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FDA Approves Marketing of Diabetes Monitoring Apps


The medical apps will allow patients to share blood glucose data with caregivers.

By University Alliance on March 26, 2015
Diabetes Monitoring Apps Given Green Light

Federal regulators have given the green light for the marketing of medical apps that will allow people with diabetes to share data about their blood sugar levels with caregivers via an iPhone or other mobile device.

The Dexcom Share Direct Secondary Displays apps are the first to be given marketing approval for real-time, remote monitoring of a patient’s glucose data, the U.S. Food and Drug Administration (FDA) announced.

“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes,” Alberto Gutierrez, an official with the FDA’s Center for Devices and Radiological Health, said in a January 2015 statement.

Nearly 26 million people in the United States have diabetes, a chronic metabolic condition that prevents the body from converting glucose into energy, the FDA reports. More than 200,000 diabetes patients are younger than 20. Elevated blood glucose levels, a condition known as hyperglycemia, can put patients at greater risk of cardiovascular disease, as well as nerve, kidney and eye damage.

The American Diabetes Association, which is celebrating its 75th anniversary in 2015, notes that monitoring blood glucose “is the main tool” patients have to control their diabetes. As of 2010, nearly 64% of diabetes patients age 18 or older self-monitored their blood glucose daily, up from about 36% in 1994, according to the Centers for Disease Control and Prevention.

Continuous glucose monitors (CGM) include a small sensor placed just beneath a patient’s skin that collects data about glucose levels. With the Dexcom Share mobile medical apps, patients can share CGM data with as many as five designated “followers” using a smartphone or other digital device.

According to Dexcom, the apps initially will be available for free at the Apple App Store for use on iPhone or iPod devices. The company also plans to make the apps available for Android devices.

The FDA considers the Dexcom Share system as low to moderate risk, which means other companies that want to manufacture similar devices will be able to skip some regulatory hurdles, potentially cutting development costs and speeding new devices to the market.

Gutierrez said the FDA’s decision “paves the way for similar technologies to be marketed in the United States.”

The CGM apps aren’t the only way digital technology is helping to improve the field of healthcare management. A 2014 study by Manhattan Research found that more than one-third of physicians had recommended the use of health apps by their patients during the previous 12 months.

The Taking the Pulse survey also found that 40% of physicians believe that communicating with patients via digital technology will boost patient outcomes, with the same percentage reporting increased use of digital tools for patient communications over the previous year.

Category: 2015 Headlines