Memorandum

Dexcom receives FDA approval for Professional Version of G4 Platinum CGM – June 5, 2014

Executive Highlights

  • Dexcom announced FDA approval for a Professional Version of its G4 Platinum CGM earlier this week.
  • Dexcom is positioning the Professional G4 Platinum as the “first and only real-time professional CGM,” a comparison to Medtronic’s iPro2, which only collects data in a blinded fashion.
  • The product could increase healthcare provider enthusiasm for CGM, help optimize more patients’ therapy, and potentially expand the CGM market in the long-run.

Dexcom just announced FDA approval for a Professional Version of its G4 Platinum CGM. This aligned with timing given in the 1Q14 call on May 1, where FDA approval for this product and Dexcom Share were both characterized as “in the final stages.” For context, this PMA supplement was submitted to the FDA in 3Q13, reflecting a review of ~8-10 months.

The announcement highlights the Professional G4 Platinum as the “first and only real-time professional CGM,” a clear reference to Medtronic’s iPro2, which is only offered in blinded mode (and thus, only retrospective data review). The G4 Platinum Professional version as a way to allow patients to experience the full benefits of real-time CGM (e.g., impact of meals, exercise), while simultaneously providing HCPs with an opportunity to retrospectively review glucose data. We certainly support the value of real-time data from a patient behavior perspective – there is no substitute for seeing one’s real-time glucose after a meal or during exercise. As well, and very importantly for real-world settings (like, life), real-time CGM makes the invisibility of diabetes much more tangible to patients.

The news is very positive for Dexcom and the CGM field for multiple reasons. First, we believe there is still clinician reluctance to prescribe CGM, given baggage associated with earlier generation, less accurate devices. The professional use indication will give clinicians a better opportunity to become acquainted with the latest generation of CGM, and could ultimately change perceptions of the technology. Second, the value of CGM data – especially the pattern recognition in Dexcom’s Studio software – should certainly help HCPs optimize more patients’ therapy and help providers feel more successful. Our hope is that CGM can get rid of the treat-to-failure model that is so prevalent in diabetes, likely related to the challenge of synthesizing and interpreting intermittent and unintelligible glucose logbook data. Last, the approval could potentially expand the CGM market in the long run, as this will give more patients a “taste” of what CGM is like – there is still tremendous room to expand this market, given that ~90% of type 1s and 99%+ of type 2s in the US are not on CGM.

  • Similar to the consumer version of the G4 Platinum, the Professional edition is approved for seven-day wear (two fingerstick calibrations per day), provides real-time glucose readings every five minutes, and offers customizable alarms and alerts.

 

Close Concerns Questions

Q: What fraction of HCPs currently prescribe Professional CGM?

Q: From an HCP perspective, how much more profitable (if at all) is professional CGM vs. prescribing personal CGM? 

Q: What is the biggest barrier preventing more clinicians from prescribing and embracing CGM?

--by Adam Brown and Kelly Close