Savvy Updates 2/3/20: Bio-Artificial Pancreas, Tetanus + Diabetes, Ultra Rapid Lispro, Dexcom Future, Diabetes Wearables, Eliminating Immunosuppressants, Risks at Chain Pharmacies

Artificial pancreas uses refillable oxygen tank to better-produce insulin was reported by Ben Coxworth for NewAtlas.com, 28 January 2020.

Developed by Israeli-based Beta-O2 Technologies, the titanium-bodied device is known as the Bio-artificial Pancreas, or the ßAir for short. Measuring about 2.5 by 2.5 inches (64 mm), it incorporates a macrocapsule containing live pancreatic cells (aka islets), along with an oxygen tank. The cells can be obtained from a human donor, from the pancreas of a pig, or they can be grown from the patient’s own stem cells in a lab. An external port on the oxygen tank allows the patient to refill it with oxygen on a weekly basis.

Once implanted under the skin, the ßAir is claimed to continuously monitor blood glucose levels, utilizing the oxygen-fed pancreatic cells to produce and deliver insulin whenever necessary. According to the company, the oxygen supply is the key to the device’s success – other experimental islet-equipped artificial pancreases, which rely on the limited amount of oxygen within the patient’s bloodstream, reportedly have difficulty keeping the cells viable.

Additionally, no immunosuppressive treatments are required in order to keep the new implant from being rejected by the body. That said, the company states that it can easily be removed if necessary.

The device has already been trialled on four patients in Sweden, who experienced no side effects after carrying the implant for 10 months – the cells remained viable throughout that period. A second-generation version is now being tested on diabetic rats, which have so far maintained normal glucose levels. A larger human trial should begin later this year.

How Does a Tetanus Shot Affect Your Diabetes? was published by Wil DuBois for DiabetesMine.com, 24 January 2020.

From all the research I could find, they don’t seem to. Which is odd, because the most common side effect of tetanus shots is pain at the injection site. In fact, the Centers for Disease Control and Prevention (CDC) says as many as two-thirds of all adults will experience pain, which can apparently last several days. And, as we all know, pain tends to raise blood sugar, at least for a time.

On top of that, about 1 percent of people develop a fever following the tetanus immunization, although no one is really sure why. It may be a productive part of the immune process, or it may simply be a side effect. Either way, any fever tends to raise blood sugar.

Thanks to the vaccine, tetanus is actually quite rare. The CDC reports an average of only 30 cases per year, which is remarkable, given that tetanus spores are described by scientists as “ubiquitous” in the environment. That means the little buggers are everywhere! Of course, most of those 30 cases each year are in unvaccinated people.

There was no evidence that the immunizations were either causing diabetes, or even triggering it in the already genetically pre-disposed mice. But in an incidental finding, the blood glucose levels of mice immunized with DTaP-IPV (engineered to protect against tetanus, along with diphtheria, whooping cough, and polio) were “significantly reduced” compared to the control mice, and NOD mice treated with a second immunization formula that also contained tetanus vax were also lower, although not as dramatically so.

Even though the pain of the injection — and the fever in some people — should raise blood glucose, could there be something about the vaccine itself that lowers BGs? In people with diabetes, could it be a wash? Could the raising and lowering effects cancel each other out, causing our sugar to remain flat?

Ultra-Rapid Lispro: What is it and why is it interesting? was written by Tim Street of Diabettech.com, 10 January 2020.

Ultra-Rapid Lispro is Lilly’s new formulation of Lispro to counter Novo’s Fiasp. In a similar fashion to Novo, they’ve added excipients to the Lispro formulation in order to speed the absorption. Specifically:

So what we have is a new, injectable insulin that will arrive around three years after Fiasp, using different excipients that in theory speed it up, significantly. According to the data presented at EASD 2019,

- Early absorption is significantly faster than Fiasp:
- 50% of max concentration was reached in two thirds of the time of Fiasp, while exposure increase in the first 15 minutes versus Fiasp was 1.5 times.
- It appears that we now have an insulin that really does have a tail that is all but done after five hours, instead of the 6-8 that all the others have.
- It’s also really noticeable how much less insulin there is in the tail after two hours.

Between them, the data from these trials shows something that is potential much more useful for use in a closed loop system. Okay, it’s not clearing at the rate of endogenous insulin, but it is quicker.

How Dexcom Is Prepping for the Next Wave of Continuous Glucose Monitoring was published by Amy Tenderich for DiabetesMine.com, 28 January 2020.

There’s no doubt that continuous glucose monitors have become today’s de facto standard of care for people with type 1 diabetes, who need to continuously make insulin dosing decisions. Making CGM a true standard of care would mean that every person newly diagnosed with any sort of diabetes would be mandated by both their doctor and insurance company to use CGM.

