Background: An implantable continuous glucose monitoring (CGM) system (Eversense® XL, Senseonics, Maryland U.S.A) recently received CE Mark for 180-day duration in adults. 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).
Methods: This study was a prospective, single-center, single-arm, 180-day evaluation of the effectiveness and safety of the implantable CGM system among Canadian adolescent and adult participants with T1D. Effectiveness measures included mean absolute relative difference (MARD), system agreement with Yellow Springs Instrument (YSI) glucose values, and Clarke Error Grid analysis using paired CGM and reference YSI glucose analyzer values. Adult participants were inserted with two sensors and adolescent participants were inserted with one sensor in the upper arm. CGM system accuracy studies were performed every 30 days. The safety assessment included the incidence of insertion or removal procedure-related and device-related serious adverse events (SAEs) through 180 days post-insertion.
Results: Thirty-Six participants (30 adolescent/6 adult, 13 female/23 male, mean age 17±9.2 years, mean BMI 22±4 kg/m2) received the CGM system. One subject withdrew at Day 1 due to intravenous access issues. CGM system agreement with YSI glucose within 15 mg/dL or 15% of YSI glucose values (N = 7163) through 60, 120 and 180 days was 82.9% (95% CI: 78.4%-86.1%), 83.6% (95% CI: 80.4%-85.7%) and 83.4% (95% CI: 79.7%-85.5%), respectively. Overall MARD was 9.4% (95% CI: 8.6%-10.5%). Clarke Error Grid analysis showed 99% of paired values in clinically acceptable error zones A and B. No insertion/removal or device-related SAEs were reported.
Conclusions: The Eversense XL CGM system is safe and accurate through 180 days of Sensor wear in a primarily adolescent population.
R. Aronson: Other Relationship; Self; Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Sanofi, AstraZeneca. Research Support; Self; Eli Lilly and Company, Becton, Dickinson and Company, Merck & Co., Inc., Senseonics, Boehringer Ingelheim Pharmaceuticals, Inc. R. Rastogi: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. X. Chen: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics.