More than half of participants — overweight adults with type 2 diabetes — lost weight over the course of the trial. Quantifiable, objective data, such as movement levels and sleep patterns in addition to patient-reported diary data entered via smartphones, was securely pulled into Medidata’s Clinical Cloud platform and integrated with other information.
“The successful completion of MOVE-2014 reinforces what we at Medidata have discovered through a number of recent initiatives: Mobile health solutions can be used to further clinical research in a reliable, secure and regulatory-compliant way,” Glen de Vries, president of Medidata, said in a statement. “Our goal was to show that mHealth tools can be incorporated into the highly structured world of clinical trials to unify in-life, direct-from-patient data with other information traditionally collected by researchers —providing a more holistic view of disease progression and patient response to therapy. We’re proud that our efforts are paving the way for life sciences companies to quickly adopt innovative technologies that have the potential to enhance data quality, trial efficiency and patient experiences.”
Participants received text message notifications about exercise, nutrition or updates from physicians, designed to keep them engaged throughout the course of the trial. Researchers also reported identify a number of data correlations based on the information collected, such as links between activity levels and pain, or behavior and weight loss.
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