A Diagnostics & Imaging Week
DexCom (San Diego) reported the completion of an 86-patient, 21-day trial in the U.S. with its Short-Term Continuous Glucose Monitoring System (STS) that evaluated performance over three consecutive seven-day periods.
Patients inserted the STS sensors themselves, wore them in their daily activities at home and work, and were allowed to view and use the real-time continuous glucose data from the STS System. The study demonstrated that the STS System functioned reliably over a seven-day period without a decline in sensor performance or any signs of infection at the insertion site.
The company said it intends to seek FDA approval for a seven-day STS sensor, in addition to the three-day STS system currently under review. DexCom expects the data from this study to be presented or published by the study investigators in the future.
"We have been able to leverage technology developed as part of our long-term implantable sensor program to the STS product platform and demonstrated with this latest study that our STS product functioned reliably for a seven-day period," said Andy Rasdal, president and CEO of DexCom. "While we continue to believe that our three-day STS system currently under review by the FDA could represent a significant breakthrough in the management of diabetes, we also believe a sensor that needs to be replaced only once per week would offer a new level of convenience in disease management to people with diabetes."
DexCom also reported that the company had its 100-day meeting with the FDA in regard to its premarket approval (PMA) application for the STS Continuous Glucose Monitoring System currently under review by the FDA. The FDA requested additional analysis and information to support its STS PMA filing. DexCom said it considers all of the requests made at the meeting to be readily answerable and expects to provide the requested information in an expeditious manner. The FDA did not request additional clinical studies.
"Since May, when our STS PMA was accepted as filed and granted expedited review status, we have had an interactive and timely review with the FDA," Rasdal said. "We believe the 100-day meeting was very productive and continued to further the common understanding between DexCom and the FDA regarding our STS PMA application and continuous glucose monitoring."