The first set of mobile apps for diabetics looking to share data collected by continuous glucose monitors can head to market thanks to a green light from the U.S. Food and Drug Administration.
The data sharing lets caregivers monitor blood sugar levels on a remote basis using Apple devices and the Dexcom Share Direct Secondary Display system, according to an announcement from the federal agency.
"This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in an announcement. "Today's marketing permission paves the way for similar technologies to be marketed in the United States."
The news comes as oversight of mHealth apps and devices continues to stir debate given the overlap of jurisdiction by the FDA and the Federal Trade Commission (FTC), as well as the issues of data collection, storage, sharing and user privacy. Lawmakers are calling on agencies to address issues of privacy and data access, while others are lobbying to ensure that regulatory decision making doesn't slow down technology innovation. As FierceMobileHealthcare reported in late 2014, some believe federal agencies need to catch up with technology advancements. However, the FTC has stated it has no desire to develop more rules, at least within the near future.
According to the FDA announcement, the Dexcom Share technology provides data via two apps, one housed on a patient's Apple mobile device and another downloaded on a caregiver or health provider's device or system. The software feeds real-time continuous glucose monitor data from Dexcom Platinum CGM system to anyone a patient wants to share the data with.
"When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels," according to the FDA.
The agency assessed the system's data capability using the de novo classification process, described as a "regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device." Dexcom will not need premarket clearance but will have to register the device and follow all required regulations.
For more information:
- read the FDA's announcement
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