Do-It-Yourself (DIY) vs. Commercial Closed-Loop Systems for Managing Type 1 Diabetes, an upcoming presentation by Dana M. Lewis, developer of OpenAPS, to the American Diabetes Association 83rd Scientific Sessions, 23 June 2023.

What is your presentation about? This presentation explores the scientific evidence for open-source automated insulin delivery (AID) systems, demonstrating the potential to enable improvements in A1C and time-in-range (TIR), reduce hypoglycemia, and also improve the quality of life of people living with diabetes. There are years of research and nearly a decade of real-world data supporting the use of open-source AID: in fact, there are now multiple randomized control trials establishing safety and efficacy, including one that was published in the New England Journal of Medicine. People with diabetes should be supported in accessing their choice of diabetes technology, including the options of open-source automated insulin delivery. In some geographic areas, open-source AID may be the only affordable and/or available option for people with diabetes, and this presentation will help the audience understand that safety and efficacy in AID and user choice are not mutually exclusive.

What makes this topic important in 2023?  Open-source automated insulin delivery systems have been in existence for almost a decade, but many providers are still unaware of them as an option, or how they might support patients choosing to access these systems. Providers may also not be up to date on the latest evidence, including the many randomized control trials (RCTs) that have established the safety and efficacy of various open-source AID systems for people living with diabetes.

How did you become involved with this area of diabetes research or care?  I helped develop the first open-source AID system (OpenAPS) and have been using it successfully for nearly a decade. I also became the first person to study and publish on open-source AID systems, leading the way for the now dozens of ongoing studies and collaborations worldwide that have been evaluating the safety and efficacy of various open-source AID systems for people living with diabetes.

Joanne: I have been using DIY Closed-Loop systems since 2016, with tremendous success.  I started a local, southern California support group that grew into a worldwide FB group called Loop and Learn, all about helping those who want the best technology for managing Type 1 diabetes.  It has been an amazing ride, with access to the very best in medical advice and brilliant developers, and an extraordinarily kind and interactive community. 

Feel free to join the following FB groups for more information: 

• • • • LoopandLearn (https://www.facebook.com/groups/LOOPandLEARN)
      • iAPS (previously known as FreeAPS-X) (https://www.facebook.com/groups/1351938092206709)
      • AAPS Users (https://www.facebook.com/groups/AndroidAPSUsers/)

And for information:

• • • • LoopandLearn (https://www.loopandlearn.org/)
      • LoopDocs (https://loopkit.github.io/loopdocs/)
      • OpenAPS (https://openaps.readthedocs.io/en/latest/)

---

Dexcom Pays PBMs Kickbacks to Exclude Rival CGMs; Senseonics Found a Way Around That by C. Scott Strumello for SStrumello.com, 6 June 2023.  

On June 3, 2023, there was an interesting announcement from the Maryland-based medical device startup Senseonics, Inc. that UnitedHealthcare will begin providing coverage for the Eversense E3 CGM System effective July 1, 2023, for people with Type 1 and insulin-requiring Type 2 diabetes. You may recall that Senseonics received a cash-infusion financial lifeline from Ascensia Diabetes Care back on August 10, 2020 when that company effectively paid for its CGM system. Still, Eversense remains comparatively tiny in the CGM space.

Scott Strumello says: “My loyal readers may also recall that I have complained that Dexcom is paying rebate kickbacks to vertically-integrated (with commercial healthcare insurance companies) Pharmacy Benefit Managers formulary managers to EXCLUDE rival CGM’s from their prescription drug formularies. 

Pembroke Consulting’s President Adam J. Fein’s describes the situation this way: “Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are one of the key factors behind the large gap between list and ‘net’ prices for brand-name drugs. They can also affect a patient’s out-of-pocket costs and access to a particular therapy.”

Dexcom is bribing (I mean paying “legally-exempted” rebate kickbacks) CVS Health/Caremark/Aetna as well as United Healthcare/OptumRx for the nitty-gritty details) to keep rival CGMs off-formulary. Currently, Cigna’s Express Scripts business unit is not publicizing its own formulary exclusions, most likely due to the FTC’s 6(b) study of PBM business practices which has the company under the proverbial microscope and it doesn’t want to offer any more ammunition regulators might use to sue the company.

