Europe’s First Fully Remote Diabetes Trial Approved
STIRLING, Scotland 10th February, 2015
eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, is proud to announce 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
- Capturing patient-reported outcomes and measurements
The pioneering platform also allows study stakeholders to work together seamlessly. For example, Langland, a healthcare communications agency, has developed a vibrant social media and web banner campaign that will drive potential participants to a Clinpal-supported website. 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 & data analysis technology,” says 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.