Memorandum

Dexcom G6 Pro CGM receives FDA clearance, Shipments to Begin in “Early” 2020; Fully Disposable Transmitter, Real-Time Mode – October 8, 2019

Executive Highlights

  • This morning, Dexcom announced FDA clearance of G6 Pro, a serious upgrade to its G4 professional CGM offering in the US. The system will launch in “early” 2020 using the same G6 sensor platform (10-day wear, factory-calibrated, auto-applicator), but moving to a fully disposable Bluetooth transmitter, offering both real-time and blinded modes, and giving users the option of the receiver or G6 app for viewing data. The new transmitter will automatically start the sensor when clicked into place, eliminating the need to scan a code or hit “start.” G6 Pro takes glucose readings every five minutes and is cleared for patients down to two years old. HCPs are going to love these upgrades.

  • G6 Pro was submitted to the FDA in early July, implying a review time of just three months. Dexcom continues to benefit from the 510(k) iCGM pathway created last year, using G6 real-time as the predicate device. For comparison, the original de novo clearance for G6 took ~six months, while approval for Abbott’s FreeStyle Libre Pro took nearly 1.5 years.

  • G6 Pro will be priced “competitively” with FreeStyle Libre Pro. With 10-day wear, no fingersticks, and a fully disposable transmitter, G6 Pro has caught up to the clinical simplicity of FreeStyle Libre Pro. It was a huge hassle to disinfect the G4 Pro reusable transmitter and keep track of the receiver and transmitter (no app), and the G4 Pro required a larger upfront financial investment and two fingersticks per day. This system should show meaningful uptake over the G4 Pro offering and give Dexcom more experience in type 2 diabetes.
  • The real-time mode for G6 Pro (and app) will also allow users to “try” G6 before committing to a personal system – an advantage over both Abbott and Medtronic’s blinded-only offerings, which don’t quite simulate their full CGM experience. This could also expand Dexcom’s sales funnel – especially in type 2 diabetes – and allow for new intermittent approaches to CGM (e.g., once quarterly, or every six months, to ensure therapeutic interventions are working well).

Early this morning, Dexcom announced FDA clearance for G6 Pro, improving every feature from its outdated professional G4 Platinum Professional offering (approved in 2012). See below for photos, details, a comparison between Abbott, Dexcom, and Medtronic’s professional CGM offerings, and our questions.

Product Details

G6 Pro Website

  • In new product details not previously mentioned, G6 Pro will “auto-start” when the transmitter is clicked into place – eliminating the need to scan the four-digit sensor calibration code or press “start sensor.” This could also enable new models of care – e.g., mail a G6 Pro sensor and it will automatically start when applied, without having to deal with Bluetooth pairing hassles.

  • The G6 Pro can be used in both blinded and unblinded modes, distinguishing it from FreeStyle Libre Pro and Medtronic iPro2 and Envision Pro, which are all blinded at present. In the “traditional” blinded mode, the sensor is started in clinic, worn for 10 days, and then downloaded in clinic to Dexcom Clarity. In the real-time mode, patients can view their data on the G6 Pro app (it will run in a simplified interface vs. the real-time consumer app) or on the clinic-owned reader – both obviously a nice way to experience what the G6 personal system is like and to see the impact of food, therapy, exercise, stress, etc. G6 Pro will also enable real-time high and low alarms, offering additional direct behavior change potential with the system – unlike blinded-only offerings where behavior change is more challenging (but certainly still possible, though not real-time).
  • The expected launch for G6 Pro in “early” 2020 is in line with the 2Q19 call in August, but slightly behind the timeline given at JPM to launch in 2019.

  • In a separate phone call, Dexcom said that G6 Pro will be priced competitively to FreeStyle Libre Pro. The latter is priced at ~$60/sensor and ~$65/reader. This is a radical reduction in price for Dexcom over the G4 Pro, which retailed at $249 for a four-pack of sensors, $399 for a reusable (six months) transmitter, and a receiver at $349. Clinics will now have to spend less money and worry less about receivers/transmitters. Professional CGM is pretty well reimbursed by both private and public insurers (as we understand it), and it’s unclear whether payers discriminate across professional CGM devices based on cost. There is huge upside for clinics to get help from CGM in identifying appropriate therapeutic changes (or starts), and to enable users to learn in real-time about the various impact of food, exercise, sleep, stress, etc.

  • The product page for G6 Pro shows a Dexcom Clarity dashboard (see above) that is more simplified from the personal version of Clarity (screenshot below). Like the current version, the new dashboard shows topline average glucose, standard deviation, and time-in-range, and offers an excellent new day-by-day time-in-range paired with the CGM trace. (Getting day-by-day time-in-range is more of a pain in the personal version of Clarity, and it doesn’t show it paired with the trace unless you select individual dates.)We imagine this new dashboard will be very useful for intermittent, 10-day wear sessions – allowing both topline and granular examination of trends.


  • Manufacturing the reusable transmitter for G6 Pro could provide useful experience before Dexcom launches its highly awaited fully disposable G7 platform (expected late 2020 limited launch). As of 2Q19, a lower-cost transmitter for the G6 had already begun manufacturing, with plans for a full launch in 4Q19. We assume that the transmitter for the G6 Pro will use the same manufacturing process as the lower-cost personal transmitter, though with different firmware on the transmitter.

  • G6 Pro is different from the "Pro-Q" retrospective-only product that was FDA cleared in November 2018. Dexcom told us earlier that Pro-Q is being used in pilot studies as a glucose recording device (i.e., blinded only); G6 Pro is the commercial product and has both blinded and real-time modes. It was only at ADA that Dexcom made this distinction clear. It is interesting to think about what the path of clinical trials will be – as we understand it, SMBG (self monitored blood glucose) systems went through something similar, when they were blinded for all clinical trials as well, for some time. At some point, however, patients did not want to do the trials without having access to “real” data. 

Feature Comparison with FreeStyle Libre Pro and Medtronic Envision Pro

With the longer wear-time, factory-calibration, and disposable transmitter, the G6 Pro moves closer to FreeStyle Libre Pro – and ahead with real-time mode and an app experience. Medtronic’s Envision Pro (CE-Mark announced at EASD 2019) added no-calibration, Bluetooth connectivity to an app, and fully disposable form factor, but is still blinded-only and only seven-day wear (which some may prefer). Additionally, Envision Pro will not be launched in US. For now, Medtronic has iPro 2 in the US, which lags significantly behind both systems (reusable transmitter, blinded only, requires fingersticks).  

The yellow highlight denotes which system(s) has the advantage on a particular category; some categories are factual, while others reflect our opinion.

 

Dexcom G6 Pro

Abbott FreeStyle Libre Pro

Medtronic Envision Pro (Europe only)

Dexcom G4 Platinum Pro

Wear-time

10 days

14 days

7 days

7 days

Calibrations?

None

None

None

2/day

Age indication

2+ years

18+ years

14+ years

2+ years

Fully disposable?

Yes

Yes

Yes

Reusable transmitter

MARD

9.0%*

12.3%

11.0%

12.9%

Bluetooth to app?

Yes

Data uploaded to Dexcom Clarity (via G6 app) or stored on transmitter for in-clinic download

No

Patient must come to clinic to have sensor downloaded with reader (NFC scan)

Yes

All data uploaded automatically to CareLink

No

Reader required to view data in unblinded mode

Blinded vs. unblinded?

Blinded and real-time modes on app or receiver

Blinded only

Blinded only

App allows manual entry of contextual info – meals, medication, exercise

Blinded and real-time modes on receiver only

*The product page for G6 Pro says that the device has the accuracy of the personal Dexcom G6 CGM system.

Close Concerns Questions

Q: How penetrated is the professional CGM market? What is the total addressable market? How much is professional CGM being used systematically with patients every year?

Q: How will healthcare providers segment between G6 Pro and FreeStyle Libre Pro? Will the devices appeal to different market segments, or is this more a matter of sales rep and clinical footprint?

Q: How much of an advantage is G6 Pro’s real-time feature, especially as a “try it before you buy” sales funnel for Dexcom’s personal G6?

Q: How much help can the G6 Pro give to patients who will not go on to real-time CGM immediately?

Q: Has FreeStyle Libre Pro helped Abbott grow the user base for its consumer version?

Q: Will there be reimbursement differences with FreeStyle Libre Pro and G6 Pro? Will payers differentiate between G6 Pro vs. FreeStyle Libre Pro?

Q: How could Dexcom use G6 Pro to test various CGM wear models in people with type 2 diabetes – e.g. one CGM session every quarter, mailer order professional CGM with remote telehealth, etc.

Q: To what extent are patients and healthcare providers aware of professional CGM? What are the biggest barriers to higher adoption – e.g., HCP awareness, time and reimbursement, hassle, patient awareness, patient interest, etc.?

Q: Will Dexcom build out robust professional CGM decision support to compete with Medtronic’s nicely designed Pattern Snapshot?

Q: How will Medtronic’s Envision Pro compete with Dexcom and Abbott in Europe? Can Medtronic build a large OUS business? When will we see a new US professional CGM from Medtronic?

 

--by Albert Cai, Adam Brown, and Kelly Close