Abstract
BACKGROUND: Maintaining glucose in the target range, while avoiding hypoglycemia, is challenging in critically ill patients. We investigated the performance and safety of Medtronic Sentrino, a newly developed continuous glucose management (CGM) system for critically ill adults. METHODS: This was a prospective, single-center, single-arm, open-label study in adult patients with cardiac ICU admission. Sentrino subcutaneous glucose sensors were inserted into patients' thigh with planned study participation of 72 h. Sensor glucose results were displayed, and the system's alerts and alarms fully enabled. Reference blood glucose was collected from central venous catheter and analyzed with a blood gas analyzer. Treatment decisions were made independently of sensor glucose values, according to the existing standard of care. RESULTS: A total of 21 patients were enrolled; all successfully completed the study. Sensor glucose values were displayed 96% of the time, and 870 paired blood glucose-sensor glucose points were analyzed. Overall mean absolute relative difference (MARD) was 12.8% (95% CI 11.9% to 13.6%). No clinically significant differences in accuracy were seen within subgroups of hemodynamic status (MARD 12.3% and 13.1% for compromised vs stable hemodynamics). Consensus grid analysis showed >99% of sensor glucose values within A/B zones. No device or study-related adverse events were reported. 100% of clinicians found Sentrino easy to use after two patients. CONCLUSIONS: In our single-center experience, Sentrino CGM system demonstrated good accuracy and reliability, with no device-related adverse events in critically ill cardiac patients, and was easy to use and integrate in the cardiac ICU. TRIAL REGISTRATION NUMBER: NCT01763567.