Dexcom marked a milestone Friday after it became the first company to get FDA pre-market approval for its mobile apps to support continuous glucose monitoring. It is part of a larger push to make it easier for care managers and loved ones to keep an eye on glucose levels to avoid complications, such as hyperglycemia, which can affect the 25.8 million people with diabetes in the U.S. and increase healthcare costs.
Unlike the Dexcom Share charging cradle that the FDA cleared in October last year, the apps for the Dexcom Share Direct Secondary Displays system allow a lot more flexibility to share data between two iOS network smartphones. The Dexcom receiver had to be docked so the person with the CGM device had to be stationary — at a desk, for example.
Here’s how the apps work, according to the FDA statement:
Two Dexcom Share System apps display data from its G4 Platinum CGM System, which gets blood glucose readings from a needle with a senor inserted just under the skin of the person being monitored. One app is installed on the patient’s mobile device and the other is installed on the mobile device of another person — a caretaker, or loved one. Users can designate who they want to receive this CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. The caretaker’s app can download the CGM data and display it in real-time.
“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,” said Alberto Gutierrez, the director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
The FDA classified the apps as class II devices exempt from pre-market submissions. It means that other companies that want to market devices like Dexcom Share system can skip the process of getting pre-market clearance from the FDA. But they’re still required to register and list their device with the agency.
The regulator emphasized that the move to approve the apps does not mean they can be a substitute for real-time continuous glucose monitoring or standard home blood glucose monitoring. The apps shouldn’t be used to determine diabetes medication dosages either — that has to be done with blood glucose meters.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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