Smartwatch App Helps Track Glucose

http://www.wsj.com/articles/smartwatch-app-helps-track-glucose-1423443067?mod=e2fb

Medical-device maker DexCom Inc. is designing an app that will display readings from its diabetes glucose monitor on Apple Inc. ’s smartwatch, giving the watch an early foothold in the health-care market at a time when regulatory treatment of such systems has eased.

DexCom’s glucose monitor tracks a person’s blood-sugar levels continuously. The company has shown a picture of the app, which converts that data into a simple graph that is just a glance at the wrist away. It says the app is expected to be ready when the Apple Watch is launched in April.

Apple declined to comment. The company hasn’t accepted any apps for the coming watch yet but has provided guidelines and code to developers for creating apps for it. The latest iPhone operating system increased its health and fitness offerings.

The Food and Drug Administration had been closely scrutinizing such applications. But the agency loosened its oversight in late January, months after a group of software engineers, many of whose children have Type 1 diabetes, developed a system for monitoring diabetes patients’ blood sugar over the Internet. The system was distributed without first getting regulatory approval.

The group’s effort challenged the slow pace of innovation and regulatory approval in the field. It also highlighted the growing role that Silicon Valley companies and software developers hope to have in monitoring and maintaining people’s health.

Some 29 million Americans have diabetes. Between 5% and 10% of them have Type 1, an autoimmune condition in which the body is unable to convert glucose into energy. People with Type 1 diabetes rely on taking insulin and regular monitoring to make sure their blood sugar doesn’t go dangerously high or low, both of which can cause life-threatening conditions.

The DexCom monitor uses a hair’s-width sensor under the skin to measure blood glucose levels every five minutes.

Previously, the FDA considered glucose monitors and any associated software to be Class III medical devices, meaning they received the highest level of regulatory scrutiny. But the spread of NightScout, the system developed by the group of software engineers, and DexCom’s submission of a separate iPhone app for review prompted the FDA to change course last month.

DexCom’s monitors will remain Class III devices, but software that helps display the data they produce on mobile devices or smartwatches now only needs to be registered with the FDA and doesn’t require prior marketing approval.

The FDA has been reassessing its health-apps policies. “We felt that the risks that the app imposed weren’t as high,” said Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.

The issue came to a head last year when the group of software engineers, working on their own time, developed NightScout, which met a critical need. The software takes data from a glucose monitor made by DexCom, mainly for Type 1 diabetes patients, and uploads it to the Internet. That allows parents—and caregivers—to keep track of their children’ blood sugar from afar via their cellphones, tablets and Pebble watches.

NightScout spread quickly to thousands of users who found each other on Facebook andTwitter . By bypassing the FDA, the system’s creators skipped a process that had snarled or deterred formal development of similar products by medical-device companies.

Last fall, the group did take the invention to the FDA. The agency’s new rules give NightScout a pathway to regulatory compliance, according to FDA officials.

DexCom still needs to make sure its Apple Watch app complies with FDA rules. But thanks to the rule change, it doesn’t need to get approval before bringing the app to market.

Steve Pacelli, DexCom’s head of strategy, said the regulatory nod for the iPhone app came in January, much faster than the company expected.