Medidata Launches its First Clinical Trial

Medidata Solutions is sponsoring its first clinical trial, evaluating the impact of mobile and cloud-based technology on health outcomes among diabetics.

By providing patients with the tools they need to track behavioral factors such as weight and physical activity, the study will test whether technology can increase the rates of therapy adoption and drive better outcomes for diabetics. Medidata’s study will use mHealth devices that provide immediate feedback to participants and are wirelessly linked to targeted messaging for unique patient engagement.

The study is being conducted in collaboration with Medidata Technology Partner Spaulding Clinical Research, a West Bend, Wis.-based clinical research solution provider and medical device manufacturer that will connect mHealth devices supplied by Withings to the Medidata Clinical Cloud. Withings’ mHealth devices will monitor the physical activity and weight of study participants.

Endocrinologist Zachary T. Bloomgarden, M.D., clinical professor of Medicine, Endocrinology, Diabetes and Bone Disease at Mount Sinai Hospital in New York, N.Y., and co-editor of the Journal of Diabetes, is the study’s principal investigator. The initial feasibility stage of the study is slated to start in the fourth quarter of 2013 and will be followed by a randomized clinical trial.

“We are proud to sponsor our first clinical study in collaboration with Spaulding and Withings to see how disruptive technology can improve patient engagement and actually lead to better medical outcomes,” Medidata Solutions President Glen de Vries said. “The opportunity to see our technology used to improve patient health in the critical area of diabetes care is incredibly exciting.”

More than 20 million Americans suffer from some form of diabetes, and Medidata claims the number has nearly doubled in the past decade due to such factors as lack of physical activity and obesity. Through activity monitoring devices, uploaded data and targeted feedback, the Medidata-sponsored study will explore the potential of technology tools to improve overall levels of patient adherence to lifestyle changes. The feedback provided to patients will address exercise levels as well as diet and regular use of recommended medications.

“Wireless and personal mobile devices provide opportunities to improve patient engagement because of their ease of use, real-time transmission of data and increased portability and convenience. This collaboration is an important step in bringing these benefits to the real world,” Spaulding Clinical Research Founder/CEO Randy Spaulding said.

“One of the major challenges in diabetes management is working with patients to adopt lifestyle changes,” added Bloomgarden. “Most diabetics have to live with this chronic condition for a long time, so using personal devices and patient engagement apps to improve quality of life would be very powerful and a huge win for our clinical care models.”

Medidata Solutions provides cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and data analytics.The company is based in New York City.