Advances in diabetes management is always big news due to the prevalence of the disease. The CDC’s latest (2017) report states that 30.2 million U.S. adults had diabetes, including 7.2 million, who were unaware of having the disease or not getting treatment. The CDC’s numbers include both Type 1 and Type 2 diabetes, but estimates 90 to 95% of the patients have Type 2 diabetes in which the body is still capable of producing insulin. We’ve covered a wide range of wearables such as continuous glucose monitors (CGMs) and closed-loop systems also called an artificial pancreas with both a CGM and an insulin pump.

The FDA has cleared Hygieia’s mobile app for personalized insulin management for people with Type 2 diabetes. This news marks one more step in the advent of smartphone apps as medical devices. The app works in conjunction with Hygieia’s d-Nav Insulin Guidance Service to adjust insulin doses, delivering the recommendations directly to patients. Available in both iOS and Android versions, the app connects to any glucose monitor that sends blood sugar level data to the cloud. With the Hygieia app, patients enter glucose event data and receive an insulin dose recommendation. According to Hygieia, d-Nav has shown the service can help patients maintain A1c levels for at least six years.

Prior to FDA clearance for use with the app throughout the U.S., the d-Nav Service was used in Ireland for six years and in a specific Blue Cross Blue Shield program in Michigan. We’re still processing the concept of apps as medical devices, but the potential advantages are massively exciting.