Big news broke last week that could change the future of closed loop technology.
OK, it's tempting to refer to this as "Bigfoot" news... as in , the closed loop (aka Artificial Pancreas system) startup based in Milpitas, CA, led by an all-star D-Dad trio -- former JDRF leader Jeffrey Brewer, former Medtronic chief engineer Lane Desborough, and financial whiz Bryan Mazlish (Mr. "Bigfoot" himself) -- along with many others well-known in the Diabetes Size now.
On Thursday July 13, to integrate a next-generation version of their FreeStyle Libre Flash CGM system in Bigfoot's emerging closed loop system, expected to hit market by 2020.
This comes just a month or so after the news that -- indicating that Bigfoot's eventual closed loop system will also connect with smart insulin pens.
Whoa, quite a powerful combo there! This certainly makes Bigfoot unique in the closed loop space, being the only developer at this point with clear plans to accommodate both insulin pumpers and pen users.
Just how will all this pan out? We recently spoke with Bigfoot CEO Jeffrey Brewer to learn more about the latest developments.
About That FreeStyle Libre
As a reminder, the Abbott FreeStyle Libre is a new type of glucose monitor referred to as a Flash Glucose Monitoring (FGM) system. It consists of a small round quarter-sized sensor that's worn on the back of the arm for 14 days. Data is collected from the interstitial fluid (just like a regular CGM) every minute, but unlike a traditional CGM the user must wave a handheld receiver over the sensor to get readings -- and unlike current CGMs on the market from Dexcom and Medtronic, the first-gen Libre does not have real-time data connectivity. One major advantage is that It doesn't require any fingerstick calibration.
While not yet FDA approved for the U.S., Libre is available in 37 other countries since first coming to market internationally in 2014, and was most recently . There's a body of growing clinical study data showing the Libre is accurate and effective for many PWDs.
A physician's version called was FDA approved in September 2016, but the patient version been before the U.S. regulatory agency since mid-2015 (!), and it's anyone's guess what the holdup is. Being able to read about European patients' experiences with Libre, American PWDs are of course anxious to get their hands on it.
But this new agreement with Bigfoot isn't about the first-generation FreeStyle Libre we'll (hopefully) see on the U.S. market very soon; it's about future technology that will go beyond the current iteration of FreeStyle Libre. Abbott's pretty hush-hush on this, so all we really know now is that the new Libre version Bigfoot plans to use will do away with the handheld scanner and will be able to share data directly with the closed loop system, making it function more like an existing CGM.
Bye Bye, Dexcom
So does this mean that Bigfoot is breaking up with Dexcom, despite a partnership announced in July 2015? The anwser is yes. Bigfoot says it's been evaluating CGM partners since its inception and has now moved to Abbott exclusively. The agreement is for four years, from the start of the system's launch. This means each Bigfoot system will come with a Libre sensor, and customers will go directly through Bigfoot, not between both companies.
Why Abbott? It's all about calibrations -- or in the case of Libre, no calibrations. We're told that was a deciding factor in choosing between Dexcom and Abbott. The possibility of human error based on calibration issues was a stumbling block in designing a closed loop system that's supposed to automate care, thereby "taking away the work" of diabetes. While Dexcom has been pushing to drop calibrations for years, even their next-gen G6 is likely to require one calibration per day. So based on the existing Libre data worldwide, the decision to go with Abbott became pretty clear, Brewer tells us.
“In the first generation of automated systems, we think sensors that require calibration have been the crippling aspect of the user experience. We’ve learned from our own personal experiences and from what we’ve seen in data modeling, that calibration is the biggest risk to a closed loop. People don’t do it well, or consistently or even at all. And that turns out to be a big problem. Our concern is that systems that require calibration aren’t going to be as easy to use or as safe as those that don’t require it.”
The Bigfoot Brain + Pens
Aside from adding Libre, the basics of the Bigfoot system as we've reported before haven't really changed in the past couple years. The "Bigfoot Brain" will be built around the former Asante Snap pump technology that Bigfoot acquired in mid-2015 using a pre-filled insulin cartridge and tubing. This is where the smart algorithm is housed, which does all the calculations for carbs, insulin delivery, etc, and a Bluetooth chip inside will talk to the Abbott Libre sensor and smartphone mobile app as the main interface.
