FDA approves blood glucose monitor compatible with smart devices

The US Food and Drug Administration (FDA) has approved the first over-the-counter continuous glucose monitor that can be paired with devices like phones and watches.

Despite previous warnings from the FDA to stay away from smart devices that supposedly measure blood glucose levels, the agency has given the go-ahead to a continuous glucose monitor that you could pair to your iPhone.

This comes in the form of the Dexcom Stelo Glucose Biosensor System, which the FDA states is for those 18 years and older who do not use insulin.

The device is intended for those with diabetes who treat the condition with oral medications or individuals who want to learn more about their blood glucose levels.

The FDA clearly states that this device isn’t intended for those who have low blood sugar (problematic hypoglycemia).

The Stelo Glucose Biosensor System utilizes a wearable sensor that is accompanied by an application that can be installed onto your iPhone, Android, and other smart devices – which will continually measure, record, analyze, and display your glucose values, the press release reads.

The device tracks trends in your glucose measurements every 15 minutes. This information is then translated and can be found in a compatible application on your smartphone or other device.

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in the press release.

These monitors don’t require a prescription, meaning that individuals can take control of their blood sugar levels without the involvement of a healthcare professional.

The device seems to be accurate, with the FDA stating that “data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs.”

However, adverse effects were recorded, such as “local infection, skin irritation, and pain or discomfort.”

The FDA suggests the approval may be a new advancement in the battle for health equity. One of the Center for Devices and Radiological Health’s strategic priorities is transitioning care and wellness into “the home setting.”

This development comes at a time when much speculation surrounds Apple’s own blood glucose monitoring feature – which has been rumored to be in process for the last decade.

Bloomberg reported that Apple’s secret project has made somewhat of a breakthrough, with those affiliated with the project telling the news outlet that Apple could be the one to bring blood sugar monitoring to the market.

Apple has supposedly tested this technology on a vast amount of individuals over the past 10 years, and the design of its non-invasive blood sugar monitoring technology is reminiscent of this new tech the FDA has approved.

Now, with over 12 years of research, the technology developed by Apple is said to be in the “proof-of-concept phase,” individuals familiar with the project told Bloomberg.

Apple’s efforts to create a non-invasive glucose monitoring system date back to Steve Jobs’ struggles with his own health and his belief in technologically enabled health care.