This week Glooko officially launched its MeterSync Cable and its companion Logbook app in Europe, which means iPhone users in European countries can now connect a handful of some of the most popular glucose meters to their phones to automatically upload data to a logbook app on the devices.
"We have also taken a step forward in Europe to provide some analytics for the data, which we can't do in the US," Glooko Chairman and Co-Founder Yogen Dalal told MobiHealthNews in an interview. "Basically we are providing an Excel spreadsheet that will chart all of the user's .csv data in a form that both our users and providers will like." Dalal said that Glooko's Chief Medical Officer Dr. Michael Greenfield, an endocrinologist, helped design the reports.
The app that Glooko offers in the US is regulated by the FDA as a Class 1 device under the MDDS ruling, which means the app can only present uninterpreted data from a medical device. For the version of the Glooko app that is available to US users, the data is only presented in logbook format.
"Europe has a slightly more relaxed view on what you can do with the data," Dalal said. 'What we have developed is a complementary macro that will take the data and chart it out," he said. "We will be filing with the FDA a 510(k) for this same Excel macro -- imagine that a 510(k)! -- but in Europe that is not required. So we are going to make it available to our European customers before we can make it available to our US and Canadian customers."
Dalal hopes that the FDA begins to relax its regulations of medical apps once it releases its final guidance for mobile apps, which is widely expected to publish later this year.
Glooko actually has to screen and filter for IP addresses to make sure that only its users from certain European countries download the Excel spreadsheet data from its website.
Dalal said that Glooko has nearly doubled its user base since January. It now has about 2,000 active users who have not only purchased the company's cable, but have also downloaded the app. That includes users for all 11 of the glucose meters that Glooko's meter works with. Dalal also pointed out that its launch with Roche was only about three weeks ago and its just beginning to ramp up its AccuChek user base.
Glooko is also looking at alternative ways to connect glucose meters to the iPhone and other smartphones. Dalal said that future versions of the Meter Sync cable might plug into meters but instead of plugging into the iPhone's 30-pin connector, they might use Bluetooth Smart instead. Dalal also said the company is looking at the method that mobile payments company Square uses to connect to smartphones -- through the phone's headphone jack.
"There is still a certain amount of interconnect anxiety going around in the industry with the much rumored changes to the iPhone's connector," Dalal said. "Apple has been encouraging accessory vendors to come in through a wireless connection unless you have to come in through their new 19-pin connector."