DexCom, Inc. of San Diego California has announced the completion of two clinical and regulatory milestone studies of an 86-patient, 21-day trial in the United States with its Short-Term Continuous Glucose Monitoring System (STS) that evaluated performance over 3 consecutive 7-day periods. Patients inserted the STS sensors themselves, wore them in their daily activities at home and work, and were allowed to view and utilize the real-time continuous glucose data from the STS System.
The study demonstrated that the STS System functioned reliably over a 7-day period without a decline in sensor performance or any signs of infection at the insertion site. Although the specific regulatory path and timing are not yet determined, the company intends to seek U.S. Food and Drug Administration (FDA) approval for a 7-day STS sensor, in addition to the 3-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.
“Since we filed our PMA [premarket approval application] for the 3-day STS Continuous Glucose Monitoring System in March, we have continued to further develop the product platform and underlying technology,” said Andy Rasdal, president and CEO of DexCom. “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 7-day period. While we continue to believe that our 3-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 announced that the company had its 100-day meeting with the FDA in regard to its PMA application for the STS Continuous Glucose Monitoring System currently under review by the FDA. The 100-day meeting is a regulatory meeting where the FDA reviews the status of the PMA application with the company and typically makes requests for additional information. At this 100-day meeting, the FDA made requests of DexCom for additional analysis and information to support its STS PMA filing. In accordance with normal FDA procedures, the FDA will be outlining these requests in writing in what is called a major deficiency letter. DexCom 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 make any request for DexCom to conduct 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,” said Rasdal. “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.”