Omnipod 5: Automated Insulin Delivery System, First Tubeless System with Smartphone Control APPROVED by the US FDA, as announced by Insulet.com, 28 January 2022.  

On January 28, 2022, Insulet announced the FDA clearance of the Omnipod 5 Automated Insulin Delivery System for people with type 1 diabetes aged 6 years and older, the first and only tubeless automated insulin delivery (AID) system in the US with compatible smartphone control and Dexcom G6 Continuous Glucose Monitor (CGM) System integration to help protect against highs and lows.

Just like Omnipod DASH, it includes a waterproof, tubeless insulin Pod that can be worn almost anywhere you’d inject insulin. You can use the Omnipod 5 App on a compatible smartphone (currently only ndroid devices, iPhone compatibility to come) to control the Omnipod 5 System.  New features include:

• • SmartAdjust™ technology:  Every 5 minutes, the system automatically increases, decreases, or pauses insulin delivery based on your customized target—helping to protect against highs and lows², day and night.
  • Activity feature: Activity with a few finger taps. When using the Activity feature, Omnipod 5 reduces insulin delivery when glucose typically goes low, like when exercising.
  • SmartBolus feature: The only AID system with a built-in bolus calculator that automatically incorporates your CGM data and trend, so you don’t have to.

Read more:  Now FDA Cleared! Omnipod 5

Nanocarriers! A Potential Solution for the Type 1 Diabetes Cure Conundrum? was reported by Ross Wollen for DiabetesDaily.com, 21 January 2022. 

Researchers at Northwestern University have devised a new technique for protecting transplanted islet cells from the body’s immune system.  The technologists hope to combine immunosuppressive drugs with targetted nanocarriers, protecting transplanted islet cells without impacting the wider immune system. The treatment could be a solution to one of the last major obstacles to a functional cure for type 1 diabetes.  The new results, published in the most recent edition of the journal Nature Nanotechnology, show that diabetic mice that received the nanocarrier-rapamycin mixture were essentially cured of their diabetes, and that they had a better immune response than mice treated with a standard oral dose of rapamycin.

The technique has been used successfully in mice, and is undoubtedly many years away from large-scale deployment in humans, if it ever gets that far. Nevertheless, we applaud any progress made towards a cure for type 1 diabetes.

The Problem with Islet Cell Transplants:

• • healthy islet cells are not easy to come by. To date, the vast majority of transplantees have received their new cells from the pancreas of a deceased organ donor, and organ donors are scarce. The treatment is basically limited to patients with a dire need,
    • The first problem, islet cell availability, appears to have been solved through the miracle of stem cell technology. At least two biotech firms, Vertex and ViaCyte, have learned how to turn pluripotent stem cells into insulin-producing islet cells. If these techniques prove to be as easily scalable as they’re reported to be, doctors will have new and abundant sources of islet cells for transplantation – no more need to wait for an organ donor.
  • transplanted islet cells do not reverse the fundamental autoimmunity that causes type 1 diabetes in the first place, and even if they did, they would still be attacked by the body’s immune system. These new cells currently need to be protected by immunosuppressive drugs, drugs that can come with hefty side effects. 
    • both Vertex and ViaCyte are working on methods of encapsulating transplanted cells, using physical barriers that will protect those cells from the immune system but allow them to sense blood glucose levels and distribute insulin.

As described by Northwestern Now, the researchers have devised a way to change the action of the common and potent immunosuppressant rapamycin. Rapamycin is a fascinating and very important drug, but it just isn’t perfect for islet cell transplantees. A low dose of rapamycin, which is customarily taken as a pill, is not enough to protect islet cells, but a larger dose has undesirable consequences, impeding the T cells’ ability to fight off regular infections and leaving the patient immunocompromised.

The Northwestern team has combined rapamycin with a targetted nanocarrier that delivers smaller amounts of the immunosuppressant exactly where it’s needed. The new treatment targets antigen-presenting cells, which essentially tell T cells where to attack. The chemistry is complex, but the result is that instead of suppressing all of the body’s T cells, the treatment instead induces the T cells to tolerate the transplanted islet cells. Rapamycin delivered in this manner should be just as effective, but require smaller doses and trigger fewer side effects.

Read more:  Nanocarriers! A Potential Solution for the Type 1 Diabetes Cure Conundrum?

In Search of the Highest A1C in Diabetes History was written by Wil Dubois (T1D and health educator) for DiabetesMine.com, 24 January 2022.  

The highest A1C turns out to be a tricky piece of data to ferret out. If you try Google, you find a gazillion people talking about their own personal highest A1Cs and comparing notes with others.  Most A1C point-of-care machines cap out at a certain number, including those at-home testing A1C kits you can buy online.

Wil Dubois posed this question online to a group of endocrinologists: What’s the highest A1C you’ve ever seen, or what’s the highest you’ve ever heard a colleague talk about? Here’s what he learned. 

I had my money on 35 percent. That would be a 3-month blood sugar average of 1,000 mg/dL. But the answers I got were surprising, as none of my esteemed colleagues had ever seen or heard of A1Cs as high as I had commonly seen in my clinic in New Mexico.

Dr. Silvio Inzucchi at the Yale School of Medicine is a diabetes guru who wrote a go-to e-book for clinical facts, “Diabetes Facts and Guidelines.” He told DiabetesMine, “The highest we usually see is in the 12-14 percent range, though I think I’ve seen an 18 percent a long time ago.”

In the same ballpark is Donna Tomky, a New Mexico nurse practitioner and diabetes educator who has been past president of the American Association of Diabetes Educators (now the Association of Diabetes Care and Education Specialists).  “Over the years, I’ve seen an A1C as high as 19 percent in a type 1 individual who purposely omitted insulin and was admitted for DKA,” she said.  “The highest I have seen personally is a 17 percent, but my colleague had a patient with a 19 percent,” she said, noting both were “teenagers with established T1D and one of whom just found out she was pregnant.”

Dr. David Hite, a diabetes education consultant based in California, reports: “I had a patient in the clinic with a 17 percent. That’s rare. I usually see new diabetics in the clinic under 14 percent. They come in because they feel like crap and can’t tolerate conditions needed to get it lower.”

Well-known USC Keck School of Medicine endocrinologist Dr. Francine Kaufman (who now serves as chief medical officer of Senseonics, Inc.) took the top prize in my straw poll with her one-word answer: 22 percent. Repeat after me: Wow!

The American Association of Clinical Chemistry is the leading authority on these diagnostic lab tests, and Dr. Darci Block is one of the big wigs who’s been a part of the Mayo Clinic’s Clinical Core Laboratory Services Division. While some lab tests can show higher results than a clinic’s point-of-care method, she wonders why it would matter just how high a particular result is above 14 percent. To her, anything over 14 is so poor that it becomes “not clinically important” given the already-urgent need to address the diabetes management, Block says.

Renowned diabetes educator and author Gary Scheiner of Integrated Diabetes Services in Pennsylvania put it more colorfully. About any A1C above 12 percent, he said: “At that high, there’s no way the patient could possibly be thinking clearly. A little bird should pop up and just start humming ‘Purple Haze.’”

Read more:  In Search of the Highest A1C in Diabetes History

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