As many of our readers well know, using a continuous glucose monitor can be life-changing for people with diabetes. And in the decade or so since they were first introduced, the technology has become more reliable, accurate and user-friendly.
Yet only a small fraction of the Diabetes Community uses a CGM.
That could be on the verge of changing dramatically, if a wave of companies are able to fully develop and bring their new CGM concepts to market. Various industry observers note that there are more than a dozen CGM systems in the works for the U.S., from next-gen models from existing companies to startups nationally and worldwide. If even a few of them come to market, it would be an explosion of CGM choice. Yet it's unlikely all of them will actually materialize, given the hurdles in the diabetes device market.
CGM has been in the news quite a bit lately, due to the recent FDA filing of Dexcom's G6 model designed for 10-day wear, that it developed in partnership with Verily; the long-awaited FDA approval of the Abbott FreeStyle Libre Flash Glucose Monitoring, that adds a new layer to the traditional CGM market; and the pending FDA review of the Senseonics EverSense system, that would be the first implantable CGM lasting 90 days under the skin! And then there's the October news from AgaMatrix, announcing a corporate restructuring that includes spinning off WaveForm Technologies as its own dedicated CGM business.
Things are certainly heating up, that's for sure! Here's an overview of what's going on:
AgaMatrix / WaveForm CGM
In early October, the New Hampshire-based AgaMatrix announced it was reorganizing its diabetes business into a parent holding company with two main branches -- AgaMatrix, that will continue developing and marketing its traditional glucose monitoring products like the Jazz wireless meter, and the newly-formed WaveForm Technologies, that will focus on developing its CGM system.
AgaMatrix/WaveForm certainly brings some street cred to table, given their pioneering work on the iBGstar meter some years ago -- the first-ever medical device that plugged directly into an iPhone (older models) and was a beacon of user-friendly, patient-centered design at the time. Unfortunately, that meter soon became obsolete with iPhone changes and inadequate insurance coverage for the meter and strips, but its leading-edge design was undeniable.
We know that the core CGM tech was bought in early 2016 from iSense CGM and Bayer, that had been jointly developing it previously.
According to the AgaMatrix marketing manager Juleen Ginty, "the WaveForm CGM system utilizes a small sensor that will transmit glucose data wirelessly through a rechargeable transmitter to a smartphone app, providing up to the minute feedback on glucose levels. Our unique sensor design will offer a virtually painless insertion process at a smaller diameter (approx. half the size of a leading competitor). This reduction in size aids the day one sensor performance, facilitating a reduced warmup time. We anticipate our sensor design and technology to enable increased sensor wear time and application on more areas of the body, compared to currently available CGM systems."
** UPDATE: In a Jan. 11 news release, WaveForm will be a 14-day sensor.
AgaMatrix says some preliminary data on the CGM tech will be shown at the recent Diabetes Technology Society meeting, starting Nov. 2, 2017 in Bethesda. Actually, that tech dates back almost 20 years in what was known as iSense. While it's likely evolved from the original design concepts, we've been told by those familiar with it that the sensor is more flat on top than the existing Dexcom sensor, and it has an oval bottom that makes it resemble a tongue-emoji. That's about all the detail available at this time.
Prior to the AgaMatrix acquisition, Bayer had completed 8 human clinical studies on the CGM technology. Now, WaveForm is doing other clinical trials needed to submit its device to the FDA for consideration. The company expects CE Mark approval for its CGM product in 2018, and is planning for an FDA submission to get to market as early as 2019.
(Note that Oregon-based iSense once also had a patch pump called Jewel in the works, which it sold to Debiotech in 2015; that remains "in development," we're told.)
We shall see...
Eversense Implantable CGM
Made by Senseonics, this implantable Eversense CGM sensor would be the first of its kind. A small, pill-like sensor about the thickness of a Tylenol tab is implanted completely under the skin during a five-minute surgical procedure. It can last 90-180 days before needing replacement. You wear a thin black box transmitter device adhered to the skin over the implanted sensor that sends data to a smartphone app, and this transmitter can be removed and re-attached to start sharing data again. This system still requires two fingerstick calibrations per day.
San Diego endo Jeremy Pettus got to try the system while in Lisbon for the recent EASD conference. He says the transmitter is "probably the size of two quarters put together but rounded and smooth." He also explains that after insertion of the sensor, there's a one-time 24-hour warm up period, before you are "off and running" for 90-180 days.
He summarizes the Pros and Cons this way:
- Super nice not to have to put on a new transmitter every week or so or worry about being out without one.
- Haven’t had to worry about a “bad” sensor, or getting question marks, or it falling off, or coming out.
- I like that I can take off the transmitter whenever I want and have nothing attached to me at all. When I put it back on, it starts reading again right away. You can’t really temporarily take off our currently available CGMs.
- It’s very accurate with MARD (measure of accuracy) that is in the 8% range which would make it at least as accurate, if not more so, than currently available CGMs.
