How to Read Dexcom Transmitter Package Symbols

By Adam Brown and Kelly Shut

What'due south bully nearly Dexcom's G6, what could exist even better, and how the new CGM compares to the G5

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Continuous glucose monitoring (CGM; for background info, click here) apply is growing, with an estimated 1.2 million users globally and two systems now available that require NO fingerstick scale: Dexcom's G6 and Abbott's FreeStyle Libre.

Following FDA clearance in March, Dexcom's G6 has begun a express launch, with wider United states of america availability starting in early on June. (Click here to acquire about Dexcom's upgrade programme for current G5 users.) The G6 has already been filed with Medicare, with a determination expected this fall. Outside the USA, G6 is expected to launch in the second one-half this year, likely starting in Europe. The G6, similar other CGMs, must be prescribed by a physician, and information technology is covered by most private insurance plans.

Relative to using fingersticks – which the vast majority of people with diabetes withal practice – G6 is a truly transformative technology for personal diabetes learning, greater safe, more than discretion, and therapy adjustments.

We are both lucky to exist part of the G6 limited launch, and this exam drive includes observations from wearing the arrangement over the past 2 weeks. We share what nosotros like and what we would love to see improved in the almost predictable product in Dexcom's history. As with whatsoever exam drive, your mileage (and opinions!) may vary. Combined, nosotros have worn CGM for over 150,000 hours, then we take seen quite a lot!

Overall, G6 improves on many fronts over G5, particularly the outstanding new one-push sensor inserter (applicator), strong accuracy without any fingerstick calibrations (maintaining a short two-hr warmup period), an extension to 10-24-hour interval wear, a slimmer on-torso Bluetooth transmitter, and clearance for use with other diabetes devices under an heady new FDA pathway.

Compared to the G5, which had 7-day sensor vesture, the G6 is expected to exist more economic due to the longer 10-solar day vesture (for reference, the out-of-pocket price for a box of 4 G5 sensors is $349).

Of course, no device is perfect, and G6 tin can notwithstanding better – the startup process "lawmaking" entry is a fleck clunky (and photograph browse did not work for us, but we never had issues with the G5), we had some issues with 10-twenty-four hour period sensor vesture, and the heavy-duty, more durable touchscreen receiver has moved away from the sleeker G4/G5 starting time-gen receiver (though we're both using our phones, as presumably most will).

Read our topline thoughts on G6 beneath, and then click in the table of contents for a more detailed swoop and lots of pictures. Ship us your questions here , which we'll answer in a follow-up commodity, including comparison to FreeStyle Libre and Medtronic Guardian Sensor 3, and more than.

What We Like in the G6

• The incredible new one-push applicator: it makes sensor insertion far less painful (Kelly is very pain-sensitive and she loves it) and less intimidating, enables simple one-handed insertion (especially for arm-wear, which isn't yet officially approved, only which Adam loves), and should be easier to train. It likewise probable contributes to improve day 1 accurateness.

• No fingerstick calibration with a short two-hr warmup: G6 completely eliminates fingersticks, but however gives the same real-time, continuous glucose readings as G5 every v minutes. An optional fingerstick calibration can be entered in cases of sensor inaccuracy.

• Like accuracy to G5 in our head-to-head comparisons. Relative to 79 Accu-Chek Guide fingersticks, Adam's G6 has had an average relative divergence (deviation) of xiii.six%, similar to xiii.nine% for a simultaneously-worn G5. G6 is also more reliable on twenty-four hour period 1, particularly right subsequently insertion – that is very welcome news.

• Longer 10-day wear reduces the number of insertions and warmup periods. Importantly, the sensor has an FDA-mandated shutoff and cannot be restarted once the 10 days are up. Nosotros tried; the app can actually detect a sensor restart and prevents the two-hour warmup from completing. This is unpacked in particular below.

• Slimmer transmitter returns to the lower-profile Dexcom CGM transmitter nosotros saw with Seven Plus and G4. The G6 reusable transmitter now sits flush in the plastic cradle on the body, rather than rising to a higher place it like with G5. Information technology'due south easier to have in and out (one time you know how to exercise it!)

