WellDoc DiabetesManager gets approved

WellDoc, a specialist in mobile health applications, has received FDA clearance for its WellDoc DiabetesManager System aimed at patients with type 2 diabetes.

The United States Food and Drug Administration (FDA) 510(k) clearance to will enable yhe firm to market the WellDoc DiabetesManager System to healthcare providers and their adult diabetes patients.

WellDoc’s system offers automated clinical coaching and behavioural algorithms driven by real-time patient data. Patients and their healthcare professionals can configure specific parameters and extend their care beyond traditional office visits by using a mobile phone application and the Internet.

The DiabetesManager system has been under development for the past five years. WellDoc says it supports medication adherence and securely provides for the capture, storage, and real-time transmission of blood glucose data and other diabetes self-management information.

This patient information is then analyzed by the company’s proprietary Automated Expert Analytics System which identifies trends and delivers relevant educational and behavioural patient coaching and decision support, enabling effective lifestyle and medication adjustments.

“With type 2 diabetes reaching epidemic rates and limited time for care, healthcare providers need new tools to more efficiently engage their patients between and during office visits,” said Richard Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet and president of the American Diabetes Association.

Dr Bergenstal added: “WellDoc’s System addresses this need by delivering real-time, evidence-based education and behavioral coaching. This enhanced engagement and communication is intended to enable providers to support positive patient behavior and improved health.”

“With the WellDoc DiabetesManager System, we provide the medical community with decision-support tools that can help doctors and patients work together to manage diabetes more effectively,” said Suzanne Sysko Clough, MD, founder and chief medical officer of WellDoc.

“WellDoc products are rigorously developed by our clinical staff using evidence-based guidelines and then tested for their impact on health outcomes. Patients and providers expect a certain quality level from all medical devices, including mHealth solutions, so obtaining FDA clearance is a critical milestone.”