Eversense XL: the FDA approved the 90-day version of the implantable CGM Sensor; recently received CE Mark for 180-day duration in adults.
An implantable continuous glucose monitoring (CGM) system (Eversense® XL, Senseonics, Maryland U.S.A) recently received CE Mark for 180-day duration in adults, and the FDA approved the 90-day implantable sensor. The current study is the first investigation of the performance of the Eversense XL through 180 days in a primarily adolescent population with type I diabetes (T1D).
When adolescents and adults with type 1 diabetes (T1D) used a new continuous glucose monitoring (CGM) device containing a sensor that can remain implanted in the arm for up to 180 days, the system provided accurate glucose measurement with no major side effects, according to the study, “First Assessment of the Performance of an Implantable CGM System through 180 Days in a Primarily Adolescent Population with Type 1 Diabetes,” presented at the ADA’s 78th Scientific Sessions in Orlando.
Continuous glucose monitoring allows people with T1D to constantly measure whether their glucose levels are going up or down, and the rate at which the changes are occurring. Current CGM devices require re-insertion of the monitoring sensor every one or two weeks using a procedure that can be uncomfortable or painful. The Eversense® XL CGM system uses a fully implantable sensor that resides under the skin for up to six months in the subcutaneous tissue layer of the upper arm. The system also incorporates a lightweight, water-resistant transmitter, which is worn on the skin over the sensor and facilitates the glucose reading calculations that are displayed via a mobile app on iOS and Android devices and can also be displayed on an Apple Watch. The transmitter can be removed and put back in place over the sensor at the discretion of the user, and it provides an “on-body” vibratory alert for low- and high-glucose values.
Two previous studies have shown the Eversense technology to be safe and effective, including a six-month European trial published in 2017 (PRECISE) and a three-month American study published earlier this year (PRECISE II). Both studies showed that the device maintained accuracy. The current study is the first to investigate the safety and efficacy of the Eversense XL CGM for 180 days in a primarily adolescent population with T1D.
The study was conducted in Canada and enrolled 36 patients—30 adolescents (average age 14 years) and six adults (average age 32 years)—with T1D. Most of the participants (64 percent) had previously used a CGM device. For insulin delivery, 32 of the 36 patients used an insulin pump, while four used multiple daily insulin injections. Study participants had a sensor implanted in the upper arm during a simple, in-office procedure in the diabetes clinic. The adults were inserted with two sensors and adolescents were inserted with one sensor. Participants were then evaluated each month with a full-day clinic visit during which multiple blood samples were drawn to measure glucose levels and to check the accuracy of the CGM device.
To compare the glucose level results from the blood samples with the data from the Eversense XL CGM device, accuracy assessments were measured through a technique that involves mapping paired-results on an error grid and evaluating the zones of the grid that deviate from the center. Results indicated that all pairs fell in the ‘ideal’ zones of A & B. There were no serious adverse events related to insertion or removal procedures, or due to the device. Researchers concluded that the system is accurate and safe for adolescents through a 180-day timeframe.
The stability of the life span of the sensor showed no significant decline in accuracy for the 180 days. Additionally, given the pediatric population that was being studied, the rapidity with which CGM use became an integral part of their family life was impressive. These teens were athletic for the most part, and were particularly appreciative that both the implanted sensor and the wearable transmitter weren’t affected by their athletic gear. The adolescents’ parents expressed their own appreciation at their new ability to be more aware of their children’s glucose levels. Use of a continuous glucose sensor can have significant implications for a patient’s ability to provide optimal self-care, and awareness of their glucose trends allows patients to adjust their insulin delivery, whether by injections or pump, to better match the child’s actual needs.
From the results it was concluded that the Eversense XL CGM system is safe and accurate through 180 days of Sensor wear in a primarily adolescent population. The 90-day CGM will be available to the public sometime in August
- The study showed that the sensor is safe and accurate over 180 days.
- The FDA approved the Eversense XL CGM system as safe and accurate for 90 days.
- Two previous studies have shown the Eversense technology to be safe and effective, including a six-month European trial published in 2017.
American Diabetes Association 78th Scientific Sessions