Rather than a traditional display, it will have a "belt-clip sized" display with icons showing the various items such as BG data and dosing. Importantly, Brewer says the system will not have a set BG target (as Medtronic's current 670G does and others like Beta Bionics are developing). Instead, it will allow flexibility by having the system learn to adjust targets based on each individual's BG needs -- because, Your Diabetes May Vary.
Investigational, Non-FDA Approved
As mentioned, Bigfoot will design its system for use by people on injections and multiple daily dosing, too. In early June just before the ADA Scientific Sessions, of London-based startup Patients Pending that makes the Timesulin smart insulin pen tracker. This will allow the Libre sensor to eventually talk directly to smart pens, and transmit the data through the Bigfoot smartphone app interface.
"I don’t know why people are forced to be a pump person or a shots person. Why can’t they do both, using whatever fits their life at that point in time? Some people switch back and forth, and I think you should be able to," Brewer says. "When you talk about consumerization, that’s a fancy term for just looking at the person and designing a system around their needs. That’s what Apple does, but it’s not traditionally what medical device companies do. That's what Bigfoot is doing.”
Research and Access
The clinical research is underway and will be the main focus for the foreseeable future:
- A clinical research study (CRC) study took place during the latter half of 2016 and wrapped up last year, and the results from that have been encouraging.
- Pivotal trials are expected to start in early 2018, and Bigfoot says it's working with FDA on what that research will look like. Once all those begin, details will be shared via ClinicalTrials.gov and the Bigfoot site itself.
- Much remains up in the air and some will be dictated by Abbott's timing, but Bigfoot hopes for approval by 2020.
The planned launch is now more than a year later than originally expected, which is disappointing -- not only for us on the consumer side, but for Bigfoot folks too. Their team of 50 people includes many living with type 1 themselves or a very personal D-connection, such as the founders being D-parents.
But Bigfoot never planned to be first -- Medtronic holds that distinction with its Minimed 670G hybrid closed loop, which got FDA approval last year and is now being slowly rolled out across the United States. They will eventually have a next-gen, more-automated model of a closed loop, and we're also expecting to see other products from , Insulet, and in the coming years. Not to mention the hundreds of (non-regulated) do-it-yourself homemade closed loop systems being used worldwide over the past couple years (including some by Bigfoot team members).
It isn't about being first, but getting it right and bringing something to market that changes the game, Brewer emphasizes.
In the past, Bigfoot has mentioned plans to adopt a monthly subscription model for this closed loop system, which they expect will cost less than combined pump/BG testing/CGM supplies cost today.
We're happy to hear that the Bigfoot team has been conscious of access and cost considerations since the start, and remain focused to making sure this can get into the hands of people who want it. No doubt, a lot will change over the next few years and we are confident Bigfoot will adapt as needed -- whether via subscription business model, or changes in insurance and Medicare coverage.
Certainly, many will be surprised that Bigfoot is dropping the best-in-class Dexcom CGM for a device that's still mostly unknown in the U.S. It's odd to be asked to imagine a world of no calibrations, and to put our faith in a future product that in its first-gen offers comparatively limited data capabilities.
That's a lot to ask, especially when so many in our D-community are highly impatient and want improved technology NOW. See also: #WeAreNotWaiting.
Many also remember the FreeStyle Navigator CGM that Abbott discontinued in the U.S. back in 2011, but remains on the market internationally; it was seen as the best, better-than-Dexcom at the time and as a botched business move that it didn't succeed here in the States. Along with all the test strip recalls and customer service issues at Abbott, the company's D-tech has often been engulfed in storm clouds... but the fact remains, Abbott has some stellar technology.
For our part, we're excited to hear about this latest collaboration, and can't wait to see what materializes. In other words, the future looks bright and we continue to as it moves forward with new options for better diabetes care!