Dive Brief:
- The American Diabetes Association's 80th Scientific Sessions begins Friday with two much-anticipated data drops from closed loop system developers Medtronic and Insulet.
- A clinical trials session centered on the latest automated insulin delivery systems designed for people with Type 1 diabetes will feature pivotal data on Medtronic's MiniMed 780G, its advanced hybrid closed loop system the company said Thursday now has a CE mark. The session will also highlight a small pre-pivotal study of Insulet's tubeless smartphone-controlled automated insulin delivery system, dubbed Horizon, which is slated to integrate with both Dexcom and Abbott CGMs and expected to come to market in the first half of 2021.
- Cowen analysts wrote the Medtronic ADA data will "serve as, at the least, an initial barometer for system competitiveness," while Insulet's will "whet appetites for what will likely prove to be the next important U.S. pump launch."
Dive Insight:
In the world of diabetes tech, last year's ADA meeting was an important debut for NIH clinical trial data on Tandem's Control-IQ closed loop algorithm, which went on to obtain De Novo authorization from FDA as the first interoperable automated glycemic controller at the end of 2019. This year's event will feature real-world outcomes with that system since it launched in January.
ADA 2020 will also spotlight forthcoming closed loop systems from Insulet and Medtronic.
Insulet just restarted its pivotal study of Horizon, meant to support U.S. approval and a launch in the first half of 2021. The pre-pivotal data covers 36 patients who used the system for 14 days. Horizon could be an important growth catalyst not just for Insulet, but for CGM makers Abbott and Dexcom, which may see an uptick in adoption of their integrated systems if Horizon uptake is strong.
At ADA Friday, researchers will present a New Zealand trial that served as the CE mark dataset for Medtronic's 780G, plus a U.S. pivotal safety study and a trial comparing the advanced hybrid closed loop system to its 670G system. In 2018 the latter became the first FDA-approved hybrid closed loop system to monitor glucose and automatically adjust insulin delivery.
Medtronic plans a U.S. launch of 780G later in its fiscal year. The company's diabetes division will host its own investor briefing late Friday.
As for the ongoing impact of COVID-19 on new business for these companies, findings from a survey of endocrinologists from analysts at Stifel this week suggested a rebound for CGM and in patient visits, but March and April declines in pump prescriptions "seem largely unchanged." However, the analysts noted that the positive trend for patient visits, either via telemedicine or in person, bodes well for pump businesses.