As many an of our readers advantageously know, victimization a continual glucose monitor can be life-dynamic for hoi polloi with diabetes. And in the decade or so since they were first introduced, the technology has get more reliable, accurate and substance abuser-friendly.

Yet just a small fraction of the Diabetes Community of interests uses a CGM.

That could be happening the verge of changing dramatically, if a wave of companies are able to fully develop and bring their new CGM concepts to grocery store. Various manufacture observers bank note that in that location 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 bear on market, it would be an explosion of CGM choice. Yet it's unlikely whol of them will in reality materialise, conferred the hurdles in the diabetes gimmick market.

CGM has been in the newsworthiness quite an bit lately, due to the recent FDA filing of Dexcom's G6 model designed for 10-day put on, that it developed in partnership with Verily; the durable-hoped-for FDA approval of the Abbott FreeStyle Libre Flash Glucose Monitoring, that adds a new stratum to the traditional CGM food market; and the pending FDA review of the Senseonics EverSense scheme, that would follow the inaugural implantable CGM lasting 90 days under the skin! And then there's the October newsworthiness from AgaMatrix, announcing a corporate restructuring that includes spinning inactive WaveForm Technologies Eastern Samoa its own dedicated CGM job.

Things are certainly heat heavenward, that's for for sure! Here's an overview of what's going along:

AgaMatrix / WaveForm CGM

In early October, the Granite State-based AgaMatrix announced it was reorganizing its diabetes lin into a parent holding company with two main branches — AgaMatrix, that will continue nonindustrial and marketing its traditional glucose monitoring products like the Jazz wireless meter, and the newly-formed WaveForm Technologies, that will focus on nonindustrial its CGM system.

AgaMatrix/WaveForm certainly brings extraordinary cred to table, disposed their pioneering do work happening the iBGstar beat some years ago — the first off-always medical device that plugged directly into an iPhone (aged models) and was a beacon of substance abuser-neighbourly, patient-centered design at the time. Regrettably, that meter soon became outdated with iPhone changes and inadequate indemnity insurance coverage for the beat and strips, but its leading-abut design was irrefutable.

We know that the core CGM tech was bought in archaean 2016 from iSense CGM and Bayer, that had been jointly development it previously.

According to the AgaMatrix selling manager Juleen Ginty, "the Wave shape CGM system utilizes a small sensor that will broadcast glucose data wirelessly through a rechargeable transmitter to a smartphone app, providing adequate the minute feedback on glucose levels. Our unique sensor design will pass a virtually painless insertion process at a smaller diam (approx. half the size of a leading competitor). This reduction in size aids the day one sensing element performance, facilitating a reduced warmup time. We anticipate our sensor design and technology to enable increased sensor wear time and lotion on more areas of the body, compared to currently ready CGM systems."

** UPDATE: In a Jan. 11 news release, WaveForm will be a 14-day sensor.

AgaMatrix says some preliminary data on the CGM technical school testament be shown at the Recent Diabetes Technology Society group meeting, starting Nov. 2, 2017 in Bethesda. Actually, that tech dates back almost 20 years in what was known as iSense. Spell it's in all likelihood evolved from the original project concepts, we've been told aside those familiar with IT that the sensor is more flavourless happening top than the existing Dexcom sensor, and IT has an elliptic bottom that makes it resemble a tongue-emoji. That's about all the detail for sale at this time.

Prior to the AgaMatrix acquisition, Bayer had realised 8 human objective studies on the CGM technology. Now, Wave shape is doing other clinical trials needed to submit its device to the FDA for consideration. The company expects CE Mark approval for its CGM mathematical product in 2018, and is provision for an FDA entry to beat to market as Old as 2019.

(Observe that Oregon-settled iSense once as wel had a speckle heart called Jewel in the works, which it sold to Debiotech in 2015; that remains "in ontogenesis," we're told.)

We shall see…

Eversense Implantable CGM

Made away Senseonics, this implantable Eversense CGM sensor would be the first of its kind. A immature, pill-like sensor about the heaviness of a Phenaphen tab is implanted completely under the skin during a pentad-instant surgical operation. It prat inalterable 90-180 days in front needing replacement. You wear a scraggy clad box transmitter device adhered to the skin over the constituted sensor that sends information to a smartphone app, and this transmitter can be removed and re-involved to start sharing data again. This system still requires two fingerstick calibrations per twenty-four hours.

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San Diego endo Jeremy Pettus got to taste the system spell in Lisbon for the recent EASD group discussion. He says the transmitter is "probably the size of two quarters put together but rounded and sleek." Atomic number 2 likewise explains that after insertion of the sensor, there's a one-time 24-time of day warm up period, before you are "off and pouring" for 90-180 years.

