Design and Development of an eCOA Specific Solution for Capturing Patient Data in Diabetes Clinical Trials


Tue, Jun 16 9:00AM
T 14


Design and Development of an eCOA Specific Solution for Capturing Patient Data in Diabetes Clinical Trials

Abstract Summary

ORAL PRESENTATION SCHEDULED: Tuesday, June 16 in Session #1B at 11:49 - 11:54 am Location: Exhibit Hall Poster Area (Hall A Entrance)

Approximately 350 million worldwide have diabetes, with almost 19 million diagnosed diabetes patients in the United States alone. This number is believed to be far higher in reality as, as many as 7 million undiagnosed patients in the U.S.A. Those who are faced with living with diabetes must stick to a strict regime comprising of blood glucose measurement, carbohydrate tracking and insulin monitoring. This can be quiet burdensome for diabetes patients, particularly for those enrolled in clinical trials where there can be additional requirements that differ from a patients regular daily routine. One step toward improving data qualtiy is to move from traditional paper methods of data capture which among other things still requires someone to transcribe the data to an electronic data capture system. Although this is a move in the right direction and is one which regulators are keen to accept, there can still be issues around compliance, burden, and data quality. It is for these reasons that we decided to rethink how diabetes patients report data in clinical trials. our aim was to engage with patients in the design of a intuitive, burden free daily diary solution with blood glucose meter integration via Bluetooth that would allow for efficient data capture, increased compliance and decreased burden for patients. Patient focus groups and one on one interviews were used to asses each version of the proposed solution in an iterative manner until the final, most patient-centric version was created. We found that when faced with the task of recording patient data in diabetes, a well-designed and thoroughly tested electronic solution can reduce burden and increase patient satisfaction. This in turn improves compliance, data quality and overall study efficiency, while meeting the needs of all stakeholders. we also analysed the risk of handling and re-use of eDiaries previously used by patients doing fingerstick tests and found this poses a low and acceptable risk.

Poster Presenter

Paul O'Donohoe
Director, Health Outcomes,
CRF Health
United States