Carematrix, a US-based company, has introduced a blinded blood pressure monitor and scale designed for remote monitoring of patients in blinded clinical trials. This technology aims to mitigate biases and enhance the robustness of clinical trial data by preventing participants from seeing their vital signs readings.
The blinded remote data monitoring devices enable study participants to take blood pressure and weight readings without accessing the data. The information is automatically transmitted to trial investigators, who can review it without associating it with specific groups or subjects in double-blind studies. According to Carematrix, this approach reduces the risk of subjects altering their behavior based on the readings they see.
The Importance of Blinding in Clinical Trials
Blinding is a critical process in clinical trials where information that could influence study results is withheld from one or more parties involved. This minimizes potential biases and strengthens the reliability of the data. Studies have indicated that patients can subconsciously change their behaviors when self-monitoring, which can distort clinical trial data if self-monitoring and behavioral changes are not the intended outcome.
John Varaklis, a strategy consultant at Regenold, emphasized the importance of limiting information available to both patients and clinicians. "When patients have the ability to read their own data results, they can sometimes skew data, or their reading may become higher or lower due to anxiety around seeing the results," he stated. "For clinicians, it’s important to limit the information they see so they do not interpret results that may favor one therapy over another or a particular group of patients."
Remote Monitoring and its Growing Role
The use of remote monitoring in clinical trials has been steadily increasing. A report by GlobalData projects that the remote patient monitoring device market will reach $760 million by 2030. Carematrix's remote monitoring equipment allows investigators to respond to health emergencies, such as significant drops in blood pressure, without compromising the blind. The devices also automatically collect and upload data, reducing human errors and bias.
Carematrix's portfolio includes other remote monitoring devices for measuring blood glucose and blood pressure. The company recently launched a remote monitoring cellular weight scale that measures body weight and weight asymmetry data, providing a comprehensive approach to remote patient monitoring.