He summarizes the Pros and Cons this way:

PROs –

  • Super Nice not to hold to put on a early transmitter every week or and then OR worry about being down without one.
  • Harbor't had to worry about a "deplorable" sensor, or acquiring question marks, or it descending off, or approaching out.
  • I like that I put up start the transmitter whenever I deficiency and have nothing attached to me at completely. When I put through it back on, information technology starts reading again right away. You can't truly temporarily take off our presently available CGMs.
  • It's really accurate with MARD (measure of accuracy) that is in the 8% range which would make it at the least as accurate, if not more so, than currently available CGMs.
  • Predictive sharp and contrabass alerts are an option and can be set to alarm when you are going to a-ok high or low in the next 10, 20, or 30 proceedings.
  • The Eversense has cloud joint capabilities also.

CONs –

  • You have to charge the transmitter all Clarence Day, which takes astir 10 transactions. The charge does last ~42 hours in case you draw a blank. I practise it while attractive a shower. If the transmitter battery runs kayoed of succus your readings will be interrupted until you charge it.
  • The charger for the transmitter is unique to the device so if you drop off information technology, you can't just last impossible and buy one (not like losing an iPhone charger or something). So, hopefully you can experience an extra united 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 magazine as others we are used to and it takes a while to recover the data you wish.
  • The insertion procedure, while not a big shot, is still a routine and something you would consume to schedule all 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 years. A 90-Day detector rendering has been pending before the FDA for the ult yr, and Senseonics' Chief operating officer 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.

Glucovation

Another all-new-sprung system was supposedly coming soon from a group of three Dexcom alum, who founded a Carlsbad, CA, startup titled Glucovation in 2014. They're developing SugarSenz, a CGM that could be appealing to those without diabetes in the general-purpose consumer commercialise. The sensor is designed to seize to your skin with strip-off gluey backing for 7-10 sidereal day wear, and the stacked-in "transceiver" would have a battery integrated into the expendable sensor take off.

Well, Dexcom sued that same year it took both parties two years to eventually square up in May 2016. Glucovation transferred complete its IP to an Irish society in 2016, creating a joint venture in China to manufacture and actually market the CGM. On that point has been no news program of any regulative filings up to now, but Glucovation even says it is planning a U.S. product launch at some point. (?) One over again, we shall see.

Abbott Libre "Flash"

Every bit many have been discussing, the Abbott Libre that fair 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 out a flat, coin-sized sensor connected your upper limb (approved for 10-day wear), and you possess to actively wave the handheld image scanner over information technology 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 abundant-to-enjoyment system that requires NO fingerstick-test calibrations has been available internationally for a some years now, and many users are praising information technology as a game-changer. There's symmetric a national advocacy press underway in the United Kingdom of Great Britain and Northern Irelan to expand access. The international DIY #WeAreNotWaiting community of interests is already hacking the device to enhance its features, too.

The next-gen Libre technical school promises to take this gamy-record changer even further, as it testament arrange forth with the handheld scanner completely, allowing it to beam glucose information directly a smartphone via Bluetooth — making IT more comparable with existent CGM functionality. So, there's that.

Dexcom Updates

Dexcom filed its G6 with the FDA at the end of the third billet closing Sept. 30 . In an earnings name connected Nov. 1, the company said it's still TBD on whether it will plunge the G6 with a unity-calibration fingerstick requirement, or waitress for a no-calibration version if regulatory commendation doesn't take overmuch longer.

Either way, Dexcom plans to launch a G6 product in 2018 for people with diabetes. This succeeding-gen tech wish mean at least 10 days of wear, enhanced accuracy and reliableness, and a unmatched-button intromission applicator and smaller sender. It bequeath also admit a Predictive Low alert alternatively of just a "hard" wary for when you've crossed the low threshold, and it bequeath be compatible with the new touchscreen color receiver — although just like now, users would not need the receiver if they opt to shine information directly to the app happening their smartphone.

The fact that we're now just a year just about forth from having ii D-devices on the market in the USA without a need for fingerstick standardization is pretty remarkable, and shows how far we've come!

Medtronic Guardian/Enlite 3

We'd personify remiss to not mention Medtronic's latest CGM engineering science, the Defender 3 sensor (formerly known as the Enlite 3) that comes with its Minimed 670G Hybrid Closed Coil system. The company has been overrun by CGM detector manufacturing delays of later and approximately PWDs exploitation the new device say they've been told sensors are connected back-order until early next year — yikes!

Meanwhile, the company is still waiting on word for FDA approving of its stand-alone CGM system, and continues development its next-gen tech called the Musical harmony CGM sensor, currently in feasibility studies. It's purported to be symmetric more accurate and certain than the existing generation, so it'll be exciting to see how all of that moves forward with the potential CGM competition unfashionable thither.

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This is all just a sampling, as at that place numerous Continent companies and smaller developers exploring the CGM existence as well. About of them even exhibit at diabetes conferences and events, or institutionalise out marketing pitches, equally they solve toward patenting technology that is years off (if it ever materializes). Then while it stool all beryllium intriguing to hear, we certainly have to take apart it all with a grain of salt and curb our enthusiasm, and then to speak.

As always with promises of diabetes build up, we'll just have to wait and see…