First Mobile App for Insulin Management Released

The FDA has just given 501(k) clearance to the first insulin-management and insulin-titration mobile phone app for individuals with type 2 diabetes.

Developed by digital insulin management company, Hygieia, the app is able to measure individualized doses for all types of insulin regimens and connect to any glucose meter that shares data with the cloud. It is available for both iOS and Android mobile phones.

The app is a portion of Hygieia’s d-Nav Insulin Guidance Service, which combines smart cloud-based technology and a small team of health care professionals to support primary care physicians and ultimately help improve the health of those living with type 2 diabetes through accurate glycemic control. The service has the potential to substantially reduce cost for at least 6 years, while also demonstrating a long-term ability to aid those with type 2 diabetes in sustaining hemoglobin A1c (HbA1c) reductions.

By using insulin-titration algorithms combined with a patient’s individual blood glucose readings, the service provides personalized insulin adjustments. The mobile phone app brings that information to the forefront, as patients can enter glucose event data into the phone app to receive a recommended insulin dose.

Currently available in Northern Ireland, the d-Nav Service is now offered in the United States by Blue Cross Blue Shield of Michigan (BCBSM). It is available at no cost and with no co-pays to BCBSM members with type 2 diabetes in its fully insured commercial plans, starting with at-risk populations in Southeast Michigan.

Reference

• Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service [news release]. Livonia, Michigan; February 20, 2019. PRnewswire.com. https://www.prnewswire.com/news-releases/hygieia-receives-510k-clearance-from-fda-for-phone-app-that-enhances-companys-d-nav-insulin-guidance-service-300797091.html. Accessed Feb. 20, 2019.