Makers of traditional fingerstick glucose meters are bracing themselves for the era of CGM (continuous glucose monitors) as that real-time technology becomes a standard of care. The only way to approach this, really, is to beat 'em or join 'em.
So we're not entirely surprised to see that alongside the many smaller "me too" companies developing CGM tech, two established makers of traditional BG meters are getting into the game with first-gen products expected to hit the market overseas by the end of 2019 and hopefully soon thereafter in the US.
The first is coming from Ascensia Diabetes Care (formerly Bayer), now working with a mostly unknown Chinese company to launch a first-generation CGM within the year and eventually co-develop a next-gen product.
The other is coming from New Hampshire-based AgaMatrix, which worked with Sanofi back in the day to develop the first-ever iPhone plug-in glucose meter (iBGStar) and a few years ago announced its plans to enter the CGM market. They have now begun sharing some details publicly on what they expect to eventually unveil.
Here's what we know so far about these two new would-be CGM competitors:
Ascensia + POCTech
First up, Ascensia Diabetes Care, makers of the popular Contour line of glucose meters and strips, announced in early January that they're teaming up with the Chinese company Zhejiang POCTech that is developing a system called (wait for it...) the CT-100. OK, we can only hope it gets better branding at some point.
This new tech is described as an "innovative four-electrode system" with "superb invivo stability." It will feature an "adjustable sensor implant angle" and be controlled via a phone app using Bluetooth connectivity and cloud data storage.
On the website, you can download a Quick Start Guide ostensibly on the existing system that shows some details of the transmitter, sensor and connection cable needed in that setup.
We reached out to POCTech for more on the new product, but didn't hear back by deadline. The most detailed description we've found so far comes from UK D-peep Tim Street at his blog Diabetech, who in Fall 2018 shared some key points gleaned from a newer user manual available online at the time (but since removed). Street writes:
- 7-day sensor. It may only need one calibration, though clearly with Dexcom and Abbott's no-calibration requirements (here in the States) that may change once it's filed or tweaked here. No talk of whether you can restart sensors, either.
- uses a "unique 4 electrodes" system via a Chinese patent, reducing noise and interference while measuring glucose
- it has a horizontal sensor with a bed that appears to hold the oval-shaped transmitter device, which sits flat on the skin. But there's some confusion about whether you can insert it at different angles. Transmitter is said to have a two-year shelf life, though it isn't rechargeable and would use a small round watch battery.
- a clinical trial prototype of the sensor and insertion device looks similar to the now-old Dexcom inserter used for the G4/G5 models. It may be used for both the stomach and arms.
- trial data shows it may have an accuracy of 8.7% MARD, which would make it the best on the market if that translates to real-world accuracy (not all CGMs have data that shows accuracy in clinical trials are as good as real-world experiences)
- it looks like what was originally conceptualized to have a CGM receiver is now evolving into a mobile app for data display
The agreement between the companies appoints Ascensia as the exclusive distributor for POCTech's current CGM product in an initial 13 markets where POCTech does not yet have a distributor, with the right of first refusal for distribution rights in other available countries. POCTech has had CE Mark approval overseas since late 2016, but hasn't yet launched; product distribution should begin in the second half of 2019.
The second part of this alliance is an agreement for Ascensia and POCTech to jointly develop next-generation products built on POCTech's existing technology.
In the press release, POCTech's leader states: "By combining Ascensia's strength in global marketing, regulatory affairs, quality systems, and capabilities for designing and testing new systems, with POCTech's expertise in sensor technology, we will together be able to provide the diabetes community with high-quality and cost-effective products."
While Ascensia's CEO Michael Kloss puts it this way: "This agreement with POCTech is the key first step in building a world-class CGM franchise for Ascensia. We are aiming to use a combination of partnerships and our own in-house CGM development program to build a pipeline of state-of-the-art CGM products that improve on what is currently available for people with diabetes."
Interestingly, POCTech's Founder and Chief Science Officer Dr. Yanan Zhang has experience years back at Medtronic Diabetes leading the company's then young Artificial Pancreas project, though he left long before the eventual commercial approval and launch of the Minimed 670G Hybrid Closed Loop in 2016 and 2017. Still, that does put an interesting spin of expertise on this new CGM.
We understand the currently available POCTech product has not yet been submitted for FDA approval, and Ascensia is not discussing the timing of its FDA filings. However, they are talking about less than two years before the co-developed next-gen system may go before regulators for review.
