When the Apple Watch launches in April, one of the first apps that will be available for the device benefits diabetics because it reports glucose levels on a graph. This app — which was designed by medical technology company Dexcom — has already been approved by the U.S. Food and Drug Administration (FDA).
Dexcom’s Apple Watch app relies on a tiny monitor that is inserted under the skin to measure blood glucose levels every five minutes. The monitor sends the data to a remote handheld device, which sends information to an iPhone app. And then the iPhone app communicates with the Apple Watch to display the blood glucose information. Being able to read the blood glucose data on an Apple Watch will be more convenient than having to review the remote handheld device or the iPhone.
About 5-10% of the 29 million Americans that have diabetes are Type 1, according to The WSJ. Type 1 diabetes is an autoimmune condition where the body is unable to convert glucose into energy. The administration of insulin is necessary for people with Type 1 diabetes. If the blood sugar becomes too high or low, it can cause risks like strokes and kidney disease.
Glucose monitors are considered Class III medical devices by the FDA, which requires the highest amount of regulatory scrutiny. However, the agency loosened restrictions on software that displays the data from glucose monitors on mobile devices and smartwatches. Now the software simply has to be registered with the FDA and will not require prior marketing approval.
A major reason why the FDA eased on its restrictions for blood glucose software is because a consortium of engineers launched an open source project called NightScout. NightScout takes data from Dexcom’s glucose monitors and uploads it to the Internet. This helps people keep track of their blood sugar levels from smartphones, tablets and smartwatches. Even though NightScout’s engineers bypassed the FDA initially, the agency ended up creating a new set of rules to cause less friction for software developers. Dexcom will be required to ensure its app complies with FDA regulation, but it will not need approval before it is marketed. Dexcom built two blood glucose apps: one for letting users view the information and one to share data with another person like a doctor or caregiver.
The Apple Watch will have a plethora of health and fitness functionalities. It has several sensors for tracking the amount of steps taken, the number of calories burned, the number of times that the user stands up and the pulse rates. The Apple Watch will ship with an app called Activity, which encourages you to be more active throughout the day. It will also have an app called Workout that offers goal-setting and pacing features during session-based workouts like running and cycling. The Apple Watch heavily relies on the iPhone to function and is not really considered a standalone device.
On Tuesday afternoon, Apple CEO Tim Cook talked about the Apple Watch during an investor presentation. “A lot of doctors believe sitting is the new cancer,” said Cook during the call. He said that many Apple employees are actively testing the Apple Watch and ten minutes before every hour, they stand up because the devices taps on their arms as an alert to stay active.