• No acetaminophen (Tylenol) interference, a long-awaited upgrade. This is particularly fantastic news.

• More consistent Bluetooth connectivity, at least in our early tests (20-foot range).

• G6 apps for Apple iOS and Android and smartwatches are bachelor at launch – unprecedented for a brand-new CGM, where there is typically lag time between phone operating systems. Data is automatically uploaded to the dainty Dexcom Clarity software for viewing online or on split up Clarity Mobile apps (Apple, Android).

• Urgent low soon alert notifies if you are expected to be less than 55 mg/dl within 20 minutes. This predictive capability adds to the usual low threshold alarms. Kelly loves this and for improve or worse has benefited from it multiple times already!

• FDA clearance for interoperability (ability to use with other devices that "talk" to the G6) should allow pumps and other devices and apps to more quickly integrate G6 and keep pace with future Dexcom CGM innovation. We'll render in a follow-upwardly piece with more on this.

Opportunities for Comeback in the G6

• A "calibration code" must be entered/scanned when starting a new sensor. The photograph scan did not work in our 25 attempts, requiring manual four-digit code entry. This is a worthwhile tradeoff to eliminate fingersticks, only it could go more seamless (e.1000., like Abbott's FreeStyle Libre, which requires no code).

• Sensor reliability over 10 total days: Kelly's first sensor brutal off after 24 hours, while Adam received a "Sensor Error" message and unreliable data on days viii-ix. On his second G6 sensor, Adam did come across errors over 20% regularly on days 9-10. Kelly tried putting her second sensor on her arm, but it got "ripped off" (she attributes that to user mistake); the third sensor (back on her abdomen) seemed to work very well.

• For many users, the inability to restart G6 and extend beyond ten days is a problem – especially those paying out of pocket for CGM. We address this decision below – we feel information technology's a positive and whether or not it'south "possible" to restart G6 – we'd like that conversation to exist over!

• G6 app user interface has shrunk some of the well-nigh useful information and muted some colors, making it slightly harder to rapidly read the electric current value and to understand 24-hour trends (i.due east., when phone is turned sideways). This seems more noticeable on smartphones with smaller screens (e.grand., iPhone SE).

• The receiver has gotten meaningfully larger and more medical-device-looking. Though it is more than durable, it is by far the least consumer-feeling part of G6. At launch, the receiver must be purchased, although many people volition just employ the phone apps exclusively.

• The reusable transmitter still lasts for 3 months, maintaining the reordering hassle some have experienced with G5 transmitters. Moving to a fully dispensable on-torso component will exist a welcome change.

• The new applicator creates a lot of plastic waste ("throw this whole thing abroad?") and there is no recycling programme bachelor at this stage.

Contents

• G6 Insertion Process with New Applicator
• Sensor Startup Without Fingersticks
• Accuracy Compared to G5
• Sensor Terminate and "No Restart"
• Transmitter
• App
• Receiver

G6 Insertion with New Applicator – A Serious Improvement

Relative to the previous syringe-like transmission inserter, G6's automatic ane-button applicator brings a serious comeback. Each sensor comes pre-attached to the applicator. To insert it, a user peels the tape off, sticks information technology on the skin, folds/breaks off a safety baby-sit, presses a button to insert information technology, and so lifts the applicator off the pare. Adam and Kelly read the quick-start guide and easily inserted G6 on their commencement attempts. Spotter Adam do it on video here.

Both Adam and Kelly were impressed with how much less painful the new inserter is: the needle goes in and out very apace and is completely hidden from sight. Kelly winces every time she puts on a G5 sensor and avoids irresolute sensors due to the hurting. She is now very excited that the new applicator makes sensor changes far less painful and much easier.

The new inserter also makes G6 well-suited to one-handed insertion, a plus for those who program to wear information technology on the back of the arm (Adam's preferred wear location). Note: This is currently a non-FDA-approved wear location, only G5 and G6 work but fine on the arm, though sometimes tend to under-read "true" glucose in Adam'due south feel.

