We often hear of new "non-invasive" technology that will free people with diabetes from finger pricks and injections, but to date, little has come of them (aside from inhalable insulin of course).
The whole "non-invasive dream" especially around glucose monitoring is a bit of a can of worms for our Diabetes Community -- as the exciting "what ifs" keep running into major hurdles. See for example: Verily Scraps Glucose-Sensing Contact Lenses.
Now, we're seeing two new approaches making headlines worldwide:
- a pea-sized biosensor that will measure saliva on your tongue to check glucose levels, and can supposedly be mass-produced in 3D printing at a low cost;
- a pill capsule about the size of a blueberry that contains a tiny needle actually made of compressed, freeze-dried insulin that will inject into the inside of your stomach wall directly; amazingly, this capsule is modeled after the African leopard tortoise, which has the ability to right itself from being turned on its back and or any other position.
We're not going to opine on how realistic these may or may not be... but simply provide a deeper look at each of these concepts in development and let you all decide for yourselves.
Glucose-Monitoring via Saliva Biosensor
This one's out of Sydney, Australia, the brainchild of The iQ Group Global -- a consortium of life science and financial services companies in the biopharma field, ranging from R&D to commercialization.
On Feb. 1, they announced the Saliva Glucose Biosensor, described as a "groundbreaking" technology that would be the world's first non-invasive saliva-based glucose test. It's a small, disposal strip with a built-in pea-sized biosensor that looks a lot like a traditional glucose test strip, but is designed to sit on the tongue to measure glucose. The reading from your saliva is beamed to a proprietary digital mobile app in real-time, that will also display historic glucose levels and trends. Word is there are also data-sharing capabilities being weaved into the app.
Professor Paul Dastoor and his Centre of Organic Electronics team at the University of Newcastle in Australia developed this tech initially, and a few years ago the iQ Group acquired it to continue development.
At this point, the sensor is still in clinical studies and remains in development. You can check out their recent research results at Science Direct here. Notably, the authors explain:
"The biosensor was clinically validated on both healthy and diabetic subjects divided into several categories based on sex, age, diabetic status etc. and correlation between blood and salivary glucose has been established for better standardization of the sensor... The developed biosensor has the potential to be used for mass diagnosis of diabetes especially in such areas where people remain prohibited from routine analysis due to high healthcare cost. Apart from that, a smartphone would be the only device the user needs for this measurement, along with a disposable low cost test strip."
We asked about launch timelines, and a spokesperson tells us they've chosen to look at China for initial market launch; plans are to submit a regulatory filing there in the coming weeks. After that, the iQ Group plans to look at possibilities for Europe and the U.S. by year's end.
Microneedle Pill for Insulin Delivery
The new microneedle insulin pill concept is being led by MIT, and also involves collaborating researchers at Harvard-affiliated Brigham and Women's Hospital, and Novo Nordisk. Leading that research is professor Giovanni Traverso, who has in fact been working for years on developing a pill coated with many tiny needles that could be used to inject drugs into the lining of the stomach or the small intestine. We covered that at the 'Mine back in 2014, and at the time it did (and still does) freak us out to think of actual steel needles stabbing us on the inside of the stomach.
With this new capsule concept, the scientists are using a "less intrusive" injecting method.
This ingestible device is dubbed SOMA (self-orienting millimeter scale applicator), and the design is based on the African leopard tortoise (no kidding!), which has a highly-curved shell that enables the animal to return to an upright position even if it's completely flipped over on its back. The microneedle pill is in that same shape, allowing it to move around and land in the same position every time inside the stomach.
Approximately the size of a blueberry, the capsule is made of biodegradable polymer and stainless steel components and it houses a tiny needle made of compressed, freeze-dried insulin. The injection is controlled by a spring held in place by a sugar disc (allowing humidity in the stomach to trigger the micro-injection).
Once the needle tip is injected into the stomach wall, the insulin dissolves at a rate being monitored by the researchers developing the capsule; in the early studies, it's taken about an hour for all of the insulin to be fully released into the bloodstream. The amount of insulin tested has ranged from 300 micrograms to 5 milligrams. After the insulin's injected, the rest of the pill device passes through the digestive system.
Research on this was presented in early February, and MIT remains in early animal studies.
Corresponding study author Robert Langer, Institute Professor from the Harvard-MIT Division of Health Sciences and Technology, is bullish on its potential: “This discovery has the potential to transform not only drug delivery, but drug discovery as well, since most current drug discovery efforts are aimed at creating small-molecule drugs that patients can take orally.”
He refers to companies like New York-based Oramed, that's been working on an oral insulin pill for years, up against such as poor absorption via the gastrointestinal tract. However, Oramed seems to be making real strides of late towards eventual FDA approval -- so we may have an actual insulin pill on the market around the same time as the microneedle pill!
This is all fascinating of course, but for anyone living with diabetes for a decade or more, we know to curb our enthusiasm -- we've seen so many "transformative" projects that never materialized into actual treatments. So while we're not holding our breath (or saliva for glucose measuring), we'd be happy to make like a leopard tortoise and flip our POV if these concepts end up suceeding after all!