Senseonics has developed a new way to continuously monitor glucose levels around-the-clock, without the need for weekly sensor insertions or having to carry another receiving device.
Senseonics a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced topline results of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Clinical Investigation.
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.
Based on innovative fluorescence technology embedded within a tiny sensor, the Eversense CGM System measures glucose from interstitial fluid below the skin surface.
The sensor wirelessly sends glucose data to the smart transmitter worn on the upper arm over the sensor insertion site. The smart transmitter calculates the current glucose value along with the direction it’s headed, how fast, and whether glucose values are expected to exceed pre-set low and high targets. Data and alerts are simultaneously sent to the smartphone app that provides real-time tracking, intuitive displays to help identify patterns, and information to help stay in range.
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.”
Simple, 5-minute in-office insertion in the upper arm is performed by your doctor.
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.
No need for a separate receiver.
“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.
Features & Functions
Sensor that lasts up to 90 days — no weekly sensor insertion
Smart transmitter with on-body vibe alerts
Readings on mobile app — no separate receiver
Predictive alerts before reaching Low or High Glucose Alarm level
Glucose readings automatically sent to app every 5 minutes
Removable/rechargeable smart transmitter
No sensor wasted when smart transmitter is removed