offered the company more money, so that's where things are now. LifeScan entering the CGM market now would be a long-shot, with Abbott and Dexcom dominating that space — and it would eat into LifeScan's already slim margins. LifeScan's time is running out — and private equity doesn't tend to play the long game.

For now, it seems the PBMs — long the masters of the rebate racket — have finally been outmaneuvered.

Author P.S., October 27, 2025: The U.S. Bankruptcy Court for the Southern District of Texas has approved LifeScan's Chapter 11 Plan of Reorganization thereby enabling the blood glucose monitoring (BGM) company to emerge from its financial restructuring process by the end of 2025. The press release (see https://www.businesswire.com/news/home/20251027291057/en/LifeScan-Receives-Court-Approval-of-Plan-of-Reorganization-Positioned-to-Emerge-as-Leader-in-Glucose-Management-with-Strengthened-Financial-Foundation/ indicates that the reorganization plan "will eliminate more than 75% of its debt" (which we know is primarily unpaid rebates which were owed to the big PBMs). "Today's approval marks a significant milestone in our financial restructuring process," said Valerie Asbury, Chief Executive Officer of LifeScan." According to Philadelphia Business News (see https://www.bizjournals.com/philadelphia/news/2025/10/29/lifescan-malvern-bankruptcy-reorganization-plan.html for details) "The reorganization plan includes transferring ownership to a group of creditors, effectively wiping out the equity held by its previous private equity owner, Platinum Equity. That said, with these substantial debts now eliminated, and Platinum Equity out of the picture, LifeScan may still remain acquisition bait for potential acquirers like the GSK spinoff Haleon with cash to make acquisitions.