Dive Brief:
- Dexcom's Partner Web Application Programming Interfaces (APIs) were cleared by the FDA, allowing approved third-party developers to connect to the continuous glucose monitoring data of Dexcom users.
- Developers can integrate CGM data with their applications, diabetes management systems or devices through the new APIs, according to Thursday's announcement. Diabetes management companies like Teladoc Health's Livongo for Diabetes and the smartwatch maker Garmin are in the testing and development phase.
- Dexcom contends that the APIs will help patients and healthcare providers as both treatment information and patient-specific CGM information will be in one place and allow for "in-the-moment diabetes management coaching and feedback."
Dive Insight:
The clearance comes as multiple diabetes tech products are planned to be released this year. However, slower FDA reviews have delayed certain product launches, such as the much-anticipated Insulet Omnipod 5 insulin pump.
The FDA's workload soared during the pandemic as coronavirus-related applications seeking review or emergency use authorization came in. The agency was also managing its typical, non-COVID-19-related submissions, which were delayed due to the prioritization of pandemic work.
While the agency has been stretched thin, work may return to normal soon, including the review of diabetes products or technologies.
Jeff Shuren, director of the FDA's Centers for Devices and Radiological Health, said at the recent BofA Securities Healthcare conference that diabetes product applications are moving forward and the agency plans to return to normalcy beginning next year, according to a report from Seeking Alpha.
"Goal is to be back to normal as we roll into 2022," Shuren said during the Washington, D.C. event. "But there are a lot of variables that could impact that. Still not done with COVID, still get submissions, and don't know if we'll get hit with another tsunami of submissions for full marketing authorization for a lot of the COVID products. Getting back on track, everything is moving for the diabetes submissions."
After diabetes technology companies like Dexcom, Insulet and Tandem Diabetes Care managed through the economic effects of the pandemic, even growing above pre-pandemic expectations in one instance, 2021 was set to be a big year for the market.
Adoption of wearables like CGMs and insulin pumps was growing over the last several years but accelerated due to the pandemic, which forced patients to stay out of healthcare settings and turn to more tech-based services.
Wall Street analysts were bullish on the space behind patient adoption as well as key product launches in 2021, primarily Dexcom's new G7 CGM and Insulet's Omnipod 5 pump, which J.P. Morgan analysts called one of the most anticipated launches of 2021.
Insulet was set to launch the Omnipod 5 product in the first half of the year but had to delay due to longer-than-expected FDA review times.
CEO Shacey Petrovic said during a May 6 first-quarter earnings call that the delay is due to FDA workload and the prioritization of COVID-19-related tasks rather than any issues with the product.
"I don't believe that there's any other drivers outside of the workload tied to the pandemic," Petrovic said. "The review process is taking a bit longer than we expected, but we're in the final stages and feel good about where we are."
Petrovic said during the May call that clearance should be expected by the end of June or shortly after.
Dexcom CEO Kevin Sayer said in a recent interview that the G7 launch is still planned for the end of 2021. While he did not provide any details regarding the G7 timeline, Sayer said the company will give an update during its July 29 second-quarter earnings call.
Abbott Laboratories, which is a rival of Dexcom in the CGM space, is rolling out a new device of its own, the FreeStyle Libre 3. The CGM system received CE mark in September 2020 and is available in Europe, but Abbott has not provided any timeline for a U.S. launch.