Ascensia as Both a BGM and CGM Provider
You may remember that Ascensia is a Swiss medtech company formed in 2015 after a merger of Bayer Health's diabetes division and Panasonic Healthcare -- creating a new branding of Ascensia for its Contour products. While the company's been developing more mobile apps and digital health tools (including an interesting Low Carb education program funded by NHS in the UK most recently), it's never made clear overtures to the CGM space until now.
Our contacts at Ascensia tell us the plan is to file the new CGM model with the FDA by the end of 2020. Depending on that regulator review process, it could be roughly 2021 when that technology hits the market here in the States.
Ascensia's VP of Global Communications Joseph Delahunty explains: "We see the currently available POCTech CGM system and future next-generation products as complimentary to our existing BGM portfolio, as we know that different people with diabetes have different needs. The use of the data for diabetes management is also a priority, so we will ensure that these CGM systems are compatible with the relevant current and future digital diabetes management solutions."
What about the fact that CGM tech is already phasing out fingersticks, going the "no calibration" route where the CGM readings are considered good enough to use for treatment and dosing decisions? Delahunty says there won't be a mass exodus from fingersticks anytime soon, but that traditional BG monitors will continue to be important for many people with diabetes.
"For an individual, we think that BGM and CGM complement each other for a number of reasons," he adds, noting that these CGMs aren't perfect. "In our opinion, people will still need to be able to use and access BGM devices, even if CGM is their primary monitoring device."
Not to mention many people may not have access to a CGM due to insurance coverage woes or other financial restraints, while others may simply continue to use a traditional glucose meter as their preferred option. "That is why we see the two being important devices in the global diabetes care market," he said.
AgaMatrix's New WaveForm CGM
In Fall of 2017, AgaMatrix split its diabetes business divisions in order to pursue its own CGM concept through a second division called WaveForm Technologies. So AgaMatrix continues to work on its currently marketed traditional meters, including the Jazz wireless Bluetooth-enabled BGM product, while the new entity develops a brand new proprietary CGM platform based on technology the company acquired in early 2016 from iSense CGM Inc. and then-Bayer Healthcare.
From investor reports, a recent public talk on the topic, and directly from the company's marketing manager Juleen Ginty, specs on the system (as of 2019) include:
- both the sensor and transmitter are worn on the body in a compact form, about the size of a nickle
this CGM system employs a proprietary, enzyme-based electrochemical sensor which is virtually pain-free to insert and measures glucose levels via interstitial fluid below the skin
the sensor will transmit glucose data wirelessly through a small, rechargeable transmitter to a smartphone app – providing up to the minute feedback on glucose levels
- preliminary studies to date show superior sensor “signal to noise” ratio and interference blocking, at a smaller diameter (approximately half the size of a leading competitor)
it has a rechargeable transmitter with warmup time of 1 hour or less
- in Europe the sensor will be for 14-day wear, average one calibration per day; that longer wear-time is apparently being studied in clinical trials for the U.S., too
- it's inserted using a unique, needle-free applicator that WaveForm claims is "virtually painless" and can be reused (unlike the Dexcom G6 with its single-use, disposable inserter)
- it offers wireless data transmission to a smartphone app every minute (with no receiver)
The press release notes that prior to the acquisition, 8 successful human clinical studies had already been completed by Bayer. WaveForm is currently conducting a series of additional human clinical trials, and improved accuracy is a bragging point. In fact, WaveForm clinical data from mid-2018 shows an 11.1%-12.1% accuracy rate -- not as good as some of the competing CGM studies published over the years, but better than other CGM accuracy results reported in comparison to this WaveForm tech.
The company anticipates a CE Mark and EU product launch in the third quarter of 2019, we're told. They also plan to begin U.S. studies and a pivotal trial across three sites in the second half of 2019, before an expected FDA filing in 2020.
In June 2020, WaveForm announced a new commercial deal with Bayer — ironic, given how the diabetes glucose monitoring tech had come from Bayer several years ago. The development deal is specific to China, where the companie will build a 15-day wear CGM that Bayer is then responsibile for selling and supporting in mainland China.
Dexcom G7, Too!
We were also intrigued to hear coming out of the JP Morgan conference that Dexcom is now openly referring to its next-gen tech with Verily as the G7! This is the former Google Life Sciences division that Dexcom teamed up with in 2015 to develop a to-date-secretive low-cost, next-gen sensor rumored to be whittled down to the size of an M&M candy. The timeline has been pushed back and is now slated for 2021, so while it remains a year or two out from possible launch, it's exciting to hear this now being referred to as the Dexcom model G7.
As always, it's TBD what actually makes it to market in any form. But it is no doubt good to see more CGMs in development, to give our D-Community more choice for something that works best for each of us.