US-based Carematrix has launched a blinded blood pressure monitor and scale designed to remotely monitor patients’ vitals in blinded clinical trials.
The blind remote data monitoring devices allow the study participants to take blood pressure and weight readings without viewing the data. The data is automatically sent to trial investigators who can review the data without associating it with a specific group or subject in double-blind studies.
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Blinding in clinical trials is the process where information that has the potential to influence study results is withheld from one or more parties involved in the study. This reduces potential biases and increases the robustness of the data obtained from the trial.
The use of remote monitoring in clinical trials has been steadily increasing in recent years. A report by GlobalData found that remote patient monitoring devices are expected to be worth $760m by 2030.
GlobalData is the parent company of the Clinical Trials Arena.
Carematrix notes that using a blinded blood pressure monitor or scale in clinical trials removes the risk of subjects altering their behaviour based on seeing specific results.
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By GlobalDataStudies have shown that patients can subconsciously change behaviours when self-monitoring, some trials have even shown this to be an effective intervention method for treating some disorders such as obesity. However, in most cases, self-monitoring and behavioural changes are not the intended outcome and can distort clinical trial data.
“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,” said John Varaklis, a strategy consultant at German consulting company Regenold.
“For clinicians, it’s important to limit the information they see so they do not interpret results that may favour one therapy over another or a particular group of patients.”
The remote monitoring equipment allows investigators to respond to health emergencies including drops in blood pressure, without breaking the blind. Additionally, the devices automatically collect and upload data, thereby reducing human errors and bias.
Carematrix’s portfolio also includes remote monitoring devices to measure blood glucose and blood pressure. Last month, the company launched a remote monitoring cellular weight scale. In addition to measuring body weight, the scale can measure weight asymmetry data on how weight is being distributed throughout the body.
