Integration of Devices in a Clinical Trial to Provide More Reliable Data for Evaluating Diabetes Treatment

PITTSBURGH — invivodata inc., a company dealing with patient reported outcomes (PRO) solutions for clinical research, announced the first integration of data from ACCU-CHEK® blood glucose meters from Roche Diagnostics with the DiaryPRO™ handheld patient diary from invivodata during a clinical trial. This advance was achieved using SyncPRO™, invivodata's integration module for improving the accuracy of all patient-reported measures in clinical trials.

In the trial, the SyncPRO solution will enable more than 300 people with type 2 diabetes to accurately and effortlessly transfer critical blood glucose data between Roche's ACCU-CHEK Aviva meter and invivodata's DiaryPRO device. By simply aligning infrared ports on the devices and following directions provided on the DiaryPRO screen, clinical trial participants will wirelessly transfer data from the meter to the DiaryPRO daily. The data are then uploaded to invivodata's back-end Web system, where researchers and clinical trial sponsors will immediately be able to view the data.

By utilizing SyncPRO, the trial's sponsor — a global pharmaceutical company — can expect a reduction in the number of errors typically found with traditional manual data-entry systems, resulting in more accurate and reliable data being delivered in a more timely way. As in most drug-development programs, these data are critical for determining the efficacy of new treatments for diabetes.

"We are thrilled to work with Roche Diagnostics and to deliver this much-needed integration module for this important critical trial," said Bob Young, senior vice president of sales and marketing at invivodata. "By integrating our proven technology with Roche's innovative diabetes management products, we are enabling clinical trial sponsors to conduct more efficient research and advance their development of effective treatments for the millions of people living with diabetes today."

invivodata has validated the ACCU-CHEK Aviva and ACCU-CHEK Active meters for use in this integration module, which is currently available in worldwide clinical trials that are conducted with oversight of an investigational review board or ethics board.

invivodata combines behavioral science, information technology and clinical expertise to capture electronic Patient Reported Outcome (ePRO) data in clinical research.

This article originally appeared in the March 2006 issue of HME Business.

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