The U.S. Food and Drug Administration (FDA) has recently approved the Dexcom mobile medical apps for continuously monitoring glucose level in patients.
On Friday, Jan. 23, the FDA announced that it has given the green light for the marketing of the first set of mobile medical apps that will enable diabetes patients to securely and accurately share information regarding their glucose levels with their doctors in real time by giving their caregivers remote access to the data.
The patients can automatically share the vital information from a continuous glucose monitor (CGM) with the help of portable Apple devices such as the iPhone.
A CGM is a small device, which includes a very small sensor that is wire-like and inserted under the skin. It provides a very steady stream of data about the glucose levels in blood.
The Dexcom Share Direct Secondary Displays system has data-sharing capabilities that help caregivers monitor the glucose level of patients remotely. Other CGMs are also available on the market, but Dexcom Share is the first one to get an approval for marketing from the FDA.
The FDA announced that the approval will make it easier for care managers, as well as family members, to keep a constant vigil on levels of glucose in patients so that any potential complications can be avoided.
Medical experts believe that the innovative technology seen in the Dexcom Share System has been long awaited by diabetics. Caregivers of children who suffer from diabetes can take necessary and prompt action if their glucose level fluctuates. The latest FDA approval will enable similar and other advanced technologies to be marketed in the U.S. in the near future.
One app is installed on a patient's device while the other app is installed on another person's device with whom the patient wants to share data. The Dexcom app can provide medical data received in real time by the CGM and transmit to the designated doctor or caregiver.
The FDA has classified the new apps as class II devices, which are exempt from any premarket submissions. Other companies that aim to market gadgets similar to Dexcom can opt to skip asking for a premarketing clearance from the agency. However, the companies are still required to register with the FDA and provide a list of their devices as well.
"Exempting devices from premarket review is part of the FDA's effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