But that raises an interesting question: If Dexcom is paying United Healthcare’s OptumRx PBM business to exclude rival CGMs from its formularies, how is it that Senseonics Eversense CGM was just approved for coverage effective July 1, 2023, when its getting kickbacks from Dexcom?  The answer is really due a technicality, but its one Ascensia is taking advantage of.

The Senseonics Eversense CGM must be inserted into patients’ arms by a medical doctor; it cannot be self-applied. Hence, that is considered a medical procedure, and not a pharmacy benefit. Voila: Senseonics can bypass the formulary exclusions United Healthcare has in place (paid for by Dexcom, Inc.) for self-inserted CGMs like Abbott Freestyle Libre 3. 

(FYI, the doctor in the photo is actually my endocrinology.  So many endos and other medical specialists develop financial “relationship” with pharma and device companies.  Do you think that is right???)

It’s nice how it works out for OptumRx that way, isn’t it? After all, it can keep collecting cash kickbacks to exclude rival CGM’s like Abbott Freestyle Libre from its formulary, yet concurrently cover a rival CGM anyway. Incidentally, one of United Healthcare’s formularies already includes Medtronic’s Guardian Link CGM as well, only it’s on a different tier from Dexcom.

I have often said that pharma has a weird, co-dependence on vulturous vertically-integrated PBMs. While Dexcom isn’t a pharma company, but a medical device company, the rebate kickbacks work the same way for pharma and medical devices. On the other hand, Dexcom shareholders are paying millions to keep rival CGM’s off-formulary, and United Healthcare’s OptumRx is still collecting all that money, yet United Healthcare is now covering Eversense CGM’s. Kind of defeats the purpose of paying legally-exempted rebate kickbacks, doesn’t it?

Thanks, Scott … FASCINATING!!!

Read refs & more: Dexcom Pays PBMs Kickbacks to Exclude Rival CGMs; Senseonics Found a Way Around That

---

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program by Philip Won & Veronique Li for TheFDALawBlog.com, 15 June 2023.

During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.  In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers.

 

• • An Innovative Approach: To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.”  CDRH previously described the TAP as a voluntary program that is intended “to de-risk the medical device valley of death by providing the industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health.” At the FDLI Annual Conference, Dr. Shuren reinforced this by stating that TAP is about “reducing the time and cost and increasing the predictability of going from concept to commercialization to address the valley of death.” The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach the market, whether due to reimbursement and/or physician or patient preference. 
  • Enhancing Review Capacity: Recognizing the value of real-time interactions, particularly highlighted during the COVID-19 pandemic, FDA aims to expand review capacity. Dr. Shuren said the ability to engage with developers in near-real-time was essential to expediting the authorization of over 2,800 devices during the pandemic. FDA intends to build on its experience by moving away from rigid stage-gate processes and fostering more fluid interactions throughout the review process.
  • Understanding Stakeholder Perspectives: FDA has acknowledged the importance of incorporating voices from patients, providers, and payors into the decision-making process and evidence-generation strategies. One mechanism to incorporate payors’ voices is through the Payor Communication Task Force. The task force facilitates communication between device manufacturers and payors. CDRH can engage with the Centers for Medicare & Medicaid Services (CMS) for parallel review – the mechanism for the FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between the FDA’s approval of a premarket application and the subsequent CMS national coverage determination (NCD). Participating in TAP, and thus having access to payors, offers the potential benefit of less time between the FDA’s marketing authorization and coverage decisions by CMS.

Read more: “TAP Dancing” Towards Faster Device Commercialization

---

A Chinese medication may be able to aid in the prevention of Diabetic Retinopathy by Morgan Malatesta, IDS intern for Integrated Diabetes Services, 13 June 2023.

A recent study in Taiwan showed that Scoparia Dulcis L. Extract (SDE) may be able to prevent this condition in people with diabetes. Considered a weed in many areas of the world, it has been used as a medicinal herb with an extensive range of usages. Scoparia Dulcis extract has been found to be anti-inflammatory (lowering inflammation), anti-hyperlipidemia (lowering cholesterol), anti-diabetic (stabilizing blood sugars), and anti-oxidative (protection from damage caused by free radicals). The SDE is cost-effective and has very few side effects.