The biggest downside to the new applicator is how much environmental waste it creates – it's fully disposable and there is quite a lot of plastic. Dexcom does not have a recycling program at this time, though we hope one is added. Diabetes products create a lot of environmental waste product already – drug labels, wrappers, infusion sets, strip vials, batteries, etc. – and we hope all time to come devices keep the environment in mind. Obviously, this creates challenging tradeoffs for companies, since improving products and reducing waste product tin exist mutually exclusive.

Sensor Startup Without Fingersticks

G6 is a no-fingerstick-calibration sensor, similar to Abbott's FreeStyle Libre. After insertion and a two-hour warmup, G6 immediately begins displaying real-fourth dimension CGM values and trend arrows – no fingerstick entry is required at startup or over the course of the x-day wear time.

The startup process is reminiscent of how calibration codes used to be on a vial of strips – e.1000., enter "code 25" when opening a new vial of strips. In this case, each 10-day G6 sensor comes with a unique 4-digit numerical code that must exist entered into the app/receiver earlier starting the two-60 minutes warmup.

On the G6 app, the 4-digit sensor code can be entered via photograph (QR code scan) or manually typed in. We could not get the app to photo scan the sensor code, despite trying 25 times and on three different sensors. In this case, the app allows manual keyboard input. (Interestingly, the transmitter series number photo browse did work perfectly.) We hope Dexcom improves the code scanning process. For those using the receiver, the code can just exist entered manually by scrolling up/down. Kelly thinks the manual code entry is a bit more of hassle than Adam does ("I've worn Libre much more you take!"). Of form, doing this once every 10 days is not that much hassle, and the tradeoff is well worth it for no fingersticks – no question!

If the sensor code is lost, a user must calibrate with fingersticks quite a bit: twice later on the two-hr sensor warmup is complete, a third time 12 hours later, a 4th fourth dimension 12 hours later on that, and then once every 24 hours.

Relative to FreeStyle Libre'southward manufacturing plant calibration, Dexcom's G6 is not quite as seamless – each individual G6 sensor code must be scanned or entered before warmup, while FreeStyle Libre requires no such entry (the sensor is but scanned with the reader and starts the warmup). Nonetheless, based on the labels, G6 is a more accurate device.

Accuracy Compared to G5

In the large move to eliminate fingerstick scale, G6 appears to maintain the accuracy of G5 in our feel – and on solar day one, the sensor performance seems much better.

For this test drive, Adam wore G6 and G5 caput-to-head at the same time, once over x days on his belly and a second time over 10 days on his arms.

Relative to 79 Accu-Chek Guide fingersticks, G6 has had an boilerplate relative difference (deviation) of only thirteen.6%, similar to 13.9% for the simultaneously-worn G5. Of the 79 comparison fingersticks Adam took, G6 was displaying a corresponding existent-time value in 96% of cases, while G5 showed a value in a lower 85% of cases.

According to G6's official user guide, the sensor has an average ix.0%-ix.8% relative difference vs. laboratory blood glucose values. For context, this means if blood sugar is 100 mg/dl on average, G6 will exist off from "truthful" blood glucose value by roughly ~9-10 mg/dl (on boilerplate). Adam is using G6 in "existent-earth" apply and comparison to a meter, so his relative accuracy has been lower than the "labeled" accuracy.

A big comeback with G6 is on solar day ane. Afterward the first ii-hour warmup, Adam'southward first G6 reading was 127 mg/dl, while the meter read 130 mg/dl. Subsequently the 2d sensor's two-hour warmup, G6 read 54 mg/dl, while Adam's meter read 58 mg/dl. On his just-started tertiary G6 sensor, the first G6 value read 89 mg/dl vs. 88 mg/dl on the meter.

G6 has also had smoother, more reliable readings than a newly inserted G5, with less jumpiness and gaps on twenty-four hour period one. See the G6 vs. G5 pictures below for 24-hour comparisons on day i and day vii – they rails very well together, just G6 eliminates the fingerstick calibrations!

