According to a 2014 study by the
Center for Disease Control, 29.1 million Americans -- 9.3 percent of the national population -- have diabetes. Particularly for those with Type 1 diabetes, keeping a close eye on blood glucose levels is key for avoiding life-threatening highs and lows. DexCom, makers of blood glucose monitors that take a reading every five minutes, is said to be developing a new Apple Watch app to interface with its monitors, expected to be ready when it becomes available in April.
In the past, the Food and Drug Administration (FDA) was holding certain health apps to the same standards as
Class III medical devices. Apps that pull information from hardware devices, such as a glucose meter, were specifically called out as an example of something that causes a "greater than minimal risk" if it failed to function properly. DexCom's G4 CGM ("Constant Glucose Monitor") is such a Class III device. A sensor/transmitter, the width of a human hair, is injected into a type 1 diabetic's skin, and the data is received by the DexCom receiver paired with the sensor/transmitter. The G4 CGM is a Class III medical device because a bad reading or malfunction could result in a life-threatening situation.
Patients, as well as their doctors, parents, and caregivers want to be able to pull that data to their smart devices, or to authorized medical personnel. For example, a parent of a type 1 diabetic child would be able to get an alert of a spike or drop in their child's blood glucose, and see it corrected or know to start trying to contact the child or those around them.
However, since apps that connected to Class III medical devices were held to the same standards as those devices, such innovations were slow in coming. Enter
NightScout, a DIY solution created by software engineers in their spare time that pulls the data without interfering with the operation of the receiver, and uploads the blood glucose information to the Internet where it can be shared with doctors and caregivers.
Just last month, DexCom received approval from the FDA for its own iOS and Android
apps allowing users to share and follow blood glucose data. In a press release about their new apps "Share" and "Follow,"
DexCom explained the FDA's new view on apps such as these.
"The FDA has specifically classified the apps which communicate with the Share receiver as a secondary display device, and has noted that similar devices which provide only secondary display for passive monitoring, but which do not replace the primary real-time display device, will be subject to the same classification, subject to compliance with certain special controls established by the Agency with respect to this secondary display," the company said. "This means that devices which comply with appropriate FDA regulations, including the special controls, will not be required to submit a premarket notification to the FDA before marketing a secondary display device for continuous glucose monitoring."
According to the
Wall Street Journal, DexCom's Apple Watch app will be one of these "secondary display devices for passive monitoring," showing the user a simple graph of the blood glucose data. Considering the FDA's new stance on health apps such as these, it's no surprise DecCom is confident the app will be set to go when the Apple Watch is available for sale in April. However, there's no news on when they will submit the app to Apple for approval, and Apple has declined to comment.
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