Results from the 90 adults with diabetes generated over 16,000 comparative glucose data points and demonstrated strong accuracy for the 90-day continuous wear period with a mean absolute relative difference (MARD) of 8.8% across the 40-400 mg/dL range when compared to YSI blood reference values.
According to the Principle Investigator, Dr. Mark Christiansen of Diablo Clinical Research, “The accuracy result is quite significant with the device. This was an important study and we are thankful to all the patients and clinics who participated. The early result shows that this system can be an important treatment option for our patients. Having a long lasting, 90-day CGM sensor that is safe and accurate will be a welcome addition to the diabetes community, as it will offer greater freedom of choice.”
The PRECISE II U.S. investigational device exemption trial enrolled 90 participants at eight clinical centers. The objective of the study was to determine the safety and effectiveness of the Eversense® CGM system over 90 days of continuous glucose sensor wear.
Participants in the study underwent unilateral (n=75) or bilateral sensor (n=15) insertions in the clinic and used the system’s smart transmitter and mobile app at home for the next 90 days. Sensor glucose readings were calculated prospectively. Calibration with a standard home blood glucose meter was performed twice a day but real-time glucose readings and trends were not made available to participants. Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.
“The promising results and compelling accuracy data shown in the PRECISE II study represent a major milestone for the company,” said Tim Goodnow, PhD., CEO and President of Senseonics. “We are quite excited to complete the full analysis and report on other outcomes in the coming months. Pending FDA review and approval, we look forward to bringing this exciting technology to the U.S. market and to people with diabetes.”
Senseonics expects to submit its Pre-Marketing Approval (PMA) package to the U.S. Food and Drug Administration in the next few months. Subject to receiving FDA regulatory approval, Senseonics plans to initiate sales in the United States. The company currently markets the system under the brand name Eversense in select European countries.
Eversense CGM System is an Investigational Device and is limited by United States law to investigational use.
A press release can be found from Senseonics website.
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