|Mendor Smart device--Courtesy of Mendor|
A coalition of companies is participating in what is expected to be Europe's first clinical trial to be conducted remotely in full. The study is of a newly CE-marked blood glucose monitor from Finnish company Mendor. Sanofi ($SNY) is contributing to the trial as part of an effort to better understand it, including how to develop patient-centric trials, as well as how to assess efficacy and perceived value in them.
Dubbed VERKKO, the study will evaluate the Mendor Smart 3G wireless blood glucose monitor. It automatically transmits blood glucose data to the company's cloud software. The data are subject to preventative analytics to adjust the patient's future behavior.
"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," Mendor CEO Kristian Ranta said in a statement. "The blood glucose meter coaches the patient through the process, helping to generate reliable data."
Although Mendor recently secured a CE mark for this monitor, the company is conducting pilot studies to build the health economic and clinical impact data for the device.
"Smart connected devices and cloud-computing will revolutionize industries in the future; Mendor Smart is our first step in providing connected diabetes management service to our customers," Mendor Business Unit Manager Juhana Nurmio said in statement. "Such technology enables for example automated insulin titration support as well as automatic preemptive high-risk patient management for providers."
For the trial, eClinicalHealth is managing patient engagement and interaction with investigators through its Clinpal web-based platform; Langland is a communications agency that is handling the patient recruitment via social media and web banner campaign.
- here are releases on the VERKKO trial and on the CE mark