The FDA on Wednesday granted 501(k) clearance for the first mobile app designed to titrate individualized insulin doses for people with type 2 diabetes, according to a press release from Hygieia.
The app, part of the company’s d-Nav Insulin Guidance Service, is cleared for use as an aid in optimizing insulin management among people with type 2 diabetes, according to the company. In addition to delivering insulin recommendations directly to the patient, it is also the first insulin-titration app that can connect to any blood glucose meter that shares data with the cloud. It is available for both iOS and Android mobile phones.
"This FDA clearance is an important milestone in our mission to improve and simplify insulin management by making the d-Nav Service as convenient, simple and accessible as possible for patients and physicians who could benefit from it," Eran Bashan, CEO of Hygieia, said in the release. "Insulin therapy is critical to the health of more than 8 million people in the United States, but it is often ineffective, largely because it requires continual, personalized adjustment that is not practical for physicians and not manageable for patients. The d-Nav Service, including the user-friendly phone app, makes insulin therapy more effective, less time intensive and less costly for everyone involved."
The d-Nav Insulin Guidance Service combines cloud-based technology and a small team of health care professionals to support primary care physicians and help people with diabetes, according to the company. Using proprietary insulin-titration algorithms and patients' individual blood glucose readings, the d-Nav Service provides personalized insulin adjustments to enhance and simplify dosing. Patients can use the mobile app to enter glucose event data and receive a recommended insulin dose.
The d-Nav Service has been in use for more than 6 years in Northern Ireland and is currently being offered in the United States by Blue Cross Blue Shield of Michigan, according to the company. It is available at no cost to Blue Cross Blue Shield members with type 2 diabetes in its fully insured commercial plans, starting with at-risk populations in Southeast Michigan. Hygieia said the company is exploring opportunities to make the d-Nav Service available to other populations and markets in the future. – by Regina Schaffer
Disclosures: Bashan reports he is CEO of Hygieia.