FDA Clears New Tool for Patients with Type 2 Diabetes

Posted in Mobile Health by MarieThibault on December 14, 2016

FDA has given patients with Type 2 diabetes a new management option by clearing the integration of a blood glucose monitoring system and a diabetes management platform. The integration is the result of a partnership between WellDoc and Johnson & Johnson's LifeScan.

Marie Thibault

FDA has just cleared the product of a partnership between a mobile health company and a veteran medical device company. The two companies partnered to integrate a blood glucose monitoring system with digital diabetes management technology to give patients with Type 2 diabetes a new tool for managing the disease.

The partnership between LifeScan, Inc., a Johnson & Johnson Diabetes Care Company, and mHealth company WellDoc, Inc. resulted in the integration of LifeScan’s OneTouch Verio Flex blood glucose monitoring system with WellDoc’s BlueStar platform. That integrated product has now been cleared by FDA.

Patients with Type 2 diabetes can have their data from the OneTouch Verio Flex blood glucose monitoring system sent to the BlueStar platform in order to receive feedback and coaching that aligns with their treatment regimen via the WellDoc technology, according to a company press release. This integrated tool is in addition to the OneTouch Reveal web and mobile app.

According to the release, the two companies are focusing on giving patients with Type 2 diabetes access to the integrate platform through health insurance plans.

“Our partnership with WellDoc highlights our sustained commitment in helping to drive better health outcomes by building a more connected patient experience. Integrating digital solutions such as OneTouch Reveal mobile app and BlueStar will help patients self-manage their diabetes and create value for health care providers,” Valerie Asbury, worldwide president of LifeScan, said in the release.

WellDoc and LifeScan announced this specific partnership in September 2016, with the intention of integrating their technologies to “create a comprehensive, data-driven, and payer-reimbursed program for Type 2 diabetes management.” The relationship between the two companies began in March 2016, when WellDoc and LifeScan announced a strategic collaboration and Johnson & Johnson Innovation-JJDC, Inc. invested in WellDoc as part of a $29.5 million Series B financing round.

WellDoc CEO Kevin McRaith said in a September press release, “Together, WellDoc and LifeScan will provide those living with Type 2 diabetes a best-in-class diabetes management solution with robus data analytics powered by BlueStar’s patented clinical and behavioral engine. We will facilitate national adoption of this innovative first-in-class digital health solution.”

Don't miss MD&M West in Anaheim, February 7-9, 2017.

Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @MedTechMarie.

[Image courtesy of PR NEWSWIRE]