Need to check your blood-sugar level? Soon, there will be an app for that. Doctors and other caregivers will soon be able to track blood-sugar levels in diabetic patients by simply using an app on their smartphone.
The Food and Drug Administration has recently approved the first set of glucose monitoring medical applications, designed to automatically and securely track and share data in real time with doctors. The system, produced by California-based Dexcom Inc., includes both a smartphone app and a small, wire-like sensor inserted just under the skin that continuously transmits data to a monitor that is externally worn.
Using the app, a patient can then choose "followers" with whom to share their blood-glucose level information. The app receives the data in real-time and transmits it to an Internet-based storage location. The patients' followers can then download the information, or view the information using the app.
While similar systems using smartphones do exist, this approval by the FDA is the first of its kind since the FDA began regulating certain medical apps in the fall of 2013.
"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," director of the FDA's Office of In Vitro Diagnostics and Radiological Health, Alberto Gutierrez says.
The approval for Dexcom's system could open the doors for other companies to produce similar technologies, as well. The app was approved as a "low to moderate risk" medical device, meaning that other manufacturers won't have to seek FDA approval prior to marketing their own products, although they will have to register their products with the FDA.
The FDA has made it clear that it has no plans to crack down and regulate most of the health-related apps on the market for tablets and smartphones. Currently, there are thousands that are already available. It has been quite clear, however, that it would begin regulating a specific subset of mobile apps "that present a greater risk to patients if they do not work as intended."
Indeed, this latest smartphone app is just one of the latest examples of how mobile technologies are beginning to change the healthcare landscape as we know it, and this sharing of data could provide some risk to patients if they fail to function as intended or become the targets of hackers.
