WellDoc is gearing up to launch a doctor-prescribed mobile health app for type 2 diabetes next year, a milestone for how apps are perceived by the medical industry and will be used in the future.
In an interview with MedCity News, WellDoc chief strategy and commercial officer Chris Bergstrom said it would be launching its physician-prescribed Mobile Diabetes Intervention System in the first half of next year. The tool is activated by the prescriber and transmits messages to the patient based on his or her blood glucose values and trends instructing patients on what to do differently if they need to improve glucose levels.
Bergstrom said it will improve the quality of doctor-patient interactions because the physician can make adjustments to the patients’ medication based on side effects using the data collected from the mobile system and other factors. It is also designed to improve patient behavior, particularly the choices they make about diet and exercise, and help them manage their diseases better.
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The mobile health app got 510(k) clearance from the U.S. Food and Drug Administration two years ago. Bergstrom, citing medical device industry blog Device Talk, noted that the average cost for a class 2 medical device is $24 million over several years to implement the proper quality systems, conduct the human factors studies and get the required data in line with FDA requirements, an expense most app developers would not be positioned to undertake. He said the fact that it secured FDA approval means it will be taken more seriously by physicians and adds credibility to those who might otherwise be inclined to write it off as a health-and-wellness app.
Bergstrom noted that the government has been working with the private sector to support mobile health, pointing to a recent meeting with the Federal Communication Commission chairman and industry leaders, including WellDoc, asking what could be done to advance mobile health. Last month, the FCC voted to approve setting aside radio-frequency spectrum for wireless medical devices that can monitor a patient’s body, known as Medical Area Body Networks.
“I’m actually seeing for the first time the relevant government agencies doing something to support mobile health,” Bergstrom said.
WellDoc’s Mobile Diabetes Intervention system was the focus of a detailed one-year, randomized, controlled study of 163 patients at 26 primary care practices highlighted at the American Diabetes Association annual conference this week. The study assessed its impact on physicians’ medication management and found that physicians who used the device doubled the medication changes they made for patients compared with those who relied on their standard care.
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