We recently learned about a group of graduate students at the University of Washington who are developing a contact lens capable of delivering insulin sans needle, a product called InsuLenz.
Ah, yet another stab (pun intended) at the non-invasive dream, this time on the insulin delivery front.
As PWDs who've been promised this type of technology for a while without any real progress, we're generally quite skeptical of these types of products. That being said, we're still intrigued... so our newest team member Amanda Cedrone recently investigated.
Even though the product is still "completely conceptual," the four-member @InsuLenz team (three PhD students and one MBA) who came up with the idea in an entrepreneurship class in September 2012 have high hopes for successful development.
Amanda spoke with two team members: Karen Eaton, 26, a PhD student in bioengineering, and Nick Au, 29, a PhD student studying medicinal chemistry and pharmacy. While neither they or anyone on the team is living with diabetes, Nick's mom is a PWD and many of Karen's family members have diabetes.
Here's what they had to say about InsuLenz...
Before I tell you about this new technology that is still in the conceptual stage, there is one important fact that the InsuLenz team was careful to point out: the contact lens is not meant to be replacement therapy. In other words, it is not meant to take the place of an insulin pump, injections, or any of the other primary means by which a diabetic gets their insulin. In addition, it's not a replacement for blood glucose testing or CGMs. Instead, it's intended to be a "rescue method," especially for PWDs at a higher risk of going into diabetic ketoacidosis (DKA) — those who don't follow their doctor's directions and aren't actively managing their diabetes.
"This is only for you if your glucose levels get super high and you don't know about it," Karen says. "It's for those people that just aren't 'compliant,' and that don't realize that not taking their insulin is a bad idea."
That might be hard to fathom for us PWDs who constantly watch our blood sugars and have a pretty good sense of how we're doing, but those PWDs apparently do exist. So sorry to anyone who had visions (another pun!) of tossing their insulin pump out the window for something smaller, less noticeable and that doesn't leave a trail. Nevertheless, any kind of insulin delivery from a contact lens would be quite the innovation!
We've been hearing about eye research relating to both insulin and islet-producing cells for a while now... from blood glucose monitoring by scanning the eye (something that recently got FDA approval!), to injecting insulin into your eye sockets and implanting insulin-producing cells into your eyeball. But this is the first we've heard of a contact lens that could do the trick.
How It Works
Now, the contact lens doesn't measure blood sugar the sense that it gives the PWD a number. No, it can simply sense extremely high glucose levels and react with insulin thanks to low pH levels in the body -- which are brought on by high blood sugar.
The InsuLenz team starts with a normal contact lens — one that can be used with or without a prescription. Then, the team takes the lens and adds their "smart polymer," which can respond to blood glucose levels in the body.
As you may know, when DKA occurs, pH levels in the body drop. Insulin levels are low, and the body can't use the glucose that's saturating our blood. So, the body starts burning excess amounts of fat and that causes the blood to become like an acid as it makes more ketones as a result. Even though the blood pH that measures acidity only drops a bit, this small dip is enough to deactivate enzymes that depend on a precise acid-balance to operate.
This smart polymer that the InsuLenz team developed is pH-responsive. Think of the smart polymer as netting -- when glucose is metabolized in the body and pH levels drop, the smart polymer is able to register that and responds by expanding, which releases insulin.
So, when the patient is wearing the contact and their blood sugar rises to a certain level, a ring around the patient's eye will change color (you can see it only when looking in a mirror) to alert you of blood sugars reaching dangerous levels. The team is still playing around with the threshold that the lens will activate at, but currently it's somewhere around a blood glucose level of 500 mg/dL.
Holy high blood sugars, Batman!
When the BG level hits that threshold, the lens will release insulin intended to bring the blood glucose down to a safer level.
This 27-second animated video (without sound) shows the basics on how this contact lens would work:
Back in 2005, a team of diabetes researchers in east-central Texas studied alternative insulin delivery methods and determined this ocular insulin absorption could work (according to rat studies) at these high blood sugar and pH levels. Endo David McClellan, who's now working with the Texas A&M Health Science Center, was a part of that team that also found certain eye drops could help enhance the absorption to make it work even better.
So, in theory, the InsuLenz idea seems possible. Not everyone is enthusiastic, however.
Diabetes expert Dr. Barry Ginsberg, who's internationally known as a go-to source on glucose monitoring tech, wonders about the feasibility and actual need for this concept. He said that smart polymers have been around for more than a decade, but the research hasn't really gone anywhere because of lingering concerns on how insulin responds in various PWDs. Ginsberg worries that this variation in how insulin works differently in different PWDs, combined with the fact that it's a dangerous medication that can easily cause hypoglycemia, makes precision more important on the BG monitoring front -- something the contact lenses don't seem to offer.
