ePRO Solutions for Diabetes Clinical Trials

2012-11-01-ScreenShot20121101at4.46.00PMApproximately 347 million people worldwide suffer from diabetes, 55.5 million in Europe alone. The increase in Type II diabetes patients stems from aging populations and dietary habits leading to obesity. More patients are being screened for and being diagnosed with diabetes since long term health complication include heart disease, kidney failure and neuropathy complications. Therefore, diabetes clinical trials have increased and the diabetes drug market has become quit desirable for some of the world’s leading pharmaceutical companies. Arithmos discusses ePRO solutions for diabetes trials.

How can clinical trial technology, more specifically ePRO, be beneficial for diabetes clinical trials?

There are numerous benefits for conducting trials using ePRO as opposed to paper due to patient compliance, immediate feedback and higher data quality. However, there are additional benefits for diabetes clinical trials included real time data access to blood glucose readings from glucometers,  real time access to episodic eDiary entries, and increased patient compliance with intuitive devices such as smartphones and tablets.

The use of ePRO for diabetes trials has been on the rise in the past decade as trials have increased to improve health outcomes measures and health status among diabetes patients. ePRO devices are used for QoL questionnaires. Clinical research is being driven by a search for minimally or non-invasive products for testing blood glucose levels rather than pricking the skin. Pharmaceutical companies are also looking for more cost-effective solutions. The FDA estimates that most clinical trials get delayed by up to one month, and it is estimated that for each day a trial is delayed it costs the Sponsor $8 million USD.

ePRO solutions for data collection can increase patient compliance, increase the speed with which data is collected and analyze data in real time.

There are a few noteworthy EDC/ePRO integration solutions that would specifically benefit diabetes clinical trials. Integrating an intuitive ePRO device with a glucose meter can electronically capture and deliver blood glucose levels for analysis. Two intuitive devices are the Apple iPad/iPhone and the Blackberry.

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With the iPhone/iPad patients are identified with a user ID and password. Data is securely transferred and does not remain on the device. Communication is encrypted and data protection is ensured.

The Blackberry Torch or Curve can be used to collect data or diary/questionnaire information. Patients are identified with a 7 digit pin number which can demonstrate evidence of patient compliance. Like the iPhone/iPad, data is transferred securely and communication is encrypted.

Arithmos has extensive experience in ePRO/EDC integration and has conducted previous studies using the iPad (for QoL questionnaires) and the Blackberry for data collection.

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