Medidata Solutions, a provider of cloud-based solutions for clinical research in life sciences, is conducting its first clinical trial to assess the impact of mobile and cloud technology on patient engagement for improving health outcomes in diabetic patients, according to a company announcement.
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. Endocrinologist Zachary T. Bloomgarden, Clinical Professor of Medicine, Endocrinology, Diabetes and Bone Disease at Mount Sinai Hospital in New York and co-editor of the Journal of Diabetes, is the study's principal investigator.
Medidata's study will use mHealth devices from Withings, maker of smart devices and applications, that will monitor the physical activity and weight of study participants, providing immediate feedback to participants and providing targeted messaging through wireless links for patient engagement. In addition, Spaulding Clinical Research, a research solution provider and medical device manufacturer, will use its capabilities to enable the mHealth devices to connect to the Medidata Clinical Cloud.
"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," said Randy Spaulding, founder and CEO of Spaulding Clinical Research, in a written statement. "This collaboration is an important step in bringing these benefits to the real world."
In related news, U.K. researchers from the Universities of Newcastle and Northumbria have developed a prototype personal health monitoring system that uses medical sensors, mobile phones, and cloud computing to help people with Type 1 diabetes.
Earlier this month, the system was used to study the physiological performance of cyclists riding in the GSMA mHealth Grand Tour from Brussels to Barcelona, a live clinical study designed to raise awareness of diabetes and promote the delivery of mHealth solutions. The study looked at the effects of multi-day endurance exercise on blood glucose levels, using data captured and transmitted wirelessly, for elite and sub-elite athletes with Type 1 diabetes, as well as cyclists without diabetes.
"When someone with Type 1 diabetes becomes more physically active, they also become more insulin sensitive so their body responds more quickly--and this may disrupt their diabetes control," said Dr. Daniel West, senior lecturer in Exercise and Health Nutrition at Northumbria, in a written statement.
In June, healthcare technology company WellDoc launched the first FDA-cleared mobile prescription therapy for Type 2 diabetes with insurance reimbursement. Called BlueStar, the patient-centered medical product requires a prescription from a licensed healthcare provider and will be "reimbursed and adjudicated" as a pharmacy benefit similar to other prescription products.
To learn more:
- read the announcement