eClinicalHealth gains approval for Europe’s first fully remote diabetes trial
eClinicalHealth, a Stirling, Scotland-based technology and consulting company providing innovative clinical trial solutions, has announced the Ethical Committee approval of Verkko in Finland—Europe's first remote clinical study to include full electronic informed consent.
The primary objective of Verkko (developed in collaboration with Langland, Mendor and Sanofi) is to study Mendor's 3G-enabled wireless blood glucose meter with a glucose profiling technology (Mendor Smart) in patients with diabetes.
The secondary objective is to evaluate the feasibility and efficacy of patient engagement and patient-investigator interaction through Clinpal—eClinicalHealth's fully integrated web-based platform. Clinpal engages patients by supporting patient recruitment, performing electronic informed consent, facilitating online patient-site communication and capturing patient-reported outcomes and measurements.
The pioneering platform also allows study stakeholders to work together. Langland, a healthcare communications agency, has developed a social media and web banner campaign to drive potential participants to a Clinpal-supported web site. Then, once enrolled, Mendor's innovative blood glucose meter wirelessly transmits patient data to the platform.
"As well as being Europe's first remote clinical study to include full electronic informed consent, Verkko is the world's first trial to use our pioneering glucose monitoring and data analysis technology," said Kristian Ranta, Mendor's CEO. "The blood glucose meter coaches the patient through the process, helping to generate reliable data."
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 form study participants.