eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, is proud to announce the final results and success of the VERKKO remote online Phase IV clinical trial for diabetes.
VERKKO developed objectives in collaboration with Sanofi, Langland and Mendor, to study the use of a patient-centric online clinical trial platform integrated with Mendor’s 3G-enabled wireless blood glucose meter in a completely remote clinical trial setting.
Sixty patients participated in the study that had no site visits. Patients self-registered their interest in the Clinpal system, after which the coordinating study site reviewed their application. Patients who were selected reviewed electronic patient information before signing the informed consent form electronically. Study materials were delivered directly to patients who then connected the smart, wireless glucose meter with their personal Clinpal account. Actively guided by the Mendor Smart glucose meter, patients completed an innovative glucose profiling protocol. Their glucose measurements were automatically transmitted from the device into the Clinpal system where they were available for real-time review by the patients and the study site.
Various performance indicators were compared with those from a previous study that used a similar study protocol but with a more traditional site-based process.
The VERKKO results exceeded expectations in many areas:
Improvements observed in relation to the comparator study:
Sanofi R&D is contributing to the VERKKO study as part of its innovation program to develop patient-centric clinical trials, to assess the efficiency and perceived value from study participants.