Abstract
Abstract Background Efficient IBD symptomatic control, especially in severe patients, is still lacking while conventional management options agents carry risks for long-term side effects such as malignancy and infections. Only about 60% of IBD patients initially respond to conventional therapy thus, a growing number of IBD patients turn to use medical cannabis to relieve their symptoms. The large selection of cannabis varieties available in the markets, together with lack of evidence-based cannabis therapy guidelines, practically turns cannabis care to a self-medicating hit-or-miss treatment. Yet, despite its large therapeutic window, cannabis care still carries unknown risks of short-and long-term side effects and tolerance. SelfX is a novel cannabis-therapy management web platform, designed to monitor patients in various clinical conditions. It is a cloud-based decision-support physician tool, consisting of personal patient wearable monitoring device, mobile app and physician web portal. Methods SelfX capability to detect and alert of IBD patients in need of cannabis treatment protocol change consideration (including cessation of treatment), was examined in a proof of concept observational clinical study. Men and Women aged 18–65 (n = 26) with IBD who were already treated with cannabis prior to the study initiation, and held a valid cannabis license from the Israeli Ministry of Health, were recruited at Meir Medical Center in Israel and completed 6 weeks of remote monitoring. A designated statistical formula developed by our team for change-point detection was applied to alert of any negative clinical trends, including an increase in resting heart rate, decrease in sleep quality, increase in daily self-report IBD scoring system, adverse events and cannabis patterns use. Results The study achieved its primary objective to alert in real-time of detected change points which enabled an educated calibration of a personal adaptive alerts function. Study group post hoc analysis revealed significant and informative system performance: 60 objective negative trends alerts, and 27 subjective negative trends alerts were detected in real time. Conclusion Currently physicians require a practical tool to monitor short-and long-term safety and efficiency of cannabis use. Our work demonstrates the importance of continuous remote monitoring alongside laboratory routine measurements for IBD patients treated with cannabis. Future interventional studies will expand valuable monitored parameters scope range and will associate monitored data points with personal cannabis patterns use. SelfX platform offers a safety-net and an educated adaptive optimisation tool for continuous remote patients management in real time.
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