Background and Aims

The “Eversense XL®” sensor is a subcutaneously inserted rtCGM system which lasts up to 180 days. Actual smartphones can be used as a data receiver sent by an on body transmitter with vibration alerts. As of today, it is only approved for use in adults.

Methods

Five children (6-12 years) and 10 adolescents (13-17 years) received the sensor subcutaneously. After a 30-day blinded period, the sensor was used regularly up to 180 days. Primary endpoint was superiority of Time Below Range (TBR) <70mg/dL after 90 days (assessed during 3 weeks before visit) compared to the first 30-day blinded period. Adverse events related to the device and procedure were captured.

Results

15 patients (7 male, 12 CSII/3 MDI, diabetes duration 5.5±3.4 years) completed the study. All adolescents and one child had the insertion in the upper arm, 3 children were inserted in the hip, and one was inserted on the belly. Two patients did not continue the study after primary endpoint at 90 days and 13 patients continued up to 180 days. Although visible skin atrophy (thinning) at the sensors tip (distant from insertion site) was visible in all patients after 180 days, no change in skin depth was measured. The atrophy resolved in all cases byt 14 days after removal.

Conclusions

The Eversense System appears safe in the pediatric population also. Skin changes were mild and rapidly reversible.

Due to the silicone-based adhesive and the possibility of removing the transmitter daily, Eversense can be an alternative for patients with severe reaction to adhesives.