Glooko secures FDA 510(k) clearance and execs from Intuit Health, Doximity

By Brian Dolan
08:10 am

GlookoSilicon Valley-based startup Glooko announced two new executive hires this week and that its MeterSync Cable and Logbook iOS app received Class II FDA Clearance 510(k). The company appointed Rick Atlinger, who previously served as a vice president at Intuit Health, as its first CEO. Glooko co-founder Yogen Dalal filled in as interim CEO since the startup's founding. Altinger launched Intuit's healthcare provider services and spearheaded the company's acquisition of patient portal company, Medfusion in 2010. Dean Lucas, who previously worked at Doximity and Epocrates, also joined Glooko this week as the company's VP of product development.

Glooko, which enables 15 of the most popular off-the-shelf glucose meters to connect to the iPhone via the company's Metersync Cable, had previously registered its device and app as a Class I device with the FDA. Altinger told MobiHealthNews that the FDA clearance cost the startup about $1 million.

"I'll be honest with you, we were on the ragged edge as a Class I device," Altinger told MobiHealthNews. "I don't think there will be any other comparable device like ours that registers as a Class I now that the FDA has come out with clearer guidelines. [As a Class I] you really can't touch any data from a Class II medical device, and all glucose meters are Class II devices. I can't speak for the FDA but from our perspective, if you are going to take the data out of that device and manipulate it in any way, shape, or fashion, you've got to get Class II clearance."

Now that Glooko is FDA cleared it can present blood glucose data in various charts and graphs in its app and enable users to manually track their food intake, activity levels and more. Altinger said that those annotations are what makes the information in the Glooko Logbook app valuable to clinicians and diabetes educators. The blood glucose data alone is not all that helpful, he said. The charting capabilities for Glooko's app are still fairly simplistic: chart by time of day, chart by date, and chart by analysis of time of day.

The next priority for the company is to launch a cable that works with Android devices. Altinger said that Glooko already has a prototype of a cable that works with eight different Android devices, but the company needs to work with the FDA to ensure the Android version is up to the same quality standards as its already cleared iOS product.

While Glooko is exploring the development of a cable that connects to meters on one end and connects to smartphones via Bluetooth instead of a hard connection, Altinger said that the customer feedback they have received to data shows that plugging in the cable has not proved to be difficult for many. Once Bluetooth Smart becomes a standard feature of most smartphones, Altinger said they may revisit their Bluetooth cable prototype.

Given his provider focus at Intuit, the addition of Altinger will kick off an additional focus at Glooko of serving the needs of not only diabetes patients -- but their healthcare providers, too. Altinger mentioned that at least one diabetes clinic is already using Glooko's cable and software -- instead of the spiderweb of proprietary cables and software from meter companies -- to collect data from patients' meters. The clinicians can then print out graphs and other visuals and share it with patients.

"Providers are reluctant to engage with [digital health companies] that are not FDA cleared," Altinger said. "Our clearance is a big accomplishment that validates us not just as a consumer health player but as someone who can be trusted in the healthcare continuum."

Altinger expects Glooko to help "at-risk" providers, or those working in ACOs or under capitation models, to help them engage their diabetes patients in better managing their conditions. He also sees health plans as a key group that Glooko hopes to work with in the future. Finally, Altinger says that the meter companies themselves could use some help from Glooko:

"There is an increasing amount of competition amongst the meter companies,"  Altinger said. "We can help them differentiate themselves in ways that are appreciated by providers. Providers have told me -- while I've been at Glooko and in my last position -- that they don't want a point solution like the iBGStar solution or the Telcare solution because it only works with a small portion of their patient population. It's also very hard to get patients to switch meters and, for some of these point solutions the strip costs are quite high."


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