Carematix Launches the World's First Connected Blinded Blood Pressure Monitor and Scale for Clinical Trials

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Sep 18, 2024, 08:42 ET

CHICAGO, Sept. 18, 2024 /PRNewswire/ -- Carematix, a leading innovator in remote patient monitoring (RPM) healthcare technology announced the launch of the world's first connected blinded blood pressure monitor and scale specifically designed for use in blinded clinical trials. This innovative solution addresses the unique challenges of clinical research by ensuring data integrity, enabling early intervention, and preserving blinding for both the trial participants and the investigators.

Blinded clinical trials are the backbone of medical innovation, but they often face challenges related to bias, data accuracy, and patient safety. The launch of Carematix's blinded blood pressure monitor and scale mitigate these challenges by offering tools that seamlessly integrate into the trial process without compromising blinding. Benefits include:

Blind Data Monitoring: These devices allow for blind data monitoring, where subjects can take readings but not see them. For double blind studies, even the researchers conducting the trial can review the data without knowing the specific treatment groups or subject. This setup helps in maintaining the integrity of interim analyses and avoids the introduction of bias during the trial.
Customizable Blinding for Chronotherapy Studies: The ability to toggle the blinding feature on and off for specific parts of a clinical study is crucial, particularly in chronotherapy research where the timing of medication administration is essential. This flexibility allows for precise, granular measurements while maintaining blinding when necessary.
Improves Patient Safety and Dosage Decisions: By using a blinded blood pressure monitor or scale in clinical trials, the risk of subjects altering their behavior based on seeing specific results is removed. This prevents patients from self-adjusting their medication, such as taking an additional dose if they see low readings or discontinuing a dose due to high readings.
Rapid Intervention Capabilities: The real-time monitoring and data transmission features allow investigators to act swiftly in response to critical health indicators, such as drops in blood pressure, without breaking the blind. This is particularly important for ensuring patient safety in trials involving vulnerable populations or high-risk treatments.
Maintaining Data Integrity and Regulatory Confidence: The devices automatically collect and transmit data, reducing the potential for human error or bias. This is essential for preserving the validity of the trial outcomes and ensuring that regulatory standards are met, potentially facilitating a smoother approval process for new treatments or interventions.

"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, Strategy Consultant at Regenold. "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. In the past, this has been extremely challenging to prevent. Carematix's blinded blood pressure monitor and scale for clinical trial use help ensure effectiveness of a particular therapy by providing more credible, objective, and quantifiable data."

"Our new blinded blood pressure monitor and scale represent a groundbreaking innovation that clinical trials have never had access to before," said Sukhwant Khanuja, CEO of Carematix. "With real-time, automated data collection that preserves treatment blinding, we're not just raising the bar—we're redefining the standards of accuracy and efficacy in clinical research."

Carematix continues to strategically evaluate use cases and is in the process of developing additional endpoint products with unique Carematix device capabilities. For more information or to schedule a demo, please visit www.carematix.com.

About Carematix
Carematix is at the forefront of remote patient monitoring (RPM) solutions, committed to enhancing patient care through innovative and cost-effective telehealth technologies. We specialize in a comprehensive range of wireless monitoring devices, including weight scales, pulse oximeters, glucometers, peak flow meters, and blood pressure monitors. Our mission is to seamlessly integrate cutting-edge technology into everyday healthcare practices, improving the management of chronic conditions and overall wellness. Serving home care settings, community health clinics, hospitals, physician groups, health plans, and pharmaceutical research, Carematix is dedicated to transforming how patients and healthcare providers interact, ensuring better health outcomes and streamlined health management.

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SOURCE Carematix Inc