Leading medical device companies have arrived in San Francisco for the American Diabetes Association (ADA) meeting, setting the stage for updates that will shape the continuous glucose monitor (CGM) and insulin pump markets.
Companies including Dexcom and Roche released news ahead of the event. Roche partnered with diabetes care platform GlucoMe, while Dexcom entered into a diabetes data exchange with Companion Medical.
More significant updates are scheduled for the weekend, when Abbott will share details of its FreeStyle Libre 2 CGM system and Tandem Diabetes Care will present data from a pivotal trial of its automated insulin delivery system.
In a preview of the annual meeting, analysts at Cowen picked the Abbott and Tandem presentations as some of the most significant of the event. After a year of growth at its diabetes unit, Abbott will use the ADA meeting to share information on the second generation of FreeStyle Libre.
Libre 2 is under review at the FDA but Abbott CEO Miles White declined to predict when it will come to market in the U.S. when talking to investors in April. The Cowen analysts think the approval could be imminent but, even if Abbott is unable to launch the device at ADA, it is likely to share additional details of the device across multiple planned presentations.
Abbott filed for approval of Libre 2 as an interoperable continuous glucose monitoring (iCGM) system, meaning it will need to meet the special controls established by FDA when it authorized the Dexcom G6 last year. Libre 2 needs to exceed multiple performance standards to qualify as an iCGM but it is unclear whether Abbott will share detailed data at ADA.
"We may not get a comprehensive update on performance improvements vs. the current Libre system (which should be required to meet iCGM special controls), as headline mean absolute relative difference/outlier data may not tell the full story," the Cowen analysts wrote.
The biggest news outside of the CGM space may come from Tandem, which is due to share data from a pivotal trial of its automated insulin delivery system, Control-IQ. Based on previous data, Cowen analysts expect patients using the system to achieve a time in range of over 75% and spend less than 2% of their time below the bottom end of the safe blood sugar range.
Tandem plans to submit a regulatory filing for Control-IQ to FDA next month and bring the device to market by the end of the year. The timeline for launch has slipped somewhat as it has taken Tandem longer than anticipated to access the study data.
Abbott and Tandem are both due to present information about their devices on Sunday. Some of their peers shared news ahead of the event.
Senseonics Holdings revealed FDA approved a dosing claim for Eversense that will enable patients who download an app to use the CGM system as a replacement for fingersticks.
T1D Exchange partnered with DreaMed Diabetes to provide its artificial intelligence-based decision support technology to six clinics. The technology, DreaMed Advisor Pro, is designed to help high-risk patients maintain balanced glucose levels.
Dexcom and Roche also shared their updates on the diabetes care platform GlucoMe and the diabetes data exchange with Companion Medical, respectively.
The Roche partnership with GlucoMe grew out of the startup hub it helped to set up last year and furthers its efforts to build a web of digital products around its diabetes devices.
The Dexcom agreement will enable users of Companion Medical’s smart insulin pen to display insulin data on Dexcom’s diabetes management software.