Glucotrack (Nasdaq:GCTK) has made great strides over the past several years as it advances its implantable continuous blood glucose monitor (CBGM).
Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements.
After the company completed the first-in-human study of the system, it shared findings from that study, which met all endpoints. Building on that momentum, Glucotrack submitted the CBGM to the FDA for investigational device exemption (IDE) this month. IDE would enable the company to initiate a U.S. clinical study for the fully implantable technology.
It marked the latest milestone as the company looks to bring a competitor to the market for the only other implantable glucose monitor from Senseonics, as well as leading short-term sensors from Abbott and Dexcom.
As CEO Paul V. Goode explained in a recent interview with Drug Delivery Business News, Glucotrack’s implantable device is much different than the available options. He believes that could set it apart.
The following has been lightly edited for space and clarity.
What is the issue Glucotrack is addressing?
Paul V. Goode: “Current sensors work very well. They’re good, and they help people. I have a grandson with type 1 who wears one and they’re wonderful products. But, when you look at what people struggle with, it’s one aspect or another that bothers them. It’s not every aspect, but it’s the adhesive, or the pain, or they’re embarrassed, what have you. You can solve that problem by going in the body. And that’s where the implantable side, and all that knowledge comes to play and and, but even more so is when you’re in the body.
How did the technology come to be?
Goode: “The most challenging place to actually measure glucose is in the subcutaneous space. The CGMS that are on the market today started out with three days [of wear]. They moved to five, seven, 10 and now 14 and 15. That’s taken a lot of time, because that is a very, very challenging space to measure. … If you’ve got to be in the body, where’s the best place to be in the body? In the blood, that’s where your immune response is actually the weakest. So, you’re in a much safer place there in terms of the chemistry and being able to sense the islets.
“The cardiac guys figured [implantables in the blood] out decades ago. So, let’s just ride their coattails and have a system very similar to what they have. That’s how the genesis of the Glucotrack technology came about.”
What do the device and procedure look like for the patient?
Goode: “From a patient’s perspective, they have [current CGMs] they’ve got to manage that go on the back of the arm. They trade the management of the back-of-the-arm device for a one-time procedure that lasts for three years.
“We believe we’re going to have more accuracy and we believe that in times of rapid glucose changes when you’re eating, stressed, exercising or ill, when you’re going up fast, you’re going down fast, because we’re in the blood, we don’t have the lag time that the interstitial sensors have. So, the patient can respond quicker. They’ll get their alert sooner and they can intervene quicker, so they spend less time above or below range.
“It’s based on cardiac technologies, cardiac procedures and tools, and so it will be done in a cardiac cath lab, just like a pacemaker, but nothing goes into the heart. It just goes subcutaneous and a little bit into the vessel. But it’s the same physicians, same procedure, techniques, same cath lab, and it’s local anesthesia, 20-to-30-minute outpatient procedure, and they’re done for three years.”
What sets the Glucotrack device apart from, say, the other notable implantable CGM maker, Senseonics?
Goode: “Compared to the wearables, our advantage is primarily that we don’t have an on-body wearable. So the data goes from the implant, via Bluetooth, to the smartphone. We’re measuring in the blood, so we don’t have the lag time. Ninety percent of the time, the lag time is not an issue. But, when you’re going up faster, going down fast, that’s when it’s an issue. And you want to know it sooner rather than later.
“There is one implantable in the market. They’re doing a phenomenal job. … They’re also measuring under the skin, in the subcutaneous tissue. Comparing ourselves to them — they’ve recently got a lot of market traction because they finally got to a one-year longevity — we believe, and are very confident, that we have the three-year longevity. That’s an advantage. A second advantage compared to them is that they still, with their present device, require an on-body wearable to power the device and collect the data. We don’t. They’re working on one that doesn’t, but that’s not out yet.
“Also, they can’t reuse the same implant location. It goes in the back of the arm. When that thing comes out, they’ve got to put a new one into another place. Eventually, they run out of real estate. We’ve designed ours so it can be in the same location and can be reused over and over.”
What stands in the way of making longevity work in a device like this?
Goode: “Longevity is always a challenge for everybody. We’re at three years and we’re very happy with it. And, we are still working to try to push it even further. We’re not stopping at three years unless the physics get in the way. Just making that longer is a challenge. The FDA has been really good to work with. But, they have their requirements as well. When you look at trying to get a three-year device out to market, there are some challenges in how you do that without having to run a three-year trial. There’s those aspects that we’re working with the FDA on, and they’ve been very, very supportive.”
Working with the FDA, how big is the recent milestone of an IDE submission?
Goode: “It really is a big milestone for us to get patients in the U.S. Nothing against other geographies. Having been in medical devices, especially implantable medical devices for as long as I have, humans are the same all the way across the world. But, there’s always something different in different geographies — the way medicine is practiced, the way patients interact with the device, or what have you, there’s always something different. Our first target market is the U.S. Coming to the U.S. is very important to get us experience to start with.
“We look at this trial as a long-term feasibility trial and as a springboard to expand, hopefully, to add more patients and sensors and to get that experience, then to work out all of the logistics so that we can then start our pivotal trial for eventual commercial approval from the FDA.”
What are we looking at for as far as timelines?
Goode: “We’re hoping that we can get through the IDE process and get into patients in the third quarter this year. Then we’ll work on whatever modifications that may or may not be needed — hopefully none — and work on those rather expeditiously. [In] protocol discussions with the FDA, we get a very good understanding of what they expect for that pivotal trial to be. We think that we could probably, with the FDA’s blessing and good performance in this trial, roll into or start a pivotal trial.
“We’d start with a one-year indication at first, and we still work with the FDA on how we expand that to three years.”
Looking deeper into the future, what about potential insulin pump integration?
Goode: “The regulatory gateway is complying with the iCGM requirements. I like to jokingly say, if we can’t meet those requirements being in the blood, then shame on us. We should be able to meet those requirements quite easily.
“The way the pump companies have been handling it these days, they’re pretty much the gatekeepers of the algorithm. It would be more of us being able to have a data structure that we can submit to them once we get a little bit further down the road. I expect that there’ll be further discussions with them to start laying the groundwork.”
Any overall thoughts on where Glucotrack stands as you move forward?
Goode: “We’re not trying to compete with Dexcom or Abbott or MiniMed. We think the products that they have are great. But, there are enough patients who can’t or won’t use it for one reason or another. The market is so big, so we’re just excited to bring something to the market where there’s a significant number of patients that want it.”
“There is a need out there, and we’re so excited to bring that to patients. We have to prove it clinically, but we think we can. … We’re very, very excited about being able to prove that as well and helping patients to better control their sugar levels.”
