First remote diabetes trial approved in Europe
Europe's first remote clinical study to include full electronic informed consent has been granted Ethical Committee approval in Finland.
The innovative VERKKO trial has been developed by eClinicalHealth in collaboration with Langland, Mendor and Sanofi to study Mendor's 3G-enabled wireless blood glucose meter with glucose profiling technology Mendor Smart in patients with diabetes.
The trial will also evaluate the feasibility and efficacy of patient engagement and patient-investigator interaction through Clinpal – eClinicalHealth's integrated web-based platform. Clinpal is designed to support patient recruitment, conduct electronic informed consent, facilitate online patient-site communication and capture patient-reported outcomes and measurements.
The pioneering platform allows the study stakeholders to work together seamlessly. In this case, Langland has developed a social media and web banner campaign to drive potential participants to a Clinpal-supported website. Then, once enrolled, Mendor's 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 programme to develop patient-centric clinical trials, to assess the efficiency and perceived value for study participants.
Headquartered in Scotland, eClinicalHealth was founded in early 2012.
Link
