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CRF Health receives FDA clearance for next-gen wireless glucometer

Melissa Fassbender

By Melissa Fassbender

19-Jan-2017
Last updated on 19-Jan-2017 at 19:22 GMT2017-01-19T19:22:20Z

(Image: iStock/bandit2523)
(Image: iStock/bandit2523)

The next-generation wireless glucometer provides rapid testing results on the company’s eCOA platform for clinical trials.

The Entra BLE Smart™ wireless glucose meter is the latest in the company’s range of wireless glucose monitoring systems, and uses low-energy Bluetooth® technology to extend battery life and enhance connectivity.

We believe that the best quality patient reported outcomes data comes from participants who are highly engaged and motivated – but oftentimes the sheer quantity and frequency of data collection required in clinical trials, particularly in diabetes, can be overwhelming for the trial participant, adding burden,” Richard C. Strobridge, VP, Healthcare at CRF Health, told us.

 
The Entra BLE Smart wireless glucose meter (Image: CRF Health)

The Entra BLE Smart wireless glucose meter (Image: CRF Health)

According to Strobridge, the introduction of wireless glucometers into clinical trials has benefited diabetics, as it allowed seamless and accurate transfer of blood glucose readings directly into the patients’ eDiary. “It was fast and highly efficient, however, classic Bluetooth is also renowned for its high power consumption,” he added.

Today, with Bluetooth Low Energy (BLE), Strobridge said the Entra Smart BLE™ takes the advancements the company has made in the field of diabetes clinical trials one step further, by extending battery life and delivering more reliable connectivity and greater compatibility with modern smartphones and personal computers.

The device is integrated with CRF Health’s TrialMax® eCOA platform for clinical trials, or MyHealthPoint®, the company’s online data collection portal.

When trial participants have to worry less about changing batteries, it makes the entire clinical trial experience better in the long term, and that means happier patients who are more likely to correctly follow the protocol, submit regular meter readings and continue with the trial until its completion,” Strobridge explained.  

Focusing on patient centricity

The interest in integrating more wearables, wireless medical devices, and even implantables into clinical studies has been gaining interest within the clinical research community as of late.

For Strobridge and CRF Health, the opportunity to wirelessly collect regular biometric data allows “deeper exploration into the effect of new treatments on a patient’s quality of life.”

Entra Health is a pioneer in remote patient monitoring using wireless medical devices, and with their expertise and highly developed technology platform we will be bringing seamless device connectivity to our award-winning TrialMax® platform, so that pharmaceutical sponsors and CROs will be able to leverage a single, fully integrated platform to collect electronic informed consent, clinical outcome assessments, and robust biometric data,” he added.

Altogether this enables more continuous connectivity to trial participants, giving them peace of mind that they are being looked after throughout the duration of the trial while creating a more transparent clinical trial experience that engages and motivates them.” 

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