What if (finally?) you could wear an insulin pump and continuous glucose monitor (CGM), and the two connected to your body in only one place, with no need for two separate infusion sites?
Sounds pretty appealing, doesn't it?
Well, research on this long-awaited dream is of course ongoing and incremental, but the good news is there are at least six players actively pursuing it -- including three in the Big Pharma sphere. We've kept our ears to the ground to hear where each stands, so here's a progress report on happenings in the slow and steady race toward a single-site device for insulin infusion and continuous glucose sensing.
You may remember that Insulet made it clear early in the year that it wouldn't be integrating with the Dexcom CGM, despite promising to do so for years. Instead, Insulet has paired up with a new, as-yet-unnamed partner to combine continuous sensoring with the Pod for a single-site device. That's good news, even if the partner company is still a close-kept secret.
On an earnings call Aug. 7, Insulet CEO Duane DeSisto described the CGM-enabled OmniPod as being in the "early R&D stages" and said the company will spend the remainder of 2013 focusing on both the insertion system and sterilization process. Animal studies remain ongoing, and DeSisto hopes that clinical data will start being available by the second half of 2014.
"We wouldn't be spending this money if we didn't think we had a path here... But we're still not far enough along, where I can sit here and tell you, 'Yeah, we'll definitely get it done.' I mean it's still a work in progress.
We're intrigued by what we're seeing, but... there are still some if's.'"
— Insulet CEO Duane DeSisto in an Aug. 7 earnings call
So, just who is Insulet partnered up with?
** March 5, 2015 Update **
Following up with Insulet on their CGM R&D after a recent earnings call, we posed a few questions and this is the response from Insulet's Chief Commercial Officer, Shacey Petrovic:
“Insulet is committed to advancing diabetes care and as part of that advancement we intend to ensure that our patients have real-time access to their blood glucose levels. To that end, we are pursuing multiple options including a continued partnership with DexCom, as well as other potential partnership opportunities. As such, we have multiple R&D initiatives underway. While we have many exciting projects in development now and with the recent senior management changes we are actively looking at ways to expedite our efforts while also seeking ways to provide additional, clinically meaningful enhancements to our patients and health care providers.
To directly answer your questions:
- Insulet is not developing a CGM censor on our own.
- Yes, Insulet is continuing to work with a partner on developing a CGM sensor.
- At this time we are not disclosing that partner.
- The only changes since 2013 are that we are looking at more CGM partners and finding new ways to work together towards a goal of a closed-loop system."
This June, BD (Becton, Dickinson & Co.) actually announced jointly with JDRF that they're collaborating to examine the possibility of a combined insulin-infusion + CGM device.
When we saw this news release, we wondered if BD might be the partner teaming up with Insulet.
Not so, the company's VP of sensing technology Parker Cassidy tells us. He's at the helm of researching that concept for New Jersey-based BD, and told us that this collaboration is not related to what Insulet is doing, and that he's also been very curious about who the unnamed partner is.
This is the third project that BD's teamed up with the JDRF on in as many years, based on all that research. Back in 2010, the 'Mine reported on their focus to improve insulin pump therapy. Last summer, the pair announced they'd be continuing their collaboration with work on more accurate and reliable CGM sensor technology that would be another stepping stone toward the Artificial Pancreas. This is a natural evolution of that earlier work, according to both Cassidy and the JDRF.
"The fundamental questions haven't been answered, so we are just studying whether we think this can be done right now," he said. "This is something that's not currently available, and the intent is to figure out how closely you can put these together on the body, physically and within the constraints of a product's size. We'd love to satisfy that unmet patient need, and solve one of the big real estate issues that people with diabetes face."
JDRF on Exploration
Dr. Aaron Kowalski, a fellow type 1 since childhood and the JDRF's VP of treatment therapies, says evolving insulin infusing and CGM sensor technology through the years has changed what researchers have thought about the idea of combining both into one delivery device. We patients have been told as long as we can remember to keep the infusion sets and CGM sensors at least an inch or two apart on our bodies. But maybe that's not necessary.
"We hear from the diabetes community very often that people don't want to wear so many devices, and that they'd like to see a combining of the two devices. We originally thought it would be hard and you couldn't do it. It turns out, it seems like you can have a sensor near the infusion site. It's very interesting that more accurate sensing technology and our means to deliver insulin could translate into putting these two small devices together."
Right now, aside from answering questions about how this might be feasible, Kowalski says a focus of this collaboration with BD is examining what the regulatory pathway might be. He said this is a new route of delivery for both these devices, and so they're exploring what the FDA might want to prove it's safe.
Cassidy says this research is in the early stages right now and focuses on optical detection, rather than the glucose-oxidase method that most other CGM sensor studies use at this point. While any tech created would be proprietary for BD, he says there's no timeline beyond the research and there's no way of knowing right now how long it could take before even a prototype would be ready.
Medtronic Sneak Peak
Medtronic is also working on a single patch device, and we heard about a sneak peak given earlier this year to those attending the ATTD conference in Paris. Here's what our friends at diaTribe reported in April about the company's CGM sensor and infusion set combined into one connection device:
From a top view, it looks like a CGM transmitter fused with an insulin pump infusion set. The underside view looks like an insulin infusion catheter and a CGM sensor separated by about half an inch. The combo set is inserted with a single insertion device. We think patients will appreciate the added convenience of integration and less on-body space — of course, this also means the CGM could only be used for three days, since insulin infusion sites need to be changed every three days. The device is still in development and there is no timeline on when it might be approved.
We asked for an update on that research, but Medtronic isn't saying much, certainly not about a timeline.
Others Researching the Combo
Others working on similar research outside the corporate boundaries include: Dr. W. Kenneth Ward at Pacific Diabetes Technologies in Oregon, Sensile Medical in Switzerland, and the Medical University of Graz in Austria.
- Ward's research (as the PDT site says) focuses on a device with a sticky base that would attach to the skin and allow an infusion set and CGM sensor to be hooked into that base, with an inserter connecting to the top to use to put the device onto your body. We couldn't reach Ward to get an update, but a few months ago the Helmsley Charitable Trust gave his group a research grant stretching over the next two years.
- The research led by Sensile Medical is part of a European consortium (with the JDRF involved) aimed at developing an artificial pancreas, and one aspect of that is creating a single-port device. Referred to as the AP@home project, the research started in February 2010 and is on a four-year timeline.
- With the Graz study, Dr. Thomas Pieber is leading research on a single infusion site device that's been going on for more than six years. Just recently in June, Pieber completed a six-month study involving 10 people on the accuracy and safety of the CGM sensor tech and the differences between readings. As of now, there's no update as to when this research might be completed and what comes next.
Obviously, there are a lot of moving parts with all this research and much of it overlaps -- corporate and academia teams are all part of bringing this together.
And that's key, Kowalski says.