Twenty-four hour period 1: G6 (pinnacle) vs. G5 (bottom)

Day 7: G6 (top) vs. G5 (lesser)

G6 users can enter an optional fingerstick calibration – e.yard., in cases where the sensor is actually very different from the meter value. Notwithstanding, the app and receiver pattern clearly discourages doing this. The "calibrate" pick is buried inside the settings carte, rather than accessible from the app main screen – come across below. This is a smart way to preserve the feature for when it'due south really needed, but nudge against using information technology. Kelly used this a lot – peradventure once a day. Adam avoided using it just to exam out the no-scale accuracy.

We even so have some questions on accuracy and reliability over 10 days, but this is based on our very express experience. Adam got a "sensor fault" message on days eight-9 of his outset G6 wear session, which resulted in very few data points really collected on these two days (similar to the "???" symbol that would come up on G4 and G5).

On his second sensor, Adam saw noticeably worse accuracy on days 9 and 10, with relative errors of twenty% or more than in many cases (e.g., reading more than 20 mg/dl off when the meter said 100 mg/dl).

Kelly'south very first G6 sensor did autumn off her body later a couple of hours on twenty-four hours one (adhesive failure), something she has never seen with G5 (this happened and then fast that she didn't really count this every bit her "beginning" sensor – she felt this was a fluke).

Sensor End and "No Restart"

After 10 days, G6 stops giving real-time readings and prompts the user to insert and starting time a new sensor. Relative to G4 and G5 a big change is the addition of a mandatory shutoff: a G6 sensor cannot be "restarted" to extend the wear time across 10 days. When trying to do and then, the app recognizes it and volition not allow the two-hr sensor warmup to consummate.

This is a complicated issue, since many people pay a lot of money for CGM and the power to extend a single sensor'due south article of clothing time – e.m. to 14 days – makes CGM more affordable.

Dexcom worked with the FDA on this issue and clearly had to make some changes. For example, G6 achieved an important new FDA classification called "integrated CGM" (iCGM), which regulates it every bit a lower-risk device (class Ii). Ultimately, this new category will speed CGM innovation, bring improvements faster, and brand CGMs easier to integrate with other devices and software (interoperability). However, the FDA also ruled that an iCGM must have a mandatory shutoff; hence, it is included in G6. Presumably this protects us against the potential for more inaccurate readings.

Like FreeStyle Libre (which besides has a mandatory shutoff at 10 days), G6 is a no-fingerstick-calibration glucose sensor canonical for insulin dosing. That puts an even higher bar on accurateness and reliability. For now, G6 has been tested and approved for 10-twenty-four hour period article of clothing, meaning Dexcom and the FDA cannot be assured of insulin-dosing safety or accurateness across x days. However, Dexcom does plan to practise a xiv-day wear trial of G6 in the 2d half of this year.

We'd similar to see an end to complaints nearly not being able to "extend" the system – or even whether it's possible. It's been decided, and we believe this decision is in the best interests of people with diabetes, the organization, and providers.

Transmitter

The Bluetooth-enabled G6 transmitter is meaningfully slimmer than G5, and should exist less susceptible to getting knocked on things. The transmitter is now flush with the plastic sensor cradle, rather than ascent above it similar with G5. The picture show below compares G5 and G6 on Adam's abdomen. Kelly was impressed with the new transmitter, and pointed out that information technology returned to "more than" (but ameliorate) what the transmitter used to look like with the 7 Plus and early G4; information technology was actually G5 that made the transmitter larger with the addition of Bluetooth. Still, this is progress!

Like G5, the G6 transmitter is reused for iii months, at which point it is thrown away. Dexcom typically ships two G6 transmitters at a fourth dimension, significant transmitters need to be reordered twice per year for most people.

Dexcom is working on a fully disposable transmitter with its Verily partnership, though has not given specific timing on when the first-gen version might launch. We'd gauge quondam in 2019 is the earliest the offset-gen Dexcom/Verily disposable transmitter could come out. It's unclear if all Dexcom G6 users will move to the dispensable transmitter, or if this will be a divide product.