Admitting that he doesn't know whether the insulin absorption in the eye would work or not, since it falls outside his expertise, Ginsberg said he's skeptical about the very high BGs and DKA levels the lenses are targeted at. Really, he's not sure how many at-risk PWDs would be willing or able to pay for such a non-precise tool.
"I'm not going to say it's not possible, but..." he mused. "Still, you don't want to come down on this too hard because this seems like it should be studied and researched more."
Loading the Insulin
Karen says an individual contact lens can probably hold about a week's worth of insulin. The team, however, only plans to add around 25 units to each contact — what they've figured is enough for one DKA episode.
While this may seem like a lot of insulin at once, studies have shown that because of things like tear fluid in your eye, only about 20 percent of the insulin released is absorbed and has an effect on blood glucose level, so the team is compensating for that fact.
Because one contact is capable of holding so much insulin, the patient only needs to use one "smart contact" at a time. They can use a regular prescription contact in the other eye.
We also wondered about how the heck all that insulin gets into a single contact lens -- after all, we PWDs know what 20 or 25 units looks like in an insulin pen, syringe, or vial. How can a little contact hold so much? Karen says this is possible because of how they make the "smart polymer." It starts off as a small molecule, and then goes through a process that chains some of those small molecules together, all the while being exposed to insulin so that it's basically absorbed into the polymer network.
The team is currently planning to use the existing fast-acting insulins on the market, like Novolog or Humalog, instead of any future "smart insulin" that may be coming down the road. Sure, there are a handful of versions in the early stages of development, but Nick says it "just wouldn't make sense to base on our project on an insulin that may or may not reach FDA approval."
But he notes that InsuLenz is open to utilizing new insulins in the future if appropriate.
Considering the InsuLenz concept is about a decade out from hitting market, it's hard to imagine that we won't have a glucose-responsive or faster-acting insulin by then. But, that's a whole different debate for another post.
The team just received a provisional application to patent the product, and within a year's time, they must apply for the actual patent. They're also working to create the first prototype in that time. Next come animal studies on the product, and once those are complete, they can apply for FDA approval. At some point during the process or after FDA approval, they hope to license the technology to a large pharma company such as Novo Nordisk. The team estimates that if all goes well, it will take around 10 years between now and when the product is ready and able to be marketed.
"We definitely have a timeline and milestones planned out," Karen said.
Don't forget that this product is designed for cases when, you know... the PWD doesn't check their blood sugars on a meter regularly or use a CGM -- which they may not, as these are high-risk PWDs who aren't using those tools much or at all.
So what kind of potential does InsuLenz really have here? The team says they see a market of about 3.3 million PWDs, which includes high-risk patients who need the help (barring Ginsberg's comments, above). They also believe the product might appeal to parents of young type 1s and to the growing number of people with pre-diabetes.
Of course, with any new product come concerns about functionality and safety, and the team acknowledges there is a lot that must be tested — for example, the accuracy of the product in determining high blood sugar.
"Doing research there doesn't seem to be too many ways there would be a false response, but you don't actually know until you test it," Karen said.
She added that the smart polymer is as safe as using a regular contact — a common concern that the team has been approached about.
Oh, and apparently the insulin-delivery wouldn't be impacted if your vision changes or you develop a scary diabetic complication like retinopathy.
The contacts are intended to be used as weekly contacts. For a year's supply, Karen and Nick estimate that it will cost around $654 per year — without insurance. With health insurance, they estimate that it will cost around $164 per year. Of course, these prices are based on the current economy and could change by the time the product is finally on the market.
The InsuLenz team believes that insurance companies will have incentive to pay for the contacts for high risk patients because according to Nick and Karen, it costs an insurance company approximately $17,000 to pay for a trip to the hospital to treat DKA.
"We want it to be covered under insurance, I don't think its feasible if it's not," Karen said.
The InsuLenz group has not been able to apply for funding yet. Because the team came up with the idea as students in a class, they must have their university sign off that the idea belongs solely to the group of four. Once that happens, they will begin applying for grants. The team is open to the idea of licensing it to a company at any point during the process.
In the meantime, funds for the patent process have come from placing at various competitions around the state of Washington.
The team competed in the University of Washington Science and Technology Showcase and won the grand prize. They also competed at the University of Washington Business Plan Competition where they won the award for best innovation idea. In June, the will be competing in the EMBA business plan competition.
"It's a drug delivery device that people don't have to deal with," Karen said. "There's no easy way to manage diabetes."
Intriguing concept, even if it does seem a little far-fetched and is useful only in emergency situations when blood sugars are unacceptably high. But, who knows? We'll be "keeping an eye" (!) on progress of this concept.