Devices & Diagnostics, Health IT

Dexcom plans to add decision support apps for glucose monitoring platform

Rarely is the FDA accused of delivering a rapid assessment of a company’s technology. But […]

Rarely is the FDA accused of delivering a rapid assessment of a company’s technology. But that’s what happened last week when Dexcom’s mobile apps to free up users of its continuous glucose monitoring system got pre-market approval Friday afternoon. It was a move the company hadn’t expected for a couple more months and it scrambled to set up a conference call this week to detail the approval and its implications for product development.

On the call, Dexcom’s CEO offered up a glimpse of its longer term plans for other digital health tools it expects to develop. For starters, there could be apps to display continuous glucose monitoring levels on Apple’s iWatch, for example. Other apps for smartphones and tablets on the Android network are a strong possibility. The apps were approved as part of the FDA’s special  regulatory pathway  for low- to moderate-risk medical devices. It means that this and other Dexcom products that do passive secondary display of data will be considered class 2 devices exempt from FDA approval.

The apps are part of Dexcom’s G4 Platinum Continuous Glucose Monitoring System. They use a secure wireless connection through Bluetooth Low Energy between a patient’s receiver and an app on the patient’s smartphone to transmit glucose levels to apps on five designated mobile “followers.” It cuts out the need for a dedicated docking cradle and allows patients a lot more freedom. It is designed for Type 1 and Type 2 diabetes patients who need insulin to regulate their glucose levels.

The apps were approved through a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device, according to a Dexcom statement.

CEO Kevin Sayer said he expected the most recent apps to be available through the Apple iStore in March, but declined to specify a date. He also used the call to clarify the FDA’s shift on the need for pre-market approval for devices that passively display data and, decision support tools for doctors, which will make use of data from the continuous monitoring platform.

On the conference call Sayer said: “If you start to think about the decision support tools we will create on smartphones, these are class 3 devices.”

In an interview with MedCity News, Steve Pacelli of Dexcom he said the burden of compliance is
arguably less than when these devices were considered class 3, but it’s not a free for all. “What the FDA has really done is impose a rule on secondary display [of data].”

Even though Dexcom and third party developers it works with will no longer be required to file for pre-market approval for passive display of secondary data, they will still need to do the software validation testing that they would conduct to seek pre-market approval anyway and keep those records on file in case of an audit.

Although using the platform to generate analytics data is a compelling prospect for the company to alert users to when they should eat something to prevent their blood glucose levels from getting dangerously low, Pacelli said doctors prefer retrospective data rather than realtime data for patients’ glucose levels because of liability concerns. He also emphasized that it is several years away from developing these kinds of tools for physicians.

“Our experience to date is that physicians…don’t want the liability of having realtime information with every single patient,” he said.

As far as competitors are concerned, Pacelli said the company views Medtronic as its closest rival developing similar technologies. Even so, “Our paths have diverged because their focus is now a quest to develop an artificial pancreas to fully automate [insulin delivery].”

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