App

The G6 app has been slightly redesigned (available on Apple and Android). On Adam'due south older iPhone SE, the G6 app has meaningfully reduced the size of the CGM bubble/tendency pointer, and this cannot be adapted in size. The new G6 app blueprint likewise leaves more white infinite on the screen and mutes the colors a bit. Fortunately, this seems to be less of an effect on a larger-sized/newer smartphones.

G5 app screenshot (left) vs. G6 app screenshot (right)

Dexcom has put a bigger focus on manually entered "events" (east.g., insulin doses, exercise), but ultimately, it's difficult work to enter them. Turning the telephone sideways to run across the 1/6/12/24-hour CGM graph now wastes half the screen on "events" – an unfortunate change, since they will exist empty for nigh people. Events volition become more useful when they are automatically nerveless from a telephone's sensors or Bluetooth-connected insulin commitment devices (pumps, smart pens).

On the plus side, we're very glad to see CGM high/low notifications are now accompanied past the bodily sensor value and tendency pointer on the phone's lock screen. Previously, G5 simply said "high glucose," just didn't actually say what the glucose value was.

Adam has had problems with his G6 app occasionally quitting in the middle of the nighttime, something he has likewise experienced with G5. The best prepare he has found is quitting the Dexcom app before bed, turning his telephone off and dorsum on, reopening the app, and putting his phone in airplane mode with WiFi turned off.

The Dexcom G6 Apple Lookout man app is identical to the G5 version. We are optimistic that the new FDA iCGM classification will speed the availability of directly-G6-transmitter-to-Apple-Watch, pregnant a user could become CGM data on the spotter without a smartphone nearby.

Overall, Adam doesn't similar the G6 app quite every bit much as the G5 (Kelly loves both) but it still retains Dexcom's mobile leadership – information technology's the simply CGM in the US with Apple iOS, Android, and smartwatch apps for viewing existent-time data. (A Dexcom app for Fitbit smartwatches will also launch in the 2d half of this yr.) Abbott'south FreeStyle Libre has the LibreLink app (Android, Apple), only information technology only available outside the Usa. Medtronic's Guardian Connect app is only available on Apple tree iOS.

Medicare still does not cover CGM with remote monitoring/app use. We continue to hope to see this change.

Receiver

The heavy-duty touchscreen receiver moves abroad from the sleeker G4/G5 start-gen receiver. Dexcom did this for reliability and durability reasons – indeed, the receiver is built like a tank and should take less breakages and returns. Notwithstanding, we assume most users will adopt app brandish.

The receiver has but one button to wake it upward and is otherwise touchscreen. Information technology is not a smartphone quality touchscreen, only it is meliorate than we expected. Hitting the domicile push button wakes up the receiver and shows the CGM graph and value; to collaborate with the receiver, a user must tap "i-2" to unlock the device – similar to Tandem'due south t:slim insulin pump.

Like G5, users can view G6 CGM data with just the app, only the receiver, or both at the same fourth dimension. The transmitter has retained the "brains" and allows for seamless switching betwixt the displays. Nosotros plant them very like shooting fish in a barrel to toggle between and saw no lag between them.

Dexcom is currently "putting plans in place" to file G6 with FDA then that purchasing a receiver becomes optional. Medtronic's Guardian Connect CGM received the first FDA approval before this year for smartphone-only display.

Please send us your questions! We'll answer them in a follow-up article, including:

• Should I upgrade from G5 to G6? From G4 to G6? What should I consider?

• Characteristic comparing betwixt Dexcom G6, Abbott's FreeStyle Libre, and Medtronic's Guardian Sensor 3 (Connect, MiniMed 670G)?

• What does the new FDA clearance for interoperability hateful as an "integrated CGM" (iCGM)?

• When are Dexcom G6-integrated airtight-loop systems coming to market?

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Source: https://diatribe.org/dexcom-g6-review-no-fingersticks-cgm-one-button-insertion-and-10-day-wear

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