Dexcom CEO Kevin Sayer notes that the latest emphasis on Time-in-Range (TIR) means that CGM becomes a diagnostic tool, that can help many specific groups stay healthy. “Our core customer base is intensive insulin users. We need to create an interface/platform that supports others,” Sayer says. Other features Dexcom is investigating:

Working with Verily to codevelop its next-generation G7 sensor, a miniaturized, low-cost CGM
Sanofi-backed Onduo entity will add a coaching platform for users, as will Dexcom’s latest partner, Livongo.
Dexcom is shooting for extended wear in their next-generation CGM sensors — ideally 14 days or longer.
Regarding skin adhesive, “We’re spending lot of money doing tape research right now. G7 will have stickier tape made of different materials.
In an increasingly interconnected world in which CGM acts as the linchpin to new automated insulin delivery (AID) systems, assuring interoperability is key.
New, tighter performance standards must be 99.1 percent on point — allowing for error in just 10 out of every 1,000 data points. “That’s why the G6 sensor shuts off frequently — it does so by design when that standard is not met, meaning the readings are not accurate enough per FDA requirements,” Sayer says.
In response to the outages, Dexcom plans to introduce a Server Status website/app where users can check the status, and get push warnings of any data sharing issues.
Dexcom is looking at doing away with the code that users have to enter when inserting a new sensor.
Another way they’re looking a simplifying the user experience is by reducing the warmup time.

New Diabetes Wearables and More at CES and JP Morgan 2020 was written by Amy Tenderich for DiabetesMine.com, 21 January 2020. At the Consumer Electronics Show (CES) in Las Vegas and the J.P. Morgan Healthcare Conference in San Francisco, investors just can’t seem to get enough of hot new gadgets and science that look promising for the multi-million-dollar diabetes market. Here’s a list of some highlights:

AerBetic noninvasive CGM: ‘like a digital diabetes alert dog.’ Made by Alabama startup AerBetic, the idea was sparked by an actual diabetes alert dog named Wiley, adopted by AerBetic CEO Anar Thors. The system uses a nano gas sensor, created by San Diego-based AerNos, to detect certain gases that human bodies emit via exhaled breath. Scientists have identified these gases as early indicators of hypoglycemia or hyperglycemia. Initially, AerBetic will be designed as wearable bracelets and pendants.

ViaCyte still bullish on cell replacement ‘diabetes cure’ ViaCyte is the San Diego-based biotech company developing a method to “reprogram” human stem cells to grow into new insulin-producing cells that would be implanted in the body housed in a tiny device — effectively, a functional cure for diabetes.

While they’ve been working on this for years (science is a slow burn), their CEO Paul Laikind says they’ve made “significant clinical progress” in the last year: “We expect that this year we can accelerate our mission to deliver transformative therapies for insulin-requiring diabetes.”

Read more:

Donor blood stem cells and T cells could help patients wean off immunosuppressive drugs after organ transplant was published by Yimy villa for Cirm.CA.Gov, 30 January 2020.

Dr. Samuel Strober and his team at Stanford University are conducting a CIRM-funded clinical trial that gives patients getting a kidney transplant a mixture of their own blood cells and cells from the kidney donor, a process called mixed chimerism.

Pairing patients and donors for transplants is done via Human Leukocyte Antigen (HLA) matching. HLA are markers on most cells in your body and are used by your immune system to recognize which cells belong to the body. If you are fully HLA matched that means your cells and the donor cells are immunologically compatible, and so less likely to be rejected. If they are HLA haplotypes, it means they are close but not fully matched so rejection is more likely.

In a trial, twenty-four of the 51 fully HLA matched patients with a persistent mixed chimerism for at least six months were able to stop taking the IS drugs without evidence of rejection for at least two years.

How Chaos at Chain Pharmacies Is Putting Patients at Risk was written by Ellen Gabler for The New York Times, 31 January 2020. Pharmacists across the U.S. warn that the push to do more with less has made medication errors more likely. “I am a danger to the public,” one wrote to a regulator.

In letters to state regulatory boards and in interviews with The New York Times, many pharmacists at companies like CVS, Rite Aid and Walgreens described understaffed and chaotic workplaces where they said it had become difficult to perform their jobs safely, putting the public at risk of medication errors.

They struggle to fill prescriptions, give flu shots, tend the drive-through, answer phones, work the register, counsel patients and call doctors and insurance companies, they said — all the while racing to meet corporate performance metrics that they characterized as unreasonable and unsafe in an industry squeezed to do more with less.

“I am a danger to the public working for CVS,” one pharmacist wrote in an anonymous letter to the Texas State Board of Pharmacy in April.

State boards and associations in at least two dozen states have heard from distraught pharmacists, interviews and records show, while some doctors complain that pharmacies bombard them with requests for refills that patients have not asked for and should not receive. Such refills are closely tracked by pharmacy chains and can factor into employee bonuses.

THIS IS SCARY! I’ve been given the wrong meds or someone else’s prescription several times in the past 2 years. WHAT TO DO? Check your filled prescription VERY carefully. If it is a new medication, ask to review it with the pharmacist. And report any unexpected side effects immediately.