In the second installment of our post-AACE 2018 promotional material coverage (see first installment on diabetes drugs), FENIX has conducted an analysis of diabetes device promotional materials covering Dexcom G6, Abbott Freestyle Libre, Medtronic 670G, Insulet Omnipod, and Tandem t:slim X2.
Recently, we’ve noticed that Dexcom has started a TV campaign for its new G6 CGM system. Interestingly, the DTC campaign was initiated prior to the June 4th product launch. Although there were a few TV commercials for G5 Mobile, we expect the TV reach to be much broader for the G6 launch. In summary, the ad theme centers on knowledge being a superpower in T1DM that can lead to better glycemic management without being inconvenient. Below, FENIX summarizes the key messages and imagery in the new G6 commercials.
Dexcom hosted its Q1 ’18 earnings call and provided updates on its recently approved G6 CGM as well as pipeline initiatives. Of note, Dexcom has initiated a limited launch of the G6 CGM and it plans a larger rollout prior to ADA in June 2018. Below are highlights from the call.
In conjunction with the Dexcom G6 approval FDA created a new device category under class II defined as “integrated continuous glucose monitoring,” or iCGM. Below, FENIX has provided an analysis and summary of this class’ FDA controls in the context of future CGM development by manufacturers such as Dexcom, Abbott, Medtronic, and Senseonics.
FDA and Dexcom announced approval of the Dexcom G6 CGM after a notably short 6-month review time, suggesting increased FDA comfort with CGM technology. The new device is the first real-time CGM approved for standalone and interoperable use. Launch is anticipated in Q2 ‘18, and Dexcom is projected to have a significant presence at ADA.
Briefing documents for the Senseonics implantable Eversense CGM were posted today by FDA in advance of the March 29, 2018 adcom. Also of note, FDA today announced approval of the Dexcom G6 and a new lower risk classification of interoperable CGM (“iCGM”). Below, FENIX has analyzed the key issues anticipated to be discussed during the adcom.
During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.
Dexcom hosted its Q4 ’17 earnings call and provided updates to its CGM business. Of note, Dexcom disclosed that while they are working with FDA on not requiring calibrations for G6, it will still allow calibrations if the user chooses. Below are highlights from the call.
In light of the recent journal publication of PRECISE II, the US pivotal IDE trial for Senseonics’s Eversense implantable CGM, FENIX has conducted a comparative analysis vs. Abbott Freestyle Libre and Dexcom G5 Mobile, with a particular focus on sensor accuracy across glucose ranges.
It was reported on Twitter that at ATTD 2018, Dexcom displayed a slide (pictured below) showing a representation of a smart insulin pen. Additionally, Dexcom presented information on the “fully enhanced Dexcom G6 CGM system” including “Urgent Low Soon Alerts.”