100 million Americans suffer from diabetes. Managing diabetes usually involves invasive glucose measuring by pricking fingers with lancets. In addition to the $200-$700 cost each year, it is painful and inconvenient. It is important for diabetics to keep their blood glucose within healthy levels so that the disease does not progress and become even more debilitating. Night time can be especially dangerous: if blood glucose levels get too low, the person may slip into a coma requiring emergency medical intervention. For patients with this risk, the treatment regimen includes waking up at night to measure their blood glucose. Given the cost and danger, many companies are trying to develop non-invasive, continuous glucometers.
Of the FDA-approved offerings on the market today, glucometers branded as “non-invasive” still require a single invasive step every 3 weeks to 3 months to insert special patches beneath the skin. Each time a new patch is inserted, the glucometer has to be recalibrated, which requires finger pricking. Other devices that claim non-invasive measurement are not continuous and require special hardware. Until now, no offering allows truly non-invasive, continuous glucose measurement using commodity devices such as existing smartwatches or fitness trackers.
Outvasive uses cutting edge artificial intelligence (AI) technology to calculate blood glucose from commodity smartwatch sensors. In theory, Outvasive allows blood glucose to be measured both continuously and non-invasively. Smartwatches can monitor heartbeat and motion using a combination of sensors. This provides waveforms that describe the heartbeat and the acceleration and rotation of the watch with millisecond granularity. In other words, although imperceptible to humans, blood glucose levels change the way our arms move and our hearts beat. Smart AI may be able to detect these small differences and correlate them with blood glucose.
An Outvasive user will be able to download an app to their smartphone and use it to connect to an existing or new smartwatch, pending FDA approval. Once connected, the app monitors movement and heart rate and then correlates it to blood glucose levels provided by the user. This initial calibration period requires that the user continue their current treatment regimen for six weeks. Once calibrated, the system will continuously monitor their glucose non-invasively and provide warnings when the levels need attention. Outvasive can create a personalized AI model for each user to predict blood glucose within 15 mg/dL, the FDA required accuracy for glucometers. The Outvasive technology exists and is already available to scale to millions of users. However, FDA approval is pending an ongoing clinical trial. Approval is expected as soon as May 2019, and no later than December 2019.