- Predictive high and low alerts are an option and can be set to alarm when you are going to go high or low in the next 10, 20, or 30 minutes.
- The Eversense has cloud sharing capabilities also.
- You have to charge the transmitter every day, which takes about 10 minutes. The charge does last ~42 hours in case you forget. I do it while taking a shower. If the transmitter battery runs out of juice your readings will be interrupted until you charge it.
- The charger for the transmitter is unique to the device so if you lose it, you can’t just go out and buy one (not like losing an iPhone charger or something). So, hopefully you can get an extra one when the device is approved.
- The interface on the app needs to be more user-friendly. It does give you reports and so on but they aren’t as slick as others we are used to and it takes a while to find the data you want.
- The insertion procedure, while not a big deal, is still a procedure and something you would have to schedule every 90 to 180 days.
The Eversense CGM is available in 13 countries, but not yet the U.S. In September, Senseonics received European approval for the Eversense XL that lasts 180 days. A 90-day sensor version has been pending before the FDA for the past year, and Senseonics’ CEO said during a recent earnings call that he expects an FDA advisory panel will be exploring the safety of the implantable sensor in early 2018.
Another all-new system was supposedly coming soon from a group of three Dexcom alum, who founded a Carlsbad, CA, startup called Glucovation in 2014. They're developing SugarSenz, a CGM that could be appealing to those without diabetes in the general consumer market. The sensor is designed to attach to your skin with peel-off adhesive backing for 7-10 day wear, and the built-in "transceiver" would have a battery integrated into the disposable sensor part.
Well, Dexcom sued that same year it took both parties two years to eventually settle in May 2016. Glucovation transferred all its IP to an Irish company in 2016, creating a joint venture in China to manufacture and actually market the CGM. There has been no news of any regulatory filings to date, but Glucovation still says it is planning a U.S. product launch at some point. (?) One again, we shall see.
Abbott Libre "Flash"
As many have been discussing, the Abbott Libre that just got FDA approval and is expected to hit the U.S. market in December is not quite a CGM as we know it (because you have to scan it to get results, and there are no alerts like a traditional CGM system). Instead, you wear a flat, coin-sized sensor on your upper arm (approved for 10-day wear), and you have to actively wave the handheld scanner over it to get readings. Though it eliminates the need for routine fingersticks, it isn't exactly "continuous" in sharing data and it does not have safety alarms for Highs and Lows like traditional CGM systems. This easy-to-use system that requires NO fingerstick-test calibrations has been available internationally for a few years now, and many users are praising it as a game-changer. There's even a national advocacy campaign underway in the UK to expand access. The international DIY #WeAreNotWaiting community is already hacking the device to enhance its features, too.
The next-gen Libre tech promises to take this game-changer even further, as it will do away with the handheld scanner completely, allowing it to beam glucose data directly a smartphone via Bluetooth -- making it more comparable with existing CGM functionality. So, there's that.
Dexcom filed its G6 with the FDA at the end of the third quarter closing Sept. 30. In an earnings call on Nov. 1, the company said it's still TBD on whether it will launch the G6 with a one-calibration fingerstick requirement, or wait for a no-calibration version if regulatory approval doesn't take too much longer.
Either way, Dexcom plans to launch a G6 product in 2018 for people with diabetes. This next-gen tech will mean at least 10 days of wear, enhanced accuracy and reliability, and a one-button insertion applicator and smaller transmitter. It will also include a Predictive Low alert instead of just a "hard" alert for when you've crossed the low threshold, and it will be compatible with the new touchscreen color receiver -- although just like now, users would not need the receiver if they opt to beam data directly to the app on their smartphone.
The fact that we're now just a year or so away from having two D-devices on the market in the USA without a need for fingerstick calibration is pretty remarkable, and shows how far we've come!
Medtronic Guardian/Enlite 3
We'd be remiss to not mention Medtronic's latest CGM technology, the Guardian 3 sensor (formerly known as the Enlite 3) that comes with its Minimed 670G Hybrid Closed Loop system. The company has been plagued by CGM sensor manufacturing delays of late and some PWDs using the new device say they've been told sensors are on back-order until early next year -- yikes!
Meanwhile, the company is still waiting on word for FDA approval of its stand-alone CGM system, and continues developing its next-gen tech called the Harmony CGM sensor, currently in feasibility studies. It's purported to be even more accurate and reliable than the existing generation, so it'll be interesting to see how all of that moves forward with the potential CGM competition out there.
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This is all just a sampling, as there numerous Asian companies and smaller developers exploring the CGM universe as well. Some of them even exhibit at diabetes conferences and events, or send out marketing pitches, as they work toward patenting technology that is years off (if it ever materializes). So while it can all be intriguing to hear, we certainly have to take it all with a grain of salt and curb our enthusiasm, so to speak.
As always with promises of diabetes progress, we'll just have to wait and see...