10 Big Deals in Type 1 Treatment in 2015
If a good time existed to have Type 1 diabetes, this would be it.
In 2015, Type 1 treatments that once seemed far-fetched have taken major steps forward. We’ve seen continued commercialization of pump technology based on artificial pancreas algorithms, good news on the future of stem cell treatments and beta cell transplants, expansion in treatment options, and real competition among insulin manufacturers.
Here, in no particular order, are our picks for the 10 biggest events of Type 1 diabetes treatment in 2015:
Medtronic releases the MiniMed 640G pump internationally, the first commercially available pump that uses predictive algorithms to anticipate lows and stop insulin delivery to ward those lows off. The pump’s release was exciting enough for the non-diabetes press to breathlessly declare the 640G an artificial pancreas. Not quite, but thanks for playing.
Of course, the 640G isn’t available yet in the U.S (Thanks, FDA). Of course, there already was a software glitch that caused inaccurate readings for some international pump users (Flipside – Thanks, FDA).
Medtronic executives seem to be eager to quicken their artificial pump research and development. That may be because….
Bigfoot Biomedical became the first company created from the #WeAreNotWaiting movement. Last year, Bryan Mazlish came out as the mythical Bigfoot, a dad who hacked together a non-closed-loop artificial pancreas system at home. This year, he, former JDRF CEO Jeffrey Brewer and others created Bigfoot Biomedical to commercialize that system. Then they went one step further and bought out the physical remnants of the defunct Asante company (RIP – Snap pump), showing they meant business.
Of course, the development of an artificial pancreas means being attached to equipment. However, another promising functional cure involves restoring the cells that produce insulin. And that’s why it’s awesome that…
Beta cell therapy showed in 2016 that it was for real. Researchers at the Diabetes Research Institute and at the University of Alberta are zeroing in on ways to protect implanted beta cells, which produce insulin, from the inevitable attack from hyperactive immune systems. They are doing this by implanting the beta cells in little safehouses that keep overeager killer T-cells out.
The Diabetes Research Institute reported that their safehouse, dubbed the BioHub, helped protect beta cells enough to keep its first human trial patient with Type 1 free of the need for insulin. The trials, funded by JDRF and the Diabetes Research Institute Foundation, are just in the beginning stages, and the University of Alberta effort to create safehouse devices called ViaCytes is behind that, but we’re hoping.
That being said – what’s with the double capitalization fad, researchers? Just asking.
Until replacement beta cells becomes something you can get at any doctor visit, it’ll be necessary to stick to insulin therapy. Luckily, pharmaceutical companies are finally teaching that old dog of a therapy some new tricks. One example is that…
Afrezza has finally gotten its day in the marketplace. The inhaled insulin product, developed by Mannkind and marketed by Sanofi, is now readily available. Of course, sales have been sluggish…just like they were with the last inhaled insulin product (RIP-Dreamboat). However, even if Afrezza only becomes a niche product, it’s still good to have it as a treatment option for those times when many injections simply aren’t an option.
The muted response to Afrezza hasn’t helped Sanofi’s bottom line. In fact, the company had a 2015 it might want to forget, partly because…
Sanofi finally loosened its grip on the basal insulin marketplace. Sanofi lawyers have been busy in recent years trying to hold onto the patent rights for its blockbuster Lantus insulin. They seem to have softened their stance now that they have a new basal insulin on the marketplace, Toujeo (Coincidence? I think not).
In this kinder gentler atmosphere, Sanofi came to an agreement with Lilly for the latter company to come out with a biosimilar (generic) form of Lantus in late 2016. Also, Novo Nordisk was able to get its new basal insulin, Tresiba, approved by the FDA this year. One hopes for a price war.
New insulin formulations don’t eliminate the risk of hypoglycemia, sadly, so that’s why it’s big news that…
Nasal glucagon proved safe for kids. The human trials conducted by Locemia Solutions provided hard evidence that the days of injectable glucagon might be numbered. Making glucagon treatment more user-friendly could make the difference between riding out a bad low at home and taking a trip to the hospital. Lilly, the company which has the lock on the injectable glucagon market, was so impressed of nasal glucagon’s chances for FDA approval that it bought up the rights to market the treatment. Let’s hope they come to praise nasal glucagon, not to bury it.
Trying non-injectable diabetes treatments seemed to be a trend in 2015 as…
Researchers used oral insulin in an attempt to ward off Type 1. A small German study, funded by JDRF, gave high doses of oral insulin to children genetically susceptible to developing Type 1. The dosing created an immune response in 5 of 6 children, one that the researchers take to mean that the body will start recognizing beta cells again, instead of just killing them. Time will tell.
Speaking of time…
Researchers have found symptoms of Type 1 years in advance of the condition’s traditional onset. Another JDRF study, this one involving like a zillion people (okay – roughly 400,000) effectively screened for early biological indicators in children who developed Type 1. Is this just an effort to deliver bad news early? Nope. The thinking is that if we’re going to stop Type 1 diabetes in its tracks, we have to get in on the opening bell. It’s sort of a “If it bleeds, we can kill it” moment in Type 1 diabetes research.
These researchers weren’t the only ones to think outside the traditional care models, because…
Some researchers think that an old tuberculosis vaccine might really slow down the development of Type 1. Faustman Labs is conducting Phase II human trials to see if a weakened bacteria strain (hereafter known as the “Notorious BCG”) can convince the body to forget to have Type 1 diabetes…at least somewhat. Phase I trial results showed that the treatment confuses the autoimmune response that usually kills off insulin-producing beta cells. That’s a good thing.
Researchers are great, but the real first responders to Type 1 diabetes care are usually parents of children with Type 1. That’s why it is great news that…
Parents of children with Type 1 are changing laws to make those with Type 1 safer than before. A grieving family in Ohio pushed for a new law to make sure people with diabetes in that state can get insulin even if their prescription is expired. D-families in North Carolina and Pennsylvania also pushed legislative action through that encouraged better doctor screening for Type 1 diabetes. Meanwhile, countless others are lobbying for bills that may bear fruit in 2016.
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