Final results of a remote online Phase IV clinical trial for diabetes proved successful, according to eClinicalHealth Limited, a technology and consulting company.
The objectives of VERKKO, developed in collaboration with Sanofi, Langland and Mendor, were 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 — all recruited through Facebook — 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 a 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.
Among the key points noted:
- Seventy-four individuals registered interest, 60 of whom were enrolled in the study, an 81 percent conversion ratio
- The average age of patients was 56 years old; several participants were 70 years and older
- Patient satisfaction in study participation was very positive with a score of 4.52 out of 5, based on a survey done at the end of the trial
- Patient responses provided suggestions for improvements in future studies
- Fifty-one patients received their Mendor Smart meters and started the profiling protocol, with 46 completing the profiling process, a 9 percent drop-out rate, which was the same as in the comparator study
- Compliance improved 18 percent with the remote trial, meaning that patients required fewer total readings to complete the profiling protocol
- Patients completed the glucose profiling 22 percent faster, signifying that patients can complete the studies more quickly
- The study site estimated having spent 66 percent less time in study coordination activities, with the study managed between a single investigator and a study nurse
The approach used in VERKKO is suited especially for late-phase trials that often involve large patient populations and require a more efficient approach. However, online patient recruitment and engagement can benefit studies of any phase.
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.
eClinicalHealth Limited, founded in 2012 and headquartered in Scotland, developed the Clinpal patient engagement platform.