The study, which appeared in one of the May 2023 publications of Medical Dialogues, was conducted by treating high glucose in human epithelial cells with various concentrations of SDE. Analysis of the study showed that the usage of SDE reduced the number of reactive oxygen species and ARPE-19 cell death when in a high glucose environment.

For those of you who are not familiar with the term, it is a condition that can cause partial vision loss or complete blindness in people with diabetes. High blood sugar causes damage to blood vessels throughout the body, especially those that feed the vessels of the eye. Damage to the retina impairs the eyes’ ability to sense light and send signals to the brain. This condition is commonly not reversible which is why it is so important for people with diabetes to get their eyes checked annually.

Read more:  A Chinese medication may be able to aid in the prevention of Diabetic Retinopathy

---

How does stress drive our brain to crave comfort food? by Robby Berman for MedicalNewsToday.com, 13 June 2023.  

For people who are stressed, it may seem as if comfort food offers the ideal — and maybe only — quick fix. A new study in mice from the Garvan Institute of Medical Research in Sydney, Australia suggests, however, that those people should think twice before tucking into a treat.  The study is published in Neuron.

The study finds that the combination of stress and comfort food switches off the brain’s mechanism for letting one know when they have had enough to eat. This can lead to an over-indulgence in one’s comfort food of choice, as well as weight gain and obesity, potential sources of yet more stress.

The brain area affected is the lateral habenula, an organ that exists in both mice and humans. Under normal conditions, the region produces a mild, unpleasant sensation in the short-term presence of a high-fat diet, switching off the brain’s reward response, thus making further eating less pleasurable. Many comfort foods are high in fat.

Working with chronically stressed mice, the researchers found that the lateral habenula remained uncharacteristically silent as high-fat foods were being eaten. The mice kept eating, apparently for pleasure, without becoming satiated.

Read more: How does stress drive our brain to crave comfort food?

---

Which of our senses evolved first? by Luis Villazon for ScienceFocus.com

We have lots of different senses, including a sense of balance, heat, pain, and the ability to sense the position of our limbs (called ‘proprioception’). But if we consider the five classic senses, then taste is the oldest by a wide margin. Taste is really just the ability to detect particular chemicals in your immediate environment, and ocean-dwelling bacteria were sensing nearby nutrients and swimming toward them at least two billion years ago.

Sight, or at least the ability to detect light, was another bacterial invention, but true image-forming eyes didn’t evolve until multicellular animals appeared around 570 million years ago. By then, many single-celled organisms had also evolved the ability to sense touch. Smell normally means the ability to detect chemicals carried in the air, so this sense had to wait around another 70 million years for the first land animals to emerge. Hearing in air came last, because sound waves are weak compared to electromagnetic waves such as light, and require specialized structures to amplify the signal, especially for high frequencies.  Fully-functioning ears didn’t evolve until 275 million years ago.

Read more: Which of our senses evolved first?

---

In July 2018, Dean published an essay with Simon G. Talbot, a plastic and reconstructive surgeon, that argued that many physicians were suffering from a condition known as moral injury. Military psychiatrists use the term to describe an emotional wound sustained when, in the course of fulfilling their duties, soldiers witnessed or committed acts — raiding a home, or killing a noncombatant — that transgressed their core values. Doctors on the front lines of America’s profit-driven health care system were also susceptible to such wounds, Dean and Talbot submitted, as the demands of administrators, hospital executives, and insurers forced them to stray from the ethical principles that were supposed to govern their profession. The pull of these forces left many doctors anguished and distraught, caught between the Hippocratic oath and “the realities of making a profit from people at their sickest and most vulnerable.”

The article was published on Stat, a medical-news website with a modest readership. To Dean’s surprise, it quickly went viral. Doctors and nurses started reaching out to Dean to tell her how much the article spoke to them. One survey found that nearly one in five healthcare workers had quit their job since the start of the pandemic and that an additional 31 percent had considered leaving. Professional organizations like National Nurses United, the largest group of registered nurses in the country, had begun referring to “moral injury” and “moral distress” in pamphlets and news releases. 

This is really interesting.  Would you consider bringing it up with your favorite health care provider on your next visit.  Maybe even share the article?  What do think about this crisis?

Read more: The Moral Crisis of America’s Doctors